bioihbjkbjnl/mcl2 huggingface dataset:
Sphenopalatine Ganglion Blocks RCT
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lidocaine; Bupivacaine; Ropivacaine; Placebo
Intervention description: Nasal application using the Sphenocath device- cleared by FDA; Nasal application using the Sphenocath device- cleared by FDA; Nasal application using the Sphenocath device- cleared by FDA; Placebo Saline using the Sphenocath device- cleared by FDA
Intervention MeSH terms: Lidocaine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind study
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or more at time of consent

          2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for
             migraine and would otherwise receive treatment clinically

          3. Ability to provide consent for the research study

        Exclusion Criteria

          1. Pregnant or breast feeding within 4 weeks of enrollment

          2. Inability to communicate with the study team

          3. Patients who cannot read and understand English

          4. Deemed unsuitable for enrollment in study by the investigator

          5. Allergy to local anesthetics or saline
A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block
Condition: Fracture of Foot
Intervention: Bupivacaine; Ropivacaine
Intervention description: Bupivacaine 0.625% with epinephrine 1:300,000; 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sciatic Nerve Block; Continuous Nerve Block

Summary:

      The purpose of this study is to compare the incidence of postoperative symptoms of neurologic
      injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous
      infragluteal-parabiceps sciatic nerve catheter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients ( ≥18 and ≤ 80) who are scheduled to undergo elective scheduled foot
             surgery and agreed to receive a sciatic nerve catheter as a part of their
             postoperative pain management. this study.

        Exclusion Criteria:

          -  history of hemostatic abnormalities

          -  chronic pain syndrome

          -  a foot deformity restricting normal foot movement

          -  severe liver or renal disease

          -  a preexisting neurologic disorder

          -  patient refusal to participate

          -  the presence of language barrier that prohibits proper communication with patient.
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Condition: Colonoscopy
Intervention: PEG electrolyte lavage solution + bisacodyl - reformulation; PEG electrolyte lavage solution + bisacodyl
Intervention description: multi dose formulation (tablet/solution) for oral administration prior to colonoscopy; multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
Intervention MeSH terms: Bisacodyl; Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colonoscopy; bowel preparation

Summary:

      To compare the safety and efficacy of 2 different bowel cleansing preparations prior to
      colonoscopy in adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indications:

          2. At least 18 years of age

          3. Otherwise in good health, as determined by physical exam and medical history

          4. If female, and of child-bearing potential, is using an acceptable form of birth
             control

          5. Negative urine pregnancy test at screening, if applicable

          6. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Exclusion Criteria:

          1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric
             retention, bowel perforation, toxic colitis, or toxic megacolon

          2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration

          3. Subjects who are undergoing colonoscopy for foreign body removal and decompression

          4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those
             secondary to the use of diuretics

          5. Subjects who are taking drugs that may affect electrolyte levels with the exception of
             routine diuretics

          6. Subjects with known clinically significant electrolyte abnormalities such as
             hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia

          7. Subjects who are pregnant or lactating, or intending to become pregnant during the
             study

          8. Subjects of childbearing potential who refuse a pregnancy test

          9. Subjects who are allergic to any preparation components

         10. Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures

         11. Subjects who have participated in an investigational clinical, surgical, drug, or
             device study within the past 30 days
Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation
Condition: Cognition in Schizophrenia
MeSH terms: Schizophrenia
Intervention: Atomoxetine; Placebo
Intervention description: 40mg 2po qam; 40mg 2po qam
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cognition; schizophrenia; Atomoxetine; Strattera; cognitive remediation

Summary:

      This research is being done because people with schizophrenia often have problems with
      thinking including learning, remembering, paying attention, and problem solving. During this
      study, we will test if cognitive remediation (computer games made to improve thinking), used
      along with a drug called atomoxetine, may help the problems in thinking as well as some of
      the symptoms of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder.

          -  Males and females.

          -  Ages 18-60 years old.

          -  All races and ethnicities.

        Exclusion Criteria:

          -  Diagnosis of an organic brain disease.

          -  Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol
             or substance dependence within the last 3 months.

          -  Meet criteria for primary negative symptoms, established by clinical judgment.

          -  Current or past history of clozapine treatment for antipsychotic non-response.

          -  Patients hospitalized in a psychiatric hospital within the previous 30 days.

