bioihbjkbjnl/mcl2 huggingface dataset:
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Belladonna and Opium Suppository; Rectal Exam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Belladonna and Opium Suppositories

Summary:

      Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a
      variety of ailments. These procedures often require that the bladder be filled and emptied
      with sterile water or saline several times during the procedure, and often result in the
      patient receiving a catheter at the end of the procedure. One common side effect is that
      patients experience bladder spasm or discomfort for a period of time after these procedures.
      Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the
      post-operative setting to relieve these symptoms.

      The principle objectives of this study are:

        1. To determine if the addition of a B and O supprette suppository at the end of
           cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary
           discomfort that patients experience in the post-operative setting.

        2. To determine if using peri-operative B and O supprette suppositories reduces the need
           for pos-operative oral Ditropan and use of narcotic pain medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing lithotripsy procedure at GW Hospital

        Exclusion Criteria:

          -  The criteria for exclusion for those patients who agree to participate in the study
             will be patients with glaucoma, severe hepatic or renal disease, bronchial asthma,
             respiratory depression at the time of administration, convulsive disorders, allergy to
             anti-muscarinics or opiates, history of anorectal surgery, pre-operative use of
             antimuscarinics, chronic pain, chronic use of analgesics, or a history of alcohol or
             opioid dependency.
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Condition: Hypothyroidism; Trisomy 21
MeSH terms: Down Syndrome; Hypothyroidism; Trisomy
Intervention: Liquid stable levothyroxine (L-T4) Tirosint-SOL; Oral tablet levothyroxine (L-T4)
Intervention description: Investigation of tolerability, palatability, and adherence of liquid levothyroxine (L-T4) for 8 weeks.; Investigation of tolerability, palatability, and adherence of maintained oral tablet levothyroxine (L-T4) for 8 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase 4, single-center, pilot, randomized, open-label, cross-over study
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 2 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Tolerability; Adherence

Summary:

      Children with levothyroxine (T21) have developmental delay and other functional
      gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For
      an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended
      in water, breast milk or formula for administration in order to treat children with
      hypothyroidism. For this age group, ease of administration may have a significant impact on
      compliance and ability to remain euthyroid. We propose that Tirosint-SOL® will be more
      favorably received due to ease of administration, improved tolerability and palatability,
      therefore leading to improved adherence when compared to L-T4 tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trisomy 21 children age 2 months to less than 5 years of age

          -  Prior confirmed diagnosis of congenital or acquired hypothyroidism

        Exclusion Criteria:

          -  Gestational age ≤ 35 weeks, concomitant anticonvulsant medications, history of
             nonadherence with medication or medical visit schedule

          -  Subjects must be able to take oral medication, no G-tube or parental fed subjects
NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
Condition: Epistaxis
MeSH terms: Epistaxis
Intervention: Doxycycline; Placebo
Intervention description: Doxycycline, 100 mg twice a day for 2 months; Matching placebo, twice a day for 2 months
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epistaxis; Hereditary Hemorrhagic Telangiectasia; HHT; Doxycycline; Nosebleed

Summary:

      The purpose of this research study is to determine whether Doxycycline can be used to control
      nosebleeds (epistaxis) for patients with Hereditary Hemorrhagic Telangiectasia (HHT).
      Patients with HHT will be randomized to one of 2 study arms: Doxycycline or Placebo for a
      period of 2 months followed by a 1-month washout period before switching treatments for a
      further 2 months period. Observation and evaluation will continue for a period of one month
      after treatment is completed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of definite HHT by the Curacao criteria or genetic diagnosis of HHT

          -  Epistaxis severity during observation month at least moderate by Epistaxis Severity
             Score (ESS) evaluation

          -  For female participants, a negative pregnancy test at Day -1 and agree to use birth
             control during treatment and for 28 days following cessation of Doxycycline

        Exclusion Criteria:

          -  Use of medication(s) contraindicated with doxycycline use within 14 days prior to the
             study (including barbiturates, tegretol, dilantin, warfarin, isotretinoin)
Clinical Investigation of the Vision-R800 Device.
Condition: Myopia; Hyperopia; Astigmatism; Presbyopia
MeSH terms: Astigmatism; Presbyopia; Hyperopia
Intervention: Vision R-800 Phoropter; Standard Phoropter
Intervention description: Refraction utilizing the Vision R-800 Phoropter with resulting glasses; Refraction utilizing the standard phoropter with resulting glasses
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and
      associated spectacle lenses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current adaptated progressive addition lens wearer, if bifocal lens required

