bioihbjkbjnl/mcl2 huggingface dataset:
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Few data are available about the late patency of side branches in association with the
      currently used stent types and implantation techniques.
    

Detailed description: 
      Among the bifurcation type, bifurcation lesion without significant side branch stenosis
      (<50%) usually did not require side branch stenting, but owing to several putative mechanism
      including dissection, thrombosis formation, embolization of plaque debris, ostial compromise
      by displaced stent strut, and snow plow effect, the side branch might be compromised. In this
      situation, the strategy to achieve optimal results has not been reported. Recently, FFR study
      showed that most jailed side branch (vessel size >2.0 mm. DS>50%) after main branch stenting
      did not have functional significance. We compared strategies with or without routine kissing
      balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation
      lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with
      serial change of FFR measurement.
    

Intervention name(s): kissing balloon; without kissing balloon angioplasty "leave alone"
Intervention type(s): Procedure; Procedure
Intervention description(s): simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions; simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Other intervention name(s): Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents; sirolimus, zotarolimus, paclitaxel, and everolimus stents
Intervention MeSH terms: Sirolimus; Paclitaxel; Albumin-Bound Paclitaxel; Everolimus; Temsirolimus; MTOR Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stent; bifurcation; balloon angioplasty
A Safety and Tolerability Study of CTP-730 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, single-ascending dose, randomized study
    

Detailed description: 
      Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects
      randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical
      research unit (CRU) on the evening before dosing and remain sequestered at the study site
      until after the last inpatient blood sample is collected at 48 hours.
    

Intervention name(s): CTP-730; Placebo for CTP-730
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
Condition: Asthma; Cough; Wheezing
MeSH terms: Respiratory Sounds; Signs and Symptoms, Respiratory
Study type: Observational

Summary: 
      GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the
      same patient by chance alone. Research reveals increased incidence for both to coexist
      leading to suspect a temporal association and possible causality. Therefore we conducted an
      observational study To determine the primary cause (RS or GER)using for the first time both
      PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously
      wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes
      cough/wheeze recordings it points to GER being the possible precipitating factor and vice
      versa.
    

Detailed description: 
      GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the
      same patient by chance alone. Research reveals increased incidence for both to coexist
      leading to suspect a temporal association and possible causality. Therefore we conducted an
      observational study To determine the primary cause (RS or GER)using for the first time both
      PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously
      wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes
      cough/wheeze recordings it points to GER being the possible precipitating factor.However, If
      cough/wheeze precedes GER recordings it points to cough/wheeze being the possible
      precipitating factor. The recordings will be investigated 1 minute before and one minute
      after each event.
    

Intervention name(s): WEEM - Wheezy Monitoring
Intervention type(s): Device
Intervention description(s): loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We studied 23 consecutive Difficult to treat infants and children suspected of suffering
        from both RS and GER with chronic respiratory symptoms. However, four dropted due to
        technical problems wiht the equipment. In 19 patients We fully analyzed the respiratory
        sounds one minute during and one minute before and one minute after each GER episode, and
        in all parental markings of cough.
      
Keywords: GER Gastrointestinal reflux; Aspiration; ASHTMA; COUGH; WHEEZE; PH-IMPEDANCE; WEEM Wheezy Monitor
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
Condition: Local Advanced High Risk Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an randomized controlled, multicenter clinical trial. The purpose of this study is to
      evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without
      capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
    


Intervention name(s): IMRT combine with cisplatin concurrent chemotherapy; IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.; Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.
Intervention MeSH terms: Cisplatin; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Local advanced; high risk; nasopharyngeal carcinoma
A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma
Condition: Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period,
      crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose
      inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on
      exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma.
      Subjects will receive each study treatment on separate visits and undergo a treadmill
      exercise challenge test for up to 10 minutes so that the effect of study treatment on
      exercise-induced bronchoconstriction can be evaluated.
    


