bioihbjkbjnl/mcl2 huggingface dataset:
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune
      response to kill cancer cells.

      PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how
      well it works in treating patients with acute myeloid leukemia in complete remission.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the tolerability of autologous dendritic cell vaccine in patients with acute
           myelogenous leukemia in complete remission.

      Secondary

        -  Evaluate the emergence of an immune response.

        -  Determine the relapse rate.

        -  Assess the occurrence of residual disease.

      OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by
      autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.
    

Intervention name(s): therapeutic autologous dendritic cells
Intervention type(s): Biological
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22)
RCT on the Effect of Endometrial Injury on Ongoing Pregnancy Rate in Subfertile Women Undergoing IVF
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Implantation failure remains one of the major factors limiting success in IVF treatment. It
      was postulated that the local injury to endometrium induces secretions of cytokines and
      growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding
      EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also
      up-regulate the gene expressions related to endometrial receptivity and optimize the
      endometrial development. In stimulated cycles, local injury to the proliferative endometrium
      has been postulated to delay endometrial development thereby inducing synchronicity between
      endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al,
      2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury
      by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the
      on-going pregnancy rate in subfertile women undergoing IVF treatment.
    

Detailed description: 
      Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong
      Kong who are scheduled for IVF treatment will be recruited. Women who have normal uterine
      cavity will be randomized into study and control groups in 1 to 1 ratio according to a
      computer-generated randomization list. Patients will be stratified according to the first or
      repeated cycle.

      For patients in the study group, in the cycle immediately preceding the scheduled IVF
      treatment, LH surge will be determined by daily serum LH level starting from 18 days before
      the next expected period. LH surge is defined as an elevation of LH to 2 times the level of
      the average of the previous 3 days and the absolute level of the LH should be more than or
      equal to 20 IU/L. Women randomized into the study group will have endometrial biopsy
      performed by pipelle 7 days after the LH surge (LH+7) and they will be instructed to use
      non-hormonal means of contraception during that cycle. All patients will then proceed to IVF
      treatment in the next cycle as scheduled. They will receive standard ovarian stimulation
      according to the departmental protocol and have a maximum of two embryos replaced 2 days
      after the oocyte retrieval. On-going pregnancy rates between the two groups will be compared.
    

Intervention name(s): Endometrial aspiration by pipelle
Intervention type(s): Procedure
Intervention description(s): Endometrial aspiration by pipelle is to be performed on LH+7 in the cycle preceding scheduled IVF treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial injury; Pipelle; Implantation; Ongoing pregnancy rate; IVF
A Study of Doxorubicin Hydrochloride Liposome Injection in Subjects With Ovarian Cancer.
Condition: Ovarian Cancer Recurrent
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are
      already receiving or who in the opinion of their treating physicians are candidates for
      Doxorubicin liposomal injection therapy .
    

Detailed description: 
      This study is a randomized, open label, two arm, single dose, crossover bioequivalence study.
      This study will be conducted in female subjects aged 18 to 65 years diagnosed with ovarian
      cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are
      already receiving or scheduled to start therapy with Doxorubicin Hydrochloride Liposome
      Injection product. Each subject will be randomized to one of the two treatment sequences (RT
      or TR) according to a randomization scheme prepared prior to start of the trial. Serial blood
      samples for determination of free and liposomal encapsulated doxorubicin plasma concentration
      for PK analysis will be obtained in each cycle., This study has an adaptive 2-stage design. A
      sufficient number of subjects with ovarian cancer shall be recruited to have approximately 42
      evaluable subjects completing all follow up procedures (Stage 1). An interim analysis of free
      and encapsulated doxorubicin will be performed at the end of Stage 1. If the bioequivalence
      of encapsulated and free doxorubicin has been established, then the study will be stopped.
      Otherwise, the study may continue into Stage 2 with additional number of ovarian cancer
      subjects. A final evaluation of bioequivalence based on free and encapsulated doxorubicin
      will be performed at the end of Stage 2 and will include all enrolled subjects completing the
      study. Bioequivalence criteria: the 94.12% confidence interval of the ratio of geometric
      means of TEST to REFERENCE for Cmax, AUC0-t, AUC0-∞, for free and encapsulated doxorubicin
      should be between 80.00% and 125.00%.
    

Intervention name(s): Doxorubicin Hydrochloride Liposome Injection
Intervention type(s): Drug
Intervention description(s): 50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 1 patients will receive either reference or test product, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation
Other intervention name(s): Doxorubicin Hydrochloride Liposomal injection 20 mg/10 mL
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Bioequivalence study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liposomal doxorubicin injection; bioequivalence study; ovarian cancer
Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of ACT-129968 in subjects with partly
      controlled asthma on reliever therapy only.
    