          -  wearable pair of glasses < 2 years old

          -  wear glasses at least 6 hours per day

        Exclusion Criteria:

          -  Eye Disease with an impact on visual acuity or binocular vision abnormalities (by
             self-report)

          -  Formal training in optometry, vision science or in the eyecare field
Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Condition: Pilonidal Cysts
MeSH terms: Cysts; Pilonidal Sinus
Intervention: Melectis G
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 890.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pilonidal cysts; Cavity wound; long healing; honey

Summary:

      The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires
      regular dressings (daily for 15 days and then every 48 hours) until complete healing. This
      healing is obtained on average in 68 days. Some patients have difficulties in healing with a
      final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary
      wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing
      is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of
      honey in pilonidal cysts is not evaluated and may accelerate healing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cavity Wound to 6 weeks of a pilonidal cyst excision

          -  Bloodless wound

          -  Pilonidal cyst not recurred

          -  Age : 18 years and older

          -  Signature of informed consent

          -  In the capacity to understand the study

        Exclusion Criteria:

          -  Bleeding wound

          -  Refused to participate in Protocol

          -  Patient immunocompromised

          -  Recurrent pilonidal cyst

          -  Patients on long-term corticosteroid

          -  Patient deprived of liberty, under guardianship

          -  Patient unable to understand the study

          -  Allergy or hypersensitivity to honey

          -  Allergy Or hypersensitivity to hyaluronic acid

          -  Allergy or hypersensitivity to guar gum

          -  Allergy or hypersensitivity to pectin

          -  Known allergy to propolis (potentially present in honey)

          -  Sensitivity to zinc oxide

          -  Sensitivity known dressings used in this trial or any component

          -  Diabetes Non-insulin or insulin
Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
Condition: Post-surgical Pain; Total Knee Arthroplasty; Foot/Ankle Surgery; Catheterization for Postop Analgesia
MeSH terms: Pain, Postoperative
Intervention: ropivacaine 0.2%
Intervention description: Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: moderate pain; severe pain; surgery; postop analgesia; TKA; adductor catheter; poplital catheter; foot/ankle surgery

Summary:

      Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for
      lower extremity post-operative pain control, specifically for total knee arthroplasty and
      foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for
      postoperative analgesia may be placed at various locations along the target nerves.
      Investigations of single-injection peripheral nerve blocks suggest that the onset of the
      block might be faster with one location over the other; but, the success rates are
      equivalent. However, remaining unknown is whether there is an optimal location to place a
      perineural catheter as part of a continuous peripheral nerve block.
    

Eligibility criteria:

        Inclusion Criteria:

          1. undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for
             postoperative analgesia following primary tri-compartment knee arthroplasty or
             foot/ankle surgery;

          2. anticipated to have at least moderate pain following surgery [NRS>3]; and,

          3. age 18 years or older.

        Exclusion Criteria:

          1. pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to
             menopause who are sexually active with the opposite sex within the previous year);

          2. inability to communicate with the investigators and hospital staff;

          3. clinical neuropathy in the surgical extremity;

          4. chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to
             surgery of at least the equivalent of 20 mg oxycodone);

          5. BMI > 40 kg/m2;

          6. allergy to study medications (lidocaine, ropivicaine);

          7. known renal insufficiency; or,

          8. incarceration.
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Intravenous Treprostinil
Intervention description: Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Intervention MeSH terms: Treprostinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Remodulin; 6-Minute Walk Test

Summary:

      This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated
      Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study
      RIV-PH-402 were eligible to enroll.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

        Exclusion Criteria:

          -  Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were
             found to be allocated to the Remodulin treatment group were not eligible to
             participate in this study.
Neural Correlates In Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Donepezil hydrochloride
Intervention description: Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Functional magnetic resonance imaging examination; Alzheimer's Disease; Donepezil hydrochloride; Aricept

Summary:

      The objective of this study was to identify neural correlates of cognitive improvement after
      3 months of donepezil hydrochloride treatment using either or both of two functional magnetic
      resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and
      Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in
      the early stage of Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to
             30 are allowed).

          -  Diagnostic evidence of Alzheimer's disease.

          -  Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.

        Exclusion Criteria:

          -  Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
Mechanisms of Weight Loss With SGLT2 Inhibition
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Intervention: Canagliflozin; Placebo
Intervention description: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.; Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Canagliflozin; Obesity; Weight Loss; Body Weight; Body Weight Changes; Overweight; Sodium-glucose transporter subtype 2 inhibitor

Summary:

      The purpose of this study is to investigate the effect of canagliflozin, a medication
      approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in
      people with type 2 diabetes who are overweight or obese.