Intervention name(s): Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg; Placebo metered-dose inhaler
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Budesonide/albuterol sulfate combination inhalation aerosol single dose; Placebo inhalation aerosol single dose
Other intervention name(s): BDA MDI 160/180 μg (PT027); Placebo MDI
Intervention MeSH terms: Budesonide; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial Evaluation of a Test Serum Post HEV (High Energy Visible) Light Exposure
Condition: Blue Light Damage
Study type: Interventional

Summary: 
      To evaluate 10 days of pretreatment with a serum (Test Product/Marvel AM) to the lower back,
      followed by a single exposure of 90J/cm2 HEV (High Energy Visible) light {400-450nm
      wavelengths} in healthy male or female volunteers.
    


Intervention name(s): Marvel AM
Intervention type(s): Other
Intervention description(s): Study staff will perform each application of approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back at each of ten sequential visits.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      Uncontrolled and prolonged oxidative stress plays an important role in the onset and
      progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given
      that many diseases can start as early as childhood, eating patterns in childhood and
      preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich
      foods can slow down the progression of chronic diseases.

      In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and
      nutritional needs, so what is offered to them is very important. This study will evaluate the
      hypothesis that providing an antioxidant-rich diet in kindergartens can result in the
      reduction of biomarkers of oxidative stress.
    


Intervention name(s): Antioxidant
Intervention type(s): Dietary Supplement
Intervention description(s): Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and
      oppositional symptoms.
    


Intervention name(s): SPD503 (Guanfacine hydrochloride); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).; Placebo
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
Condition: Dyslipidemia; Atherosclerosis; Acute Coronary Syndrome; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Acute Coronary Syndrome; Atherosclerosis; Dyslipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate an oral formulation of RVX000222 for safety,
      pharmacokinetic and efficacy in healthy subjects.
    

Detailed description: 
      One-third of the US population, almost 80 million adults, have cardiovascular disease and
      mortality associated with heart disease which still remains a leading cause of death around
      the world. The major risk factors for cardiovascular disease associated with atherosclerosis
      is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low
      levels of high density lipoprotein (HDL).

      HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL
      mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the
      body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention
      studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the
      capacity to reverse coronary atherosclerosis.

      RVX000222 is a member of a novel class of small molecules that are candidates for the
      treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.
    

Intervention name(s): RVX000222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RVX000222 twice daily (b.i.d.) for 28 days; Placebo twice daily (b.i.d.) for 28 days
Other intervention name(s): RVX-208; apabetalone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; High density lipoprotein; Dyslipidemia; Atherosclerosis; Apolipoprotein A-I
Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts
Condition: Human Papillomavirus Infection; Anogenital Warts
MeSH terms: Warts; Papillomavirus Infections; Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the effectiveness of destructive therapy for
      anogenital warts in combination with the use of Ingaron in comparison with destructive
      therapy.
    

Detailed description: 
      Literature data and the results of preclinical studies of interferon-gamma, as well as the
      features of HPV immunopathogenesis, show the expediency of studying the use of Ingaron in
      this pathology.

      The study was planned to include 50 outpatients of both sexes aged 18 to 50 years with a
      confirmed diagnosis of anogenital warts.

      In the course of the study, Ingaron was administered at a dose of 100,000 IU once a day every
      other day in the period of 10 days.

      Patients were divided into 2 groups: study and control.
    

Intervention name(s): Interferon gamma human recombinant (IFN-G)
Intervention type(s): Drug
Intervention description(s): received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Other intervention name(s): Ingaron; Interferon gamma human recombinant
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interferon gamma; IFN-g; HPV; Anogenital warts
DOAC ADRs Retrospective Study on Genetic Variations
Condition: Drug-Related Side Effects and Adverse Reactions; Treatment Failure
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      The purpose of this study is to see if the participant's genetic profile and clinical factors
      (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may
      have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots
      from forming in the blood vessels.
    

