bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy
Condition: Lung Neoplasms; Postoperative Pain
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy
      and it has reduced the operative morbidities and mortalities. However, thoracoscopic
      lobectomy also results in operative acute pain and the incidence of chronic pain after
      thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,
      torque at trocar and working window by operator, and compression of intercostal nerves have
      been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous
      patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,
      sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic
      delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the
      effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous
      paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might
      reduce the side effects of IV PCA and control the operative pain effectively. In this study,
      we investigate the effectiveness of continuous paravertebral infusion of local anesthetics
      thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.
    


Intervention name(s): 0.5% ropivacaine; Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
Intervention type(s): Drug; Drug
Intervention description(s): (n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA); (n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)
Intervention MeSH terms: Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pain control, VATS
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
Condition: Severe Hepatic Impairment; Normal Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The influence of severely diminished liver function on the metabolism, safety, and
      tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are
      compared to the data gained from 8 age- and BMI-matched men with normal liver function.
    

Detailed description: 
      Screening takes place between Day -22 and Day -2, and subjects are admitted to the clinic on
      Day -1. Each subject receives a single oral dose of enzalutamide on Day 1, under fasted
      conditions. They are discharged on Day 7; ambulant visits take place until Day 50. An End of
      Study Visit (ESV) occurs 7-10 days after the last PK sampling or early withdrawal.

      Full PK profiles are obtained for enzalutamide, metabolite 1 of enzalutamide (M1) and
      metabolite 2 of enzalutamide (M2) up to 1176 hours (Day 50) after administration.

      Safety assessments are performed throughout the study. For subjects with severe hepatic
      impairment, additional Child-Pugh classification and laboratory safety tests (including liver
      function tests) are performed regularly after administration.
    

Intervention name(s): enzalutamide
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): ASP9785,; MDV3100,; Xtandi
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Pharmacokinetics; Safety; Severe hepatic impairment; Enzalutamide
Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
Condition: Healthy; Pharmacokinetics of ASP7991
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics
      of ASP7991 after multiple oral administrations to non-elderly subjects.
    

Detailed description: 
      In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a
      double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered
      repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes
      after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the
      safety in the blinded manner for deciding an escalation to the step.
    

Intervention name(s): ASP7991; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: ASP7991
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Plasma concentration; Urinary concentration; ASP7991
Speech Therapy in the Management of Chronic Cough
Condition: Cough; Speech Therapy
MeSH terms: Cough; Communication Disorders
Study type: Interventional

Summary: 
      Speech and language intervention (speech therapy) is one of the few methods which seem to be
      useful in management of persistent chronic cough. This method has not been available for
      patients with cough in Poland so far.The aim of the study is to implement speech therapy to
      the management plan of patients with difficult-to-treat chronic cough and to analyze its
      efficacy in this particular group.

      Patients with difficult-to treat chronic cough will be offered speech and language
      intervention as an added therapy. The effectiveness of speech therapy will be measured by
      changes in cough severity, its influence on quality of life and cough challenge test before
      and after speech therapy measured in every patient.
    

Detailed description: 
      The efficacy of management of chronic cough in adults is limited. Speech and language
      intervention (speech therapy) is one of the few methods which seem to be useful in management
      of persistent chronic cough. This method has not been available for patients with cough in
      Poland so far.

      The aim of the study is to implement speech therapy to the management plan of patients with
      difficult-to-treat chronic cough and to analyze its efficacy in this particular group.

      Patients, who are diagnosed and unsuccessfully managed because of difficult-to treat chronic
      cough, will be offered speech and language intervention as an added therapy. It is based on
      the technique described by Vertigan et al.The entire therapy will consist of eight sessions
      once a week.

      Cough severity, its influence on quality of life and cough challenge test with capsaicin will
      be assessed by Visual Analogue Scale, Leicester Cough Questionnaire and cough challenge test
      with capsaicin will be performed before and after speech therapy in every patient to analyze
      its effectiveness
    

Intervention name(s): Speech and language intervention
Intervention type(s): Behavioral
Intervention description(s): Speech therapy includes education about cough and vocal hygiene, teaching strategies to reduce cough, breathing and vocal exercises. The whole therapy consists of eight sessions once a week.
Other intervention name(s): Speech therapy; Voice therapy
Intervention model: Single Group Assignment
Intervention model description: prospective, single arm, single center study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic cough; speech and language intervention; difficult-to-treat cough
A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of selpercatinib on how fast midazolam
      gets into the blood stream and how long it takes the body to remove it when administered in
      healthy participants. Information about safety and tolerability will be collected. The study
      will last up to about 6 weeks, inclusive of screening period.
    


