bioihbjkbjnl/mcl2 huggingface dataset:
Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
Condition: Non-obstructive Azoospermia
MeSH terms: Azoospermia; Pain, Postoperative
Intervention: Gabapentin; Placebo
Intervention description: Gabapentin 600mg tablet; Placebo tablet
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 74.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative
      and post-operative period to reduce or potentially eliminate narcotic usage following scrotal
      surgery. Research study results have shown that the use of anti-inflammatories in the
      peri-operative period reduces both pain and narcotic use. The hypothesis is that adding
      another agent in the multi-modal pathway will further reduce pain and potentially reduce
      narcotic usage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants undergoing microsurgical testicular sperm extraction.

          -  Participants over 18 years of age who can provide informed consent

          -  Participants with no contraindication to the consumption gabapentin or documented
             allergy/intolerance

          -  Participants not currently using opiates for another reason

        Exclusion Criteria:

          -  Contraindication to the consumption of celecoxib or gabapentin

          -  History of substance abuse (including prior opiate abuse)

          -  Narcotic use within last 3 months

          -  Any of the following comorbidities: renal failure, heart disease, peptic ulcer
             disease, cerebrovascular disease, significant liver disease, untreated depression,
             chronic pain disorder, or bleeding diatheses

          -  Medical history or concurrent illness that the investigator considers sufficiently
             serious to interfere with the conduct, completion, or results of this trial, or
             constitutes an unacceptable risk to the subject
Randomized Open Investigation Determining Steroid Dose
Condition: Covid19
MeSH terms: COVID-19
Intervention: Weight-based dexamethasone dose
Intervention description: Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized in a parallel fashion into either the standard dexamethasone dose of 6 mg or weight-based dexamethasone of 0.2 mg/kg (maximum dose of 20 mg)
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dexamethasone; COVID-19; COVID pneumonia; respiratory failure; steroids

Summary:

      Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of
      steroids may be more effective. The purpose of this research study is to compare the current
      standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum
      dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater or equal than 18 years old

          -  COVID-19 infection confirmed by positive PCR test

          -  Hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen

        Exclusion Criteria:

          -  Corticosteroid use for > 48h within the past 15 days prior to enrollment

          -  Use of steroids with doses higher than the equivalent to dexamethasone 6 mg

          -  Use of immunosuppressive drugs

          -  Pregnant women

          -  Chronic oxygen use

          -  Known history of dexamethasone allergy

          -  DNR / DNI

          -  Patient or proxy cannot consent
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Intervention: Oteseconazole (VT-1161) 150mg capsule; Fluconazole 150mg capsule; Placebo
Intervention description: 600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.; 150mg administered every 72 hours in 3 sequential doses starting on Day 1.; Administered once weekly starting on Day 14.
Intervention MeSH terms: Fluconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 219.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is
      defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months.
      Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective
      treatment of RVVC than other oral antifungal medications.

      This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the
      treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part
      of the study is a 2-week induction phase for the treatment of the patient's current VVC
      episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to
      a random assignment. The second part consists of an 11-week maintenance phase, when the
      patient will take either oteseconazole (VT-1161) or a placebo according to the random
      assignment from the first part of the study, and then a 37-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  3 or more episodes of acute VVC in the past 12 months

          -  Positive KOH test

          -  Total vulvovaginal signs and symptoms score of ≥3 at screening visit

          -  Total vulvovaginal signs and symptoms score of <3 at Day 14

          -  Must be able to swallow pills

        Exclusion Criteria:

          -  Presence or a history of another vaginal or vulvar condition(s)

          -  Evidence of major organ system disease

          -  History of cervical cancer

          -  Poorly controlled diabetes mellitus

          -  Pregnant

          -  Recent use of topical or systemic antifungal or antibacterial drugs

          -  Recent use of immunosuppressive or systemic corticosteroid therapies
S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Condition: Cataract; Macular Degeneration
MeSH terms: Cataract; Macular Degeneration
Intervention: selenium; vitamin E; vitamin E placebo; selenium placebo
Intervention description: 200 mcg daily for 7-12 years; 400 IU daily by mouth for 7-12 years; daily for 7-12 years; daily for 7-12 years
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13475.0
Sex: Male
Minimum age: 50 Years
Maximum age: 120 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cataract; advanced macular degeneration

Summary:

      RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent
      cataracts or age-related macular degeneration in men receiving these drugs as part of a
      clinical trial for the prevention of prostate cancer.

      PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work
      in preventing cataract and age-related macular degeneration in men enrolled on SELECT
      (SWOG-S0000).
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT)
             SWOG-S0000

          -  Diagnosis of 1 of the following:

               -  Age-related macular degeneration (AMD) at baseline or at follow-up

               -  Cataract or a cataract extraction at follow-up (Closed for accrual as of
                  10/01/29)

                    -  Participants with a prior diagnosis of cataract at baseline followed by
                       another cataract event (cataract diagnosis or a cataract extraction) at
                       follow-up are not eligible

                    -  Participants with a prior diagnosis of cataract at baseline followed by a
                       diagnosis of AMD at follow-up are eligible

        PATIENT CHARACTERISTICS:

          -  See Disease Characteristics

        PRIOR CONCURRENT THERAPY:

          -  Not applicable
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; LUMIGAN
Intervention description: Consists of 1 Bimatoprost SR administration in the study eye.; Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a
      single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular
      Hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment

          -  Participant is currently a nonsmoker and has not smoked any nicotine-containing
             products within the previous 6 months

        Exclusion Criteria:

          -  Current or anticipated enrollment in another investigational drug or device study

          -  Females who are pregnant, nursing, or planning a pregnancy during the study
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Condition: Scoliosis; Pain
MeSH terms: Scoliosis
Intervention: Methadone; Normal Saline; Morphine
Intervention description: Perioperative IV methadone to be given; control arm; Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Methadone; Gabapentin; Postoperative Pain; Posterior Spinal Fusion; Pediatric

Summary:

      Acute pain management following major surgical procedures in pediatric patients continues to
      be a challenge, especially after extensive posterior spine fusions.

      Spine surgery is particularly traumatic, initiating pain in both peripheral and central
      pathways. While the standard management of post-surgical pain involves a multimodal approach,
      opioids provide the predominant benefit. However, opioid use is associated with many adverse
      effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease
      total opioid consumption and adverse effects as well as improve satisfaction with pain
      management after scoliosis repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10-18 years

          -  Idiopathic scoliosis

          -  Fusion levels planned for 10 or greater

          -  English speaking

          -  American Society of Anesthesiology (ASA) class 1 - 3

        Exclusion Criteria:

          -  Current narcotic use / History of substance use disorder

          -  Morphine, hydromorphone or methadone allergies

          -  Pregnancy

          -  Seizure disorders

          -  Bleeding disorders

          -  Neuromuscular scoliosis

          -  History of renal or hepatic disease

          -  Long QT syndrome

          -  Obstructive sleep apnea

          -  Body mass index > 40

          -  Inability to tolerate standard analgesic medications (gabapentin, ketorolac,
             acetaminophen)

          -  Non-English speaking
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Condition: Arthritis
MeSH terms: Arthritis
Intervention: Theraworx; Placebo
Intervention description: Theraworx foam applied to skin and/or compression wrap; Placebo foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40,
      which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are
      both conservative and surgical with surgical options including osteotomy, bone excision,
      ligament reconstruction, and various prosthetic implants. The conservative treatment options,
      however, are limited to NSAIDs and bracing or steroid injections.

      Advances in topical therapies have the potential to deliver focused treatment to the CMC
      joint. Novel treatment of inflammation can potentially reduce inflammation and pain
      associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that
      has theoretical impact on inflammation reduction in human subjects treated with the topical
      foam.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Thumb CMC arthritis

          2. greater than or equal to age 18

          3. Interested in non-operative treatment of thumb arthritis

        Exclusion Criteria:

          1. Recent corticosteroid injection into the thumb joint

          2. Non-English speaking

          3. skin lesions or rashes on the thumb

          4. current use of topical anti-inflammatory medications

          5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the
             PI)

          6. known allergy to magnesium
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; 400 mg tablet administered orally once daily; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy of therapy with
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and
      tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with
      chronic genotype 2 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females

          -  Aged 20 years or older

          -  Treatment naive or treatment experienced

          -  At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2,
             participants must be ineligible or intolerant of RBV.

        Key Exclusion Criteria:

          -  Previous exposure to an NS5A or NS5B inhibitor

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Pregnant or nursing female or male with pregnant female partner

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL
Intervention description: Tablets administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in
      adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected males and non-pregnant/non-lactating females

          -  Treatment-naïve or treatment-experienced individuals

          -  Compensated cirrhosis at Screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
Condition: Cholera
MeSH terms: Cholera
Intervention: PXVX0200 Lot A; PXVX0200 Lot B; PXVX0200 Lot C; Placebo
Intervention description: Lot P700-1CA03; Lot P700-3CA03; Lot P700-6BA03; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3146.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men or women,

          -  age 18 to 45 years inclusive;

          -  normal medical history and physical examination

          -  Women must have a negative pregnancy test.

        Exclusion Criteria:

          -  travel to a cholera endemic area in the previous 5 years;

          -  abnormal stool pattern or regular use of laxatives;

          -  Currently active unstable or undiagnosed medical conditions

          -  current or recent antibiotic use;

          -  pregnancy or nursing;

          -  Previously received a licensed or investigational cholera vaccine

          -  History of cholera or enterotoxigenic E. coli infection

          -  History of Guillain-Barré Syndrome

          -  Received or plans to receive any other licensed vaccines, except for seasonal
             influenza

          -  Recipient of bone marrow or solid organ transplant

          -  Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders
             diagnosed or treated during the past 5 years

          -  Use of systemic chemotherapy in the previous 5 years prior to the study

          -  any immunosuppressive medical condition
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF/VEL; SOF/VEL/VOX
Intervention description: 400/100 mg FDC tablet orally once daily.; 400/100/100 mg FDC tablet orally once daily.
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)
      and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV
      infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected males and non-pregnant/non-lactating females

          -  Treatment-naive or treatment-experienced individuals

          -  Non-cirrhosis or compensated cirrhosis at screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 862.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of episodic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1
             or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior
             to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine
             Headache Days (MHD).

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to Galcanezumab or another CGRP antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to Galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.