bioihbjkbjnl/mcl2 huggingface dataset:
VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C
Condition: Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Substance-Related Disorders; Alcohol-Related Disorders
Study type: Interventional

Summary: 
      This study implement a values-based motivational interviewing (VBMI) intervention to promote
      treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30
      Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C
      virus (HCV) infection.
    

Detailed description: 
      The investigators will conduct a prospective study of 30 Veterans with treatment-naive
      genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential
      Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center.
      Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based
      motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be
      prescribed in accordance with the package insert.
    

Intervention name(s): VBMI
Intervention type(s): Behavioral
Intervention description(s): 12 week values based motivational interviewing intervention with a licensed psychologist
Other intervention name(s): Values Based Motivational Interviewing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
Condition: Aqueous Tamponade; Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state
      of the lens and related parameters of the eye, and whether the changes of the above
      parameters are correlated with age, gender, diabetes or not, etc., so as to provide
      references for the diagnosis and treatment of related diseases and scientific research.
    


Intervention name(s): pars plana vitrectomy
Intervention type(s): Procedure
Intervention description(s): pars plana vitrectomy and Silicone oil removal to distinguish subjects
Other intervention name(s): Silicone oil removal
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular
        hole, retinal detachment, and other diseases, or underwent vitreous silicone oil tamponade
        and vitreous silicone oil removal due to various causes
      
Keywords: aqueous tamponade; cataract; lens thickness; axial length; pars plana vitrectomy
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of an aripiprazole injection in subjects with schizophrenia
      that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in
      this study will receive one injection of aripiprazole and will need to stop taking their
      other antipsychotic medication two weeks after the injection. The study will last one month.
      Subjects will be required to come to a clinic for evaluations and drug and urine collection
      five times during the course of the study.
    


Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): 400 mg intramuscular injection of aripiprazole
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Schizophrenia; Aripiprazole
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Condition: Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare adhesion prophylaxis with
      polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety,
      side effects and usability in addition to gaining early evidence of the effectiveness of
      polylactide-caprolactone-trimethylenecarbonate copolymer.
    


Intervention name(s): polylactide-caprolactone-trimethylenecarbonate copolymer; Icodextrin 4%
Intervention type(s): Device; Device
Intervention description(s): Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum; 1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Intervention MeSH terms: Icodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Berlin Magnetic Seizure Therapy Depression Trial 01
Condition: Unipolar Depression; Bipolar Depression
MeSH terms: Seizures; Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic
      seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive
      episode. The investigators will perform add-on tests to assess clinical and cognitive
      response to treatment. It is hypothesized that MST will have an antidepressant efficacy with
      a beneficial neurocognitive adverse effect profile.
    


Intervention name(s): magnetic seizure therapy
Intervention type(s): Procedure
Intervention description(s): antidepressant treatment with MST
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size
      and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass
      procedure, involves significant changes to the size and function of the stomach and leads to
      more rapid gastric emptying. Consequences will be faster absorption and higher peak
      concentration of ethanol after surgery than before. There are growing concerns that surgery
      for obesity in this way may cause alcohol abuse.

      In this study the investigators compare changes in FPM of ethanol following two different
      bariatric surgical procedures.
    


Intervention name(s): Gastric bypass; gastric sleeve
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis.; Sleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital,
        Trondheim, Norway
      
Biospecimen description: 
      blood samples
    
Keywords: bariatric surgery; alcohol drinking; alcoholism; ethanol; metabolism
A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
Condition: Healthy; Cigarette Smoking
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is
      safe (does not cause prolonged cough, shortness of breath or other problems), but causes
      changes in sputum cell samples that the scientists can measure. The investigators are also
      interested in seeing if the exposure to the endotoxin decreases the body's natural ability to
      clear mucus from the lungs.
    

Detailed description: 
      The purpose of this study is to determine the range of neutrophil response (influx of PMNs to
      the airways as determined in sputum) after inhalation of CCRE (20,000 EU), shown in previous
      studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy
      smokers to be well tolerated. This dose induces measurable increases in neutrophil content of
      induced sputum that can be employed to screen large populations for susceptibility to the
      inflammatory effect of inhaled endotoxin. Limitations of the understanding of actions of
      inflammatory stimuli on airway function are likely due to the fact that functional
      assessments of dynamic airway response /in vivo/ have generally been limited to those based
      on spirometry and examination of airway samples for assessment of cells and mediator content.
      Slowing of mucociliary clearance (MCC), a key component of airway defense, can be induced by
      inflammation and almost certainly contribute to mucus plugging and decreased clearance of
      inhaled irritants. Measures of mucociliary clearance (MCC), by inhalation of radiolabeled
      particles to label airway surface liquid, suggest that clearance of secretions is impaired to
      a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.
    