Intervention name(s): Placebo; Setipiprant
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo administered orally twice daily; ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
Other intervention name(s): matching placebo; ACT-129968
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the safety and tolerability of single ascending
      intravenous doses of MEDI7814 in healthy adult subjects.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety
      and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male
      subjects and female subjects of non-childbearing potential.
    

Intervention name(s): Placebo; MEDI7814, 1 MG/KG; MEDI7814, 3 MG/KG; MEDI7814, 10 MG/KG; MEDI7814, 20 MG/KG
Intervention type(s): Other; Biological; Biological; Biological; Biological
Intervention description(s): A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.; A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy subjects; MEDI7814; FTiH
Biomarkers of Injectable Extended Release Naltrexone Treatment
Condition: Heroin Dependence; Opioid Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the biological markers of treatment of opioid dependent individuals with
      an extended release formulation of the opioid antagonist naltrexone. The biological measures
      include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and
      behavioral tests probing various aspects of personality, memory, reward processing and
      attention.
    

Detailed description: 
      This study is using blood oxygenation level dependent (BOLD) functional magnetic resonance
      imaging (fMRI) to examine the brain predictors of adherence and outcomes of opioid antagonist
      therapy. Opioid-dependent intravenous heroin users are offered up to 3 monthly injections of
      the extended-release naltrexone (XRNTX) contingent upon successful outpatient non-opioid
      detoxification, with an additional 4 weeks of follow up. Brain responses to heroin-related
      pictures are recorded using fMRI prior to the 1st XRNTX injection and approximately 2 weeks
      thereafter the 1st XRNTX injection. Primary clinical variables include the number of
      injections (maximum of 3) accepted by participants, change in self-reported craving for
      opioids after exposure to drug-related visual cues during the brain fMRI sessions, urine
      levels of ten commonly abused substances and self-report of cigarette use.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly
Other intervention name(s): Vivitrol ®
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: naltrexone; neuroimaging; heroin; addiction; dependence; opioid; Vivitrol®; functional magnetic resonance imaging
SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
Condition: Neonatal Resuscitation
Study type: Interventional

Summary: 
      This study is designed to compare two different methods of oropharyngeal suctioning (with
      bulb syringe or suction catheter) in newborn infants at birth.
    

Detailed description: 
      Objective of the study: This trial aims to compare two different methods of oropharyngeal
      suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at
      birth.

      Primary outcome measure: Oxygen saturation during the first 10 minutes of life.

      Study design: This is a single center, prospective, randomized clinical trial comparing two
      different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in
      newborn infants needing suctioning at birth.

      Setting: The study is conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia),
      which is a level III hospital with around 3,600 deliveries per year.

      Immediately after birth, all infants needing suctioning are randomized to receive suctioning
      with bulb syringe or suction catheter. All resuscitative procedures are performed following
      the Helping Babies Breathe algorithm. An external observer, not involved in the care of the
      newborn, is responsible of the positioning the probe of the pulse oximeter and the collection
      of the data.

      We aim to enroll 60 neonates.
    

Intervention name(s): Bulb syringe; Suction catheter
Intervention type(s): Device; Device
Intervention description(s): Suctioning with a bulb syringe; Suctioned with a suction catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation Of The Relationship Between Imagery Ability, Balance And Functionality After Stroke
Condition: Stroke; Motor İmagery Ability; Mental Chronometry; Balance; Functionality
MeSH terms: Stroke
Study type: Observational

Summary: 
      It was aimed to determine the relationship between post-stroke imagination ability, balance,
      and functionality, and to compare the motor imagery skills of those who had stroke with
      compatible healthy individuals.
    

Detailed description: 
      İn the study, 20 individuals with hemiplegic or chronic hemiparesis who agreed to participate
      by signing the voluntary consent form, who meet the inclusion criteria, and 20 healthy
      individuals who are similar in terms of age, gender and education level will be included.

      The individuals included in the study will be divided into two groups:

      Group 1: Stroke Patients Group 2: Control Group
    

Intervention name(s): Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test.; Berg Balance Scale, Functional Reach Test; Timed Up and Go Test, Functional Independence Scale
Intervention type(s): Other; Other; Other
Intervention description(s): Imagery ability was determined.; Balance level was determined.; Functionality was evaluated.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In this study, we will enroll patients based on the statistics of the articles titled
        "Motor imagery in stroke patients or plegic patients with spinal cord or peripheral
        diseases" and "Effects of a single mental chronometry training session in subacute stroke
        patients - a randomized controlled trial". We calculated the power analysis from this
        article. According to this calculated; α=0.05, 1-β=0.90, effect size=0.96.