          -  Patients with an unstable medical condition, as determined by the Investigator

          -  Colorblindness

          -  Concurrent treatment with electroconvulsive therapy or psychotherapy.

          -  Pregnant women.

          -  Must be able to read, speak, and understand English.

               -  We do not have the resources necessary to properly study non-English speaking
                  patients in this study. The computer software used for cognitive remediation and
                  some clinical assessments are only available in English. The need to provide such
                  resources in foreign languages would be prohibitive to the successful completion
                  of the study.
Does Deflating the Tracheal Cuff Shorten Weaning Time?
Condition: Weaning; Tracheostomy
Intervention: Deflating tracheal cuff; Deflating tracheal cuff 2
Intervention description: Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.; Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Tracheostomy; decannulation; weaning; Tracheostomy Weaning

Summary:

      The purpose of this study is to determine whether deflating the tracheal cuff in
      tracheostomized patients, during disconnections from ventilatory support along the weaning
      phase shortens the weaning time.
    

Eligibility criteria:

        Inclusion criteria: tracheostomized patients for any of the following reasons:

          -  Prolonged time under mechanical ventilation (>21 days) or prolonged weaning.

          -  Motor component of Glasgow Coma Score <6 points or inability to adequate manage the
             airway (>2 aspirations every 8 hours).

        Exclusion Criteria:

          -  High risk of aspiration (neuromuscular disease affecting bulbar functions,
             tracheostomies indicated as a part of a surgical procedure involving the upper airway
             or high risk of aspiration observed after specific evaluation previous to
             randomization).

          -  Death before starting weaning attempts.
Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
Condition: Fever
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Diclofenac potassium; Acetaminophen
Intervention description: Diclofenac potassium; Acetaminophen
Intervention MeSH terms: Acetaminophen; Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Antipyretics; fever; diclofenac; acetaminophen; children; acute upper respiratory tract infections

Summary:

      The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg)
      is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of
      fever during 2 hours, in the treatment of febrile children with acute upper respiratory
      infections.

      This is a comparative double blind, double dummy, randomized study on the effectiveness of
      Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory
      tract infections. The patient will be randomized to either group: Group A (Diclofenac
      potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional
      trained will measure the temperature during 2 hours. During the study period, parents or
      legal representatives will be invited to fill a survey about the habits and knowledge
      regarding fever management at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5
             ° C and no greater than 39.5° C, associated with acute upper respiratory tract
             infections

          -  Parents or legal representatives who have provided written informed consent and
             provided a phone number for the call at end of study

        Exclusion Criteria:

          -  History of hypersensitivity to any drugs or excipients of the study

          -  Any medication, surgical, or medical condition, which might significantly alter the
             absorption, distribution, metabolism, or excretion of medications

          -  Background or suspected hematological disorders, febrile seizures, asthma, peptic
             ulcer or gastrointestinal bleeding

          -  Neurological and hemodynamics disorders

          -  Evidence of liver or kidney impairment or heart failure

          -  Patients who have received previous treatment with antipyretics; acetaminophen (up to
             4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)

          -  Any surgical or medical condition, which in the opinion of the investigator, may place
             the patient at risk

        Other protocol-defined inclusion/exclusion criteria may apply
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Condition: Arrhythmia; Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter
Intervention: Fat tissue needle aspiration
Intervention description: Small fat tissue sampling performed by needle aspiration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-Arrhythmia Agents; Amiodarone, chronic treatment; Amiodarone, adverse effects; Biopsy, Fine-Needle, Adipose tissue; Drug concentrations in tissues; Drug accumulation in tissues

Summary:

      The objective of this study is to determine if concentrations of amiodarone in fat tissue
      increases constantly over time during chronic treatment with this drug, and if blood
      concentrations reflect accurately the concentrations in fat tissue or not. This is because
      excessive concentrations of this drug in tissues can produce adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients taking amiodarone for more than 3 months (any dose, any indication)

        Exclusion Criteria:

          -  Impossibility to perform needle aspiration of abdominal wall (local infection, skin
             disease)

          -  Coagulation disorders, INR > 3.0 if warfarin treatment

          -  Patient unable to give informed consent
Anesthesia for Pain After Ankle Fracture Surgery
Condition: Chronic Pain; Ankle Fracture Surgery; Regional Anesthesia
MeSH terms: Chronic Pain; Fractures, Bone; Ankle Fractures
Intervention: Ropivacaine; Nerve block
Intervention description: Single injection of ropivacaine immediately prior to surgery.; insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
      reduce development of chronic pain in patients undergoing surgery for ankle fracture compared
      to standard of care. Subjects will be followed for one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Referred for surgery for open reduction and internal fixation for ankle fracture

