bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after
      administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest
      and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg
      Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium
      after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg
      Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing
      0.451 mg levomefolate calcium
    


Intervention name(s): BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium; BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG); BAY 86-7660,levomefolate calcium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days; Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days; Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
Intervention MeSH terms: Calcium, Dietary; Tetrahydrofolates; Dienogest; Calcium; Nandrolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Glymphatic Kinetics In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      This study is being done in order to see how gadolinium-based MRI contrast (Magnevist)
      travels through the central nervous system (CNS) when injected through the spinal column, and
      to compare differences between two age groups (age 20-50, and 51-80). This will allow
      investigators to evaluate how much contrast has crossed into the tissue surrounding the
      brain. Such information will help investigators determine whether this kind of contrast can
      be used to model how other drugs might travel through the CNS and evaluate its use as an
      illustrative imaging marker that mirrors the glymphatic system.
    

Detailed description: 
      This is a prospective, longitudinal study of MR imaging of intrathecally delivered gadolinium
      contrast (Magnevist, Gd-DTPA) in healthy adult male and female subjects. Subjects will be
      divided into two groups (20-50 years old and 51-80 years old) both of which will receive
      intrathecal injection of the drug Magnevist (Gd-DTPA), followed by serial MR imaging over the
      course of 10-12 hours. The purpose of the study is determine the transport kinetics of
      Central Nervous System (CNS) exposure to gadolinium contrast injected into the lumbar
      intrathecal space (lower back) and evaluate changes with age. This will allow investigators
      to evaluate the brain parenchymal penetration of gadolinium as an illustrative imaging marker
      that mirrors the glymphatic system. Investigators hypothesize the exposure and penetration
      patterns of the neuraxis to neurotherapeutic drugs can be modeled using gadolinium
      intrathecal contrast administered in the lumbar intrathecal space.
    

Intervention name(s): MR Imaging; CT-guidance
Intervention type(s): Other; Other
Intervention description(s): All subjects will undergo six sessions of MR imaging over a 10-12 hour period; All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Glymphatic network; healthy; central nervous system
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      Recurrent regurgitation stress the infants and their parents and often results in an
      inappropirate use of PPI prescription in infancy. The aim of this study is to evaluate the
      efficacy of Mg alginate in infants with symptoms of gastroesophageal reflux.
    


Intervention name(s): Mg alginate
Intervention type(s): Dietary Supplement
Intervention description(s): Mg alginate after feedings
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled cross-over trial
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the relationship between the pharmacokinetics and pharmacodynamics of
      UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).
    


Intervention name(s): Maraviroc (UK-427,857); Maraviroc (UK-427,857); Maraviroc (UK-427,857); Maraviroc (UK-427,857); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 25 mg oral tablet once daily for 10 days; 50 mg oral tablet twice daily for 10 days; 100 mg oral tablet twice daily for 10 days; 300 mg oral tablet twice daily for 10 days; Matching placebo oral tablet twice daily for 10 days
Other intervention name(s): Celsentri, Selzentry; Celsentri, Selzentry; Celsentri, Selzentry; Celsentri, Selzentry; Celsentri, Selzentry
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; Treatment Naïve
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, multiple doses, one-sequence design study in two parallel groups
      of healthy volunteers
    

Detailed description: 
      Single centre, open-label, multiple doses, one-sequence design study in two parallel groups
      of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending
      doses of Lamotrigine (LMT) in last phases; Group B: Pre-treatment with LMT, treatment with
      LMT and ascending doses of ESL in last phases
    

Intervention name(s): Eslicarbazepine acetate; Lamotrigine
Intervention type(s): Drug; Drug
Other intervention name(s): ESL; LMT
Intervention MeSH terms: Lamotrigine; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of mPEG-R-Crisantaspase Given IV
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, multicenter study with a dose escalation of Asparec®
      administered once every two to four weeks for two administrations. The primary objective of
      this study is to determine the Maximum Tolerated Dose following one single dose of Asparec
      when administered in a population of patients with relapsed or refractory hematological
      malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which
      are to evaluate the safety of Asparec and to determine the PK profile as assessed by
      measurement of plasma L-asparaginase enzymatic activity following single and repeated doses
      of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be
      measured.
    