Intervention name(s): Midazolam; Selpercatinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise
Condition: Masks
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study will be to assess the effects of the use of masks on inspiratory
      muscle strength, metabolic parameters, heart rate, subjective perception of effort and the
      sensation of dyspnea before, during and after an aerobic test of 30 minutes long and a fixed
      load at lactate threshold. A randomized study of repeated measures will be carried out. A
      total sample of 35 active participants will be recruited. All participants will carried out a
      lactate threshold test and then 3 visits to the laboratory (separated at least 48 hours from
      each other) in order to perform 3 test of 30 minutes long without mask, with a surgical mask
      or with a FFP2 respirator (in a randomized order) at an intensity around lactate threshold
      intensity. Maximal inspiratory pressure, oxygen saturation, heart rate, blood lactate
      concentration, subjective perception of effort and dyspnea will be assessed before, during
      and after the 3 fixed intensity tests.
    


Intervention name(s): steady intensity aerobic test of 30 minutes long
Intervention type(s): Diagnostic Test
Intervention description(s): the use of different type of masks during an aerobic exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Transoesophageal Echocardiography in Liver Transplantation
Condition: End Stage Liver Disease
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Observational

Summary: 
      Severe hypotension during reperfusion in liver transplantation is a frequent adverse event.
      Rare data exist so far about pathophysiology of this phenomenon. The exact role of left
      ventricular function, which might be impaired causing hypotension, has not been elucidated
      during the period of reperfusion.

      Goal of this study is to:

        -  perform transesophageal echocardiography in order to assess systolic and diastolic left
           ventricular function during reperfusion

        -  determine inflammatory mediators in the plasma which could cause left ventricular
           dysfunction
    


Intervention name(s): Transoesophageal echocardiography
Intervention type(s): Behavioral
Intervention description(s): Transoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients on waiting list for liver transplantation
Circadian Misalignment and Insulin Sensitivity
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      This study will evaluate the effect of circadian misalignment on insulin sensitivity in
      healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the
      research facility for two study periods of 3 and 3.5 days. In one of the study periods, the
      behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a
      hyperinsulinemic euglycemic clamp.
    

Detailed description: 
      Recent evidence shows that misalignment of the circadian rhythm (e.g. by rotating shift work)
      impairs glucose metabolism markedly, possibly by decreasing insulin sensitivity in peripheral
      tissues and liver. Nowadays our society is indispensably connected to a lifestyle that allows
      wakefulness at every time of the 24 hours cycle. Social jetlag is a phenomenon that affects a
      large part of the general population, thus circadian misalignment extends far beyond those
      who are on a shift work schedule. Therefore, decreased insulin sensitivity in individuals
      affected by circadian misalignment may help to explain the increased prevalence of T2DM in
      night shift workers that has been found in epidemiological studies.

      The study is an interventional randomized crossover trial in which each subject serves as it
      owns control. For the study, the investigators ask the subjects to participate in two study
      periods, one of 3 days length (control condition) and the other of 3.5 days length
      (misalignment condition). During the 3.5 day misalignment condition, subjects will shift
      their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment.
      Insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp. Secondary
      parameters will include ex-vivo skeletal muscle mitochondrial function and whole-body energy
      metabolism.
    

Intervention name(s): Circadian Misalignment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Circadian Rhythm; Circadian Misalignment; Insulin Sensitivity
Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study focusing on sound therapy in patients with fibromyalgia is a single-centre,
      prospective, randomized study which evaluates the improvement or not of painful symptoms
      following relaxation sessions with sound therapy.
    

Detailed description: 
      Sound therapy consists in sound use as therapy and appears to mitigate or even relieve some
      symptoms.

      The SonoMyal study intends to compare the effects of relaxation sessions with sound therapy
      delivered by tuning forks to a control group who will benefit from relaxation sessions
      without tuning fork activation, in a population of women with fibromyalgia.

      The treatment consists in one session per week during 3 weeks, for a total of 3 sessions.
      Questionnaires to assess pain, anxiety and the ability to let go will be completed by
      patients before the beginning of the first session and at the end of the last session.

      The main objective of the study is to assess with a Visual Analogue Scale of pain if 3
      relaxation sessions with sound therapy delivered by tuning forks can improve pain perception
      in patients with fibromyalgia.
    

