bioihbjkbjnl/mcl2 huggingface dataset:
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: suvorexant; placebo
Intervention description: First in class orexin antagonist approved by the FDA for the treatment of insomnia; Pill with inactive ingredients
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine effects of blocking the orexin system with suvorexant
      after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD
      symptoms, and intersession habituation.
    

Eligibility criteria:

        Inclusion Criteria:

        - Adult men and women (age 18 or older) who meet the Diagnostic and Statistical Manual of
        Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD.

        Exclusion Criteria:

          -  Medical or psychiatric conditions that require consistent use of medication that
             affects sleep or psychiatric symptoms, except for hormonal contraceptives

          -  Any persistent medical condition that affects sleep

          -  Inability to remember most details of the index event

          -  Diagnosis of a sleep disorder other than insomnia including polysomnography findings
             of apnea/hypopnea index > 10/hour

          -  Consumption of more caffeine than 5 cups of coffee/day equivalent

          -  Smoking > 20 cigarettes/day

          -  Habitual bedtimes after 3AM, habitual rise times after 10AM, or average napping > 2
             hour/day in a given week

          -  Moderate or severe alcohol use disorder within the past 6 months or moderate or severe
             drug use disorder within the past year

          -  Positive urine toxicology for illicit drugs including cannabis

          -  A history of psychotic disorders or bipolar disorder

          -  Current depression with history of recurrent depression that precedes exposure to a
             traumatic event

          -  Suicidal ideation with intent to act or with specific plan and intent in the past 6
             months [Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)] or
             history of a suicide attempt

          -  Completion of exposure-based therapy targeting the index trauma

          -  Pregnancy or breast feeding

          -  Known sensitivity or allergy to an orexin receptor antagonist

          -  Limited ability to read or write English.
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
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
Condition: Pain
Intervention: Acetaminophen; Placebo
Intervention description: administered every 6 hours by mouth up to 4 doses
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: labor pain; acetaminophen

Summary:

      The hypothesis is if administration of acetaminophen during labor will reduce the amount of
      neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo
      capsules will be administered at the time of neuraxial analgesia placement and then
      administered every 6 hours until delivery. Overall consumption of neuraxial pain medication
      will be determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >/= 18 years of age not allergic to study medications

        Exclusion Criteria:

          -  pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme
             function changes non-English speaking subjects
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Condition: Cardiac Amyloidosis
MeSH terms: Amyloidosis
Intervention: F-18 florbetapir
Intervention description: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: F-18 florbetapir; Amyvid; PET scan; Early detection

Summary:

      The investigators postulate that F-18 florbetapir will show improved detection of cardiac
      amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis

          2. Patients with a ratio of affected to unaffected free light chains >5 or free light
             chain difference of >50

        Exclusion Criteria:

          1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall
             thickness ≥ 13mm

          2. Contraindication to florbetapir or its components

          3. Refusal to participate in the study
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
Condition: Candidiasis; Vaginosis, Bacterial
MeSH terms: Candidiasis; Vaginosis, Bacterial; Vaginal Diseases
Intervention: Boric acid and probiotics; Antibiotic (Clindamycin); Antifungal (Clotrimazole)
Intervention description: Vaginal capsules administered once a day during 7 days.; Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.; Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
Intervention MeSH terms: Anti-Bacterial Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole; Antifungal Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether a formula of boric acid and probiotics for
      vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis
      in comparison to pharmacological reference controls (depending on the suspected diagnosis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18 years and agreement to participate by signing the consent form.

          -  Women with clinical manifestations of acute infectious vulvovaginitis (burning,
             pruritus, erythema, oedema, and abnormal vaginal discharge).

        Exclusion Criteria:

          -  Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or
             Trichomonas vaginalis infection.

          -  Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to
             the study.

          -  Patients receiving other treatment (drug, probiotics or vitamin supplements) that can
             significantly interfere with study evaluations during the 3 months of follow-up.

          -  Pregnant or high risk for pregnancy.
Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Intervention: Ketamine IV Infusion; Ketamine IV push
Intervention description: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.; Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; emergency department

Summary:

      Objective: The purpose of this study is to determine if administering ketamine as an
      intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse
      drug reactions without attenuating its analgesic effects.

      Study design: prospective, randomized, controlled, double-blind trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pain NRS ≥5

          -  Anticipated stay in ED ≥1 hour

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Vital sign abnormalities (SBP <90, SBP > 180, HR < 50, HR > 150, RR <10, RR > 30,
             weight <45 kg, weight > 115 kg)

          -  Arrhythmias

          -  Altered mental status (active psychosis/delirium)

          -  Administration of opioid pain medication in previous 1 hour

          -  history of acute head or ocular trauma

          -  presence of known intracranial mass or vascular lesion
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Condition: Menorrhagia; Metrorrhagia; Medicated Intrauterine Devices
MeSH terms: Menorrhagia; Metrorrhagia; Hemorrhage
Intervention: Tamoxifen; Placebo (for Tamoxifen)
Intervention description: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course; Sugar pill manufactured to mimic the tamoxifen 10mg tablet
Intervention MeSH terms: Tamoxifen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: levonorgestrel; breakthrough bleeding

