bioihbjkbjnl/mcl2 huggingface dataset:
VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients included in the study with high risk acute myeloid leukemia or myelodysplastic
      syndrome as defined will receive an allogeneic transplantation conditioned by either
      myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive
      a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with
      donor lymphocyte infusion.
    


Intervention name(s): Azacitidine; DLI
Intervention type(s): Drug; Other
Intervention description(s): Azacitidine (AZA) is to be administered every 28 days beginning day +56 to 100 posttransplant for one year provided the patients has a platelet count of >15 x 109/L without transfusion for at least 2 successive days, and an absolute neutrophil count of >1 x 109/L without growth factor for at least 2 successive days, and no acute GVHD greater than grade I and no clinical evidence of life-threatening infection. AZA is given 32 mg /m²/day subcutaneously for 5 days every 28 days (; Donor lymphocyte infusion (DLI) is to be given from day +126 (week 18) in patients without immunosuppressive therapy for at least one month and following 3 cycles of AZA, and without clinical signs of GVHD, and without uncontrolled infection and without a recent history of >grade 2 acute GVHD. DLI are schedules every 8 weeks. There are 3 DLI scheduled.
If first cycle of AZA is postponed beyond day 56 (maximum to Day 100), all subsequent cycles and DLI will be post poned too.
Intervention MeSH terms: Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogreffe, LAM , MDS; Azacitidine (VidazaÒ); Injection de lymphocytes de donneur (DLI)
Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done in healthy volunteers to help researchers understand how ABT-614
      works in the human body, specifically in the brain. The PET imaging technique can be thought
      of as a way to take pictures of chemical changes in the brain. To take a PET scan (picture),
      a substance with low levels of radioactivity (radiotracer) has to be injected when you are in
      the PET camera. The radiotracer is only radioactive for a short period of time. In this
      study, PET is being used to measure how the study drug attaches to specific receptors in the
      brain. The radiotracer used in this study, [11C]-(+)-PHNO, is currently being used for
      studies in people at the CAMH PET Centre.
    


Intervention name(s): ABT-614
Intervention type(s): Drug
Intervention description(s): Baseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will enroll eligible subjects into a long-term safety study (Part B).

      Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic
      control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of
      enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3
      months prior to the screening visit. The study design of Part B is a randomized, open-label,
      2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1
      ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.
    


Intervention name(s): Dapagliflozin 5 mg; Dapagliflozin 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin, a blood glucose lowering drug. Oral dose; Dapagliflozin, a blood glucose lowering drug. Oral dose
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japanese patients with type 1 diabetes with inadequate glycemic control on insulin
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the
      prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients
      will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment.
      Patients demonstrating stable response at the end of the open-label treatment phase will be
      assigned to receive agomelatine or placebo for 52 weeks.
    


Intervention name(s): agomelatine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: agomelatine, Major Depressive Disorder, MDD, depression
Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap
Condition: Free Tissue Flaps
Study type: Interventional

Summary: 
      Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and
      general anesthesia with epidural anesthesia in patients who undergoing free flap
      transposition using Duplex ultrasound.
    

Detailed description: 
      Maintaining adequate blood flow is important on the success of free flap surgery. Epidural
      anesthesia can influence blood flow during surgery. Therefore, investigators aim to compare
      the effect of epidural anesthesia combined with general anesthesia and general anesthesia
      alone on blood flow in arterial anastomosis site of the free flap.
    

Intervention name(s): Epidural anesthesia
Intervention type(s): Other
Intervention description(s): After anesthesia induction, epidural catheter is inserted into lumbar epidural in epidural with general anesthesia group. A 10 ml of 0.2% ropivacaine should be given in epidural space via a catheter when anastomosis of free flap is finished in epidural with general anesthesia group.
Other intervention name(s): Epidural anesthesia with ropivacaine
Intervention MeSH terms: Anesthetics; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study
Condition: Preeclampsia; Cardiovascular Risk Factor; Cardiovascular Diseases; Hypertension
MeSH terms: Pre-Eclampsia; Cardiovascular Diseases
Study type: Interventional

Summary: 
      RATIONALE:

      Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of
      cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a
      relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been
      acknowledged as a serious CVD risk factor in women. In clinical practice, however, these
      women are still underappreciated for their CVD risk. It has not been established yet how
      adequate lifelong prevention in these potentially high risk women can optimally be achieved
      from their childbearing years onwards.