Intervention name(s): Sound therapy associated with relaxation; Relaxation alone
Intervention type(s): Other; Other
Intervention description(s): Each patient will attend a total of 3 sessions of about 15 minutes each, once by week.
Sessions will start with relaxation. Then, sound therapy will be delivered using weighted medical tuning forks which resonate at a specific frequency. At the end of the session, the patient will be invited to take a short rest.; Each patient will attend a total of 3 sessions of about 15 minutes each, once by week.
The procedure will be exactly the same than the other arm (relaxation, rest time), but the operator will not activate any tuning fork (so there will be no sound delivered during the session).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fibromyalgia; Chronic pain; Sound therapy; Tuning fork
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
Condition: Tetanus; Hepatitis B; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Diphtheria; Neisseria Meningitidis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine
      co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4
      months of age.
    


Intervention name(s): GSK2202083A vaccine; Prevenar 13®; Infanrix hexa™; Menjugate®; Rotarix™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses given at 2, 4 and 12 months of age; 3 co-administered doses; 3 doses given at 2, 4 and 12 months of age; 3 co-administered doses; Oral, two doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Observational

Summary: 
      RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients
      with cancer in the laboratory may help doctors learn more about the effects of rituximab on
      cancer cells. It may also help doctors identify biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in samples from patients with follicular
      lymphoma treated with rituximab.
    

Detailed description: 
      OBJECTIVES:

        -  Correlate immunoglobulin Fc receptor (FcγR) polymorphisms with response, response
           duration, and time to resistance in samples from patients with follicular lymphoma (FL)
           treated with single-agent rituximab on ECOG-E4402.

        -  Identify gene expression profiles that correlate with response, response duration, and
           time to rituximab resistance in these patients.

        -  Determine whether the FL microenvironment is predictive of initial response and duration
           of response to rituximab.

      OUTLINE: DNA and RNA from banked peripheral blood mononuclear cells (PBMCs) and
      formalin-fixed paraffin-embedded (FFPE) tumor samples are analyzed for
      immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma
      microenvironment by real-time PCR, microarray hybridization, and IHC.

      PROJECTED ACCRUAL: A total of 259 PBMC samples and 300 FFPE blocks will be accrued for this
      study.
    

Intervention name(s): gene expression analysis; microarray analysis; polymerase chain reaction; polymorphism analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E4402 from whom samples were submitted for research
      
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning,
      versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the
      study as an active control.
    


Intervention name(s): montelukast sodium; Comparator: loratadine; Comparator: placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): montelukast 10 mg tablet orally once daily in the morning for 4 weeks; loratadine 10 mg tablet orally once daily in the morning for 4 weeks; placebo tablet orally once daily in the morning for 4 weeks
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins
      (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor
      any and all side effects of the nasal Menopur.
    

Detailed description: 
      Gonadotropins are used during fertility treatments such as intrauterine insemination (IUI) or
      in vitro fertilization (IVF). These fertility medications are given by injection that contain
      follicle-stimulating hormone (FSH) alone or combined with luteinizing hormone (LH). During a
      regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in
      the brain to naturally stimulate the ovaries to make a single egg each month. When FSH and/or
      LH are given as an injection as fertility treatment, they work directly on the ovaries to
      make multiple follicles which are cysts containing the eggs.

      Injections of gonadotropins are started early (usually on the third day) in the menstrual
      cycle to cause multiple eggs to grow to a mature size. Close monitoring of patients with
      ultrasound and blood are usually needed for monitoring. The ultrasound measures the size of
      the ovarian follicles. Blood is usually drawn every other day or daily (for a total of 12
      days on average) for measurement of Estradiol (E2), progesterone (P4), and luteinizing
      hormone (LH). The measurement of E2, P4 and LH is intended to quantify the response of the
      ovaries to the daily injectable gonadotropins. When the follicles grow to a large size
      (usually 18 mm), human chorionic gonadotropin (hCG), another injectable medication, is then
      used to trigger the maturity of the eggs before performing egg retrieval during an IVF cycle.

      Instead of injectable gonadotropins, this study uses nasal gonadotropins (Menopur) in order
      to evaluate its safety and efficacy of in women undergoing IVF.
    

Intervention name(s): Menopur; Synarel; HCG trigger; Clomiphene citrate; Letrozole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Nasal versus injectable; nasal; injectable; oral; Oral
Other intervention name(s): gonadotropin; GnRH agonist; HCG; Clomid; Femara
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene; Menotropins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Infertility; Gonadotropins; Menopur; Ovarian stimulation