bioihbjkbjnl/mcl2 huggingface dataset:
MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study
Condition: Pregnancy; Primiparity; Hypertension; Preeclampsia; Intrauterine Growth Retardation
MeSH terms: Pre-Eclampsia; Fetal Growth Retardation; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether close monitoring of patients with a high
      sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent
      preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/
      early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality
      and morbidity and 2/ a simple urinary PlGF screening will be effective.
    

Detailed description: 
      We will measure plasmatic sFlt-1 level between 25 and 28 weeks of gestation and flow velocity
      of uterine arteries by Doppler (22 - 26 weeks of gestation) in primipara. Patients will be
      stratified according to the results of the uterine artery Doppler measurement, and then
      randomized in two groups A and B. In group A, sFlt-1 concentration will be communicated to
      the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sFlt-1
      is 957 ng/mL. In patients with a high plasmatic concentration of sFlt-1 (+), the pregnancy
      will be closely monitored including repeated clinical, biological, and ultrasound
      examinations. Patients with sFlt-1 plasmatic concentration below 957 ng/mL (-) will be
      routinely followed-up.In group B, the result of sFlt-1 measurement will not be communicated
      and the pregnancy will be routinely monitored.Abnormal Doppler recordings in either group
      will result in a close monitoring as per our usual local practice. Urinary PlGF (expressed as
      a ratio PlGF/creatininemia) will also be measured and the results will be analyzed at the end
      of the study. Beside sFlt-1, we will store the plasmatic samples to measure other biomarkers
      that could be relevant in the future (no DNA analysis will be done without a new patient
      consent).
    

Intervention name(s): Transmission of sFlt-1 results to the investigator; No transmission of the sFlt-1 results to the investigator
Intervention type(s): Other; Other
Intervention description(s): Transmission of sFlt-1 results by the laboratory to the investigator; The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.
Other intervention name(s): Transmission of sFlt-1; No transmission of the sFlt-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preeclampsia; Hypertension; Intra uterine growth retardation; Antiangiogenic factor; Prevention
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
Condition: Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.

      PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have
      an advanced malignancy (cancer) or stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

      Phase I

        -  Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy.

        -  Determine the safety and tolerability of this drug in these patients.

      Phase II

        -  Determine the progression-free survival and time to progression in patients with stage
           IV melanoma treated with this drug.

        -  Determine the biological activity of this drug in these patients.

      OUTLINE: This is an open-label, dose-escalation study.

        -  Phase I (parts 1 and 2):

             -  Part 1: Patients receive PI-88 subcutaneously (SC) once daily on days 1-4 and
                15-18.

      Cohorts of 3-6 patients receive escalating doses of PI-88 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity. Once the MTD has been determined in part I, the
      effect of dose frequency is determined in patients in part II.

        -  Part 2: Patients receive PI-88 SC once daily on days 1-4, 8-11, 15-18, and 22-25 at a
           dose based on the MTD determined in part 1.

      Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is
      determined.

        -  Phase II (patients with metastatic melanoma): Patients receive PI-88 as in phase I, part
           2 at the MTD.

      Treatment in both phases repeats every 28 days in the absence of disease progression or
      unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 18-69 patients (18-30 for phase I [part 1], 6-9 for phase I
      [part 2], and 25-30 for phase II) will be accrued for this study.
    

Intervention name(s): PI-88
Intervention type(s): Drug
Intervention description(s): 250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle
Other intervention name(s): Mannopentaose phosphate sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific; stage IV melanoma; recurrent melanoma
A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
Condition: Neutropenia (Low White Blood Cell Count)
MeSH terms: Neutropenia; Leukopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is
      approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds
      of white blood cells (WBC) known as neutrophils. This type of white cell is important in
      fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by
      increasing the number of neutrophils that are produced in the body.

      This is important for patients who have low neutrophils due to chemotherapy, other treatments
      such as bone marrow transplant or certain other conditions with symptoms/problems related to
      low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in
      the body compared to Neupogen®.
    