        Stroke patients treated at Istanbul Medipol University Pendik Hospital Physical Medicine
        and Rehabilitation Clinic Neurology Rehabilitation Unit and healthy individuals matching
        them will be included.
      
Keywords: stroke; motor imagery; mental chronometry; balance; functionality
A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      This is a single centre, 2-cell, single blinded full-face (products applied at lesional
      sites) study to evaluate changes in melasma through a cosmetic facial serum formulation and
      marketed 2% Hydroquinone product
    

Detailed description: 
      This is a single blind (outcomes assessor), randomized, 2 cell, full face study to evaluate
      changes in mild malar melasma through use of a cosmetic facial serum formulation or marketed
      2% hydroquinone. This study will accept up to fifty participants per cell (100 participants
      overall) who meet the inclusion/exclusion criteria to ensure that at least forty participants
      per cell complete the study. Participants will be randomized to receive either the cosmetic
      product or the hydroquinone product.

      The study schedule will be different depending which product the subject is allocated to.

      If accepted onto the study, all participants will be provided with a marketed face wash and
      moisturiser to use for one week before the baseline visit.

      At the baseline visit, following collection of baseline measures subjects will be allocated
      to either the cosmetic product or 2% hydroquinone. Products will be applied only to lesional
      areas on the face twice daily. Participants will also be provided with a sunscreen for use
      throughout the test phase of the study. They will continue to use the face wash and
      moisturiser with which they have previously been provided.

      Participants allocated to the cosmetic product will be asked to return to the study centre
      for assessments at weeks 4, 8, 12 and regression (8 weeks after stopping product
      application).

      Participants allocated to 2% hydroquinone will be asked to return to the study centre 3 days,
      1, 2, 4, 6 and 8 weeks after baseline and regression 8 weeks after stopping product
      application).
    

Intervention name(s): Cosmetic facial serum Q69; 2% Hydroquinone
Intervention type(s): Other; Drug
Intervention description(s): Cosmetic facial serum; 2% Hydroquinone cream
Intervention MeSH terms: Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: face
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      women who have breast cancer that is metastatic or cannot be treated with surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in women with locally unresectable or metastatic breast
           cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or
           third-line chemotherapy.

        -  Evaluate the toxic effects of this regimen in these patients.

        -  Determine the time to progression in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour
      followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for
      2-8 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.
    

Intervention name(s): docetaxel; fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): 75 milligrams per meter squared intraveneously; 350 milligrams intraveneously
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer
Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      10 healthy male volunteers will be studied after

        -  a 6 day weight maintenance, balanced diet

        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body
           weight/day

        -  a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body
           weight/day and 20g amino-acids per day At the end of each 6 days period, the following
           measurements will be obtained

        -  intrahepatic lipids (1H-MRS)

        -  metabolic effects of fructose ingestion (measurement of substrate oxidation,
           gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)

      This is a randomized, double blinded study
    


Intervention name(s): Fructose+maltodextrin placebo; amino-acid + fructose
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: hepatic fat content; hepatic de novo lipogenesis
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Irbesartan 300 mg Tablets under fed conditions.
    


Intervention name(s): Irbesartan; Avapro
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Detection of Mild Cognitive Impairment in Individual Patients
Condition: Mild Cognitive Impairment; Mild Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      Our central hypothesis is that the early metabolic lesions of MCI can be reliably detected in
      individual subjects by objective analysis of [18]F-fluorodeoxyglucose (FDG) positron-emission
      tomography (PET) brain images, earlier and more accurately than by subjective clinician
      rating.
    

Detailed description: 
      Our goal with this proposal is a prospective, longitudinal study that will examine subjects
      over a three-year span to establish the presence of MCI, evaluate progression of disease, and
      determine the validity of this method in detecting early MCI. Specifically, we predict that
      by using our Cognitive Decline Index (CDI) method of objective examination of FDG PET brain
      images from patients diagnosed with MCI or mild AD, we can accurately discriminate very early
      abnormalities in cerebral metabolism, and that this research method can be validated and
      translated into a clinically useful tool for the early detection of MCI. Our long-range goals
      are the development of methods and tools that enable the detection of pathology in individual
      patients at risk for cognitive impairment.
    

Intervention name(s): PET scan & fMRI
Intervention type(s): Other
Intervention description(s): Subjects will be screened and if applicable for the study will be scheduled for an MRI. At the third visit they will complete the PET scan. They will return at 6, 12, 24, and 36 months and complete another PET scan at the last visit.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects must have a diagnosis of MCI or mild AD.