bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male
      Subjects
    

Detailed description: 
      To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO
      (REPO-A (4000 IU)) in Healthy Male Subjects
    

Intervention name(s): BEPO-A; REPO-A
Intervention type(s): Drug; Drug
Intervention description(s): BEPO-A (Bioreactor manufacturing process); REPO-A (Roller bottle manufacturing process)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain
      experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after
      three weeks of treatment compared to the baseline period.
    

Detailed description: 
      A 3 week randomised crossover study to investigate the effect of repeat oral dosing of
      CNV2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral
      neuropathy (DPN). Each 3 week treatment period is seperated by a 2 week washout period. The
      primary outcome measure is the change from baseline in the PI-NRS after three weeks of
      treatment. Secondary outcome measures include pain responder rates, clinical and patient
      global impressions of pain, and the Neuropathic Pain Symptom Inventory.
    

Intervention name(s): CNV2197944; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Condition: Proximal Femur Fractures
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      Fracture femur is a common injury which is associated with excruciating pain. Positioning for
      neuraxial blocks is always challenging because even slight overriding of the fracture ends is
      intensely painful .It can causing major patient distress which accompanied by well-known
      physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and
      increased cardiac work that may compromise high-risk cardiac patients.

      Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of
      the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but
      it is also associated with minimal risk as the local anesthetic is injected at a safe
      distance from the femoral artery and femoral nerve. It is always safe to perform the fascia
      iliaca compartment block prior to spinal anesthesia as the patient can respond during
      administration of the local anesthetic and can prevent intra-neuronal injections
    

Detailed description: 
      On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient
      will be connected to basal monitoring devices; pulse oximetry and non- invasive blood
      pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device
      in all cases.The injected local anesthetic solution will be prepared by a staff member who
      was not involved in the study) according to the randomization. After 20 minutes from the
      injection the investigators will assessed nerves that had been blocked.

      On arrival to the operative theater, under complete aseptic technique spinal anesthesia will
      be carried out in the sitting position (if there is severe pain at positioning we will use
      lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After
      feeling the desired space, the needle will be advanced (paramedian approach) till free flow
      of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic
      fentanyl will be injected.
    

Intervention name(s): Placebo; Bupivacaine; Ultrasound guided fascia iliaca compartment block; Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml; Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml; Ultrasound guided fascia iliaca compartment block; Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
DC Vaccination for Post-remission Therapy in AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20
      patients including a safety-run in phase I part comprising 6 patients.

      Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs),
      presenting two leukemia-associated antigens.
    

Detailed description: 
      20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive
      WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4
      weeks and 1 per month thereafter for 23 consecutive months.

      Primary objective is to assess the safety and tolerability of the DC vaccine in the
      aforementioned population and the feasibility.

      Secondary objectives include evaluation of clinical response and exploratory immune
      monitoring assessments.
    

Intervention name(s): WT1/PRAME vaccination
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
Transfer of Subjects From Subutex/Suboxone to RBP-6300
Condition: Opioid Related Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine if opioid dependent subjects who are already receiving
      Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will
      continue their pre-study prescribed dosage of Subutex and/or Suboxone
    

Detailed description: 
      During the open-label Run-In Period (study days -7 to -1), participants receive
      Subutex®/Suboxone® at one of three dose levels, depending on the dose level for that subject
      on entry to the study: 8 mg/day, 16 mg/day, or 24 mg/day.

      During the 7-day, active drug-controlled, double-blind Transfer Period (study days 1-7),
      participants are randomized to either Subutex®/Suboxone® or RBP-6300 active drug at dosing
      levels equivalent to the level during the Run-In Period plus placebo matching the other drug.

      This is followed by a 3-day single-blind Subutex®/Suboxone® Transition Period in which
      participants receive the same dose given during the Run-In Period.
    

Intervention name(s): RBP-6300; Subutex®/Suboxone®; Placebo for RBP-6300; Placebo for Subutex®/Suboxone®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7).
Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate.; Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods.
Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods.
Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone.; Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods.
Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period.; Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
Other intervention name(s): buprenorphine hemiadipate HCl; naloxone HCl; buprenorphine; naloxone; placebo; placebo
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Opioid dependence
Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA)
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Background: Therapeutic outcomes of leukotriene receptor antagonist (LTRA) vary in
      asthmatics，and there's not an ideal and simple way for prediction at present.

      Objective：To investigate whether leukotriene D4 bronchial provocation test (LTD4-BPT) could
      be an indicator of actual therapeutic outcome of LTRA.