Detailed description: 
      This is a randomized, open-label, multiple-dose, crossover study evaluating the
      pharmacodynamics and Pharmacokinetics equivalence following SC administration of test and
      reference product in healthy volunteers. The study will be conducted at a single Phase 1
      unit. There will be 30 healthy subjects in each of the two sequences.

      After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2
      treatment sequences:

        -  Filgrastim Hospira (US) in Period 1 followed by US-approved Neupogen® in Period 2.

        -  US-approved Neupogen® in Period 1 followed by Filgrastim Hospira (US) in Period 2.

      Subjects will receive one of each of the drugs once a day for 5 days in each of the treatment
      sequences.
    

Intervention name(s): Filgrastim Hospira (US); U.S.-approved Neupogen®
Intervention type(s): Biological; Biological
Intervention description(s): 5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days; 5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: filgrastim
Effect of Modulation of TENS in Pain After Cesarean Section
Condition: Pain
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve
      stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.
    

Detailed description: 
      Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off)
      and evaluated by NRS (numeric rating scale) before, immediately after application of TENS,
      and every 20 minutes until he was one hour after the application of electroanalgesia, to
      verify its effectiveness over time.
    

Intervention name(s): transcutaneous electrical nerve stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cesarean section; pain; transcutaneous electrical nerve stimulation; postpartum period
Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum
Condition: Pectus Carinatum; Quality of Life; Pain, Postoperative; Somatosensory Disorders
MeSH terms: Pectus Carinatum; Somatosensory Disorders; Pain, Postoperative
Study type: Observational

Summary: 
      The purpose of the study is to assess changes in health-related quality of life in patients
      undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term
      effects of surgical intervention in relation to the development of persistent postoperative
      pain and / or sensory disturbances in the surgical field.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus
        University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1,
        2012 to May 1, 2013 are invited to participated in the study
      
Keywords: Pectus carinatum; Quality of life; Pain, postoperative; Somatosensory disorders
Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research
Condition: Pain
Study type: Interventional

Summary: 
      Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is
      increasingly practiced worldwide. The effects of acupuncture in chronic pain have been
      investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for
      treating allergy. Recently, investigators found that histamine H1 receptor antagonists at
      relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing
      test. Investigators aim to further explore whether histamine H1 receptor antagonists also
      facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical
      trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA
      analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged
      between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham
      acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at
      ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36
      and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain
      threshold. It is expected that the completion of this proposed study will enhance our
      knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a
      low dose and help to define its application for clinical use.
    


Intervention name(s): electroacupuncture; antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate); antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate); acupuncture
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz); Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz); Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz); Minimal needling at ST36 and GB34
Other intervention name(s): chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab); chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs); shallow needling
Intervention MeSH terms: Chlorpheniramine; Maleic acid; Histamine Antagonists; Dexchlorpheniramine; Histamine H1 Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Electroacupuncture (EA); Antihistamine; Pain
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Condition: HIV; Chlamydia; Gonorrhea; Syphilis; Hepatitis C
MeSH terms: Hepatitis C; Gonorrhea; Syphilis
Study type: Interventional

Summary: 
      This study seeks to implement a sexual health promotion intervention for male sex workers in
      Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will
      increase testing, treatment and vaccination for sexually transmitted infections, including
      intentions of participants to engage in these services beyond the conclusion of the
      intervention. At the community level, the study hypothesis is that male sex workers will be
      more aware of sexual health care and more likely to access these services in the future.
    

Detailed description: 
      The intervention is administered in community and clinic settings. The full intervention
      consists of seven core modules: Sexual Health, Sexual Diversity, HIV/STI Transmission,
      Behavioral Risk and Risk Reduction, Alcohol and Drugs, Stigma, and HIV/STI and Health Seeking
      Practices. In the community, outreach is conducted by Health Educators to deliver the
      intervention modules that young men express and interest in, as well as to provide risk
      reduction materials including condoms and lubricant. Study interviewers conduct a
      cross-sectional interview of young male sex workers in community venues (the interviewers and
      health educators are never present in a venue at the same time), and a random sample of
      interviewees are invited to a local clinic, where they receive a more detailed interview, the
      full intervention (delivered one on one by a Health Educator and including all seven
      modules), a clinical exam, testing for HIV and other STIs (HBV, HCV, gonorrhea, syphilis,
      chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.
    