Detailed description: 
      Planned sample size: Up to 36 evaluable subjects will be enrolled in the study: a maximum of
      30 subjects for the dose escalation phase and up to a maximum of 12 patients in the expansion
      phase.

      Inclusion criteria consists of:

      Patients with any relapsed or refractory hematological malignancy, for which standard
      curative or life prolonging treatment does not exist, or is no longer effective or tolerable.

      For the following hematological malignancies, patients must have received at least: Low rade
      NHL: 3 prior lines of therapy, ALL, aggressive NHL and other hematological malignancies: 2
      prior lines of therapy, Aged 18 to 50 years and ECOG performance status of 1, 1 or 2.

      All patients will be treated with Asparec once every two to four weeks for two IV
      administrations infused in 60 minutes. Patients without Disease Progression may receive
      additional administrations, each administration starting at least 14 days but no later than
      28 days after the previous Asparec administration.
    

Intervention name(s): mPEG-r-crisantaspase
Intervention type(s): Biological
Intervention description(s): IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%
Other intervention name(s): Asparec
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; Lymphoma; C240588.448; C115.378.400
Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis
Condition: Prostatic Neoplasms Benign; Radiotherapy Side Effect; Lymph Node Disease
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal
      vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010
      and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as
      well as toxicity according to CTCAE v4.03.
    

Detailed description: 
      Collection of data and retrospective analysis of patients with high risk prostate cancer
      treated with radiotherapy to pelvic lymph nodes.

      What influence has irradiation of pelvic lymph nodes on patients with high risk prostate
      cancer in terms of progression free survival and toxicity. How does this influence side
      effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and
      genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)
    

Intervention name(s): Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Retrospective analysis of men irradiated for high risk prostate cancer including pelvic
        lymph nodes (L5/S1)
Bariatric Surgery and Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Bariatric Surgery
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each
      disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric
      surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two
      conditions separately, and these treatment modalities both present a unique set of challenges
      in terms of patient-adherence. Furthermore, the combined effects of these therapies on body
      weight and OSA severity are unclear, and require longitudinal investigation. The purpose of
      the research proposed herein is twofold: A) To prospectively demonstrate the specific
      physiologic/psychological improvements in OSA risk factors and disease severity that occur in
      a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP
      and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss,
      dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or
      non-compliant with prescribed PAP therapy. The investigators anticipate that results will be
      used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in
      bariatric surgery patients. Furthermore, this line of research has many implications for
      strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and
      other clinical sub-specialties that are integral to the postoperative health of these
      patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese women, 20 - 85 years of age
Investigation of Fat Oxidation During Moderate Versus Vigorous Intensity Exercise
Condition: Healthy; Sedentary Lifestyle
Study type: Interventional

Summary: 
      Exercise is widely suggested as an important lifestyle change for weight loss, however, the
      optimal level of intensity moderate versus vigorous remains unclear. It is known that in
      athletes, during very high-intensity exercise, fat oxidation is decreased and energy is
      gained mainly from carbohydrate utilization. The aim of this study is to find an optimal
      workload based on fat oxidation rate during exercise in volunteers with a sedentary
      lifestyle.
    

Detailed description: 
      It is planned to recruit 12 healthy volunteers with a sedentary lifestyle in the study group.
      Since different regimens (fed, fasted and moderate versus vigorous) will be compared in the
      same subjects, no control group is necessary. Subjects will perform a cycling test with 5 min
      incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load
      will be selected after the incremental intensity exercise). The expiration of carbon dioxide
      (CO2) and consumption of oxygen (O2) will be measured, to determine the total fatty acid and
      carbohydrate oxidation during cycling. Concomitantly, it is planned to measure blood lactate
      and glucose concentrations during exercise experiments as well as a wide range of blood
      biochemistry parameters before and after exercise.

