bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: High dose; Low dose; Placebo
Intervention description: 6 capsules of IBD98-M, twice a day; 4 capsules of IBD98-M; Placebo
Intervention MeSH terms: Mesalamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed
      Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the
      clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week
      treatment period and 2 weeks follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior
             to screening

          2. Female patients must be postmenopausal, sterile, or have a negative urine pregnancy
             test prior to entering the study and use adequate contraception during the study if of
             childbearing potential.

          3. Diagnosis of active UC with UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the UCDAI
             mucosal appearance subscore

        Exclusion Criteria:

          1. Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis

          2. Female patients who are pregnant or breastfeeding

          3. Ulcerative proctitis with ≤15 cm of disease

          4. Patients with infectious colitis as determined by assessment for Clostridium difficile
             (C. difficile) and fecal pathogens at screening or treatment for C. difficile within
             30 days prior to screening

          5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger
             score of ≥10), colonic perforation
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Condition: Intra-dialytic Hypotension
MeSH terms: Hypotension
Intervention: Mannitol (20%); 0.9% saline
Intervention description: 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session); 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Intervention MeSH terms: Mannitol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Kidney failure can result from a variety of conditions and can be temporary or permanent.
      Hemodialysis is available as a replacement treatment to perform the work that the kidneys
      normally do. However, the dialysis procedure can be associated with rapid changes in the
      composition of the blood - this may lead to changes in blood pressure and in turn reduced
      blood supply to important parts of the body. We aim to investigate if giving a medicine
      (called mannitol) during dialysis may be able to reduce the frequency of these low blood
      pressure events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal failure requiring intermittent hemodialysis initiation; adult patients aged over
             18 years; written informed consent

        Exclusion Criteria:

          -  Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days;
             cardiac transplant; ventricular arrhythmia; unstable angina; use of
             pressors/midodrine; enrollment in conflicting research study; institutionalized
             individuals; pregnancy; prisoners; documented allergy to mannitol
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fluoride Varnish; Glass Ionomer Sealant
Intervention description: Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.; Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 597.0
Sex: All
Minimum age: 2 Years
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Fluoride varnish; Glass ionomer sealant; Prevention

Summary:

      The goal of this project is to conduct a community-based randomized clinical trial to compare
      the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride
      varnish applied every six months and fluoride releasing glass ionomer sealants applied
      annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Family resides in the South Bay or Central San Diego area

          -  Parent/Guardian can consent in English or Spanish

          -  Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no
             restoration)

          -  Child is cooperative and behaviorally suited for the clinical trial interventions

          -  Child is a registered patient at San Ysidro Health Center Inc.

        Exclusion Criteria:

          -  Any siblings of participants

          -  Child with cavitated lesions

          -  Child with a health condition, special need, or with a complicated factor that will
             prevent from completing the required number of visits during a 36-month follow-up
             period

          -  Anything, that in the opinion of the investigator, would preclude the child from
             complying with the protocol or jeopardize the safety of the child while on the
             protocol
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Condition: Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: Serlopitant High Dose; Placebo Oral Tablet; Serlopitant Low Dose
Intervention description: serlopitant tablets - high dose; placebo tablet; serlopitant tablets - low dose
Intervention MeSH terms: Serlopitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic
      Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 13 years or older

          -  Pruritus prior to and during the initial screening period

          -  Diagnosis of atopic dermatitis

          -  Judged to be in good health in the investigator's opinion

        Exclusion Criteria:

          -  Prior treatment with study drug or similar drug

          -  Pruritus due to another reason besides atopic dermatitis

          -  Presence of any medical condition or disability that could interfere with study

          -  History of hypersensitivity to serlopitant or any of its components

          -  Currently pregnant or male partner of pregnant female

          -  Females of childbearing potential who are unable or unwilling to use adequate
             contraception or who are breast feeding
ALS Reversals - Lunasin Regimen
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Lunasin Regimen; Historical control
Intervention description: LunaRich X Capsules, Reliv Now, ProVantage; Matched historical controls will be identified from the PatientsLikeMe database.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial
      utilizing a historical control group. Participants will receive a Lunasin regimen and will be
      asked to register for an account of PatientsLikeMe website, where after the initial in-clinic
      visit, they will be asked to enter specific data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged at least 18 years.