Intervention name(s): Sexual Health Promotion Intervention
Intervention type(s): Behavioral
Intervention description(s): The seven core modules are 1) the Importance of Sexual Health, 2) Sexual Diversity, 3) HIV and other STIs, 4) Behavioral Risk and Risk Reduction, 5) Alcohol and Drugs, 6) Stigma and 7) Health Seeking Practices. The five optional modules are 1) HIV Treatment and Adherence, 2) Stress Reduction, 3) HIV Status Disclosure, 4) MSM/Gay Disclosure, and 5) Other Sexual Health Concerns
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Condition: Enteral Feeding
Study type: Interventional

Summary: 
      Oral feeding is one of the primary functions of the neonatal brain. In preterm infant
      population, competency at oral feeding is one of the major milestones in preparation for
      discharge. Mother's voices have been shown to have a net stimulatory effect and premature
      infants have been found to have increased cardiorespiratory stability after listening to
      mother's voices. Main objective of this study is to determine if it is possible to expose
      preterm infant in a systematic manner to mother's voices before their feeds and to determine
      if this exposure results in an increase in their oral intake.
    

Detailed description: 
      Achievement of full oral feedings is directly associated with length of neonatal intensive
      care unit stay. Extremely low gestational age infants with dysfunctional oral feeding in
      early childhood have lower cognitive and language skills compared with those with normal oral
      feedings. Also, previous studies have shown a strong association between oral feeding and
      infant maturity and behavior state and positive feeding experience. In recent years, there is
      emerging evidence that non-medical developmental care interventions in the neonatal intensive
      care units such as kangaroo care, single family rooms, and music and massage therapy may be
      beneficial for preterm infants and improve their long term neurodevelopmental outcomes.
      Beneficial effects of exposure to mother's voice and sounds on preterm infants in the
      neonatal intensive care units are well documented. Our study proposes to examine the
      association between exposure to mother's voice prior to and during oral feeding and oral
      feeding volume and rate in preterm infants.
    

Intervention name(s): Maternal Voice Exposure
Intervention type(s): Behavioral
Intervention description(s): Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Maternal Voice
The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis
Condition: Steatohepatitis, Nonalcoholic
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the current study is to evaluate the safety and efficay of Montelukast in
      treatment of patients with fatty liver disease.
    


Intervention name(s): Control group; Montelukast group
Intervention type(s): Drug; Drug
Intervention description(s): patients received matching-image placebo once daily at bedtime for 12 weeks.; patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Belimumab in the Prevention of Kidney Transplant Rejection
Condition: Transplantation, Organ
Study type: Interventional
Phase: Phase 2

Summary: 
      Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes
      a transplanted kidney is rejected by the patient's immune system. Many types of immune system
      cells, including B cells, are active in rejection. B cells produce antibodies against
      anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that
      help prevent transplant rejection affect cells other than B cells. Belimumab is a medication
      used to treat a disease called lupus. Belimumab slows development of antibody-producing B
      cells. This study will test whether belimumab works on parts of the immune system that cause
      rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like
      flipping a coin, a computer will randomly assign half to be given belimumab and half to be
      given placebo (a fake medicine). Patients and doctors will not know which medicine was
      assigned until the study is over. A total of 7 doses of study medicine will be given through
      a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4,
      8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be
      given. After all of the doses have been given, patients will be watched and tested at 24, 36,
      and 52 weeks after the transplant surgery. Blood samples will be tested to see what study
      medicines do to the immune system in transplant patients. If patients get a kidney biopsy,
      the samples will be tested to see if belimumab had any effect. Patients will be asked many
      questions to see if they are having any side effects. The study will be done at Addenbrooke's
      Hospital in Cambridge and Guys &St Thomas Hospital in London, United Kingdom. A
      pharmaceutical company, GlaxoSmithKline, is funding the study.
    


Intervention name(s): Belimumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Belimumab (10 mg/kg) will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2); Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Infection; Quality of Life