        Exclusion Criteria:

          -  Unable to give informed consent in English

          -  Unable to complete surveys in English

          -  Unable to understand instructions for using pump in English

          -  Unavailable for followup

          -  Polytrauma; undergoing other surgeries or having other orthopedic injuries related to
             the precipitating cause of the ankle fracture

          -  Infection

          -  Peripheral vascular disease

          -  Diabetes

          -  Currently undergoing chemotherapy

          -  Pregnancy

          -  Currently lactating

          -  Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs

          -  Severe renal impairment (Class 3 or worse kidney disease)

          -  Liver disease (cirrhosis or liver failure)

          -  Prior allergic reaction to any type of local anesthetic

          -  Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic
             doses started because of hospital admission are not an exclusion)

          -  Currently taking antidepressants or other psychiatric medications

          -  Single shot local nerve block prior to surgery was ineffective

          -  Selected for neuraxial anesthesia rather than general anesthesia for the open
             reduction surgery

          -  Already receiving chronic analgesic therapy for a separate chronic pain condition
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
Condition: Knee Osteoarthritis; Knee Rheumatism
MeSH terms: Rheumatic Diseases
Intervention: Obturator nerve regional block; Adductor canal regional block; Saline
Intervention description: Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.; Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.; Saline as placebo comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: adductor canal regional block; obturator nerve regional block; total knee arthroplasty; knee replacement surgery; Knee rheumatoid arthritis

Summary:

      One common anesthetic that is performed for total knee replacement surgery is spinal
      anesthesia with an adductor canal regional block, which involves injecting numbing medication
      in the thigh region for pain control after surgery. The aim of this study is to determine
      whether the addition of another regional block called obturator nerve block, which involves
      injecting numbing medication in the upper thigh region, will improve pain control after
      surgery while not sacrificing mobility after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo total knee arthroplasty

          -  Planned use of regional anesthesia for procedure

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Patients on immunosuppressive therapy

          -  Patients with history of diabetes

          -  Patients with lower limb neuropathy

          -  Patients with history of chronic opioid use for > 3 months, including but not limited
             to, fentanyl, morphine, oxycodone, methadone

          -  Patients with known allergy or intolerance to any drug used in the study

          -  Patients with history of alcohol or drug abuse

          -  Patients with history of intolerance of nonsteroidal anti-inflammatory drugs

          -  Patients with hepatic or renal insufficiency

          -  ASA score of 4 or greater
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: duloxetine; fluoxetine; citalopram; paroxetine; sertraline
Intervention description: 30-120 milligrams (mgs) orally daily for 12 weeks; 20-80 mgs orally daily for 12 weeks; 20-40 mgs orally daily for 12 weeks; 20-50 mgs orally daily for 12 weeks; 50-200 mgs orally daily for 12 weeks
Intervention MeSH terms: Duloxetine Hydrochloride; Sertraline; Fluoxetine; Paroxetine; Citalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Severe Depressive Episode

Summary:

      The purpose of this study is to compare duloxetine with other antidepressants in the
      treatment of severe depression.
    

Eligibility criteria:

        Inclusion criteria:

          -  At least 18 years of age

          -  Have major depression and are currently in a severe depressive episode

          -  Have a degree of understanding such that patient can communicate with the investigator
             and study staff

          -  All females must test negative for pregnancy

          -  Females of childbearing potential must use reliable method of birth control during the
             study and for 1 month after taking the last dose of study drug

        Exclusion criteria:

          -  Have not responded to duloxetine for depression in the past

          -  Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a
             cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive
             disorder (OCD)

          -  Are at significant risk for suicide

          -  Have not responded to 2 or more adequate trials of antidepressant medications during
             the current depressive episode

          -  Have a serious, unstable medical condition

          -  Have a current or recent history of substance abuse or dependence

          -  Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or
             vagus nerve stimulation (VNS) in the past year

          -  Have started psychotherapy within 6 weeks prior to study entry

          -  Have a serious medical illness or clinically significant laboratory abnormality that
             is not stabilized or is anticipated, in the judgment of the investigator, to require
             hospitalization or use of an excluded medication during the course of the study