bioihbjkbjnl/mcl2 huggingface dataset:
Combined Chromoendoscopy and Water Method for Screening Colonoscopy
Condition: Colon Polyp
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a
      dilute solution of Indigocarmine (IC) delivered by the water method (study method) will
      improve adenoma detection rate compared with the water method with plain water alone (control
      method).
    

Detailed description: 
      Background: Warm water infusion in lieu of air insufflation (water method) improves overall
      success of screening colonoscopy and our retrospective data indicate a higher adenoma
      detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted
      staining or pancolonic chromoendoscopy have been described.

      Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a
      dilute solution of Indigocarmine (IC) delivered by the water method (study method) will
      improve adenoma detection rate compared with the water method with plain water alone (control
      method).

      Methods: After informed consent patients undergoing screening colonoscopy will be randomized
      to be examined by the study or control method. Study method will employ a 0.008% IC solution.
      Control method will employ plain water. The water method in both study and control groups
      will be applied as previously described. The colonoscopy will be performed under sedation.
      Primary outcome measure: adenoma detection rate; secondary outcome: relevant
      procedure-related variables.
    

Intervention name(s): Water method and chromoendoscopy; Water method
Intervention type(s): Procedure; Procedure
Intervention description(s): Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy; Control method will use plain water with water method for screening colonoscopy
Other intervention name(s): Water method; Chromoendoscopy; Screening colonoscopy; Screening colonoscopy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: screening colonoscopy; adenoma; water method
Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate safety,
      tolerability and pharmacokinetic (the exposure of the trial drug in the body) and
      pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin
      degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM),
      both explorative formulations, not similar to the proposed commercial formulation, in healthy
      male Japanese subjects.
    


Intervention name(s): insulin degludec; placebo; insulin degludec/insulin aspart 50
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose administered subcutaneously (s.c., under the skin).; Administered subcutaneously (s.c., under the skin); Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety
      parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator
      use in premenopausal and postmenopausal women.
    

Detailed description: 
      Premenopausal women: Baseline blood and genital samples will be taken in the follicular and
      luteal phase (visits 2 and 3). The participant will be given TFV gel and instructed to insert
      two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion
      for blood and genital samples (visits 4/4a and 5/5a).

      Postmenopausal women: Premenopausal women: Baseline blood and genital samples will be taken
      (visit 2). The participant will be given TFV gel and instructed to insert two doses,
      separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood
      and genital samples (visit 3/3a). Estradiol cream will be distributed at visit 4. Post
      estradiol blood and genital samples will be taken at Visit 5. The participant will given TFV
      gel and instructed to insert 2 doses as before, while continuing to use the estradiol cream.
      Post TFV gel and estradiol cream blood and genital samples will be taken (visit 6/6a).
    

Intervention name(s): TFV 1% gel; Estradiol vaginal cream
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Condition: Chronic Heart Failure With Reduced Systolic Function
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
      with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and
      quality of life in patients with chronic heart failure with reduced systolic function.
    

Detailed description: 
      A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of
      once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and
      NTproBNP), symptoms, health status, and quality of life in patients with chronic heart
      failure with reduced systolic function.
    

Intervention name(s): Dapagliflozin; Dapagliflozin matching placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Farxiga; Placebo
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; dapagliflozin; Sodium-glucose co-transporter-2 (SGLT-2) inhibitors
Outcome After Laparoscopic Surgery for Peptic Ulcer Perforation
Condition: Intraabdominal Abscess After Procedure; Leakage; Pneumonia; Operation Wound; Infection
MeSH terms: Abscess; Abdominal Abscess; Wound Infection; Surgical Wound Infection; Peptic Ulcer; Peptic Ulcer Perforation
Study type: Observational

Summary: 
      Despite advances in laparoscopic surgery for perforated peptic ulcer (PPU), intra-abdominal
      abscess (IAA) is recognized as one of the commonly reported complications with relation to
      the extent of infectious abdominal contamination. Herein, the investigators report their
      experience of laparoscopic surgery for PPU with/without peritoneal irrigation and discuss
      postoperative outcome. The investigators retrospectively examined the electronic medical
      records of the patients who underwent laparoscopic surgery for perforated peptic ulcer at a
      single medical center in Taiwan between January 2013 and August 2021. Retrospectively, the
      investigators would include those patients with clinical diagnosis of PPU who underwent
      emergent laparoscopic surgery. The patients with previous abdominal surgery, pathologic
      confirmed malignant ulcer perforation or concomitant ulcer bleeding were excluded. The
      investigators focused on post-operative complications and outcome after laparoscopic surgery
      with or without peritoneal irrigation. This information can be important in improving
      surgical options with respect to risk and potential benefits in this setting.
    


Intervention name(s): Peritoneal irrigation; Suction only
Intervention type(s): Procedure; Procedure
Intervention description(s): For patients allocated to the irrigation group, peritoneal lavage was performed at the surgeon's discretion based on surgical findings and preference.; In the suction only group, one surgical gauze each was placed in the splenophrenic space and Morison's pouch to soak up any remaining purulent fluid followed by turning the patient into the Trendelenburg position for inspection of the lower abdominal cavity. Any interloop adhesions were carefully divided and the gauze-wiping maneuver was used to soak up the residual peritoneal fluid, and all bowel loops were investigated to the root of the mesentery.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From October 2012 to February 2021, 688 patients presented to the emergency room with a
        clinical diagnosis of PPU underwent surgery in our hospital. Five hundred and ninety-seven
        patients were operated in an open approach including 21 patients who were given
        laparoscopic surgery initially but then intraoperatively converted to laparotomy because
        the large perforation site cannot be primarily repaired, or the perforation site was
        difficult to identified or approached. The remaining 91 patients who underwent laparoscopic
        repair were included in this study.
      
Keywords: Laparoscopic surgery; Perforated peptic ulcer; Peritoneal irrigation; Gauze wiping and suction; Intra-abdominal abscess
Effects of Repeat Dosing of GSK1521498
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall purpose of this study is to see whether the drug is safe and well tolerated when
      given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of
      people will be given the drug at variable strengths. The blood levels of the drug will be
      measured and the effects on mood and cognition (the mental processes involved in awareness,
      learning and judgement) will be assesed.
    

Detailed description: 
      This study is to test a new drug which may be used for treating eating behaviour and patterns
      that some overweight and obese patients find difficult to control. The drug works by
      inhibiting the effects of messenger molecules called opioids, e.g. endorphins. These opioids
      are naturally produced within the human body and control hunger, thirst, and the pleasurable
      feelings we relate to eating food. The drug attaches to opioid binding sites in the brain,
      known as mu-opioid receptors; this blocks the natural effect of opioids which may reduce the
      craving to eat fatty or sugary foods. Single doses of the drug have been given to humans and
      showed it was safe. Now the drug will be given every day for 10 days to check that the drug
      is safe and tolerated when given repeatedly. The study is in two parts:

      Part A: people will receive a sleeping tablet to make them sleepy (or a dummy drug) and will
      complete some questionnaires and simple tests including computer exercises to test the effect
      of this tablet on mood and cognition. This information will be used to help judge what is
      happening in Part B.

      Part B: requires staying in the unit for 10 days to receive a tablet every day and complete
      questionnaires and other tests to check for any mood and cognitive changes. Various other
      assessments will include effects on eating behaviour, pain measures and changes in body
      composition (content of fat, muscle and water).
    

Intervention name(s): Zolpidem or placebo - Hypnotic drug given for sleep disorders; GSK1521498 or placebo
Intervention type(s): Drug; Drug
Intervention description(s): The information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B.; The first group will start at a low dose (10 mg GSK1521498 or placebo) for 10 days. The study team will then assess the data gathered from the first cohort and will select the dose that the next cohort will receive for 10 days. There will be up to 4 cohorts.
Intervention MeSH terms: Zolpidem; Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Safety and tolerability; Repeat dose; Personality traits; Fat mass; Healthy volunteers
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether therapy with the combination of PSI-7977 and
      daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus
      (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response
      with undetectable HCV RNA 12 weeks post treatment
    


Intervention name(s): PSI-7977; Daclatasvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, oral, 400 mg, once daily; Tablets, oral, 60 mg, once daily; Tablets, oral, 200 mg
Other intervention name(s): BMS-790052; Copegus ®
Intervention MeSH terms: Ribavirin; Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of CLR3001 in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms
      relatively quickly in adult patients with major depressive disorder (MDD).
    

Detailed description: 
      CLR3001 is thought to work by helping the body's natural responses overcome depression.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg
      and Viread 300mg after a single oral dose in healthy male volunteers.
    


Intervention name(s): Viread 300mg; DA-2802 319mg
Intervention type(s): Drug; Drug
Intervention description(s): single dose administration after 10hr fasting; single dose administration after 10hr fasting
Other intervention name(s): Tenofovir disoproxil fumarate; Tenofovir disoproxil orotate
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B
Secured Internet-mediated Psychotherapy With Psychiatry Patients
Condition: Psychiatric Disorders
MeSH terms: Mental Disorders; Problem Behavior
Study type: Observational

Summary: 
      This is the second phase (Phase B) of the main project "Bank for Thoughts", which has the
      following aims:

        1. Improvement of software for secured (encrypted and access-controlled) asynchronous
           text-based communication within health services. (Adjustments for use in psychiatry.)

        2. Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient
           child and adolescent psychiatry.

        3. Development of indications and precautions for text-based Internet-mediated
           psychotherapy.
    

Detailed description: 
      This phase (Phase B) concentrates on qualitative evaluation of open clinical single case
      trials using asynchronous Internet-mediated text-dialogue for psychotherapeutic purposes.

      Single patients in differing treatment phases, conditions, age and sex categories are
      interviewed after using Internet-contact as a supplementary tool in psychotherapy. Their
      therapists are interviewed as well.

      The purpose is systematically gathering single-case experiences with the tool, to build a
      hypothesis for research and preliminary guidelines for experimental clinical use of
      Internet-mediated psychotherapy.
    

Intervention name(s): eTherapy
Intervention type(s): Device
Intervention description(s): secured e-mail system between patient and therapist
Other intervention name(s): Treatment as usual
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Clients in CAMH services
      
Keywords: eTherapy supplementary
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
Condition: Pediatric Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension
      in children with left to right shunt.

      analyze the efficacy and side effects.
    

Detailed description: 
      Eligibility criteria:

      Inclusion:

        1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.

        2. free from chronic pulmonary disease

        3. never performed any cardiac surgical

        4. never got any treatment for PH

        5. agree to enroll in this study. Exclusion

      1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon
      therapy.

      Outcome measure:

      Pulmonary artery pressure
    

Intervention name(s): Beraprost Sodium; Sildenafil Citrate
Intervention type(s): Drug; Drug
Intervention description(s): 1 mcg /kgbw daily, divided in three dosages orally for 12 weeks; 0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
Other intervention name(s): Dorner; Viagra
Intervention MeSH terms: Sildenafil Citrate; Beraprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval
Condition: Fertilization in Vitro
Study type: Interventional

Summary: 
      Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients.
      Local anaesthesia or sedation are commonly used to manage many situations of anxiety,
      including the oocyte retrieval. However, this sedation should be as mild as possible in order
      to preserve oocytes.

      HappyMed Video Glasses are a recent medical device that allows the immersion of patients in
      films, cartoons or concerts. By distracting patients, this technology can reduce anxiety,
      discomfort and ultimately pain associated with care.

      This randomized monocentric trial compares audiovisual distraction versus usual care for the
      management of anxiety and pain related to oocyte retrieval.

      Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed
      Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a
      better comfort and a faster walking ability.
    

Detailed description: 
      Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be
      enrolled in this study and their anxiety level will be collected via a questionnaire.

      After randomization, patients will either benefit from audiovisual distraction using HappyMed
      Video Glasses, (medical device with CE marking), or from the usual management during
      procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12
      hours before anaesthesia. The patients will be stratified according to whether or not a
      previous intervention was performed. Anaesthesia will be started and maintained with
      administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method).
      The aim is a patient who spontaneously ventilates and does not react to gynaecological
      stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the
      initiation of the surgical procedure. The effect of these drugs is longer than the
      intervention duration and will not influence the protocol.
    

Intervention name(s): HappyMed Video Glasses; Propofol; Sufentanil
Intervention type(s): Device; Drug; Drug
Intervention description(s): HappyMed allows the immersion of patients in films, cartoons or concerts.; The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.; 0.1 µg/kg
Intervention MeSH terms: Sufentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oocyte retrieval; Sedation