      Methods：A single centre, open-labeled trial was performed in 32 asthmatics with positive
      LTD4-BPT result for a month. All subjects were categorized according to airway responsiveness
      to leukotriene D4（PD20FEV1-LTD4）. Subjects received montelukast therapy (10mg, once per
      night), and reassessment was performed (3~5) days after withholding LTRA. The primary
      end-point was the difference in monthly PEFR. Secondary endpoints included the difference in
      FENO, PD20FEV1-LTD4, PD20FEV1-MCh, pre-test FEV1, ACT score, AQLQ symptom score, week 4
      PEFmax and PEFmin as compared with week 1, gradual decrease in the use of salbutamol and the
      days without using salbutamol.
    

Detailed description: 
      Our primary goal was to determine whether LTD4-BPT could be a clear indicator for assessing
      efficacy of LTRA. Logistic regression model was adopted for statistical analysis. In this
      model, pre-treatment PD20FEV1-LTD4 represented anticipated efficacy. The median of
      PD20FEV1-LTD4 was used for classification of asthmatics, with a lower figure representing a
      better anticipated outcome. Various variables, including the difference in pre- and post-
      treatment FENO, PEFmax, PEFmin, PEFR, PD20FEV1 and asthma scores, were introduced in the
      model representing the actual efficacy of LTRA. We aimed to test whether there would be
      certain parameters that assist prediction of anticipated outcome.
    

Intervention name(s): leukotriene receptor antagonist (montelukast)
Intervention type(s): Drug
Intervention description(s): montelukast (10 mg, once per night)
Other intervention name(s): singulair
Intervention MeSH terms: Montelukast; Leukotriene Antagonists
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Leukotriene; leukotriene receptor antagonist; bronchial provocation test; therapeutic outcome
Bright Light Therapy for Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study investigates whether bright artificial light adds to hypocaloric diet to lose
      weight in obese subjects.
    

Detailed description: 
      The study is aimed to check a preliminary evidence that bright light may help to lose weight
      in obese people (Thor Helge Bergan, Norvay, 2002, unpublished). Subjects: aged 20-65 y, BMI >
      30, non-seasonal (SPAQ score <8, no seasonal problem), in good general health, with regular
      sleep from 22:00-1:00 to 6:00-9:00. Study season: November-April. Placebo-controlled,
      single-blind, crossover. At least 1 mo between two arms; at similar phase of menstrual cycle
      (if present). If could not complete at the first year, the second arm is to be done the next
      winter. Intervention: Lightbox (4300 lux) - during one arm, deactivated ioniser - during
      another arm (sequential alternation upon entering the study) for 3 weeks each morning (at
      least 18 days) starting between 6:00-9:00. Seating distance (from the face to the device) is
      41 cm, duration - 30 min. Diet: a target amount of kcal per day is calculated based on age,
      weight and gender (WHO), e.g. for a woman 40 y ang 80 kg it is 1502 kcal per day. Food
      content - is also as recommended by WHO. Food distribution over day - usual for the
      particular test subject but constant over sessions. Food diary is completed daily and
      subjects calculate kcal themselves based on a Table of kcal. Outcomes: Weight is measured
      during a visit to doctor a day before and day after the 3-week session, and also at home
      every week. Motivation and Expectation are rated by 3-point scales in a Diary, at the
      beginning of each session. Mood, activity and appetite are self-estimated using a VAS-like
      10-points scale every week. At the end of each arm the "Easiness of dieting" scale and
      Adverse event(s) are completed. In the diary, there are also columns for sleep on and off
      times, intervention time, duration and distance, number of kcal. A target number of subjects
      to complete the study is 40.
    

Intervention name(s): Light therapy
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obesity; Light therapy; Hypocaloric diet
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
Condition: Covid19; Chronic Kidney Diseases; Proteinuria
MeSH terms: COVID-19; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Observational

Summary: 
      COVID-19 pandemic affected the admission of patients to the hospital especially the older
      patients (> 65 years old) because of curfews and the reluctance of patients to apply to the
      hospitals. Chronic kidney disease is characterized with the progressive loss of kidney
      function over the time and regular follow-up of patients for their kidney function and
      treatment of complications is recommended in these patients.
    

Detailed description: 
      The chronis kidney disease patients followed in Nephrology outpatient unit are going to be
      enrolled in the study and their kidney functions (calculated with the mdrd formula to asses
      the estimated glomerular filtration rate (eGFR)) will be evaluated 6 months before and after
      the COVID-19 pandemia. And the rate of initiation of renal replacement therapies and the
      change in proteinuria will be evaluated 6 months before and after the COVID-19 pandemic.
    

Intervention name(s): change in kidney function and proteinuria
Intervention type(s): Other
Intervention description(s): change in eGFR nad proteinuria in patients with chronic kidney disease
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with chronic kidney disease (eGFR<60 ml/dk) between the ages 18-80 followed up in
        nephrology outpatient clinic.
Bioequivalence Study of Different Aprocitentan Tablet Formulations
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2
      different tablet formulations. The clinical pharmacology data will be used to determine
      bioequivalence of 2 different tablet formulations.
    


Intervention name(s): Aprocitentan (Formulation A); Aprocitentan (Formulation B)
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of 25 mg.; A single oral dose of 25 mg.
Other intervention name(s): ACT-132577; ACT-132577
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Improving Followup of Abnormal Colon Cancer Screening Tests
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether direct mailings to patients with positive
      fecal occult blood tests can increase rates of performing followup colonoscopy.
    

Detailed description: 
      Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant
      reduction in colorectal cancer mortality, although only when accompanied by a complete
      diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with
      a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard
      Medical Associates. This project will use a pre-post study design to increase the rate of
      followup colonoscopy in the setting of positive FOBT results. Patients in the intervention
      group will receive a personalized mailing highlighting their positive result and need for
      colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling
      office. The primary outcome will be the performance of colonoscopy, however we will also
      perform chart reviews to identify predictors of completing appropriate followup.
    

Intervention name(s): Patient mailing
Intervention type(s): Behavioral
Intervention description(s): Patient will receive a mailing recommending colonoscopy, followed by telephone outreach
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal cancer; Fecal occult blood test; Abnormal test result; Missed diagnosis; Delayed diagnosis
A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aim of this study is to document the pharmacokinetics of dopamine transporter
      DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as
      the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of
      Metadate CD at 10 hours after administration.
    

Detailed description: 
      OROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending
      pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. Another new
      long-acting formulation is Metadate CD. Metadate CD consists of capsules with two types of
      beads. It was designed to replace IR-MPH BID treatment. The main target of MPH in the brain
      is the dopamine transporter (DAT). We have an exquisitely sensitive methodology to measure
      DAT occupancy using C-11 Altropane and Positron Emission Tomography (PET). The time course of
      decay of the C-11 Altropane permits repeated imaging, thus allowing documentation of the
      pharmacokinetics of DAT receptor occupancy.
    

Intervention name(s): OROS methylphenidate hydrochloride; methylphenidate hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients
      scheduled for multi-slice CT.
    


Intervention name(s): ONO-1101
Intervention type(s): Drug
Intervention MeSH terms: Landiolol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ONO-1101; Landiolol Hydrochloride; Multi-slice CT; Coronary Artery Disease
Effects of Subanesthetic Dose of Ketamine Given on Postoperative Mood in Patients Undergoing Fractional Curettage
Condition: Ketamine; Minor Surgical Procedure; Total Mood Score; Woman
Study type: Interventional
Phase: Phase 4

Summary: 
      When given intravenously in doses below 1.2mg/kg, ketamine has been shown to work as an
      antidepressant. Ketamine is a common induction drug used during general anesthesia. It is
      known to reduce postoperative pain in this instance. Limited studies have evaluated the
      effect of a single subanesthetic dosage of ketamine administered as an adjunct to general
      anesthesia on acute mood states in patients undergoing minor surgery. The aim of this
      randomized controlled study was to examine if a single intravenous administration of 0.5
      mg/kg ketamine given at the induction of propofol/fentanyl anesthesia has an effect on acute
      mood states before the discharge of women undergoing fractional curettage.
    

Detailed description: 
      Women admitted for fractional curettage between the ages of 18 and 75 were asked if they
      would like to participate in the study. Exclusion criteria included uncontrolled
      hypertension, pregnancy, history of psychologic disorders, use of brain-affecting medicines,
      substance abuse, seizure disorders, or ketamine allergy. After receiving informed consent,
      the patient would be given a POMS questionnaire. The participants were then assigned randomly
      to one of two groups. Group A will receive ketamine intravenously at a dose of 0.5 mg/kg as
      part of the induction process for general anesthesia. In addition to their anesthetic, Group
      B will get the same amount of saline instead of ketamine. Patients were treated by a
      different anesthetic professional (who is blinded to the group the patient is in). All other
      induction medicines were administered at the discretion of the anesthesiologist. Two hours
      after the surgery, participants were again administered the POMS questionnaire, questioned
      about their pain level, and their data sheet was updated accordingly. During the trial, the
      levels of sedation, systolic and diastolic blood pressures and heart rate were measured. In
      addition, any adverse events were documented.
    

Intervention name(s): Ketamine; Saline
Intervention type(s): Drug; Other
Intervention description(s): 0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered; 0.09% Saline (0.05ml/kg) intravenously administered
Other intervention name(s): subanesthetic dose of Ketamine; Placebo
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: ketamine; POMS questionnary; acute Mood; fractional curettage; propofol