      OBJECTIVE:

      To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP)
      home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In
      addition to evaluate the effectiveness of BP home monitoring on the occurrence of
      hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms,
      work ability and life-style behaviour.

      STUDY DESIGN:

      Randomized, open label feasibility study to compare eHealth guided self management of BP
      monitoring and lifestyle advice with 'usual care'.

      STUDY POPULATION:

      Approximately 200 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be
      invited to participate (both early and late PE). Patients will be recruited from the
      departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the
      department of cardiology Radboudumc.

      INTERVENTION:

      eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice
      (intervention-group) will be compared with "usual care".

      PRIMARY OUTCOME:

      Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk
      women after a previous PE in pregnancy at 1 year of follow-up.
    


Intervention name(s): Home Blood Pressure Monitoring (HBPM)
Intervention type(s): Device
Intervention description(s): Home blood pressure monitoring using the Withings Wireless BP monitor. Patients will be asked to measure their blood pressure twice daily for 7 consecutive days. This will be repeated for every month for 1 year.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized at the end of the baseline visit to self-measurement of bloodpressure at home (intervention group) or usual care (control group).
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Patient empowerment; Women's Health; Home Blood Pressure Monitoring
Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a
      clinical scale according to Good Laboratory Practice and study its efficacy when compared to
      a Supervised Physical Therapy Program alone.
    

Detailed description: 
      Umbilical cord derived MSCs bank will be generated and all patients given the same cells from
      the same biological sample.

      Thorough clinical, cognitive and motor analysis will be performed at baseline and compared to
      outcomes at 3 different time points of all enrolled patients.

      The study will consist of three arms: 1- Stem cells treatment 2- Stem cells and supervised
      physical therapy 3- Supervised physical therapy
    

Intervention name(s): Umbilical cord derived Mesenchymal Stem Cells; Supervised physical therapy
Intervention type(s): Biological; Other
Intervention description(s): Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients; A combined physical therapy program of Balance, strengthening and endurance exercises
Other intervention name(s): UC-MSCs; SPT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Umbilical Cord Mesenchymal Stem Cells; Multiple Sclerosis; Neuroimmunology; Autoimmune disease; Physical therapy
Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine
      (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune
      response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).

      Primary Objective:

        -  To describe the safety profile (injection site reactions and systemic events) of each
           vaccine during the 21 days following vaccination, and serious adverse events (including
           adverse events of special interest) throughout the study in all adult and
           child/adolescent participants.

      Secondary Objectives:

        -  To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine
           (QIV) induce an equivalent immune response at 21 days post-vaccination in both age
           groups (lot consistency)

        -  To describe the compliance of the immunogenicity of QIV to the European Medicines Agency
           Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
    

Detailed description: 
      All participants will receive a single injection of their assigned vaccine during Visit 1.
      They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit
      2), and also monitored for safety for up to 6 months post-vaccination.
    

Intervention name(s): Quadrivalent Influenza Vaccine (split virion, inactivated); Quadrivalent Influenza Vaccine (split virion, inactivated); Quadrivalent Influenza Vaccine (split virion, inactivated); 2011 to 2012 Trivalent Influenza Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine; Trivalent Inactivated Influenza Vaccine
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with
      lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week
      periods.
    


Intervention name(s): LAM group; ADV group
Intervention type(s): Drug; Drug
Intervention description(s): Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.; Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Other intervention name(s): Lamivudine; adefovir dipivoxil
Intervention MeSH terms: Lamivudine; Adefovir; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment naive; CHB; adefovir; monotherapy
Cognitive Function in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the study is to investigate the relationship between cognitive function,
      functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.
    

Detailed description: 
      Cognitive impairment in patients with MS is a common problem that significantly affects
      quality of life. It shows an association between functional capacity and physical fitness
      levels and cognition in non-MS populations, and especially in the elderly.

      Although cognitive dysfunctions are known, few studies have been found on its relationship
      with secondary problems caused by the disease and its correlation with other symptoms.
    

