bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Metoclopramide Nasal Spray; Placebo Nasal Spray
Intervention description: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID); One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Intervention MeSH terms: Metoclopramide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; Gastroparesis; Delayed gastric emptying; Nausea; Vomiting; Bloating; Abdominal pain; Early Satiety; Gastric stasis; Gastropathy

Summary:

      The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray
      compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between the ages of 18 and 75 years

          -  Willingness and ability to give written informed consent

          -  The ability to read, understand and speak English

          -  Prior diagnosis of Type 1 or Type 2 diabetes

          -  Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying

          -  A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization

          -  Willingness to discontinue current treatment for diabetic gastroparesis and to avoid
             all proscribed (excluded) medications, as specified by the protocol, for the duration
             of the study

        Exclusion Criteria:

          -  Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of
             gastroparesis and disorders known to be associated with abnormal gastrointestinal
             motility

          -  A history of allergic or adverse responses, including, but not limited to, acute
             dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or
             similar product

          -  A history of, or physical findings suggestive of, tardive dyskinesia

          -  A history of epilepsy or currently using and unwilling or unable stop other drugs
             known to be associated with extrapyramidal reactions at screening

          -  Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the
             skin) currently present, initially diagnosed or recurring within five (5) years of
             screening

          -  Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening

          -  Hemoglobin A1c >11.5% at screening
Cocaine/Crack and Reduction of Compulsion With Biperiden
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Biperiden; Placebo
Intervention description: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.; Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
Intervention MeSH terms: Biperiden
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 111.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cocaine; crack; treatment; dependence; biperiden

Summary:

      Considering the effects of the cholinergic system on the drug reward and self-administration
      mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process.
      Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in
      attenuate compulsion, one o the main symptoms of the drug dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

        Exclusion Criteria:

          -  Being under treatment with psychoactive drugs

          -  Have been diagnosed for other Psychiatric Disorders

          -  Have dependence diagnosis for other drugs, except for tabacco
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P10; Rituxan; MabThera
Intervention description: 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 384.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,
      Rituxan and MabThera in Patients with Rheumatoid Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is male or female between 18 and 75 years old, inclusive.

          2. Patient has a diagnosis of RA according to the revised 1987 ACR classification
             criteria (Arnett et al 1988) for at least 6 months prior to randomization.

          3. Patient has active disease as defined by the presence of 6 or more swollen joints (of
             66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL
             (≥15 mg/L) or an ESR ≥28 mm/hour.

          4. Patient has experienced an inadequate response to previous or current treatment with
             the anti-TNF agents infliximab

          5. Patient has a proper discontinuation period after treatment with interleukin-1
             receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.

        Exclusion Criteria:

          1. Patient has taken more than 2 biologic agents.

          2. Patient has previously been administered Rituximab or participated in a Rituximab
             biosimilar study.

          3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized
             proteins.

          4. Patient has current or past history of chronic infection with hepatitis B, hepatitis
             C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive
             result to the screening test for these infections.

          5. Patient has an infection requiring oral antibiotics 2 weeks before randomization,
             parenteral injection of antibiotics 4 weeks before randomization, other serious
             infection 6 months before randomization, a history of recurrent herpes zoster or other
             chronic or recurrent infection 6 weeks before randomization.
Nifedipine for Acute Tocolysis of Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: Nifedipine; Placebo; Usual care
Intervention description: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.; Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.; Usual evaluation, monitoring and care for women with preterm labor.
Intervention MeSH terms: Nifedipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: Female
Minimum age: 16 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if nifedipine treatment of women in preterm labor
      receiving corticosteroids results in postponement of delivery when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 16 and 44 years of age inclusive

          -  Singleton pregnancy

          -  Intact membranes

          -  Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive

          -  Reported or documented uterine activity

          -  Cervical dilation between 2 cm and 4 cm inclusive

        Exclusion Criteria:

          -  Multifetal gestation

          -  Less than 28 weeks' gestation

          -  34 or more weeks' gestation

          -  Ruptured membranes

          -  More than 4 cm dilated

          -  Previously received a course of corticosteroids for fetal lung maturation

          -  Oligohydramnios

          -  Fetal growth restriction

          -  Chorioamnionitis or temperature of at least 38.0 degrees Celsius

          -  Fetal death

          -  Preeclampsia

          -  Suspected placental abruption or placenta previa

          -  Lethal fetal malformation or amniotic fluid index at least 35

          -  Systolic BP < 90 mmHg or diastolic BP < 50 mmHg

          -  Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)

          -  Chronic hypertension treated with antihypertensives in pregnancy

          -  Seizure disorder or HIV

          -  Maternal allergy to nifedipine

          -  Known maternal cardiac disease

          -  Women who have received progesterone therapy in the second or third trimester for
             prevention of preterm birth
Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Condition: Contraceptive Usage
Intervention: Etonogestrel contraceptive implant
Intervention description: Etonogestrel contraceptive implant
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants were randomized to receive a contraceptive implant before hospital discharge or at their six week postpartum visit
Masking: None (Open Label)
Enrollment: 81.0
Sex: Female
Minimum age: 15 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Implanon; Bleeding Acceptability; Contraceptive Implant; Adolescent Pregnancy Prevention; Post Partum Insertion of Implanon

Summary:

      The specific aim of this study is to evaluate whether insertion of a long-acting
      contraceptive implant in postpartum adolescents prior to hospital discharge increases use of
      this highly effective contraception during the first twelve months postpartum among
      adolescents who elect Implanon® as their preferred method of contraception. Additionally,
      this study aims to compare the acceptability of bleeding in postpartum adolescents who have
      an etonogestrel contraceptive implant prior to discharge versus those with insertion at the
      six week postpartum visit. The investigators will evaluate the acceptability of bleeding
      rather than collect prospective diaries because the investigators feel subjective perceptions
      of bleeding impact contraceptive continuation more than quantitative differences in bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 15-21

          -  women

          -  english or spanish speaking

          -  less than 120 hours post partum

        Exclusion Criteria:

          -  women who are breastfeeding

          -  contraindications to Implanon® insertion including current or prior thrombo-embolic
             disease, liver disease, hypersensitivity to components of Implanon®, or are using
             medications such as rifampin, phenytoin, or carbamazepine that increase metabolism of
             steroid hormones.

          -  indicate unwillingness to continue follow-up for one year.
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Remdesivir; RDV Placebo; Standard of Care
Intervention description: Administered as Intravenous (IV) infusion once daily; Administered as IV saline once daily; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces
      the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in
      participants with severely reduced kidney function who are hospitalized for coronavirus
      disease 2019 (COVID-19).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by
             Polymerase Chain Reaction (PCR) or other commercially available or public health assay
             (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory
             specimen

          -  Hospitalized for COVID-19

          -  Weighing at least 40 kilograms (kg)

          -  Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic
             evidence of pulmonary infiltrates for COVID-19

          -  Have either:

               -  a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR)
                  < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD)
                  requiring chronic dialysis

               -  b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum
                  creatinine (SCr) within a 48-hour period that is sustained (ie, requires
                  confirmatory SCr) for ≥ 6 hours despite supportive care

          -  The interval between COVID-19 symptoms onset and randomization is no more than 10 days

        Key Exclusion Criteria:

          -  Received any investigational drug, RDV, or other antiviral treatment for COVID-19

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
             limit of normal

          -  Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal
             membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney
             injury (AKI)

          -  Positive serum pregnancy test at screening for women of childbearing potential or
             currently breastfeeding

          -  Known hypersensitivity to the study drug, metabolites, or formulation
             sulfobutylether-beta-cyclodextrin (SBECD)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1
Intervention description: Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants
      with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study
      SGT-54-02 (NCT03564119).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for the extension study.