      The investigators expect to find optimal conditions for the sedentary population for burning
      of fat, which is the major source of energy during moderate-intensity exercise. Measurements
      of the fat and carbohydrate oxidation in healthy volunteers with a sedentary lifestyle will
      contribute to the understanding of exercise regimens for the most effective fat oxidation.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected in incremental intensity exercise).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; fed; fasted; fat; carbohydrate
Most People With Low Back Pain Have Associated Cervicothoracic Musculoskeletal Dysfunction: an Observational Study
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      In general , the diagnosis of back pain can be broken into three major categories: Mechanical
      ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection
      , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders ,
      neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical
      factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red
      herrings that must be considered most seriously.

      The investigators have observed in their practice that lateral pressure on 5th lumbar
      vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over
      cervicothoracic spines reproduce original low back and leg pain. So the question arises
      whether Cervico-thoracic dysfunction is associated with low back pain with or without
      radiation to lower extremities?
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with low back pain who had attended our hospital and sub centres with a complaint
        of low back pain
Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients
Condition: Amenorrhea
MeSH terms: Amenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Antipsychotics such as risperidone could induce amenorrhea in schizophrenic patients. The
      investigators conducted a randomized, placebo-controlled study to test the efficacy of
      metformin for antipsychotic induced amenorrhea in schizophrenia patients.
    


Intervention name(s): metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
VRH Pain Reduction During Burn Wound Care and Physical Therapy
Condition: Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.
    

Detailed description: 
      The purpose of the study is to examine whether there is more effective relief of pain and
      anxiety during wound care procedures in burn-injured patients that are treated with Virtual
      Reality Hypnosis with post-hypnotic suggestion.
    

Intervention name(s): using VR hypnosis/distraction and audio hypnosis
Intervention type(s): Behavioral
Intervention description(s): a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Virtual Reality Hypnosis
Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
Condition: Infections, Human Immunodeficiency Virus and Hepatitis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744
      (744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a
      commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and
      levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in
      Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive
      oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC
      free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC
      alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined
      on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel and
      ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration with
      744 results in a significant change in OC exposure compared to OC alone. Subjects will return
      to the study center for final follow-up evaluations 7 to 14 days after the last dose of study
      medication (Days 28 to 35).
    


Intervention name(s): Ethinyl Estadiol; Levonorgestrel; GSK1265744
Intervention type(s): Drug; Drug; Drug
Intervention description(s): EE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water; LNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water; GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water
Intervention MeSH terms: Cabotegravir; Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ethinyl estradiol; GSK1265744; pharmacokinetics; oral contraceptive; oral contraceptive containing levonorgestrel and ethinyl estradiol; levonorgestrel
Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom
Condition: COVID; AKI
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in
      December 2019. It quickly spread to rest of the world and was declared pandemic by World
      health organisation. Initial case series focused on lung involvement in the form alveolar
      haemorrhages and respiratory failure. However, subsequently, there have been reports of
      kidney involvement resulting in severe acute kidney injury. However, the reported incidence
      from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease
      is lacking.
    

Detailed description: 
      On 31st December 2019, a cluster of pneumonia cases were detected in Hubei province of China
      where the cause was unclear. The cause for these cases was subsequently identified as a virus
      which was referred to as SARS-CoV-2, and the associated disease as COVID-19.This evolved
      rapidly into a global pandemic with first case reported in UK as early as on 30th January
      2020. As of 30th April 2020, there have been 3.05 million laboratory confirmed cases
      world-wide with 161,145 cases in United Kingdom (UK) in 539,768 cases tested for COVID-19.
      The epidemiology of COVID-19 has differed in China, US and Italy which have different
      demographic characteristics, testing methods and different ways to curb the spread of
      infection which can be altered by many things, including behaviour, and the stringent social
      distancing measure.Though the pandemic started in China, as of 30th April 2020, it has
      reported only 58.32 cases per million people (pmp) as compared to United kingdom which has
      reported 2433.8 cases pmp. This has resulted in different epidemiology of COVID-19 and organ
      system involvement. Lung involvement in the form of alveolar haemorrhages and respiratory
      failure has been well document in patients with COVID-19 and has been focus of attention,
      however, other organs are also affected in COVID-19, but there has been limited information
      kidney involvement in COVID patients.
    

Intervention name(s): acute kidney injury
Intervention type(s): Other
Intervention description(s): AKI in COVID positive cases
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is hospitalised patients suspected to have SARS CoV-2 infection