Intervention name(s): 20K EU CCRE
Intervention type(s): Biological
Intervention description(s): Inhalation of CCRE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Otherwise healthy current cigarette smokers; current cigarette smokers
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Condition: Skin Infection
MeSH terms: Cellulitis; Skin Diseases, Infectious
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing
      aid associated skin breakdown better than standard care of bacitracin ointment alone in adult
      patients.
    

Detailed description: 
      This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids
      (BAHI) implantation surgery. Patients will be randomized to either postoperative medicinal
      honey or postoperative standard care of bacitracin ointment alone using a random number
      generator. There will be a total of two patient groups. The type of BAHI device used,
      laterally and the surgical technique will be recorded.

      Treatment groups:

      Group 1-patients undergoing BAHI implantation who will be postoperatively treated with
      medicinal honey.

      Group 2- patients undergoing BAHI implantation who will be postoperatively treated with
      bacitracin ointment as standard care.
    

Intervention name(s): Medicinal honey; Bacitracin
Intervention type(s): Drug; Drug
Intervention description(s): Treat healing surgical site with medicinal honey; Treat healing surgical site with bacitracin
Other intervention name(s): MEDIHONEY
Intervention MeSH terms: Bacitracin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements
Condition: Healthy Participants
Study type: Interventional

Summary: 
      Curcumin, Omega-3 and Vitamin-D (COD) are commonly used dietary supplements, which are
      licensed natural health products in Canada. The investigators are interested to see what
      effects (good or bad) these supplements taken in combination, might have on a person and the
      potential impact of these supplements, in combination, on inflammation and the immune system,
      in the body. This is because the investigators study Rheumatoid Arthritis (RA), an autoimmune
      disease that affects the joints of the body, causing joint pain and swelling.

      The investigators want to first evaluate the tolerability and potential negative effects of
      these three supplements in combination, also known as "side-effects" in healthy persons. This
      pilot study will also help us determine the length of time research participants need for
      their research visits for future clinical trials.

      The investigators also want to explore the utility and validity of two different 24-hour food
      recall methods (ASA24-Canada-2018 and Keenoa food diary) and the dietary inflammatory index
      (DII) using both recall methods. The DII is a score calculated from dietary data, to
      establish the inflammatory potential of an individual's diet.

      This research pilot study aims to enroll 50 persons. The investigators want to identify
      common side effects of the supplements when all three are taken together, as well as any
      other potential side-effects that might occur that are not common. Based on the scientific
      research, persons who have taken these supplements individually (e.g., Vitamin D alone or
      Omega-3 alone), show that serious side effects are unlikely and if they do occur are mild.
      Pure curcumin, like that being administered in this study, containing no fillers, has not
      shown to have adverse effects and is well tolerated. However, no scientific studies have been
      done using all three of these nutritional supplements together, in humans.
    


Intervention name(s): Curcumin, Omega-3 and Vitamin-D (COD)
Intervention type(s): Dietary Supplement
Intervention description(s): Acumin™ Turmeric Complex (Dr. D's Ultra BioTurmeric) 500 mg daily (NPN 80087842)
Omega-3 supplements (combination of DHA and EPA) 900 mg daily (NPN 80019234)
Vitamin D3 supplements 2500 IU daily (NPN 80108995)
Intervention MeSH terms: Vitamin D; Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intranasal Insulin on LH Concentrations in Man
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a
      condition called hypogonadotrophic hypogonadism (HH). People with this condition produce
      little or no sex hormones. Obesity and metabolic syndrome are also associated with HH.
      Research suggests that insulin in the brain may benefit the glands that release these
      hormones. During this study, subjects will spray a small amount of insulin into their
      nose.This will increase insulin concentrations in the brain. The purpose of this study is to
      find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in
      obese diabetic men with HH.
    