          2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of
             the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not
             more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

        Exclusion Criteria:

        -
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
Condition: SARS-CoV-2
Intervention: Standard of Care (SOC) and Colchicine+Rosuvastatin
Intervention description: Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
Intervention MeSH terms: Colchicine; Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rosuvastatin; Colchicine

Summary:

      This is a pragmatic randomized open-label study of the safety and efficacy of the combination
      of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in
      hospitalized patients with SARS-CoV-2
    

Eligibility criteria:

        Inclusion Criteria 1.18 years or older and confirmed SARS-CoV-2 infection by RT-PCR 2.
        Patient is admitted to the floor (non-ICU) within 48 hours of hospital admission 3. The
        patient, or legally authorized representative, has been informed of the nature of the
        study, agrees to its provisions and has provided witnessed (by 2 independent members of the
        health care team) oral informed consent, or a photograph of the signed informed consent
        approved by the Institutional Review Board (IRB)

        Exclusion Criteria:

          1. Known pregnancy or nursing mothers

          2. Known allergy to statins or colchicine

          3. Patient is on chronic colchicine or oral corticosteroid treatment

          4. Acute liver disease defined by elevated transaminases (AST/ALT > 3x ULN)

          5. Severe chronic kidney disease defined as glomerular filtration rate (GFR) <
             30mL/min1.73 m2

          6. Severe QTc prolongation (>500ms narrow QRS<120ms and >550ms for wide QRS>120)

          7. Presents with severe disease on admission (WHO ordinal scale of clinical improvement
             scores 5-8)

          8. Rhabdomyolysis or CPK > 5x ULN

          9. Thrombocytopenia defined as platelet count < 50,000 / mm3

         10. Leukopenia defined as white blood cell count < 3000 ml

         11. Severe anemia defined as Hemoglobin value <8 g/100ml

         12. Participation in any other clinical trial of an experimental treatment for COVID-19
A Safety and Efficacy Study of NAC in Patients With TA-TMA
Condition: Thrombotic Microangiopathies; Hematologic Diseases
MeSH terms: Vascular Diseases; Hematologic Diseases; Thrombotic Microangiopathies
Intervention: N-Acetylcysteine; Placebo Oral Tablet
Intervention description: 50mg/Kg.d, oral; 50mg/Kg.d, oral
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 170.0
Sex: All
Healthy volunteers: No
Keywords: N-acetylcysteine; Complement; Thrombotic Microangiopathies

Summary:

      HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen
      within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal
      failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a
      small, simple molecule that began as a generic drug almost 40 years ago. It has since been
      approved by the FDA for many indications. The investigators conducted an prospective clinical
      trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients be scheduled to undergo HSCT;

          2. Not received decitabine 6 month ago;

          3. Without severe organ damage;

          4. ECOG 0-2;

          5. Informed consent were obtained.

        Exclusion Criteria:

          1. Be sensitive to NAC;

          2. Bronchial asthma；

          3. Peptic ulcer；

          4. Severe organ damage；

          5. Pregnancy and breastfeeding women；
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Condition: cUTI
MeSH terms: Urinary Tract Infections
Intervention: Eravacycline; Levofloxacin
Intervention MeSH terms: Levofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Except for the responsible study site pharmacist or designee and separate unblinded clinical research associates to monitor drug supply and adherence to study drug blinding and randomization procedures, all study staff and participants were blinded to treatment assignment.
Enrollment: 908.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to
      assess the efficacy and safety of eravacycline compared with levofloxacin in participants
      with complicated urinary tract infections (cUTI).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male and female participants with either:

        a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total
        population), OR b. cUTI with at least 1 of the following conditions associated with a risk
        for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately
        100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial
        obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v.
        Azotemia of renal origin (not congestive heart failure or volume related) such that the
        serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN:
        creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as,
        bladder diverticula, redundant urine collection system) EXCEPT surgery within the last
        month

        Exclusion Criteria:

        1. Concurrent use of non-study antibacterial drug therapy that would have a potential
        effect on outcome evaluations in participants with cUTI, including:

          1. Participants with a history of a levofloxacin-resistant urinary tract infection

          2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late
             Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)