          -  Sporadic or familial ALS diagnosed as possible, laboratory-supported probable,
             probable, or definite as defined by revised El Escorial criteria.

          -  Patient is able to understand and express informed consent (in the opinion of the site
             investigator).

          -  Patient has access to the Internet on a desktop computer, laptop, or tablet and has a
             working email address.

          -  Patient or caregiver is willing and able to use a computer and enter data on a secure
             website.

          -  Patient is able to read and write English.

          -  Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile,
             or using adequate birth control methods) for the duration of the study and three
             months after study completion. Adequate contraception includes: abstinence, hormonal
             contraception (oral contraception, implanted contraception, injected contraception or
             other hormonal contraception, for example patch or contraceptive ring), intrauterine
             device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide,
             or another adequate method.

        Exclusion Criteria:

          -  Patient is taking other experimental treatments for ALS.

          -  Prior side effects from Lunasin.

          -  Known soy allergy.

          -  Patient has a medical or psychiatric illness that could in the investigator's opinion
             interfere with the patient's ability to participate in this study.

          -  Pregnant women or women currently breastfeeding.
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Condition: Idiopathic Parkinson's Disease; Drug Induced Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias; Dyskinesia, Drug-Induced
Intervention: Topiramate; Placebo; Amantadine
Intervention description: Topiramate as adjunct to amantadine; Placebo control; Existing treatment for all participants
Intervention MeSH terms: Topiramate; Amantadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 30 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Parkinson's disease; dyskinesia; Indonesia; amantadine

Summary:

      The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed
      comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in
      the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on
      amantadine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria

          2. Current age between 30-90

          3. Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity
             (CGI-s) score (see attachment) > 3 (mild) established by clinician's total assessment
             of patient including objective observation during the screening process. *

          4. Stable doses of all antiparkinsonian medications for at least 4 weeks

          5. Stable treatment with at least 200 mg amantadine for at least 4 weeks.

          6. Presence of a caregiver willing to participate in the study

          7. In the opinion of the enrolling investigator, the subject will be able to maintain
             current dosing schedule of antiparkinsonian drugs for the duration of the trial.

          8. Subjects must be free of dementia, depression and psychosis as determined by clinical
             examination.

          9. The subject must be willing to participate in all study related activities and visits.

        Exclusion criteria:

          1. Any subjects with clinical evidence suggestive of an atypical or secondary form of
             Parkinson's Disease

          2. Any subject who, in the opinion of the Principal Investigator, has a concomitant
             medical illness which would preclude them from being treated with amantadine,

          3. Any subject who, in the opinion of the Principal Investigator, will be unable to
             maintain current stable dosing of their anti-parkinsonian medications for the duration
             of the trial,

          4. Any subject with evidence for dementia, depression, or psychosis, as determined by
             clinical examination.

          5. Any subject who has not signed informed consent, or unable or unwilling to participate
             in all of the study related activities.
Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Bevacizumab
Intervention description: TAS-102 Twice a day by mouth day 1-5 and 8-12; Bevacizumab by intravenous infusion once every 14 days
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer; Advanced Colorectal Cancer

Summary:

      Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
    

Eligibility criteria:

        Inclusion criteria:

          -  Written informed consent

          -  Histologically proven, unresectable, evaluable metastatic colorectal cancer

          -  16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based
             flourorpyrimidine-containing chemotherapy plus Bevacizumab

          -  Patients must have stable disease (or better) during the initial induction
             chemotherapy with first-line chemotherapy.