Detailed description: 
      Genes can have variants or mutations that can increase the participant's risk for bleeding
      when receiving a direct oral anticoagulant (DOACs). The investigators will be studying
      participants on DOACs who have had bleeding and also participants who are on DOACs who did
      not have bleeding (control group). The goal of the study is to determine the accuracy of
      Cipherome's Drug Safety Score (DSS) in it's ability to predict adverse drug reactions (ADRs).
      A DSS score ranges from 0 to 1, with scores less than 0.3 correlated with a higher risk of
      ADRs and scores more than 0.7 correlated with a lower risk of ADRs. The participant's DSS
      score will be compared with the actual clinical outcome using a statistical test to determine
      the accuracy of the DSS.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Any adult patient 18 years and older, who experienced major bleeding, clinically relevant
        non major bleeding or treatment failure while taking a DOAC during the study time frame and
        is able to provide informed consent.
      
Biospecimen description: 
      Blood DNA sample
Distant Healing for HIV/AIDS
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether individuals praying at a distance (also
      known as "Distant Healing") can positively affect the health of people with HIV/AIDS.
    

Detailed description: 
      Significant numbers of people with HIV/AIDS seek spiritual or "psychic" treatment. Distant
      healing could potentially be of benefit to large numbers of HIV/AIDS patients, as it is
      widely available and requires no travel or other activity on the part of the patient.
      However, the treatment can be costly and has not yet been proven effective in a controlled
      clinical trial. This study will evaluate the efficacy of distant healing in patients with
      HIV/AIDS.

      Participants in this study will be randomly assigned to either the distant healing group or a
      control group. All participants will have hour-long study visits at entry and Months 6 and
      12. At study visits, participants will complete a demographic questionnaire, self-report
      health and symptom inventory, quality of life assessment, and profile of mood states. Blood
      will be drawn at each study visit.
    

Intervention name(s): Non-local/distant healing or prayer
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: AIDS; HIV; Prayer; Healing; Complementary Therapies
A New Supplement for the "Metabolic Syndrome"
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum
      and corosolic acid for the treatment of metabolic syndrome. Participants receive the
      supplement or a placebo.
    

Detailed description: 
      The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum
      and corosolic acid. They act in different way reducing insulin resistance, which is the main
      cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with
      the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were
      the improvement of the parameters that characterizes the metabolic syndrome, such as glucose
      and insulin levels, triglycerides, HDL-cholesterol and blood pressure.
    

Intervention name(s): Sineos
Intervention type(s): Dietary Supplement
Intervention description(s): glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance, blood pressure,
Nevada Environmental Tobacco Smoke and Health Study
Condition: Cardiovascular Disease; Cancer
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is
      widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study
      is designed to test whether exposure to ETS in the workplace effects a person's risk of
      developing chronic diseases such as cardiovascular disease and cancer. The second part of
      this study is designed to test whether antioxidant supplementation in this group of ETS
      exposed individuals can reduce their risk of developing chronic disease.

      The study will look at 375 non-smokers who either work on a casino floor or as bartenders or
      cocktail servers. Initial baseline data will be collected (questionnaires and blood samples
      taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant
      supplementation and high antioxidant supplementation. They will be followed over a two-year
      period, coming in for follow-up testing every six months. Statistical analysis will be
      conducted to see whether this group of ETS exposed individuals has a greater risk of
      developing chronic disease and whether the use of antioxidant supplements can moderate any
      risks.
    


Intervention name(s): Antioxidants
Intervention type(s): Drug
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Oxidative Stress; Cardiovascular Disease; Cancer
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Study for the outcome and safety of individualized busulfan dosing with bortezomib for
      patients preparing for a second stem cell transplant to treat multiple myeloma.
    

Detailed description: 
      Evaluation of six-month response in relapsed multiple myeloma subjects, who have had a prior
      autologous HSCT (greater than one year previously) receiving an IV busulfan-based
      conditioning regimen with the combination of pharmacokinetic (PK)-guided IV busulfan dosing
      and bortezomib, followed by a second autologous HSCT.

      Assessment of the safety profile of this conditioning regimen will also be completed.
    

Intervention name(s): IV busulfan; bortezomib; Autologous Hematopoietic Stem Cell Transplant (HSCT)
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): PK-directed dosing of IV busulfan for 4 days; Single IV bortezomib at a dose of 1.3 mg/m^2.
Other intervention name(s): Busulfex®; Velcade®
Intervention MeSH terms: Bortezomib; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Bone marrow transplant; Stem cell transplant; Busulfan; Bortezomib