bioihbjkbjnl/mcl2 huggingface dataset:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell
      transplantation in treating women who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the toxicity and response rates to sequential high dose chemotherapy
      without induction chemotherapy in women with metastatic breast cancer. II. Determine the
      hematopoietic recovery rate in these patients after infusion of blood derived CD34+
      progenitors isolated using a CD34+ affinity device for positive purification of the
      autograft. III. Compare response rates and duration of responses between these patients
      treated in this trial to patients treated in a previous trial using the same sequential high
      dose chemotherapy with induction conventional dose chemotherapy.

      OUTLINE: Patients receive cyclophosphamide IV daily for 2 days, and etoposide IV and
      cisplatin IV daily for 3 days. Filgrastim (G-CSF) is administered subcutaneously twice daily
      beginning 24 hours after completion of chemotherapy until the last day of apheresis. Upon
      hematopoietic recovery, peripheral blood stem cells (PBSC) are collected over several days.
      Within 35 days of mobilization chemotherapy, patients receive cyclophosphamide IV, thiotepa
      IV, and carboplatin IV continuously on days -7 to -4, followed by a 2 day rest period. CD34+
      selected PBSC are reinfused. Beginning 4 hours after reinfusion, patients receive G-CSF
      subcutaneously daily until hematopoietic recovery. Patients may then receive radiation
      therapy to sites of prior bulk disease at the discretion of the investigator. Within 30 days
      of hematopoietic recovery or immediately following post transplant radiation therapy,
      patients receive oral anastrazole daily until disease progression. Patients are followed
      monthly for 6 months, every 3 months for 1 year, every 4-6 months for 5 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
    

Intervention name(s): filgrastim; anastrozole; carboplatin; cisplatin; cyclophosphamide; etoposide; thiotepa; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Carboplatin; Etoposide; Anastrozole
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical study with the BMS-986147 compound in healthy subjects. The
      purpose of this study is to guide the dose range and dose frequency for future studies with
      BMS-986147 and will provide guidelines for selection of a potentially effective dose in
      patients.
    


Intervention name(s): BMS-986147; Placebo matching BMS-986147
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Subjects
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in
      combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.
    


Intervention name(s): HBsAg vaccine with Entecavir
Intervention type(s): Drug
Intervention MeSH terms: Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      You are being asked to take part in a research study of COLD-fX, a product designed to boost
      the immune system. COLD-fX is an extract from the roots of North American ginseng and it may
      offer some benefit to people with seasonal allergies.

      The purpose of the present study is to find out how effective and safe COLD-fX is in
      improving quality of life and reducing symptoms of seasonal allergies such as hay fever.
      COLD-fX is not yet approved for treatment of seasonal allergies. We are seeking to enroll 200
      participants in the Capital Health region.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study will be carried out to establish the
      effects of CVT-E002 200 mg twice daily for 4 weeks in patients with seasonal allergic
      rhinitis.
    

Intervention name(s): COLD-fX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200mg BID for 4 weeks; 200mg BID for 4 weeks
Other intervention name(s): CVT-E002
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergies; Nasal; Congestion; Sneezing; Pruritus; Teary; Eyes
The Effect of Thyroid Hormon Levels on the Corneal Measures
Condition: Thyroid Disorder; Corneal Opacity
MeSH terms: Corneal Opacity; Thyroid Diseases
Study type: Observational

Summary: 
      In this cross-sectional comparative study, it is aimed to investigate the topographic
      measurements,aberrometrics and densitometrics values of corneas in hypothyroid and
      hyperthyroid patients compared to healthy individuals. A number of 20 hypothyroid patients
      (group I), 20 hyperthyroid patients (group II), and 20 age-matched healthy controls (group
      III) have been recruited. The Pentacam high resolution imaging system is used to determine
      corneal topographic measurements,aberrometry and densitometry.
    

