bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: chlorhexidine gluconate oral rinse (0.12%); placebo
Intervention description: chlorhexidine gluconate oral rinse
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventilator-associated pneumonia

Summary:

      Recent studies have found that poor oral hygiene may foster the colonization of the
      oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care
      unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent
      ventilator-associated pneumonia (VAP).

      The specific aims of this investigation are: 1) to organize the necessary infrastructure to
      develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to
      prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if
      the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque,
      oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients included in this study will be those admitted to the trauma intensive care
             unit (TICU) of Erie County Medical Center (ECMC) hospital. All patients admitted to
             the TICU who are intubated and mechanically ventilated within 24-48 hours of admission
             will be eligible for study admission, with the exception of those demonstrating the
             following exclusion criteria: a) a witnessed aspiration (to eliminate patients with
             chemical pneumonitis); b) a confirmed diagnosis of post-obstructive pneumonia (e.g.
             advanced lung cancer); c) a known hypersensitivity to CHX; d) patients for whom
             consent can not be obtained; e) a diagnosed thrombocytopenia (platelet count less than
             40 and/or a INR above 2) or other coagulopathy; f) a do not intubate order; g)
             children under the age of 18 years; h) Pregnant women; i) Legal incarceration; j) If
             transferred from another ICU; k) Those with oral mucositis; l) Those with
             immunosuppression (either-HIV or drug induced [e.g. organ transplant patients or those
             on long term steroid therapy]); m) Patients re-admitted to the TICU

          -  Comatose and intubated patients will be included since they represent patients at
             greatest risk for respiratory infection.

        Exclusion Criteria:

          -  Patients for whom consent can not be obtained.
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Empagliflozin; Placebo (matching empagliflozin); ramipril
Intervention description: Empagliflozin will be taken once daily; Placebo will be taken once daily; Ramipril will be taken once or twice daily
Intervention MeSH terms: Empagliflozin; Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial
      with empagliflozin compared to placebo that is added to open-label ramipril.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent.

          -  Male or female patients diagnosed with type 1 diabetes (T1D) at least 6 months prior
             to informed consent or type 2 diabetes (T2D) or non-diabetic obese patients.

          -  T1D patients must use and be willing of and be willing to continue throughout the
             duration of the trial either:

          -  multiple daily injections of insulin OR

          -  continuous sub-cutaneous insulin infusion of any insulin type, with at least 3 months
             experience

          -  For patients with T1D or T2D,HbA1c of 6.5 - 11%

          -  Age at least 18 years of age

          -  Body mass index of >=18.5 kg/m^2

          -  Estimated glomerular filtration rate greater than or equal to 60 ml/min/1.73m2

          -  Blood pressure greater than 90 /60 mmHg and less than or equal to 140 / 90 mmHg

          -  Use of a highly effective method of contraception.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  For patients with T1D, treatment with an antihyperglycaemic agent within 3 months
             prior to visit 1

          -  occurrence of severe hypoglycaemia within 3 months prior to visit 1

          -  hypoglycaemic unawareness within 3 months prior to visit 1

          -  occurrence of diabetic ketoacidosis within 3 months of visit 1 and until visit 3
             Further exclusion criteria apply
CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Comfort Cool thumb splint by North Coast Medical; Custom made thermoplastic & neoprene splint
Intervention description: Comfort Cool(TM) splint, a prefabricated neoprene splint, fit according to the participant's size (S, M, M+, L). Participants instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Used for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.; The Hybrid splint was based on Pat McKee's custom-made splint design, fabricated from neoprene and 1.6 mm Rolyan Aquaplast Watercolors (Bollingbrook, IL). Participants were instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Splint was worn for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Osteoarthritis, carpometacarpal joint; Thumb splints; AUSCAN-HI 3.1; Grip and pinch strength

Summary:

      Osteoarthritis (OA) of the thumb carpometacarpal (CMC) joint is a common condition that is
      seen regularly in outpatient occupational therapy and physiotherapy departments. Prevalence
      rates of symptomatic thumb OA have been found to be as high as 25%. The conservative
      treatment of choice consists of splinting. There are many different types of thumb splints
      available, but no specific guidelines as to which is preferred. There is limited evidence to
      support the benefits of splinting.

      The purpose of this study is to compare the effectiveness of two different thumb splints: the
      Comfort Cool, a prefabricated neoprene splint and a custom made neoprene and thermoplastic
      thumb splint. These are two of the most commonly prescribed splints in local occupational
      therapy departments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  physician diagnosis of CMC OA

          -  45 years or older

          -  able to read and write in English

        Exclusion Criteria:

        • previous thumb surgery
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS Topical product
Intervention description: once daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal
      Use Treatment with DSXS .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 18 years of age or older.

          -  IRE-approved, signed informed consent form that meets all criteria of current FDA
             regulations.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy.
A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Glucose oxidase+5%glucose; Saline+5%glucose
Intervention description: A hydrogen peroxide producing enzyme; Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Healthy persons are invited to participate in the study and are given a home protocol
      (WURSS21), nasal spray and a sample pin. The included persons are told to make a
      nasopharyngeal sampling from the nose when they are sure that they have caught a common cold.
      After the sampling they start to spray and also fill in the records daily. The aim of the
      study is to investigate whether a nasal spray with glucose oxidase could shorten an episode
      of common cold.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults

        Exclusion Criteria:

          -  Ongoing allergy
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Dronabinol and Palmitoylethanolamide
Intervention description: Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
Intervention MeSH terms: Palmidrol; Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Motor tics; Vocal tics; Cannabinoids; Dronabinol; PEA; Palmitoylethanolamide; Tourettes; TS

Summary:

      This is an investigator-initiated proof of concept study with the purpose to examine the
      safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the
      treatment of adults with Tourette syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult between 18-60 years of age

          -  Meet DSM-5 criteria for the diagnosis of Tourette syndrome

          -  Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at
             baseline

          -  On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning
             the trial

          -  Accepted method of birth control

        Exclusion Criteria:

          -  Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental
             disorder or intellectual disability (IQ<70)

          -  Recent change (less than 4 weeks) in other medications that have potential effects on
             tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs,
             clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication
             change is defined to include dose changes or medication discontinuation.