      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than
      absorb, glucose. Canagliflozin is also often associated with weight loss.

      The study population will generally be type 2 diabetics, ages 18-75 years old, who are
      overweight or obese.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 2 diabetes

          2. BMI 25-45 kg/m2

          3. Hemoglobin A1C > 6.5% but < 9%

          4. Normal renal function (GFR > 60)

          5. Age 18-75

        Exclusion Criteria:

          1. Type 1 diabetes

          2. History of recurrent UTI or mycotic genital infections

          3. Treatment with insulin or a GLP1 agent

          4. Pregnant or breastfeeding
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Degludec; Insulin Glargine
Intervention description: Insulin Degludec 10 IU SC every 24 hours for 6 days; Insulin Glargine 10 IU SC every 24 hours for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The
      long-acting insulin has showed to improve glycemic variability however the behavior of
      insulin glargine versus insulin degludec is unknown.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from
             25.0-34.9 kg/m2 Diagnosis of T2DM

          -  Fasting plasma glucose ≤300 mg/dL at the time of scrutiny

          -  A1C between 6.5 and 11%

          -  Written informed consent

        Exclusion Criteria:

          -  Women pregnant or breastfeeding

          -  Untreated thyroid disease and/or uncontrolled hypertension [≥150 systolic and
             diastolic ≥90]

          -  Consumption of oral agents or other medications or supplements with proven properties
             that modify the behavior of glucose. In the case of antihypertensives, these may be
             included if treatment was not modified previous 3 months and no change during the
             study.

          -  Total cholesterol >240 mg/dL

          -  Triglycerides ≥400 mg/dL

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice
             the normal range

          -  Glomerular filtration rate <60 mL/min [Cockcroft-Gault]
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Condition: Dental Implant; Immediate Dental Implant; Soft Tissue Augmentation
Intervention: Immediate implant; SCTG; ADM
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the esthetic outcomes following immediate implant
      combined with the autogenous tissue graft or acellular dermal matrix compared to immediate
      implant alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who are in need of a tooth extraction at the maxillary premolar, canine and
             incisor region, and subsequent single implant placement.

          -  The reasons for extraction will include poor endodontic prognosis and/or unrestorable
             teeth (extensive caries, traumatic fractures, fractures of endodontically treated
             teeth, root perforation, root resorption with or without radiographic periapical
             lesion up to 3 mm in diameter). patients who are systemically healthy or with
             controlled common systemic conditions (controlled hypertension, controlled diabetes
             HbA1c up to 7 %).

          -  adjacent teeth have to be present and the eligible tooth has esthetically acceptable
             buccal gingival margin position prior to surgery, compared to neighboring teeth and
             contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).

          -  level of radiographic bone level has the distance from CEJ to interproximal crest up
             to 4 mm.

          -  Location of buccal alveolar crest has to be generally within 4 mm from the free
             gingival margin, verified after the extraction, before randomization; and
             fenestration, if present, up to 3mm in diameter at the apical part of the root and
             affecting less than 30% of the buccal socket wall.

        Exclusion Criteria:

          -  currently smoke exceeding 10 cigarettes/ day

          -  severe parafunctional habits, malocclusion or intent of orthodontic therapy in the
             future and are pregnant.

          -  teeth in the surgical site will be excluded if there is advanced periodontal disease
             or periapical lesion causing significant bony defects that are beyond the criteria
             mentioned at Section 3.3.

          -  allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin,
             polymixin B and Vancomycin) will not be included in the immediate implant combined
             with ADM group.
Hormones Inflammation and Thrombosis
Condition: Acute Coronary Syndrome; Thrombosis
MeSH terms: Thrombosis; Acute Coronary Syndrome; Inflammation
Intervention: Aspirin 81 mg
Intervention description: Aspirin 81 mg orally daily for 7 days
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acute coronary syndrome; clotting; hormones; women

Summary:

      The investigators are attempting to determine if the response to aspirin in women is related
      to the level of estrogen and progesterone that a woman has.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women age 18-80

          2. Signed informed consent.

        Exclusion Criteria:

          1. History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),

          2. On chronic aspirin therapy,

          3. On chronic NSAID therapy.

          4. Chronic anticoagulation with coumadin,

          5. Known thrombocytopenia (Platelet count < 100,000),

          6. Pregnancy (self-report),

          7. Currently on any type of contraceptive or hormone replacement therapy,

          8. Hysterectomy and/or oophorectomy.

          9. Recent GI bleeding

         10. Bleeding diathesis

         11. Chronic Systemic Infection