Detailed description: 
      Thyroid hormone diseases can cause different symptoms and signs in the body according to the
      hormone levels, particularly in the eyes. Corneal tissue can be affected by many biochemical
      and hormonal factors, and many ocular surface and systemic diseases can affect the
      cornea.Hyperthyroidism has been shown to cause symptoms such as conjunctival chemosis,
      proptosis, increased intraocular pressure, limitation to globe movements due to the
      restriction of extraocular muscles, increased orbital volume, increased risk of glaucoma with
      inflammation in the trabecular meshwork and exposure keratopathy, especially in Graves'
      disease. In the case of hypothyroidism, studies have shown fluid retention and edema in all
      body tissues, thereby resulting in increased thickness in the cornea, as well as a decrease
      in corneal hysteresis, which increases the risk of glaucoma. In this study, it is aimed to
      assess whether thyroid hormone changes affect those parameters by objectively measuring
      corneal changes via corneal topography, corneal densitometry and corneal aberrometry.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 patients diagnosed hypthyroidia ,20 patients diagnosed hyperthyroidia ,20 age matched
        healthy individuals
      
Keywords: Thyroid disorder; Corneal opacity; Corneal aberrations
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets
      (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a
      washout period during fasted study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Olanzapine Orally Disintegrating Tablets 5mg
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, multiple ascending dose study
      conducted at one study center in the United States. Safety and tolerability will be assessed
      throughout the study and serial blood samples and urine samples will be collected for the
      safety and pharmacokinetic assessment of SXC-2023.
    


Intervention name(s): SXC-2023; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Targeted Lung Denervation for Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in
      patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a
      similar safety profile and improved physiological and functional outcomes to a sham-control.
    

Detailed description: 
      A prospective, sequential two phase multicenter, randomized double-blind, safety, &
      feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the
      optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the
      optimal energy dose to a sham control. All subjects will be followed for a minimum of 3
      years.
    

Intervention name(s): Holaira™ Lung Denervation System with energy delivery; Holaira™ Lung Denervation System without energy delivery
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Targeted Lung Denervation; Intervention; Lung Function; Safety; Device
Eletriptan Pharmacokinetics In Korean Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK)
      characteristics to those seen in other populations.
    


Intervention name(s): Eletriptan commercial tablet; Eletriptan commercial tablet; Eletriptan commercial tablet; Eletriptan commercial tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 mg tablet, single dose; 40 mg tablet, single dose of 1 X 40 mg; 40 mg tablet, single dose of 2 X 40 mg; 40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetic; eletriptan; Korean; crossover
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
Condition: Parkinson's Disease; REM Sleep Behavior Disorder
MeSH terms: Parkinson Disease; REM Sleep Behavior Disorder; Mental Disorders
Study type: Interventional

Summary: 
      Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD),
      a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and
      brainstem.

      Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic
      drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic
      pathways which belong to the so-called "reward system".

      A strong link was found between these two disorders and therefore the investigators believe
      that RBD is associated with impaired reward system.

      The main objective of this study is to evaluate differences in brain activation between PD
      patients with and without RBD.

      The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the
      reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD,
      explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.
    

Detailed description: 
      Type of study: Prospective, case control study.

      Number of centers: 2 (Clermont-Ferrand and Vichy)

      Patients :

      The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without
      RBD and 25 healthy volunteers, age-and sex-matched without any contraindications to perform
      an MRI)

      Study Performance :

      During the first visit (J0, inclusion visit, 3 hours), each subject will perform a clinical
      and neurological examination (MDS-Unified Parkinson Disease Rating scale (MDS-UPDRS)) and
      neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by
      the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack
      of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed in a
      subsequent visit at the MRI department for the functional MRI (J0+1week, 1 hour). This
      session will be of about 45 minutes. The reward system was explored using an experimental
      task during functional Magnetic Resonance Imaging (fMRI). The name of this task is
      the"monetary incentive delay task".
    

Intervention name(s): fMRI
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinson 's disease; REM sleep behavior disorder; Reward system; Functional MRI
Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
Condition: Circumcision Adult; HIV CDC Category B2; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The protocol, approved by the Medical Research Council, was issued to assess the safety and
      efficacy of the non-surgical device for applying it to the national scale up of adult male
      circumcision in Zimbabwe
    

Detailed description: 
      Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of
      men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009;
      Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues
      in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to
      35% if about 50% of men are circumcised. All modelings conducted show that MC programs must
      be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic
      into a terminal decline.

      The PrePex Device offers hope for rapid scale up of adult male circumcision in resource
      limited settings.

      Once the safety and efficacy have been established, it is important to conduct operations
      research to determine how best to implement both device and surgical circumcisions in the
      national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to
      determine the safety of the PrePexTM device, its performance and the ease of use in an
      implementation roll out.
    