Summary:

      This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in
      new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of
      participants will receive a course of tamoxifen three weeks after insertion of the IUD, while
      the other half of participants will receive a course of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes

          -  access to reliable cell phone

          -  willing to receive and respond to daily text or email message to assess bleeding

        Exclusion Criteria:

          -  using IUD for indication other than contraception

          -  postpartum within 6 months, pregnant, or breastfeeding

          -  removal and replacement of IUD

          -  undiagnosed abnormal uterine bleeding prior to placement of IUD

          -  bleeding dyscrasia

          -  anti-coagulation use

          -  active cervicitis

          -  allergy to tamoxifen

          -  history of venous thromboembolism

          -  personal history of breast or uterine malignancy

          -  use of medication contraindicated with use of tamoxifen (coumadin, letrozole,
             bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
Condition: Non-transfusion Dependent Thalassemia
MeSH terms: Thalassemia
Intervention: deferasirox
Intervention description: Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing.
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Non-transfusion dependent thalassemia; NTDT; deferasirox; ICL670; LIC; Liver Iron Concentration

Summary:

      Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia
      based on change in liver iron concentration from baseline after 52 weeks of treatment.
      Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT
      patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia
        intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron
        concentration >/= 5 mg Fe/g dw Serum Ferritin >/= 300 ng/mL

        Exclusion Criteria:

        HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood
        transfusion 6 months prior to study start, significant proteinuria, creatinine clearance
        </= 40 ml/min, serum creatinine > ULN, ALT >5 x ULN, active hepatitis B or C, cirrhosis

        Pediatrics Only:

        A patient's weight of at least 20 kg is required to allow dosing of 5 mg/kg with one tablet
        of 125 mg
Remission Through Early Monitored Insulin Therapy - Duration Month
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Glargine; Lispro; Dexcom G6
Intervention description: Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.; Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.; Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.
Intervention MeSH terms: Insulin Glargine; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 10 participants will be recruited soon after diagnosis of type 2 diabetes and started on short term insulin therapy to achieve euglycemia with insulin doses guided by continuous glucose monitor algorithm
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin therapy; Continuous glucose monitor

Summary:

      REMIT-DM is a feasibility pilot study where participants will be recruited soon after their
      diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four
      weeks with titrations of insulin guided by glucose levels and trends provided by a continuous
      glucose monitor (CGM), with the purpose of achieving diabetes remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18

          2. A1C criteria - >7.0

          3. Newly diagnosed with T2D within 4 years

          4. Lifestyle controlled

          5. Subject may be on up to 2 medications for diabetes.

          6. Smart phone or home computer compatible with DEXCOM CLARITY software

          7. English speaking

          8. Assessed by endocrinologist and diabetes educator to be able to perform skills
             necessary for CGM use and insulin delivery

        Exclusion Criteria:

          1. Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies

          2. Pregnant

          3. Chronic Kidney Disease (CKD) Stage IV or greater

          4. Mental and/or cognitive disorder (based on documented disorder and/or assessment of
             physician or educator)

          5. No access to computer for downloading CGM

          6. BMI <18.0
Effect of Neuromuscular Blockade and Reversal on Breathing
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Intervention: Sugammadex; Neostigmine; Placebo
Intervention description: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.; Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.; Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study the investigators will assess (i) the effect of partial neuromuscular blockade
      (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to
      isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by
      sugammadex, neostigmine or placebo in healthy volunteers.

      Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced
      by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from
      TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male gender

          -  age 18 years and older

          -  body mass index < 30 kg/m2.

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function;

          -  allergies to muscle relaxants, anesthetics or narcotics;

          -  a (family) history of malignant hyperthermia or any other muscle disease;

          -  any medical, neurological or psychiatric illness (including a history of anxiety).
Effect of Vitamin D Supplementation on Balance in CKD
Condition: Renal Insufficiency, Chronic; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Intervention: Vitamin D
Intervention description: Vitamin D taken in two different dosages daily for six months.
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: dialysis; end stage renal disease

Summary:

      Patients with end-stage renal disease on dialysis (ESRD5D) are 4-5x more likely to suffer
      from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further,
      70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become
      routine care for many in this patient population, but evidence is lacking to support this
      practice. The proposed projects objective is to gather needed preliminary data regarding the
      effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be likely to be able to complete the study

          -  must be able to walk without a walking aid

          -  must be able to complete questionnaires interactively research staff

          -  must have been on dialysis for greater than 3 months

          -  all patients must be receiving standard of care per their nephrologist

        Exclusion Criteria:

          -  peritoneal dialysis

          -  an allergy to vitamin D

          -  liver disease

          -  intestinal disorders that would interfere with vitamin D absorption

          -  taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or
             other drug therapies for osteoporosis

          -  are pregnant