          -  No progressive disease at the time of initiation of maintenance therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

          -  Adequate organ and marrow function

          -  Women of child-bearing potential and men must agree to avoid pregnancy

          -  Patient must start maintenance therapy at least 14 days after the last administered
             induction chemotherapy but no later than 30 days.

        Exclusion Criteria

          -  Patients whose tumors have progressed on first-line treatment

          -  Patients with active concurrent malignancy, other than superficial, non-invasive
             squamous cell carcinoma of the skin or uterine cervix, within the past three years.

          -  Women who are pregnant or lactating

          -  Unstable heart disease

          -  Uncontrolled active infection requiring antibiotics within one week prior to first
             dose.

          -  Patients with active CNS malignancy.

          -  Persistent protein in the urine

          -  Patients with bowel obstruction or uncontrolled vomiting.

          -  Patients with serious psychiatric or medical conditions that could interfere with
             treatment.
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Fentanyl; Placebo
Intervention description: Fentanyl delivered via sublingual spray; Matching placebo delivered via sublingual spray
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual
      Spray compared with placebo in participants with postoperative pain after a bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Willing and able to remain confined in the study unit for the entire duration of each
             treatment period and comply with restrictions related to food, drink and medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  History or current use of over-the-counter medications, dietary supplements, or drugs
             (including nicotine and alcohol) outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff;

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding);

               3. the analysis of results
Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
Condition: Pancreatic Carcinoma
MeSH terms: Pancreatic Neoplasms
Intervention: Best Practice; Quadratus Lumborum Block; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given standard of care; Undergo QL block; Ancillary studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how an additional anesthetic nerve block, called a quadratus
      lumborum block, works to reduce the need for opioids in patients after pancreatic surgery.
      Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce
      the need for opioid medications upon discharge, and reduce the risk of opioid dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing elective open pancreatic resection for potentially curative intent
             (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with
             QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain
             pill).

        Exclusion Criteria:

          -  Patients with current or past substance (drug or alcohol) abuse disorder.

          -  Laparoscopic or minimally invasive surgery.
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Condition: Confirmed Coronavirus Disease
MeSH terms: COVID-19
Intervention: Ruconest
Intervention description: Patients will be randomized to Ruconest or Standard of Care
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC)
      in patients admitted for stage II COVID-19 infection may reduce the risk of disease
      progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster
      clinical improvement compared to SOC alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-85 years,

          -  Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19
             infection).

          -  Evidence of pulmonary involvement on CT scan or X-Ray of the chest,

          -  Symptom onset within the previous 10 days AND at least one additional risk factor for
             progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3)
             obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary
             disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen
             saturation at rest in ambient air of <94%

        Exclusion Criteria:

          -  Contraindications to the class of drugs under study (C1 esterase inhibitor);

          -  History or suspicion of allergy to rabbits;

          -  Women who are of childbearing potential and not using methods of contraception during
             the entire study period;

          -  Pregnant or breastfeeding females or has a positive serum β-human chorionic
             gonadotropin (hCG) pregnancy test at screening;

          -  Chronic liver disease (any Child-Pugh score B or C);

          -  Currently admitted to an ICU or expected admission within the next 24 hours; and

          -  Currently receiving invasive or non-invasive ventilation
Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Condition: Hallux Abducto Valgus
Intervention: Botulinum toxin type A; Placebo
Intervention description: Investigators will inject the reconstituted solution into foot muscles.; Investigators will inject the reconstituted solution into foot muscles.
Intervention MeSH terms: Hemagglutinins; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of treatment with
      multiple doses of Dysport in adults suffering from clinically significant pain associated
      with HAV who have not undergone surgery for their condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of HAV

          -  Painful HAV in the study foot at Baseline

        Exclusion Criteria:

          -  Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in
             the study foot

          -  Other podiatric or orthopedic condition which would interfere with the evaluation of
             pain and/or function

          -  Medical history or clinical evidence of any vascular disease and/or diabetic condition