bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Condition: Acute Myeloid Leukemia
MeSH terms: Virus Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia)
      induction and consolidation chemotherapies related aplasia. The main aim of this study is to
      measure incidence of respiratory viral infections during AML induction and consolidation
      chemotherapy related aplasia. Primary end point is a positive polymerase chain
      reaction(PCR)associated with clinical signs.
    

Detailed description: 
      Bacterial and fungal infection treatment is well defined with guidelines. Few data are
      available for viral infections and concern essentially allogeneic stem cell transplantation.
      These infections are associated with a high mortality and morbidity rate. Data concerning AML
      are essentially retrospective, pediatric and with a little number of patients. Respiratory
      viral infections incidence is not known. These infections may be responsible for a higher
      mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia,
      co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral
      therapy. This study aims at understanding viral infections epidemiology during long term
      aplasia and optimizing their management.
    

Intervention name(s): Multiplex respiratory viral PCR
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Acute Myeloid Leukemia
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple doses of pregabalin in pediatric patients with partial onset seizures that are
      incompletely controlled on their current medications.
    


Intervention name(s): Placebo; Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Orally-administered pregabalin
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; safety; tolerability; pharmacokinetics
Surgery for Masaoka-Koga I-II Thymoma
Condition: Thymoma; Masaoka Stage I; Masaoka Stage II
MeSH terms: Thymoma; Thymus Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the safety and perioperative outcomes of the
      subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for
      Masaoka-Koga I-II thymoma.
    

Detailed description: 
      It is a multi-center, open, prospective randomized phase II&III clinical trial sponsored by
      Shanghai Zhongshan Hospital with other four hospitals in China participating in. 100 patients
      with thymoma (Masaoka-Koga I-II ) diagnosed by enhanced computed tomography were recruited
      and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (SATT group) and
      the lateral intercostal approach thoracoscopic thymectomy (LATT group) according to the
      proportion of 1:1. The safety and perioperative outcomes are compared between the two
      surgical regimens.
    

Intervention name(s): the subxiphoid approach thoracoscopic thymectomy; the lateral intercostal approach thoracoscopic thymectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger.; Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.
Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.
Other intervention name(s): SATT; LATT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thymoma (Masaoka Stage I-II); the subxiphoid approach; the lateral intercostal approach
Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible
Condition: Osteonecrosis Due to Drugs, Jaw
MeSH terms: Osteonecrosis
Study type: Interventional

Summary: 
      Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated
      in two groups randomly : In group1, 10 patients underwent debridement and primary closer of
      the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement
      area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.
    

Detailed description: 
      All patients undergo surgical necrotic bone debridement in combination with antibiotic
      therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly
      allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area
      closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients
      were evaluated after 1(time1) ,6(time2) and 12(time 3) months.

      The size of bone lesion was measured by using come beam computer tomography (CBCT).

      Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more
      than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog
      scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a
      time span of 3 months without clinical symptoms were documented in each group.
    

Intervention name(s): Topical Phenytoin 5%
Intervention type(s): Drug
Intervention description(s): Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
Intervention MeSH terms: Phenytoin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteonecrosis; mandible
Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      To investigate whether 24IU oxytocin can result in changes in functional brain connectivity
      in patients with schizophrenia and healthy individuals using functional magnetic resonance
      imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism
      on the functional connectivity
    


Intervention name(s): oxytocin
Intervention type(s): Drug
Intervention description(s): 24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Intervention model description: After completion of clinical and cognitive assessments, all subjects will undergo a baseline fMRI scan. Later subjects will receive24IU oxytocin and saline placebo in counterbalanced order on two separate days and undergo repeat fMRI scans.
Masking: None (Open Label)
Primary purpose: Other
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
Condition: Sleep; Memory
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of two hypnotic medications, zolpidem
      extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug
      duration will allow greater memory consolidation than a hypnotic with longer drug duration.
    

Detailed description: 
      A growing body of evidence has demonstrated that sleep promotes memory consolidation in
      healthy individuals. However, little research has been conducted regarding the effect of
      hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not
      brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers.
      Another study reported significant impairment of sleep-dependent memory on a motor task with
      triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide
      some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation,
      but further investigation is clearly needed in this area. Because hypnotics are commonly
      prescribed for insomnia, it is important to determine if there is a significant risk of
      impairment in sleep-dependent memory consolidation associated with these medications.
      Further, investigation of alternative doses and drug regimens upon memory consolidation
      appears warranted.

      The purpose of the current study is to determine the effect of two hypnotic medications on
      sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which
      will be active for most of the sleep period when administered at bedtime, will be compared to
      zaleplon, which will be active for half of the sleep period when administered in the middle
      of the night. This comparison allows us to address the question of whether a few hours of
      drug-free sleep results in better memory consolidation than sleep with drug throughout the
      night.
    

Intervention name(s): zaleplon; zolpidem extended release; bedtime placebo; middle of the night placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg; 12.5 mg; placebo; placebo
Other intervention name(s): Sonata; Ambien CR
Intervention MeSH terms: Zaleplon; Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: sleep; memory; hypnotics; zaleplon; zolpidem; Sonata; Ambien; Hypnotics and Sedatives; Polysomnography; Monitoring, sleep
A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This single arm study will evaluate the efficacy and safety of repeated courses of MabThera
      in patients with active rheumatoid arthritis who have participated in ML19070, and have
      completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2
      infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to
      3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2
      years, and the target sample size is 100-500 individuals.
    


