bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
Condition: Perennial Allergic Rhinitis; Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional

Summary: 
      Alleviation of allergic symptoms induced by house dust mites when using the medical device
      AM-301.

      This clinical investigation explores the efficacy and safety of AM-301 when used to reduce
      symptoms of house dust mite sufferers. The primary objective is to compare the efficacy of
      AM-301 Device between treated and non-treated subjects in the treatment of perennial allergic
      rhinitis (PAR).
    


Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Device; Device; Other
Intervention description(s): Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens.
One Spray of AM-301 per nostril; Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens.
Two Sprays of AM-301 per nostril (with different spray angles); No treatment
Other intervention name(s): Bentrio; Bentrio
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Allergic rhinitis symptoms; Runny nose; Itchy nose
Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A
      (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with
      midazolam in healthy subjects.
    

Detailed description: 
      -  In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.

        -  In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID)
           oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg
           IPI-145 concomitantly administered with 2 mg of midazolam.
    

Intervention name(s): IPI-145; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg BID Oral Capsule; 2 mg midazolam syrup
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy subjects; DDI; CYP3A
Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients
Condition: Heart Transplantation; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The overall goal of this study is to determine if non-invasive imaging with state of the art
      CT coronary angiography can be used to screen for transplant coronary artery disease in the
      setting of heart transplant.

      Our current protocol at UCSF for heart transplant patients involves screening with stress
      tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of
      the lumen of the coronary arteries and to assess wall thickness.
    

Detailed description: 
      Our hypothesis is that state of the art CT coronary angiography can be used to acquire data
      regarding the coronary arteries in the setting of heart transplant and be used to risk
      stratify patients with regards to the developments of transplant coronary artery disease.

      Specific Aim 1- To test the hypothesis that coronary CTA can accurately measure
      cross-sectional vessel wall area using conventional coronary angiography with intra-vascular
      ultrasound as the standard of reference.

      Specific Aim 2- To test the hypothesis that coronary CTA can accurately measure
      cross-sectional vessel wall thickness, vessel area and luminal area using conventional
      coronary angiography with intra-vascular ultrasound as the standard of reference.

      Secondary Aim - To asses the correlation of cross-sectional vessel wall area, vessel wall
      thickness, vessel area, luminal area and vessel wall index with global and regional left
      ventricular function using coronary CTA.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All heart transplant patients at UCSF with known transplant coronary artery disease will be
        candidates for the study
      
Keywords: transplant coronary artery disease; CT angiography; conventional angiography; intravascular ultrasound; Heart transplant patients with known transplant coronary artery disease
Validity and Reliability of the 6 Minute Pegboard Ring Test
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD
      and its applicability on these patients.
    

Detailed description: 
      Duchenne muscular dystrophy (DMD) is the most common type of progressive muscular dystrophies
      and is an X-linked recessive, rarely autosomal dominant, muscle disease. DMD begins in
      childhood and progresses until they become unable to walk. Individuals with DMD experience
      skeletal muscle weakness, difficulty breathing, and decreased exercise capacity. In these
      patients, traditionally lower extremity tests are; 6-minute walk tests, treadmill tests and
      Cardiopulmonary exercise tests are used. However, it is reported that the upper extremity is
      also affected in individuals with DMD. The 6-Minute Pegboard and Ring Test (6PBRT), which is
      valid and reliable in most disease groups, is also a test that can be applied to the upper
      extremities. It is important to use 6PBRT frequently in clinical research practice for
      patients with DMD and to know its validity and reliability. To our knowledge, the validity
      and reliability of this test in individuals with DMD has not been established in the
      literature. This study aimed to investigate the validity and reliability of 6PBRT in
      individuals with DMD and its applicability on these patients.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with Duchenne muscular dystrophy
      
Keywords: Duchenne Muscular Dystrophy; 6 Minute Pegboard and Ring Test; arm exercise endurance; upper extremity
CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women
Condition: Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      CO2 laser energy is currently used widely for the treatment of postmenopausal women who have
      vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with
      hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect
      of CO2 laser on young women and compare it to topical lidocaine.
    

Detailed description: 
      The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be
      more effective in treating vestibulodynia than current treatment with a topical lidocaine
      ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in
      women on hormonal contraceptive treatment. To date, there are no effective treatments that
      address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that
      delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own
      body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The
      MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying
      cause. This may be more effective than using the topical lidocaine which makes the tissue
      numb.
    

Intervention name(s): CO2 laser; Lidocaine patch 5%
Intervention type(s): Device; Drug
Intervention description(s): Mona Lisa CO2 laser; lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.
Condition: Binge Eating
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability of topiramate
      compared to placebo in patients with binge eating disorder receiving Cognitive Behavior
      Therapy (CBT)
    

Detailed description: 
      This was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial
      comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate
      versus placebo in obese patients with BED receiving group CBT. The aim of this trial is to
      investigate the efficacy and tolerability of adjunctive topiramate to CBT in obese patients
      with BED through improvement in binge eating, related psychopathology, and weight loss. The
      study hypothesis is that the patients using topiramate + CBT will loose more weight than
      patients using placebo + CBT.Tolerability will be investigated through reported adverse
      events and dropouts, with reasons for leaving the study being analyzed. The randomized
      patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily
      for 21 weeks
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Binge-Eating Disorder
The ATLAST Long-Term Study
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Study is a multi-center, prospective, open label, single-arm, three-month, long-term
      study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA).
      The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.
    


Intervention name(s): Attune Sleep Apnea System
Intervention type(s): Device
Intervention description(s): Observation of Attune Sleep Apnea System for use during sleep.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches
      on physical and cognitive variables in individuals with low back pain.
    

Detailed description: 
      Patients participating in the study were divided three parallel groups. The patients in the
      stabilization exercise group were instructed to perform spinal stabilization exercises, the
      patients in the yoga group were instructed to perform yoga program consisting of breathing,
      relaxation and flexibility exercises. The patients in the aerobic exercise group were
      instructed to perform aerobic walking training. The severity of the pain evaluated through
      visual analog scale, functional status and quality of life, alexithymia, kinesiophobia,
      catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability
      Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance
      Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal
      Cognitive Assessment respectively. Assessments were repeated before and after the treatment.
    

Intervention name(s): Yoga exercise program; Spinal stabilization exercise program; Aerobic walking program
Intervention type(s): Other; Other; Other
Intervention description(s): Yoga exercise program will be applied two sessions per week, totally eight week.; Spinal stabilization exercise program will be applied two sessions per week, totally eight week.; Aerobic walking program will be applied two sessions per week, totally eight week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; exercise; cognitive; aerobic; yoga
Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      Several studies have highlighted the cardioprotective effects of acute normovolemic
      hemodilution during cardiac surgery. The aim of our study is to show that an increase in
      endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute
      normovolemic hemodilution against ischemia-reperfusion phenomena.
    

Detailed description: 
      The major physiologic function of EPO is thought to be the induction of erythropoiesis.
      However, a growing body of evidence indicates that EPO has tissue-protective effects and
      prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of
      EPO have been shown in human myocardium.

      Several studies have demonstrated that acute normovolemic hemodilution before aortic cross
      clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute
      anemia increases the endogenous EPO concentration, which explains the cardioprotective
      effects of acute normovolemic hemodilution.
    

Intervention name(s): acute normovolemic hemodilution
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Phase 3 Substudy to Evaluate Executive Function in Adults With PKU Who Are Participating in the Phase 3 Study, 165-302
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      A Phase 3 substudy to evaluate executive function in adults with phenylketonuria who are
      participating in the phase 3 Study, 165-302. Approximately 100 subjects, aged ≥ 18 to ≤ 70
      years old, with PKU will be enrolled.
    

Detailed description: 
      Study 165-303, is a Phase 3 substudy enrolling approximately 100 subjects, aged ≥ 18 to ≤ 70
      years old, with PKU who are participating in the Phase 3 study, 165-302.

      Per the 165-303 protocol, the investigator does not assign a specific intervention to the
      study participants. In accordance with the protocol for Study 165-303, subjects were asked to
      perform selected set of three tasks from the CANTAB tool (Rapid Visual Processing [RVP],
      Spatial Working Memory [SWM], and Stop Signal Task [SST]) to assess executive function and
      each subject's self perception of their current state was measured using a subject global
      assessment questionnaire that contains seven questions about current state perception of
      attention, energy level, tiredness, confusion, sadness, anger and tension.

