bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess priming with antigenically mismatched live attenuated
      A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in
      healthy adults.
    

Detailed description: 
      This study will assess priming with antigenically mismatched live attenuated A/H7N3 influenza
      virus vaccine (H7N3 pLAIV) followed by inactivated A/H7N9 influenza virus vaccine (H7N9 pIIV)
      in healthy adults.

      Participants will receive a dose of H7N3 pLAIV on Days 0 and 28, followed by a single dose of
      H7N9 pIIV on Day 84.

      On Days -2 and 26, participants will be admitted to an inpatient clinic. They will receive
      the H7N3 pLAIV vaccine on Days 0 and 28. They will remain in the clinic for 9 days after
      receiving the vaccine and until they are no longer shedding vaccine virus. An additional
      study visit will occur on Day 56.

      On Day 84, participants will receive the H7N9 pIIV vaccine. Additional study visits will
      occur on Days 87, 91, 98, 112, 140, and 180. Study visits may include physical examinations,
      nasal washes, and blood and urine collection. Participants will be contacted by phone on Day
      264 for follow-up health monitoring.
    

Intervention name(s): H7N3 pLAIV; H7N9 pIIV
Intervention type(s): Biological; Biological
Intervention description(s): Approximately 10^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device; 30 micrograms administered by intramuscular (IM) injection
Other intervention name(s): Live attenuated A/H7N3 influenza virus vaccine; Inactivated A/H7N9 influenza virus vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Condition: Diabetic Retinopathy; Melatonin; Circadian Dysrhythmia; Circadian Rhythm Sleep Disorder, Unspecified Type
MeSH terms: Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm; Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of
      patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the
      other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the
      patients will cross over to the other treatment arm.
    


Intervention name(s): Melatonin 4 mg Tablet
Intervention type(s): Drug
Intervention description(s): Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Double-blind, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Solvent Usage on Post-treatment Pain
Condition: Root Canal Infection; Pain
Study type: Interventional

Summary: 
      No clinical evidence has been yet published regarding the comparison of postoperative pain
      after removal of the root canal fillings with or without solvent. The aim of this study was
      to evaluate the effect of combined usage of ProTaper retreatment instruments and a
      gutta-percha solvent, on the postoperative pain intensity after retreatment.
    

Detailed description: 
      Scientific literature contains a few studies regarding the amount of apically extruded debris
      caused by solvent or solvent free use of rotary instruments. It was reported that the use of
      ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount
      of apically extruded debris compared to their solvent free use. Nevertheless,no clinical
      evidence has been yet published regarding the comparison of postoperative pain after removal
      of the root canal fillings with or without solvent. The aim of this study was to evaluate the
      effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the
      postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred
      to Department of Endodontics with a diagnose of failed root canal treatment were examined
      radiographically and clinically. Endodontically treated, clinically asymptomatic,
      single-rooted teeth with one canal exhibiting chronic periapical infection were included. A
      hundred cases who matched the determined criteria were selected and randomly allocated to two
      groups:

      Non-solvent Group (n=50):

      ProTaper retreatment instruments were used in combination with with X-Smart electric motor
      for the removal of root canal fillings.

      Solvent Group (n=50):

      ProTaper retreatment instruments were used with the abovementioned technique but in
      combination with a gutta-percha solvent
    

Intervention name(s): Non-solvent; Solvent
Intervention type(s): Procedure; Procedure
Intervention description(s): Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.; Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Debris extrusion; Filling removal; solvent
KRN7000 in Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to determine the safety, tolerability and effectiveness of
      KRN7000 for chronic hepatitis B infection.
    

Detailed description: 
      KRN7000 is reported to inhibit HBV replication in HBV transgenic mice. Anti-viral effects of
      KRN7000 can be expected in HBV, as the compound is able to induce not only IFN-alpha/beta but
      also IFN-gamma and TNF-alpha. In two clinical trials, KRN7000 was safe in both healthy
      volunteers and solid cancer patients; particularly, the compound has not been reported to
      show drug-related serious adverse events. A phase I/II trial is of significance in assessing
      the safety and efficacy of KRN7000 treatment for CHB patients.

      The 300 microgram/m2 dose level, comparable to 10 microgram/kg, can be considered as the
      highest safe dose level for the phase I/II trial for CHB patients with 3 dose levels. Dose
      incrementation will be performed in a logarithmic manner: 0.1, 1 and 10 microgram/kg.

      In the phase I trial for solid tumor patients, weekly administration of KRN7000 did not allow
      sufficient time for NKT cell recovery. As KRN7000 is reported to be an activating ligand for
      NKT cells, it is logical to assume that a dosing interval that provides time for recovery of
      NKT cells is optimal. In fact, cytokine production after repeating dosing, when NKT cells
      were hardly detected in the peripheral blood, was not observed. As it took approximately 4
      weeks for NKT cells to recover to pre-dose levels after a single administration, monthly
      administration is now proposed for this trial.
    

Intervention name(s): KRN7000
Intervention type(s): Drug
Intervention MeSH terms: KRN 7000
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic; hepatitis b
Health Effects of Biodiesel Exhaust Exposure
Condition: Vascular Endothelium
Study type: Interventional

Summary: 
      Urban air pollution is a major contributor to greenhouse gases and has been shown to increase
      cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing
      and research, with biodiesel emerging as one of the strongest contenders within international
      markets. The pursuit of alternative renewable fuels is incredibly complex and has powered
      research in agriculture, biotechnology, production, transportation, feedstocks, ecology and
      biomass manufacturing. In spite of this, health effects have been an almost completely
      overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust
      exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further
      investigations into the chemical composition of biodiesel exhaust will also be performed.
    


Intervention name(s): Forearm venous occlusion plethysmography study
Intervention type(s): Other
Intervention description(s): Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Air Pollution; Biodiesel exhaust; Diesel exhaust; Vascular function; Fibrinolysis; Acute endothelial responses
Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Objectives: The aim of this research is to compare the effectiveness of myofascial release
      therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint
      sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction
      syndrome.

      Material and Methods: A single-blind randomized clinical trial will be conducted in a
      university research clinic. Sixty-four subjects with temporomandibular disorders and
      myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group
      (myofascial release protocol and Rocabado exercise therapy) and control group (exercise
      therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and
      joint sounds will be collected at baseline, and forty-eight hours after the intervention
      phase.
    


Intervention name(s): myofascial release protocol and Rocabado exercise therapy; exercise therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myofascial pain syndrome; exercise therapy; randomized controlled trial
HALT Progression of Polycystic Kidney Disease Study B
Condition: Kidney, Polycystic
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the
      progression of cystic disease and on the decline in renal function in autosomal dominant
      kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical
      trials targeting different levels of kidney function: 1) early disease defined by GFR >60
      mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73
      m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the
      first three years. Participants enrolled in Study B will be followed for five-to-eight years,
      with the average length of follow-up being six and a half years.

      Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an
      angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
    

Detailed description: 
      * Specific Aim of Study B

      To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the
      setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction
      of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or
      death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60
      mL/min/1.73m2).

      * Hypothesis to be tested in Study B

      In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73
      m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline
      in kidney function over ACE-I monotherapy, independent of standard blood pressure control
      (110-130/80 mm Hg).
    

Intervention name(s): Lisinopril; Telmisartan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.; Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.; Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other intervention name(s): ACE-I; ACE; Ace-Inhibitor; ARB; Control
Intervention MeSH terms: Telmisartan; Lisinopril; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polycystic kidney disease; polycystic; kidney; disease; adpkd; halt; pkd; blood pressure; bp; hypertension; renal; renin-angiotensin-aldosterone-system; RAAS
SSRI and Buprenorphine
Condition: Opiate Dependence; Depression
MeSH terms: Opioid-Related Disorders; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test whether treatment of depressive symptoms using escitalopram
      improves adherence to Buprenorphine and reduces symptoms of depression for individuals
      receiving Buprenorphine through their medical provider.
    

Detailed description: 
      Participants interested in receiving Buprenorphine will be offered the opportunity to enroll
      in this study. Enrolled study participants will complete interviews at baseline and again
      every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized
      controlled trial, participants will either receive a placebo or escitalopram (10mg). All
      participants will also be followed by their Buprenorphine clinic medical provider. Questions
      during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication
      adherence and drug-related experiences. Comparison(s): Participants randomized into the
      medication component of the study as compared to participants randomized into the placebo
      component of the study.
    

Intervention name(s): escitalopram; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg escitalopram/day for 3 months; placebo capsule/day for 3 months
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opiate use; depression; buprenorphine; escitalopram
Efficacy of Cetuximab in Combination With Irinotecan and 5- FU/FA in Treatment of Metastatic Gastric Cancer
Condition: Adenocarcinoma of Stomach or Esophagogastric Junction
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on the current promising results with irinotecan and cetuximab in patients with
      recurrent metastatic colorectal cancer, and the excellent results of Irinotecan and 5-FU in
      gastric cancer , the present clinical study to evaluate the overall response rate, the time
      to progression and the overall survival of the combined treatment of cetuximab and irinotecan
      and 5-FU in patients with esophagogastric cancer is urgently needed.
    

Detailed description: 
      Cetuximab will be analysed with biological markers
    

Intervention name(s): Cetuximab IF
Intervention type(s): Drug
Intervention description(s): Cetuximab loading dose 400 mg/m² weekly dose 250 mg/m² Irinotecan 80 mg/m2 i.v. over 2 hours day 1, 8, 15, 22, 29, 36 Folinic acid 200 mg/m2 over 24 hours day 1, 8, 15, 22, 29, 36 FA will be given as sodium folinate 5-FU 1500 mg/m2 continuous infusion over 24 hours day 1, 8, 15, 22, 29, 36
Other intervention name(s): na-folinat oncofolic
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma; gastric cancer; esophagogastric junction cancer
Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure
Condition: Blood Pressure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a supplement called Provex CV can reduce blood
      pressure and other risk factors for heart disease. Heart disease is the leading cause of
      death in this country and it is important to identify dietary factors, including supplements,
      that can reduce heart disease risk factors. The supplement to be tested in this study is made
      of a combination of natural compounds found in plants such as grapeseed extract, green tea,
      and quercetin. Each compound individually has been shown to improve blood pressure or reduce
      inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of
      inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This
      investigational trial of Provex CV has been approved by the United States Food and Drug
      Administration.
    


Intervention name(s): Provex CV; placebo
Intervention type(s): Drug; Other
Intervention description(s): dietary supplement, 2 capsules per day by mouth; corn starch, 2 capsules per day by mouth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort,
      dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to
      moderate atopic dermatitis.
    


Intervention name(s): 50 mg S-777469; 200 mg S-777469; 800 mg S-777469; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): S-777469, 50 mg BID; S-777469, 200 mg BID; S-777469, 800 mg BID; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis
Effect of Polyphenols on Peripheral Vascular Disease.
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally
      high risk for cardiovascular events. Oxidative stress seems to play a role in impairing
      flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa
      seems to exert artery dilatation via oxidative stress inhibition.

      OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation
      via down-regulation of NOX2, the catalytic core of NADPH oxidase.
    

Detailed description: 
      Atherosclerosis represents the major cause of worldwide death; it is a complex phenomenon
      that encompasses the intricate interplay of classic cardiovascular risk factors, oxidative
      stress and inflammation.

      Peripheral artery disease (PAD) is a clinical setting that well represents the model of
      widespread atherosclerosis. PAD affects 20% of patients over the age of 75. Furthermore, PAD
      patients are at an exceptionally high risk for cardiovascular events and the majority will
      eventually die of a cardiac or cerebrovascular etiology.

      Polyphenol could represent a novel therapeutic strategy to counteract atherosclerosis. During
      the last decades, a growing interest in polyphenols resulted from prospective and
      epidemiological studies that showed the beneficial effects of these substances on human
      health. In particular, polyphenols exert their beneficial effect by inhibition of NADPH
      oxidase (NOX2), an enzyme directly involved in atherosclerosis; thus, the activation of this
      enzyme leads to an enhanced production of oxidative stress and inflammatory processes.

      The objective of this study is to evaluate the effect of polyphenols on oxidative stress and
      inflammation and on surrogate markers of atherosclerosis in PAD patients. Polyphenols,
      inhibiting NOX2-mediated oxidative stress and immune-mediated process, could represent a
      novel therapy to reduce the high risk of cardiovascular events in PAD.
    

Intervention name(s): dark chocolate with crossover to milk chocolate; milk chocolate with crossover to dark chocolate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 40 g/d of dark chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of milk chocolate for 4 weeks; 40 g/d of milk chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of dark chocolate for 4 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Peripheral arterial disease; Oxidative stress; Cocoa; polyphenols; NADPH oxidase