Intervention name(s): PrePex™ device
Intervention type(s): Device
Intervention description(s): PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: male circumcision; HIV; Zimbabwe
Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild
      to moderate allergic asthma
    


Intervention name(s): Omalizumab; Omalizumab; Omalizumab
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Xolair, IGE025; Xolair, IGE025; Xolair, IGE025
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Evaluation of Musculoskeletal System Symptoms and Biochemical Parameters in COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The neutrophil-lymphocyte ratio (NLR) used to demonstrate inflammatory status in recent years
      can be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count
      at routine blood tests.
    

Detailed description: 
      Dysregulation in immune responses has been reported in association with hyperinflammation in
      COVID-19 patients, NLR has been linked to the severity of the patient's clinical status, and
      an increase in NLR is reported to be an independent risk factor for in-hospital mortality.
      Pain is a frequently seen symptom at the onset of viral infections and throughout the course
      of the disease. Although the pain mechanisms triggered by viral pathogens are not yet
      entirely understood, pain is thought to arise as a result of direct activation of nociceptor
      neurons by pathogens and their interaction with molecular ligands. Toll-like receptor 7
      (TLR7), a pathogen recognition receptor that plays an important role in immune responses to
      viruses by binding to viral RNA, is known to be involved in pain development in different RNA
      virus infections. Park et al. showed that extracellular micro RNAs activate nociceptive
      neurons via the TLR7 pathway. Although these mechanisms have been demonstrated for different
      viral infections, the viral pathogenesis leading to pain in COVID-19 is still unclear. The
      purpose of this study was to investigate the prevalence of headache and muscular pain in
      patients diagnosed with COVID-19 and to determine the relationship between these symptoms and
      inflammatory parameters.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18-65 and diagnosed with COVID-19 will be included in the study.
      
Biospecimen description: 
      Peripheral venous blood specimens will be collected using standard surgical procedures during
      presentation and were investigated in the Abant İzzet Baysal University Medical Faculty
      central laboratory. Complete blood count parameters (hemoglobin, leukocytes, erythrocytes,
      platelets, and leukocyte subtypes) will be analyzed using a Syxmex XN-1000 (Kobe, Japan)
      automatic analyzer. D-dimer and fibrinogen parameters will be measured on a Sysmex CS-2500
      (Kobe, Japan) device, and biochemical parameters (CRP, ferritin, procalcitonin, LDH,
      troponin) on an automatic biochemical analyzer (Abbott Architect C8000, USA). In addition,
      the NLR will be calculated by dividing the absolute neutrophil count by the absolute
      lymphocyte count.
    
Keywords: pain
Corticosteroid Treatment for Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence
      against viral and bacterial stimuli by modulating the immune response. The aim of this study
      was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome
      and to investigate whether corticosteroid attenuate its levels. In addition, to explore the
      effect of corticosteroid therapy on the prognosis of ARDS.
    

Detailed description: 
      The acute respiratory distress syndrome (ARDS) is caused by an inflammatory injury to the
      lung that is characterized clinically by acute hypoxemic respiratory failure. Pathologically
      complex changes in the lung are manifested by an early, exudative phase followed by
      proliferative and fibrotic phases. Persistent ARDS is characterized by ongoing inflammation,
      parenchymal-cell proliferation, and disordered deposition of collagen, all of which may be
      responsive to corticosteroid therapy. Systemic corticosteroids have been considered a
      potentially beneficial therapy. However, several studies have failed to provide convincing
      evidence to prove the efficacy of corticosteroids in decreasing the mortality of ARDS. For
      the secondary outcomes, such as oxygenation improvement and reduction of the duration of
      mechanical ventilation, have shown consistent findings in favor of corticosteroid therapy.
      However, the underlying mechanisms that account for the anti-inflammatory actions of
      corticosteroid in ARDS patients have not yet to be elucidated, and the activities do not
      appear to be controlled by a single mechanism. Interleukin-18 (IL-18), along with
      interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen,
      environmental or host-derived danger signals. Inflammasomes are innate immune regulatory
      protein complexes which seem to play a key role in the host immune response of patients with
      ARDS. The aim of this study is to determine the role of steroid on IL-18 levels in serum of
      patients with ARDS and its effect on prognosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients diagnosed with acute respiratory distress syndrome (ARDS) based on Berlin
        criterion by two clinicians
      
Keywords: corticosteroid; acute respiratory distress syndrome