Intervention name(s): Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
Intervention type(s): Other
Intervention description(s): 6-minute walk test and 5-time sit-to-stand test (STS-5) were used for functional capacity assessment. For cognitive reserve assessment, the Cognitive Reserve Index questionnaire was used. Reaction time, cognitive function and visiospatial perception were evaluated with the mobile application. In addition, the Fatigue Severity Scale; Beck Depression Questionnaire and Nottingham Health Profile were used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple sclerosis; cognitive function; cognitive reserve; functional capacity
VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
Condition: Pharmacokinetics
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when
      co-administered in male and female subjects with varying levels of renal impairment and
      healthy normal controls.
    


Intervention name(s): VNRX-5133 and VNRX-5022
Intervention type(s): Drug
Intervention description(s): intravenous infusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The study will enroll approximately 32 subjects assigned to treatment groups based on renal function.
Masking: None (Open Label)
Primary purpose: Basic Science
Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study
Condition: Hyperventilation; Chronic Idiopathic Hyperventilation; Dysfunctional Breathing; Respiratory Alkalosis
MeSH terms: Respiratory Aspiration; Hyperventilation; Alkalosis, Respiratory; Alkalosis
Study type: Interventional

Summary: 
      Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing
      which has proven hard to treat effectively. The investigators hypothesised that by
      periodically inducing normocapnia over several weeks, it would be possible to raise the
      normal resting level/set point of CO2 and achieve a reduction of symptoms.

      Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing
      mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.

      Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline
      and once each week at least three hours after mask use, as well as spirometric values, breath
      holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.
    


Intervention name(s): Partial Rebreathing Mask
Intervention type(s): Device
Intervention description(s): Inducing normal CO2 for two hours a day for four weeks
Other intervention name(s): CDA mask; Balancair Mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperventilation; Chronic Idiopathic Hyperventilation; Dysfunctional Breathing; Respiratory Alkalosis; Respiratory Acidosis
PARTNER Recruitment and Brief Intervention Pilot Study
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Purpose of the study:

      This is a pilot randomized controlled trial to identify methods of involving underage youth
      in interventions to reduce alcohol use through the primary health care system. The trial will
      compare the effectiveness of using an onsite behavioral health specialist for screening,
      intervention and referral with basic written information and staff recommendations typically
      provided in primary care offices.
    

Detailed description: 
      There will be approximately 3-5 sites who will participate in this study. These sites may
      include two private practices in Roxboro and Creedmoor, North Carolina, the Duke Hospital and
      two practices in the Five County region of NC who are implementing Integrated, Collaborative,
      Accessible, Respectful, and Evidence-based (ICARE). In each clinic one day of the week (or 2
      half days) will be chosen randomly from the days the clinic identifies as appropriate. During
      this time a behavioral health specialist (BHS) will be on site to recruit potential
      participants. All patients will be asked to speak to the specialist. On two other randomly
      selected days printed material will be given to all parents of underage patients and the
      underage patients. This material will describe the study and give the specialist's contact
      information. If the patients are 18 to 21 years old the material will be given directly to
      the patient.

      The BHS will ask all interested participants to sign the informed consent/minor consent and
      one parent/legal guardian will be asked to counter sign the informed consent if subject is
      not 18 years of age yet. All participants signing informed consent will be given the CRAFFT
      and the PARTNER basic information questions in an interview with the specialist.

      The primary outcome measure will be the number of participants recruited per day by the on
      site BHS versus appointment recruitment method. In addition, the total number of clinic
      visits for patients' ages 14 to 21 years old on each day of the week will be totaled by age,
      gender and ethnicity to determine the penetration rates for the recruitment procedures. And
      lastly, medical records at the treatment referral sites will be checked to identify the
      number of participants referred.

      The study will recruit subjects at each site for approximately last six months.
    

Intervention name(s): Counseling
Intervention type(s): Behavioral
Intervention description(s): Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.
Other intervention name(s): CRAFFT; Other Shared Items Proposal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Screening; Brief Intervention
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open label, cross-over study in healthy adult subjects to investigate
      cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study
      will be conducted at a single US center. Each subject will be randomized to receive a single
      SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC
      injection will be administered by a health care provider at a different injection site (arm,
      thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference
      treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and
      thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for
      PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after
      dosing (Days 3, 10, and 17).
    


Intervention name(s): cotadutide multidose pen injection; cotadutide multidose pen injection; cotadutide multidose pen injection
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): SC injection in the upper arm; SC injection in the lower abdomen; SC injection in the thigh
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other