bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg
      per day and will compare agomelatine and paroxetine tolerability. Eligible patients will
      receive double-blind study medication for 8 weeks. One week after completion of the
      double-blind treatment phase there will be a single follow-up visit.
    


Intervention name(s): Agomelatine; paroxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Either 25 mg or 50 mg agomelatine orally once daily
Other intervention name(s): Paxil
Intervention MeSH terms: Agomelatine; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: agomelatine, Major Depressive Disorder, MDD, depression
Breath Analysis in Asthma
Condition: Asthma; Exhaled Breath; Mass Spectrometry
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to answer the question whether a disease-specific profile of
      breath in patients with asthma can be detected by an untargeted metabolomic study using
      exhaled breath analysis by mass spectrometry.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from asthma will be included according to the predefined inclusion and
        exclusion criteria.

        Healthy controls will be recruited from the general population by printed flyers, newspaper
        advertisements and personal communication.
Characterization of Bovine Adrenal Medulla as a New Surrogate Model of Non-histaminergic Itch
Condition: Itch
Study type: Interventional

Summary: 
      With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
      itch induced by BAM8-22
    

Detailed description: 
      With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
      itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human
      body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a
      TRPA1 antagonist (A-967079)
    

Intervention name(s): A-967079 and BAM8-22 application; A-967079 and BAM8-22 application after 5 minutes.; A-967079 application.; Vehicle and BAM8-22 application.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml) and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules; A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml). BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied 5 minutes after to a previously determined area on the volar forearm using inactivate cowhage spicules; A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml) will be applied to a previously determined area on the volar forearm; Vehicle (in PBS, subcutaneous injection of 0.1ml) and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Nephrostomy on Relative Function of Obstructed Kidney
Condition: Obstructive Uropathy
MeSH terms: Urologic Diseases
Study type: Interventional

Summary: 
      Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal
      function has an important role in the treatment of obstructed kidneys. Nephrectomy can be
      recommended when the relative renal function is 10% or less in radionuclide examinations.
      Recently, however, nephron sparing approaches have come to the fore. This indicated the need
      to evaluate the possibility of recovering the function of the kidney before nephrectomy. The
      aim of this study is to compare relative functions of obstructed kidneys in technetium 99m
      dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.
    

Detailed description: 
      Obstructive uropathy is one of the most important causes of acute renal injury and end-stage
      renal failure. obstruction of urine flow increases the intratubular pressure. This pressure
      increase causes decrease in renal blood flow and starts the inflammatory process. In the
      first few hours after total ureter obstruction, due to the increase in intratubular pressure
      glomerular filtration ceases and tubular transport is markedly decreased. Long lasting
      obstruction results in renal fibrosis and end stage renal damage. Basically obstructive
      uropathy leading to irreversible renal damage and loss of renal function is the main
      indication for simple nephrectomy. Serious renal parenchymal damage is defined as
      non-functioning kidney having relative renal function (RRF) 10% or less in the literature.
      But recently in some studies it was suggested that by applying the nephrostomy catheter,
      ability of kidney to regain function can be evaluated before nephrectomy. So, possibility of
      gaining function should be kept in mind. In this study effect of percutaneous nephrostomy
      tube on serum creatinine, blood urea nitrogen (BUN) and RRF in obstructed kidney with RRF 10%
      or less. Before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and RRF in
      DMSA was recorded and compared.
    

Intervention name(s): Percutaneous nephrostomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Intervention model description: Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive uropathy; relative renal function; DMSA
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the study was to characterize and quantify the histopathological changes
      in the surgical specimens obtained in patients undergoing prostatectomy in addition to
      imaging changes (MRI) following a single injection of Liproca Depot in patients with
      localized prostate cancer.
    

Detailed description: 
      The primary aim of the study was to characterize and quantify the histopathological changes
      in the surgical specimens obtained in patients undergoing prostatectomy in addition to
      imaging changes (MRI) following a single injection of Liproca Depot in patients with
      localized prostate cancer.

      The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca
      Depot, and to follow the pharmacokinetic profile.
    

Intervention name(s): 2-hydroxyflutamide (2-HOF)
Intervention type(s): Drug
Intervention description(s): Two components are mixed, transferred to a syringe and administered with injection into the prostate
Other intervention name(s): Liproca Depot
Intervention MeSH terms: Hydroxyflutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of EXG-5003
Condition: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the
      safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.
    


Intervention name(s): EXG-5003; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): COVID-19 self-replicating mRNA vaccine; placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill
      tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together
      with radiation therapy works in treating patients with recurrent head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated
           radiotherapy improves the overall survival of patients with recurrent squamous cell
           carcinoma of the head and neck.

      Secondary

        -  To determine the progression-free survival and local-regional progression in these
           patients.

        -  To identify and estimate the incidence rate of acute and late toxicities associated with
           this treatment regimen.

        -  To determine the pattern of disease progression in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also
      receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy
      once daily 5 days a week in weeks 2-7.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 4 years.
    

Intervention name(s): cetuximab; cisplatin; intensity-modulated radiation therapy; Nab-Paclitaxel
Intervention type(s): Drug; Drug; Radiation; Drug
Intervention description(s): cetuximab; cisplatin; IMRT; Nab-Paclitaxel
Other intervention name(s): chemo; chemo; IMRT; chemo
Intervention MeSH terms: Paclitaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent hypopharynx Cancer; recurrent larynx Cancer; recurrent verrucous carcinoma; squamous cell carcinoma; recurrent oral cavity cancer; recurrent metastatic occult primary cancer; recurrent oropharynx cacner; recurrent paranasal sinus and nasal cavity cancer; tongue cancer
INVSENSOR00013 Respiratory Rate Clinical Performance Study
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this prospective study is to compare the noninvasive respiration from pleth
      (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured
      by capnography (RRref), Masimo's RAM technology and the manual annotation.
    


Intervention name(s): INVSENSOR00013
Intervention type(s): Device
Intervention description(s): Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cell- Based Noninvasive Prenatal Testing (NIPT): Single Cell Prenatal Diagnosis (SCPD)
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      The purpose of the overall study is to develop improved methods for recovery of fetal cells
      from the mother's blood in order to develop a clinically useful form of cell-based,
      diagnostic, noninvasive prenatal testing (NIPT). Luna Genetics will analyze blood samples
      from healthy pregnant women. A phlebotomist will be sent to any location in the United States
      to collect the blood sample. Sample identifiers will be removed as the first step so that
      laboratory personnel will not see or have access to identifiers. No information will go back
      to patients or their physicians.
    


Intervention name(s): Redraw for analysis of blood samples from healthy pregnant women
Intervention type(s): Diagnostic Test
Intervention description(s): If less than two fetal cells are recovered from maternal blood, a redraw is indicated
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ocular Findings in Women With Primary Antiphospholipid Syndrome
Condition: Primary Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Observational

Summary: 
      Antiphospholipid antibody syndrome (APS) is an autoimmune disease characterized by systemic
      thrombosis and bad obstetric history. APS secondary to another medical disorder is the most
      common. Visual and ocular changes e.g. vaso-occlusive disease of retinal and choroidal
      vessels are found in patients with secondary APS. Patients with primary APS have also been
      reported to have ocular changes e.g. retinal vascular occlusion

      The aim of our study to detect prevalence of ocular changes in women diagnosed with primary
      APS and correlation of these changes with adverse obstetric outcome. If a correlation is
      present, ocular findings in women with APS could be used in the future as a predictor for
      poor obstetric outcome.
    