Intervention name(s): rituximab [MabThera/Rituxan]
Intervention type(s): Drug
Intervention description(s): 1g iv on days 1 and 15
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational [Patient Registry]

Summary: 
      The goal of this project is to develop a test to assess frontal lobe function using a rapid,
      inexpensive, objective, and standardized method, without the need for expertise in cognitive
      test administration. Such methods would be particularly helpful in traumatic brain injury
      (TBI), where objective measures are needed, and would greatly expand the capacity to make
      such assessments in clinical practice and research.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males and females (military health care beneficiaries and non military health care
        beneficiaries) age between 18 and 60 years who have a diagnosis of moderate or severe
        traumatic brain injury as well as age, gender, education matched non-TBI volunteers.
      
Keywords: Traumatic brain injury; functional near infrared spectroscopy
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this investigation is to demonstrate non-inferiority in outcome of
      Custodiol-N against Custodiol in heart transplantation.
    


Intervention name(s): Custodiol-N; Custodiol; organ perfusion for heart transplantation
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation; comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Condition: Parkinsonian Disorders
MeSH terms: Parkinsonian Disorders
Study type: Interventional

Summary: 
      Freezing of gait (FOG) means that patients cannot walk without any known causes, other than
      parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet
      suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive
      procedure using electromagnetic induction to stimulate brain. Transcranial magnetic
      stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim
      of this study is to the therapeutic effect of rTMS for the FOG.
    


Intervention name(s): rTMS Motor cortex; rTMS Supplementary motor area
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-centre, open-label, randomized, parallel trial to compare the effect of
      Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers
      in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin
      monotherapy.
    

Detailed description: 
      Studies have showed that fluctuations of glucose seem to have more deleterious effects than
      sustained hyperglycaemia in the development of diabetic complications. The present randomized
      controlled trial was designed with primary aim to evaluate glycaemic fluctuation in the
      comparison between twice-daily Exenatide and other treatment paradigm (e.g. insulin Aspart
      30).
    

Intervention name(s): Exenatide; Biphasic insulin Aspart 30
Intervention type(s): Drug; Drug
Other intervention name(s): Byetta
Intervention MeSH terms: Insulin Aspart; Exenatide; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chinese population
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
Condition: Hormone Receptor Positive Malignant Neoplasm of Breast
MeSH terms: Breast Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor
      positive breast cancer patients

      Phase II multicenter 1:1 randomized clinical trial Total 208 patients

      Primary endpoint Clinical response rate

      Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent
      mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy
      Toxicity profile of neoadjuvant letrozole, metformin
    

Detailed description: 
      To identify the anti-tumor effect of metformin with preoperatively given letrozole in
      postmenopausal estrogen receptor positive breast cancer patients
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks; Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks
Other intervention name(s): Arm1_Metformin_experimental; Arm2_Letrozole alone_Placebo
Intervention MeSH terms: Metformin; Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neoadjuvant endocrine therapy; metformin; postmenopausal breast cancer
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Condition: Advanced Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Active Controlled, Comparative, Open-Label, Multi-Center, Phase 3
      clinical study to compare the efficacy, safety, and pharmacokinetics of leuprolide acetate
      for injection 3.75mg (depot) of two brands (Luprodex and Lucrin) administered in subjects
      with advanced adenocarcinoma of the prostate.

      Approximately 168 subjects (males )of age above 18 years fulfilling the eligibility criteria
      will be enrolled. The IP will be given as a monthly dose for two cycles on day 0 and day 28.

      The pharmacokinetic analysis will be done for 12 patients receiving Luprodex. The primary and
      secondary outcomes will be captured on days as per protocol. Adverse events will be noted for
      safety evaluation.
    


Intervention name(s): Leuprolide Acetate 3.75 MG/ML
Intervention type(s): Drug
Intervention description(s): Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Preventing FAS/ARND in Russian Children
Condition: Fetal Alcohol Syndrome (FAS); Fetal Alcohol Spectrum Disorders; Alcohol Abuse in Pregnancy
MeSH terms: Fetal Alcohol Spectrum Disorders; Alcoholism
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate an intervention aimed at reducing risk for
      alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian
      children. The study will determine whether physicians, trained in a dual-focused brief
      motivational intervention and monitored for performance, can foster greater change in
      knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women
      who are at risk than standard care.
    

Detailed description: 
      The study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to
      reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing
      age women who are heterosexually active, and not consistently using contraception). The trial
      will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief
      physician intervention (DFBPI) and determine whether physicians, trained in DFBPI and
      monitored for compliance, can foster greater reduction of women's risk behaviors compared to
      standard care. The intervention is specifically designed to be deliverable routinely by
      Obstetrics and Gynecology physicians(OB/GYN) to large numbers of women at women's clinics.
    

Intervention name(s): Dual-Focused Brief Physician Intervention (DFBPI); Services as usual
Intervention type(s): Behavioral; Other
Intervention description(s): The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.; Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: alcohol; pregnancy; fetal exposure; prevention; FAS; Alcohol-Related Neurodevelopmental Disorder (ARND)
Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients
Condition: PCOS
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation
      (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome
      (PCOS) who were assigned for ICSI and frozen blastocyst transfer.

      200 infertile women were divided randomly into Group C, which received Cetrorelix injection
      (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on
      day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of
      225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts
      underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes
      included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and
      prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of
      profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and
      clinical pregnancy rates, and the miscarriage rate.
    


Intervention name(s): Injection of Cetrorelix; Oral insertion of dydrogeserone
Intervention type(s): Drug; Drug
Intervention description(s): Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.; Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment