bioihbjkbjnl/mcl2 huggingface dataset:
Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the
      development and growth of cancer.

      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who
      have advanced head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and biological activity of EGFR antisense DNA and DC-chol
      liposomes in patients with advanced squamous cell carcinoma of the head and neck. II.
      Determine the toxicity and maximum tolerated dose of this regimen in these patients. III.
      Determine the antitumor response in patients treated with this regimen. IV. Determine the
      effect of this regimen on EGFR expression levels, STAT protein expression/activation levels,
      and apoptosis rates in biopsied tumor cells of these patients.

      OUTLINE: This is a dose-escalation study. Patients receive EGFR antisense DNA and DC-chol
      liposomes intratumorally weekly for 4 weeks. Courses repeat every 4 weeks for up to 6 months
      in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients
      receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study.
    

Intervention name(s): EGFR antisense DNA; growth factor antagonist therapy; DC-cholesterol liposome
Intervention type(s): Biological; Biological; Drug
Intervention MeSH terms: Mitogens
Primary purpose: Treatment
Keywords: untreated metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of
      various formulations of XW10172 in healthy volunteers.
    


Intervention name(s): XW10172
Intervention type(s): Drug
Intervention description(s): Various formulations
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Post Market Study of the InnFocus MicroShunt
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      Prospective, multicentric, single arm post market study to gather safety and effectiveness
      data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma
      patients
    

Detailed description: 
      The purpose of this study is to collect additional safety and effectiveness data on the
      InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who
      are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥
      18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.
    

Intervention name(s): InnFocus MicroShunt implantation
Intervention type(s): Device
Intervention description(s): Implantation will include the use of Mitomycin C applied with sponges.
Other intervention name(s): InnFocus MicroShunt; MIDI Arrow
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma shunt; glaucoma drainage device
IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
Condition: Sleep Apnea, Obstructive; Primary Open-angle Glaucoma
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in
      the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common
      sleep-related breathing disorder and is characterized by repeated partial or complete upper
      airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the
      diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called
      respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous
      positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The
      association between OSAS and glaucoma has been extensively studied, although a few reports
      have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading
      to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic
      neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure
      (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.

      The purpose of this study is to investigate how IOP varies in time, particularly during sleep
      in OSAS patients with or without glaucoma, and if the IOP variations are associated with the
      use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable
      investigational device using a contact lens sensor that monitors the IOP fluctuation
      continuously over 24-hours.
    


Intervention name(s): SENSIMED Triggerfish®
Intervention type(s): Device
Intervention description(s): Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
GrandAides; a Workforce Innovation to Address Post Acute Care
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Randomized controlled trial with two groups looking at post hospital care for patients who
      were admitted with congestive heart failure. The control group includes standard of care
      provided to the patients after discharge including a hospital employed community health
      worker. The intervention group receives a specially trained GrandAide following the GrandAide
      model for post acute care. Difference in ER visits and readmissions was measured.
    

Detailed description: 
      GrandAides program is a credible messenger community health worker based program that assumes
      a community health worker from the community who has specialized education around a certain
      chronic condition will be able to support patients in the outpatient setting more effectively
      than current standard of care. In this study a GrandAide visited a patient discharged from
      the hospital in their home for 4 weeks providing education, checking vital signs, and
      assisting with communication with the cardiologist. The study measured the difference in
      hospital admissions and ER visits between the group that was assigned a GrandAid and the
      group that took part in standard care. The groups were assigned randomly. The difference was
      calculated using one and two tailed t-test results.
    

Intervention name(s): GrandAides
Intervention type(s): Behavioral
Intervention description(s): Enhanced post acute care for patients recently admitted for congestive heart failure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Electromyography-biofeedback on the Motor Activation of the Extension of the Hand
Condition: Stroke, Complication
Study type: Interventional

Summary: 
      Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent
      physiotherapy technique. Although its use is widespread in sports science and sports
      performance, its use for the rehabilitation of patients with neurological pathologies is less
      studied.

      Objective: The purpose of this research was to determine the changes that occur in the
      application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of
      the hand and the foot in subjects with cerebrovascular damage.

      Design: A randomized, double-blind, two-arm parallel group study was performed.

      Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the
      foot as a consequence of a stroke was randomized divided in intervention or control groups.

      Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of
      15-minute duration each of them, in the upper and lower members. On the other hand, the
      control group underwent another 12 sessions of 15-minute duration, in which manual
      physiotherapy techniques were performed.
    


Intervention name(s): surface electromyography-biofeedback
Intervention type(s): Device
Intervention description(s): Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for
      treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its
      reproductive system toxicity. The investigators are inspired by Chinese external therapy, an
      immemorial therapy for thousands of years, and take its advantage to make TwHF topically in
      order to get an effective and safe treatment for active RA patients.
    


Intervention name(s): Topical tripterygium gel; Placebo gel
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Tripterygium wilfordii Hook F; double-blinded; randomized controlled trial; Tripterygium; Administration; Topical
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
Condition: Qt Interval, Variation in
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
    

Detailed description: 
      This study is a single center, open label, dose escalation trial to evaluate prolongation
      effect on QT interval of NPC-15 (melatonin 8mg or 16mg).

      The trial compose of 3 periods; During the each period, eligible volunteers wll be
      administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential
      manner.
    

Intervention name(s): NPC-15 and/or Placebo
Intervention type(s): Drug
Intervention description(s): The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)
Other intervention name(s): Melatonin and/or Placebo
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: QTc prolongation effect
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of a Merck clinical trial formulation of
      ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
    


Intervention name(s): Comparator: Treatment A (Zofran, ondansetron); Comparator: Treatment B (Zofran, ondansetron); Comparator: Treatment C (Zofran, ondansetron)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO); a single 8 mg tablet of Zofran marketed in the U.K., taken PO; a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other intervention name(s): Zofran, ondansetron; Zofran, ondansetron; Zofran, ondansetron
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device
Condition: Type 1 Diabetes Mellitus With Artificial Pancreas Device
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study evaluates the ability of deep learning to improve the knowledge about structural
      and vascular retinal changes in diabetic patients undergoing artificial pancreas device,
      using optical coherence tomography angiography.
    

Detailed description: 
      hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's
      glycemic levels with insulin doses appropriate to the patient's blood glucose.

      The optical coherence tomography angiography represents a novel and noninvasive diagnostic
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary
      vascular features.

      The study evaluates the changes in optical coherence tomography angiography features in
      diabetic patients undergoing artificial pancreas device, elaborating these data with
      artificial intelligence.
    

Intervention name(s): hybrid artificial pancreas systems (CSII)
Intervention type(s): Device
Intervention description(s): artificial device that adjust the patient's glycemic levels with insulin doses appropriate to the patient's blood glucose
Intervention MeSH terms: Pancrelipase
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with diagnosis of type 1 diabetes treated with
        artificial pancreas device. They did not present other ophthalmological disease
Atomoxetine in the Treatment of Binge Eating Disorder
Condition: Binge-eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The specific aim of this study is to assess the efficacy and safety of atomoxetine compared
      with placebo in outpatients with binge eating disorder.
    


Intervention name(s): atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Coinfection; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and
      well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs
      (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.
    

Detailed description: 
      Primary Objective •To assess the efficacy of grazoprevir 100mg and elbasvir 50mg by
      determining the proportion of sustained virological response 12 weeks after the end of
      therapy (SVR12; HCV RNA concentration less than 10 IU/ mL at follow-up week 12) in
      peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV
      co-infection, compared with treatment-naïve patients with 1 HCV and HIV co-infection.

      Secondary Objective

      •To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus
      ribavirin experienced patients by measuring frequency of SAEs and AEs leading to
      discontinuation.
    

Intervention name(s): grazoprevir and elbasvir
Intervention type(s): Drug
Intervention description(s): For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Intervention MeSH terms: Grazoprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of a Serious Health Game on Children's Eating Behavior
Condition: Eating Behavior
Study type: Interventional

Summary: 
      Background: Currently the dietary intake patterns of children do not meet the prescribed
      dietary guidelines. Consequently childhood obesity is one of the most serious health
      concerns. Therefore, innovative methods need to be developed and tested in order to
      effectively improve the dietary intake of children. Learning children how to cope with the
      overwhelming number of unhealthy food cues could be conducted effectively by serious health
      games.

      Objective: The main aim of this study was to examine the effect of a serious health computer
      game on young children's eating behavior and attitudes towards healthy and unhealthy foods.

      Methods: A cluster-randomized controlled trial with a between-subject design was conducted
      (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were
      in the control condition. Children in the control condition attended regular classes and did
      not play a game. The game was designed in collaboration with researchers and pilot-tested
      before conducting the experiment among a group of children repeatedly. After one week of
      playing, attitudes towards food snacks and actual intake was assessed, whereby children could
      eat at libitum from fruits or energy-dense snacks.
    


Intervention name(s): Serious health game
Intervention type(s): Behavioral
Intervention description(s): Serious health game
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Improving Appetite Regulation in Patients With Obesity
Condition: Weight Loss; Weight Gain Prevention; Obesity
MeSH terms: Obesity; Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      Over 70% of U.S. adults have overweight or obesity. Currently, the most efficacious
      behavioral intervention for obesity is standard behavioral treatment (SBT), often composed of
      group sessions, calorie goals, and physical activity goals. With this approach, participants
      often lose 8-10% of the person's baseline weight, and also decrease risk for cardiovascular
      disease. Long-term weight loss, however, is limited; many participants return to baseline
      weight within five years following treatment. One reason SBT may not create long-term weight
      loss may be due to treatment components that teach participants to rely on external methods
      for changing eating decisions (e.g., counting calories, restricting certain foods), rather
      than internal cues of hunger and satiety. Because individuals with obesity report significant
      challenges with adhering to these cues, augmenting behavioral interventions with appetite
      self-regulation training may be a solution. Thus, the investigator propose to examine the
      feasibility and acceptability of a 6-month remotely-delivered appetite regulation + lifestyle
      modification intervention to treat obesity.
    

Detailed description: 
      Aim 1. Using a single-arm design, the investigator will examine the feasibility and
      acceptability of a 6-month, remotely-delivered, appetite self-regulation intervention for
      weight loss maintenance.

      Aim 2. Examine the preliminary efficacy of the intervention on weight maintenance at 4 and 6
      months.
    

Intervention name(s): Appetite Self-Regulation Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of content from Appetite Awareness Training (AAT), a cognitive-behavioral intervention to promote intuitive eating and the Diabetes Prevention Program (DPP)20, a behavioral lifestyle intervention. The goal of AAT is to enable participants to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants to reduce binge and overeating. Participants are taught to respond to external cues to eat (e.g., social gatherings), self-monitor the participant's adherence to biological signals of hunger and satiety, and to develop appropriate coping skills to manage urges to eat when not physically hungry.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Sevelamer Hydrochloride in Peritoneal Dialysis Patients
Condition: Endstage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as
      effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression
      of cardiovascular calcification.
    

Detailed description: 
      Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent
      cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be
      an important predictor of mortality and cardiovascular death in ESRD patients and is largely
      attributed to the increased prevalence of vascular calcification.
    

Intervention name(s): sevelamer hydrochloride
Intervention type(s): Drug
Intervention description(s): First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)
Other intervention name(s): Renagel
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vascular,; valvular calcification,; phosphate binder,; sevelamer,; endstage renal disease; peritoneal dialysis