Intervention name(s): Ophthalmological examination
Intervention type(s): Diagnostic Test
Intervention description(s): Detailed anterior segment examination using slit-lamp biomicroscopy for signs of anterior uveitis, and detailed fundus examination using slit-lamp fundus biomicroscopy with + 90 diopter lens searching for signs of vasculitis and posterior uveitis.
Other intervention name(s): slit lamp biomicroscopy; slit lamp exam
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female patients (inpatient or outpatient) with primary antiphospholipid syndrome at
        Kasr-Alainy hospital (The Cairo University Hospital)
      
Keywords: Antiphospholipid Syndrome - Bad obstetric history - Ocular
The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults
Condition: Minor Urologic Surgery; Lower Extremity Surgery
Study type: Interventional

Summary: 
      There are some differences between elderly and young adult patients regarding the anatomy of
      upper airways. Elderly patients have larger upper airways than young adult patients at all
      pharyngeal levels as revealed by CT. Another study explained that there is a progressive
      descent of the larynx and epiglottis with aging, which lengthens the upper airway and
      possibly makes it more likely to collapse.

      The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in
      elderly patients with young adults. In this study, the investigators will measure the ease of
      insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure,
      gastric leak pressure, fiberoptic position and intraoperative complications of the classic
      LMA.
    


Intervention name(s): classic LMA insertion
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: classic laryngeal mask airway; elderly patients
Proprioception in the Improvement of Sports Performance in Long Jumpers.
Condition: Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      Introduction: In jumping sports the tendinopathies of patellar and Achilles tendon are very
      frequent. Sports performance is the action that optimizes the relationship between physical
      abilities and the exercise to be performed. Good proprioceptive work favors the correct
      execution of the technique in jumping sports.

      Aim: To evaluate the effectiveness of the lower limb proprioception exercise in the increase
      of sports performance, in adults and federated long jumpers Study design: Randomized
      single-blind multicenter study, with follow-up period. Methods: The 139 subjects included in
      the study will be randomly assigned to the two study groups: experimental (proprioception
      protocol) and control (non-intervention group). The intervention will be carried out for 4
      weeks, with two weekly sessions, lasting 25 minutes. Three evaluations were carried out
      (baseline, post-intervention and follow-up). The study variables will be: Proprioception
      (evaluated by the Romberg test and the SEBT), and sports performance (evaluated with
      vertical, horizontal jump and competition simulation tests). The analysis of normality will
      be carried out by the Kolmogorov Smirnof test and in the case of homogeneity of the groups,
      through the t-student test of related measures and an ANOVA of repeated means, we will
      calculate the difference between the different evaluations and the effect intra and
      intersubject.

      Expected results. To observe improvement in sports performance, once the proprioceptive
      exercises have been carried out.
    


Intervention name(s): Proprioceptive training
Intervention type(s): Other
Intervention description(s): The intervention to the experimental group will consist of the application of the protocol of proprioception exercises. Before the exercises of the protocol, a warm-up will be carried out that will last 3 minutes and consists of exercises of joint mobility and jumping rope.
The protocol consists in carrying out two exercises per session, of 10 minutes each. A minute of rest will be implemented between the warm-up and the completion of the protocol, in addition to one minute between the two proprioception exercises in each session. The exercises will vary from week to week, and all the protocol exercises should be done barefoot. The exercise protocol proposed in this study consists of a total of 7 exercises: of unipodal and bipodal support, with unstable surfaces and postural changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Proprioception; Sports performance; Long jump; Physiotherapy; Randomized clinical trial.
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety
      and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive
      sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.

      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in
      healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).
      Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours
      after each sexual activity. The following hypotheses will be tested:

      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual
      events.

      The number of satisfying sexual events will not differ significantly between subjects treated
      with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone
      alone.

      Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.

      Sexual desire/arousal will not differ significantly between subjects treated with placebo and
      subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.

      Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase
      the number of satisfying sexual events and sexual desire/arousal.
    


Intervention name(s): Placebo; Testosterone; Buspirone hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solid Oral Dosage. Maximum every other day (on an as needed basis); Solid Oral Dosage. Maximum every other day (on an as needed basis); Solid Oral Dosage. Maximum every other day (on an as needed basis)
Intervention MeSH terms: Buspirone; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSDD
A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type
      2 diabetes.
    


Intervention name(s): Placebo; Pioglitazone; MSDC-0160 90 mg; MSDC-0160 220 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily, oral; Once daily, oral; Once daily, oral; Once daily, oral
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment