bioihbjkbjnl/mcl2 huggingface dataset:
Happy Mommy! Happy Baby! Study
Condition: Pregnancy; Stress, Psychological; Stress, Physiological; Maternal-fetal Relations
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      The purpose of this study is to determine how difficult life-events that women experienced
      during their childhood might affect their babies.

      Women who are asked to participate in this study will fill out forms about their physical and
      mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses
      measured and have their baby's development and stress responses assessed.
    

Detailed description: 
      The objectives of this study are to further our understanding of maternal prepubertal
      adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound
      to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to
      determine the degree of maternal stress and prepubertal adversity, and an acoustic startle
      paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also
      utilizes an infant stress test to assess infant arousal.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from the greater Philadelphia and surrounding areas who are ages 18 - 45 and between
        8 and 17 weeks pregnant will be considered for enrollment into this study. All subjects
        must be physically healthy without a serious major medical illness, as well as be carrying
        a healthy fetus. Subjects will be recruited through fliers, advertising, and social media
        and may be directly approached at a University of Pennsylvania Health System (UPHS) or UPHS
        affiliated obstetrics and gynecology clinic. We anticipate the composition of the proposed
        study population to reflect the greater Philadelphia referral base. The projected
        composition from Philadelphia is African American 42.58%, Hispanic 8.5%, Asian 4.42%, Other
        2.04% and White, not of Hispanic Origin, 42.46%.

        Additionally, we plan to include father's of the babies that are willing and able to
        complete the ACE questionnaire.
      
Biospecimen description: 
      -  Salivary cortisol;

        -  Blood plasma Corticotropin-releasing Hormone (CRH).
    
Keywords: pregnancy; stress, psychological; stress, physiological; maternal-fetal relations
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Condition: Influenza
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the immune response and the tolerability of the influenza vaccine
      administered in children aged 6-13 years old.
    


Intervention name(s): Influsplit SSW® 2005/2006
Intervention type(s): Biological
Intervention description(s): Study influenza vaccine was administered intramuscularly in the non-dominant arm
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Baclofen for the Treatment of Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is first evidence from preclinical and clinical studies for the efficacy of the
      selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of
      this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen
      for relapse prevention in alcohol-dependent patients.
    


Intervention name(s): Baclofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.; Placebo
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Outcome in ICU Treated COVID-19: Return to Work
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Return to work (not being on sick leave) within one year after intensive care unit (ICU)
      admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors
      for not having returned to work will be compared to patients admitted to hospital and general
      population controls.

      The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of
      follow up. The hospital admitted cohort comprises four hospital admitted patients with
      COVID-19 per ICU patient, matched on age, legal gender and region. The general population
      controls are matched to the ICU patients in a one to four fashion on age, legal gender and
      region.

      ICU patients are identified in the Swedish intensive care registry. The hospital admitted
      patients are identified in the national patient registry and the population controls are
      identified in the population registry. Data on socioeconomics and income are provided by the
      Statistics Sweden. Data on comorbidity, medications and death are provided from the National
      board of health and welfare. Finally, data on sick leave are provided from the Swedish Social
      Insurance Agency.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Observational study. No intervention.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population consists of all patients a fulfilling the eligibility criteria.
      
Keywords: Long term outcome; Return to work; COVID-19; Risk factors; Critical care
Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      To develop a pragmatic migraine model the investigators will induce headache in healthy
      volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be
      pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used
      to test new drug candidates.
    

Detailed description: 
      There remains a great need for more effective anti-migraine drugs with fewer side effects.
      Human experimental models are valuable in early phase development of new anti-migraine drugs
      but useful models have not yet been developed. The investigators' group has shown that
      Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers
      and in patients with migraine without aura (MO).

      To validate cilostazol as a model, the headache must respond to specific migraine treatment
      with sumatriptan.

      Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced
      headache can be pre-treated with a specific anti-migraine drug; sumatriptan.

      Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
    

Intervention name(s): Placebo; Sumatriptan
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Femoral Nerve Blockade in Endovenous Laser
Condition: Pain
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      Varicose veins affect a majority of adult population in the western world. They decrease
      quality of life and may also cause venous ulcers. Therefore varicose vein treatments are
      justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins.
      At the outpatient setting, however, treating both limbs at the same time may be painful to
      the patient especially, if simultaneous phlebectomies are performed.

      The study aims to evaluate, if femoral nerve blockade can significantly decrease pain during
      the procedure without prolonging the stay in the hospital.
    

Detailed description: 
      Varicose veins affect a majority of adult population in the western world. They decrease
      quality of life and may also cause venous ulcers. Therefore varicose vein treatments are
      justified.

      Thanks to technical advancement open surgery has been replaced By endovenous means. Currently
      endovenous thermal ablation is a golden standard for main trunk disease. For efficient
      patient and procedure flow majority of thermal ablations are performed at the outpatient
      setting. However, if patient is suffering from significant varicose veins, treating both
      legs, may be unpleasant to the patient.

      Aim of the study is, whether addition of femoral nerve blockade to the tumescent anesthesia
      can decrease pain during the procedure without prolonging the stay in the hospital.
    

Intervention name(s): Femoral nerve blockade; The current standard treatment
Intervention type(s): Drug; Procedure
Intervention description(s): The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.; Tumescent anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; femoral nerve blockade; varicose vein
Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into
      2 groups:

        -  group I: women who had only good-quality embryo transfer.

        -  group II: women who had both good-quality and poor-quality embryo transfer.

      primary outcome was ongoing clinical pregnancy rate
    


Intervention name(s): Embryo transfer
Intervention type(s): Other
Intervention description(s): Transfer of different qualities of embryos at blastocyst stage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Condition: Haemophilus Influenzae Type b (Hib) Infection
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of single dose of two commercially
      available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59
      months of age.
    