Detailed description: 
      Studies over the last few years have clearly established that at least 25% of men with type 2
      diabetes have subnormal free testosterone (T) concentrations in association with
      inappropriately low leutinizing hormone (LH) and FSH (follicle stimulating hormone)
      concentrations. These patients thus suffer from hypogonadotrophic hypogonadism (HH). Obesity
      and metabolic syndrome are also associated with HH. Animal studies and in vitro data have
      shown that insulin action and insulin responsiveness in the brain are necessary for the
      maintenance of the functional integrity of the hypothalamo-hypophyseal-gonadal axis. Insulin
      concentrations can be increased in the brain by delivering insulin intranasally with vianase
      device. The aim of this project is to study the effect of one dose of intranasal insulin on
      release of LH in obese diabetic men with HH. 15 obese men with type 2 diabetes and low free T
      along with normal LH concentrations will be recruited for the study. The study will be
      carried out at the clinical center of Texas Tech (Odessa campus). There will be two study
      visits, each comprising of blood tests every 15 minutes over 6 hours. 40 IU of intranasal
      insulin or saline will be given after a baseline period of blood sampling of 2 hours.
      Student's t-test will be used to compare the change in LH concentrations after intranasal
      saline or insulin.
    

Intervention name(s): intranasal insulin; placebo (intranasal saline)
Intervention type(s): Drug; Drug
Intervention description(s): insulin; saline
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypogonadotropic hypogonadism
Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
Condition: Focal Onset Epilepsy; Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Observational

Summary: 
      The specific aim is to determine if there are patterns of temperature differences in the
      abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a
      non-epileptic control group. The hypothesis is that individuals with partial/focal onset
      epilepsy will have colder recorded temperatures in the abdominal area than individuals in a
      matched control group.
    

Detailed description: 
      The concept of "Abdominal Epilepsy" has been described in the neurology literature. The
      present study seeks to amplify understanding of this clinical entity by measuring abdominal
      area and low back skin temperature changes which may be affected through the function of the
      abdominal ganglia, specifically the Celiac, Superior Mesenteric and Inferior Mesenteric
      Ganglia.

      This not an intervention study. It is study comparing abdominal area and low back skin
      temperature in individuals with the Partial/Focal Onset Epilepsy with a match control group
      of individuals with no epilepsy history. The implications of the outcome of the finding any
      significant temperature changes between the experimental and control groups is great enough
      to warrant the highest level of scientific scrutiny that this registration permits.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects
      
Keywords: epilepsy; thermography
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Condition: Schizoaffective Disorder; Schizophrenia; Bipolar Disorder; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Testing an mHealth mobile interventionist texting program on illness management.
    

Detailed description: 
      The ultimate objective is to evaluate a validated mHealth intervention that can be
      realistically integrated into community mental health settings to increase the availability,
      reach, and broad impact of illness management approaches for people with serious mental
      illness (SMI).
    

Intervention name(s): Mobile Interventionist
Intervention type(s): Other
Intervention description(s): A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mhealth; texting intervention; mobile health; mobile mental health
Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients
Condition: Systemic Sclerosis; Scleroderma; Pulmonary Hypertension; Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to determine the timeline of progression from pre-pulmonary
      hypertension to diagnosable pulmonary hypertension based on right heart catheterization.
      Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension
      to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT
      symptoms.
    

Detailed description: 
      Systemic sclerosis (SSc) is a rare, often fatal idiopathic disease, which has no effective
      therapy. One of the most major complications of systematic sclerosis is pulmonary
      hypertension (PHT), which is now the cause of all scleroderma related deaths. New therapeutic
      advances have improved short-term management of pulmonary hypertension in scleroderma, but
      long-term outcomes are unknown. With this in mind, Dr. Steen has developed Pulmonary
      Hypertension Assessment Registry of Scleroderma (PHAROS), a preventive, multi-center, web
      based observational study that looks at the natural history and outcome of scleroderma
      patients who are at high risk or have early pulmonary hypertension. Patients entered into the
      registry will be followed in prospective fashion noting the clinical course of disease by
      both scheduled and event driven follow up. A thorough baseline history will be collected to
      determine key prognostic and correlative factors for both disease prevalence and progression.
      Yearly follow up consisting of questionnaires, pulmonary function tests, echocardiogram, 6
      minute walk tests and predefined patient characteristics will also be conducted to further
      understand and note the progression of scleroderma related PAH. Event driven follow up will
      occur to record findings and record specific predetermined events in the clinical course of
      disease.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care, rheumatology and pulmonary hypertension clinics.
      
Biospecimen description: 
      Serum stored for future analysis
    
Keywords: Systemic Sclerosis; Scleroderma; Pulmonary Hypertension; PHAROS; PHROS; Exercise Echocardiogram; Pulmonary Functional Tests; Six minute walk tests; 6 minute walk tests; Right heart catheterization