          -  Recent change in behavioral treatment for Tourette syndrome or comorbid conditions
             (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within
             the last 12 weeks.

          -  Taking any co-medications (over the counter or prescription), food
             supplements/additives which can have a drug interaction with dronabinol or PEA.

          -  Positive pregnancy test or drug screening test

          -  History of cannabis dependence

          -  Significant Medical Comorbidity

          -  History of hypersensitivity to any cannabinoid or sesame oil
Crossover Trial of AD109 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD109; Atomoxetine; R-oxybutynin; Placebo; Digit System Substitution Test
Intervention description: Oral administration before bed; Oral administration before bed; Oral administration before bed; Oral administration before bed; a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Intervention MeSH terms: Oxybutynin; Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of AD109 versus its individual components or placebo in
      patients with obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.

          -  AHI 10 to <20, or AHI ≥20 if meets other PSG criteria

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery
             disease or cardiac failure) or hypertension requiring more than 2 medications for
             control. A medication for these purposes is defined by dosage form, such that a
             combination antihypertensive medication is considered 1 medication

          -  CPAP should not be used for at least 2 weeks prior to first study PSG

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.
Buprenorphine for Late-Life Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Buprenorphine
Intervention description: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Depressive Disorder, Major; Late-Life Depression; Geriatrics; Buprenorphine

Summary:

      The goals of this pilot study are to gather data about the safety and clinical effect of
      low-dose buprenorphine in older adults with treatment resistant depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 50 years

          -  Major depressive disorder

          -  Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic
             dose, each for at least 6 weeks, or is a depression non-responder from an ongoing
             study of late-life depression at our research clinic.

        Exclusion Criteria:

          -  Concomitant use of strong or moderate CYP3A4 inhibitor.

          -  Refusal to stop all opioids.

          -  Refusal to discontinue all alcohol.

          -  Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day
             prescribed at a stable dose for at least the past 2 weeks.

          -  Hepatic impairment (AST/ALT > 1.5 times upper normal.

          -  Lung disease requiring supplemental oxygen.

          -  Estimated creatinine clearance <30 mL/min.

          -  Inability to provide informed consent.

          -  Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.

          -  Dementia.

          -  Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective
             disorder, schizophreniform disorder, delusional disorder, or current psychotic
             symptoms.

          -  Abuse of or dependence on alcohol or other substances within the past 3 months.

          -  Meets criteria for history of abuse or dependence upon opioids.

          -  High risk for suicide.

          -  Contraindication to buprenorphine.

          -  Inability to communicate in English.

          -  Non-correctable clinically significant sensory impairment.

          -  Unstable medical illness.

          -  Subjects taking psychotropic medications that cannot be safely tapered and
             discontinued prior to study initiation.
Citalopram in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Citalopram; Placebo
Intervention description: 20mg/day for 4 weeks, then 40 mg/day for 4 weeks; Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks
Intervention MeSH terms: Citalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Irritable bowel syndrome; Antidepressant; IBS; Serotonin-reuptake inhibitor; SSRI; Visceral sensitivity; Barostat; Quality of life; Depression

Summary:

      Hypotheses:

        1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported
           global symptom rating and "adequate relief of IBS symptoms," does not differ between
           non-depressed IBS patients treated with the SSRI citalopram and patients treated with
           placebo.

        2. Secondary null hypotheses:

             1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument,
                do not differ between patients treated with the SSRI citalopram and patients
                treated with placebo.

             2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon
                distention, do not differ between patients treated with the SSRI citalopram and
                patients treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria are:

          1. Fulfilling Rome II IBS definition;

          2. Age ≥18 yrs and able to give informed consent;

          3. Normal sigmoidoscopy, colonoscopy or barium enema within 5 years, normal complete
             blood count and thyroid studies, and negative stool ova and parasite exam for patients
             with diarrhea.

        Exclusion Criteria:

        Exclusion criteria are:

          1. Current psychiatric diagnosis or active treatment with antidepressants;

          2. Pregnancy;

          3. Major systemic illness, or illness that could explain IBS-like symptoms;

          4. Active IBS therapy other than fiber or loperamide.
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Intervention: VIA-2291; Placebo
Intervention description: 100 mg, oral dosing, 1 time daily for 12 weeks; oral dosing, 1 time daily for 12 weeks
Intervention MeSH terms: Atreleuton
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory
      biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients must be of non-childbearing potential

          -  Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery

          -  One or more of the following clinical features: Prior history >4 weeks of
             cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with
             North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior
             history of amaurosis fugax occurring at any time

          -  Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting
             blood glucose levels >6.9 mmol/L

          -  Baseline hsCRP >2 mg/L

          -  Echolucent plaque

        Exclusion Criteria:

          -  Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable
             plaque requiring urgent carotid endarterectomy

          -  Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

          -  Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1 x ULN (i.e., above the
             normal range) or positive screening test for hepatitis B (hepatitis B surface antigen)
             or hepatitis C (by ELISA)

          -  Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as
             HbA1c >11% at screening

          -  Congestive heart failure (CHF) defined by the New York Heart Association as functional
             Class III or IV

          -  Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery
             (within 4 weeks of enrollment)

          -  Current atrial fibrillation

          -  Planned cardiac intervention

          -  Acetaminophen use in any form in the 7 days before enrollment