Intervention name(s): Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib); Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
Intervention type(s): Biological; Biological
Intervention description(s): a single dose was administered; a single dose was administered
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b (Hib); Vaccine; Anti PRP antibody
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in patients with advanced solid tumours. Part A will investigate the
      PK of olaparib in patients with mild or moderate renal impairment compared to patients with
      normal renal function; Part B will allow eligible study patients continued access to olaparib
      after the PK phase and will provide additional safety data.
    


Intervention name(s): Olaparib tablet dosing
Intervention type(s): Drug
Intervention description(s): Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: oncology,; cancer,; neoplasm,; anticancer drug,; pharmacokinetics,; area under curve,; olaparib,; solid tumour,; mild renal impairment,; moderate renal impairment
Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS Versus Placebo in the Treatment of a Single Attack of Acute Migraine Headache
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single
      acute migraine attack with or without aura
    


Intervention name(s): BIBN 4096 BS; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The major objective of this proposal is to test the hypothesis that the addition of
      divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly
      improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a
      double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or
      schizoaffective disorder.
    

Detailed description: 
      Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective
      disorder. It has been found that cognitive dysfunction may be even more important than
      positive or negative symptoms in predicting functional outcomes such as community adjustment,
      ability to work, social interactions, and caretaker burden. Preclinical data from our
      laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER
      can improve cognitive impairment in patients.

      The major objective of this proposal is to test the hypothesis that the addition of
      divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly
      improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a
      double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or
      schizoaffective disorder.
    

Intervention name(s): divalproex sodium ER; placebo
Intervention type(s): Drug; Drug
Intervention description(s): divalproex sodium ER1000 mg; placebo identical in appearance to active comparator
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia, cognition, mood stabilizer
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
Condition: Congenital Heart Disease in Children; Extracorporeal Circulation; Complications
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart
      disease causes significant morbidity and mortality. The perioperative period is a period of
      major vulnerability implicated in the appearance of these sequelae, and it is therefore
      essential to monitor brain function during ECC. The quality of cerebral oxygenation in the
      perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which
      makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The
      association between time spent outside the limits of cerebral self-regulation and the
      occurrence of perioperative encephalopathy is not known. The purpose of this study is to
      determine whether disturbances in brain self-regulation during the operative period are
      associated with the occurrence of postoperative encephalopathy in children operated on for
      congenital heart disease in the neonatal period. The main objective of the research is to
      determine the association between time spent outside individually determined cerebral
      self-regulation limits and the appearance of brain lesions suggestive of low brain output.
      Secondary objectives will investigate the association between time spent outside
      self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical
      and encephalographic criteria and will study factors predictive of the development of
      postoperative encephalopathy.
    


Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): Pre and Post operative MRI
Intervention model: Single Group Assignment
Intervention model description: Monocentric, prospective and pilot study
Masking: None (Open Label)
Primary purpose: Other
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
Condition: Heart Failure, Systolic
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if metformin is taken up into the failing myocardium.
      Recent experimental and epidemiological studies have shown beneficial effects of metformin on
      heart failure. It is unknown whether this effect is direct or indirect.

      The aim of the study is to investigate if metformin is taken up in heart failure using a
      novel 11C-metformin tracer and positron emission tomography (PET).
    


Intervention name(s): 11C-metformin
Intervention type(s): Radiation
Intervention description(s): 200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Intervention model description: All 6 subjects allocated to the study will receive 11C-metformin intravenously.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Heart Failure; Organic cation transporter; Pharmacogenetics; Pharmacokinetics; Positron Emission Tomography
Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI
Condition: Diabetes; Effects of Liraglutide Administration on Brain Activity; Weight Loss; Hunger
MeSH terms: Diabetes Mellitus; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to help us understand the effects of diabetes medication
      Liraglutide on weight loss and hunger. The investigators have already determined what the
      highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide
      was approved by the FDA in January 2010 for treatment of diabetes.

      The investigators will also study the following:

        1. The impact of Liraglutide on brain responses to food

        2. It's effect on physiological and mental performance

        3. If its effect on the brain differs among obese and lean diabetic subjects.
    

Detailed description: 
      This is a randomized, placebo controlled, cross-over, double-blinded study to assess the
      effects of liraglutide on brain activation in areas involved in cognitive control and reward
      during food visualization.

      Study participation will span approximately 1.5-2 months. Subjects will learn to
      self-administer the medication and will have a total of 8 study visits plus one screening
      visit. The visits will include the following tests/procedures:

        1. Vital signs (blood pressure, temperature, heart rate, breathing rate)

        2. Height, weight and other body measurements like waist

        3. Blood tests

        4. Urine pregnancy test (women only)

        5. Electrocardiogram (EKG)

        6. Medical history

        7. Physical exam

        8. Body Composition tests

        9. Study logs to record food intake and blood sugar

       10. functional MRI

      We plan to recruit a total of 24 subjects to be treated with placebo and liraglutide. We
      propose to enroll 12 obese diabetic (type 2) and 12 lean diabetic (type 2) subjects. Equal
      numbers of men and women will be enrolled and the randomization will block for gender.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In the experimental arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject Liraglutide once per day for 18 days. Subjects will start the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week.; In the placebo arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject placebo once per day for 18 days.
Other intervention name(s): victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: fMRI; Liraglutide; diabetes; GLP-1
Bilateral Laryngeal Paralysis Reinnervation
Condition: Vocal Cord Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech
      alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve
      root to patients with bilateral laryngeal paralysis.
    


Intervention name(s): surgical reinnervation
Intervention type(s): Procedure
Intervention description(s): laryngeal reinnervation with a phrenic nerve root
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bilateral vocal cord paralysis; reinnervation; phrenic nerve