      The time points for administering the above tools are as follows, which coincide with time
      points in part 2 and part 4 of Study 165-302: screening (entry into Part 2 165-302 Day 1 of
      Week 1), baseline visit (Part 2 Week 8), and 3 additional study visits at different time
      points in the Part 4 of 165-302 study.
    

Intervention name(s): Administration of CANTAB and Subject Global Assessment
Intervention type(s): Other
Intervention description(s): At designated visits, subject will perform the CANTAB tasks and complete the Subject Global Assessment Questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with PKU who are currently enrolled in 165-302 Part 2.
      
Keywords: PKU; PEG-PAL; Pegvaliase; BMN 165; rAv-PAL PEG; PRISM 302; PRISM 303; BioMarin; 165-302
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in a single center, open-label study with a single group fixed
      sequence design to evaluate the effect of repeated oral administration of 600 mg
      RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of
      VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.
    


Intervention name(s): Rifampicin; Midazolam; BAY1002670_Vilaprisan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.; 2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam; 2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
Intervention MeSH terms: Rifampin; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vilaprisan; PK; rifampicin; midazolam,; CYP3A4 induction; drug-drug interaction
The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste
Condition: Pain; Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

Summary: 
      In our study, we used nitrofurantoin as a root canal medication in patients suffering from
      symptomatic irreversible pulpitis in alleviating pain compared with double antibiotic paste.
    

Detailed description: 
      This study aims to compare the efficacy in alleviating pain between intracanal medicaments
      Nitrofurantoin versus double antibiotic paste.
    

Intervention name(s): Nitrofurantoin; Double Antibiotic
Intervention type(s): Drug; Drug
Intervention description(s): Nitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions; DAP is a combination of two antibiotics which are ciprofloxacin and metronidazole
Intervention MeSH terms: Anti-Bacterial Agents; Nitrofurantoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study investigates whether an intensive lifestyle intervention for type 2 diabetes had
      long-term effects on Medicare enrollment, health care use, and health care spending.
    

Detailed description: 
      The Look AHEAD study tested whether participants with type 2 diabetes assigned to an
      intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular
      morbidity and mortality, relative to a control group receiving usual care and diabetes
      support and education. During the 12-year intervention period, the ILI led to persistent
      reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical
      fitness. In addition, the ILI led to reductions in hospitalizations, hospital days, and
      prescription drug spending during the intervention period (through 2012). However, the
      longer-term effects (2012 and later) on health care use and spending remain unknown.

      In an ongoing ancillary study, the researchers are investigating the effects of the ILI on
      economic outcomes, during and after the study. As a part of this study, the study team is
      linking consenting Look AHEAD participants to Medicare databases. The researchers will
      investigate the long-term effects of ILI on health care use and health care spending.

      By 2012 nearly all Look AHEAD participants were eligible for Medicare due to age (over 65).
      To the extent that Look AHEAD participants developed severe disabilities, the participants
      may have gained Medicare eligibility earlier through enrollment in Social Security Disability
      Insurance (SSDI). Thus, the researchers will also test for differences in the Medicare
      enrollment channel between ILI and control group participants, specifically whether the
      groups enrolled through SSDI at different rates.
    

Intervention name(s): Intensive lifestyle intervention; Diabetes support and education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lifestyle intervention focused on weight loss through diet and physical activity; Behavioral intervention focused on diabetes support and education
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes Look AHEAD participants that consented to administrative data
        linkages, provided individual identifiers that could be linked with Medicare data, and were
        successfully linked to Medicare data.
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will
      be conducted in the United States and consists of a single ascending-dose stage followed by a
      multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult
      patients between 50-85 years old who have mild to moderate Alzheimer's disease.
    


Intervention name(s): anti-Abeta; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous single and multiple doses; Intravenous single and multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AD; Alzheimer's; Alzheimers
Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Generally, benign breast tumors are excised under the local anesthesia. But such action was
      so invasive that every patient would experience the physiological and psychological stimuli
      unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its "easy
      come,easy go" property during short-lasting operations than isoflurane. We purposed that
      sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane
      with relative less alteration in hemodynamics, less postoperative side effects and
      easily-control the depth of anesthesia.
    


Intervention name(s): Sevoflurane; Isoflurane
Intervention type(s): Drug; Drug
Intervention description(s): 3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.; 3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.
Other intervention name(s): Sevofrane
Intervention MeSH terms: Sevoflurane; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sevoflurane; Isoflurane; Breast tumor; Anesthesia