bioihbjkbjnl/mcl2 huggingface dataset:
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Condition: Postpartum Contraception; Family Planning
Intervention: Etonogestrel-Immediate; Etonogestrel-Delayed
Intervention description: The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).; The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Desogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: contraceptive implant; postpartum contraception; breastfeeding and contraception

Summary:

      A barrier to initiating progestin contraceptives in the early postpartum period is the
      concern of interference with breastfeeding, specifically lactogenesis. In this trial, the
      investigators aim to describe the effects of immediate insertion of the contraceptive implant
      on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate
      post-delivery insertion in delivery room versus insertion of a contraceptive implant in the
      postpartum ward prior to medical discharge. For this study, 82 consenting women will be
      randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room
      or insertion of the implant following delivery in postpartum room and prior to medical
      discharge (24-48 hours following delivery).

      Participants complete a questionnaire that asks questions about breastfeeding continuation,
      supplementation, duration, and exclusivity. This questionnaire also includes questions about
      contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care
      visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who are patients of the Stanford University Obstetrics service

          -  Pregnant women who delivery a healthy infant, regardless of gestational age.

          -  Intend to breastfeed

          -  Desire the contraceptive implant as their method of contraception

          -  Agree to be randomized to delivery room vs. postpartum ward insertion

        Exclusion Criteria:

          -  Not English or Spanish speaking

          -  Allergy or Contraindication to contraceptive implant.
Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
Condition: Strongyloides Stercoralis Infection
MeSH terms: Infections; Strongyloidiasis
Intervention: Moxidectin 2 mg; Ivermectin 3 mg; Placebo
Intervention description: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.; Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.; Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
Intervention MeSH terms: Ivermectin; Moxidectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel study with 2 treatment arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded (Participant and Care provider) Additionally, the principal investigator and the statistician will be blinded.
PK substudy is single-blinded (Participant)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based
      on the outcome of NCT04056325 part A.

      The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia.
      It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of
      moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The
      efficacy of the treatment will be assessed by collecting three stool samples once
      per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a
      quantitative duplicate Baermann assay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18-65 years)

          -  Infected with S. stercoralis (positive)

          -  Absence of major systemic illnesses

          -  Written informed consent

        Exclusion Criteria:

          -  Any abnormal medical conditions or chronic disease

          -  Negative diagnostic result for S. stercoralis

          -  No written informed consent by the individual.

          -  Pregnant and lactating women.

          -  Recent use of an anthelmintic drug (within past 4 weeks)

          -  Attending other clinical trials during the study

          -  Known allergy to study medications (i.e. moxidectin, ivermectin)

          -  Currently taking medications with known interaction (i.e. for warfarin)
Novel Use Of Hydroxyurea in an African Region With Malaria
Condition: Sickle Cell Anemia; Sickle Cell Disease; Malaria
MeSH terms: Malaria; Anemia, Sickle Cell
Intervention: Hydroxyurea; Placebo
Intervention MeSH terms: Hydroxyurea
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 12 Months
Maximum age: 47 Months
Healthy volunteers: No
Keywords: Hydroxyurea

Summary:

      Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute
      painful episodes and reducing the need for blood transfusions in children with sickle cell
      anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan
      Africa, the areas with the most children with SCA.

      The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for
      children with SCA in a malaria endemic region within sub-Saharan Africa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric subjects with documented sickle cell anemia (HbSS supported by hemoglobin
             electrophoresis or by peripheral blood smear showing sickled red blood cells)

          -  Age range of 1.00-3.99 years, inclusive, at the time of enrollment

          -  Weight at least 5.0 kg at the time of enrollment

          -  Willingness to comply with all study-related treatments, evaluations, and follow up

        Exclusion Criteria:

          -  Known chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)

          -  Severe malnutrition determined by impaired growth parameters as defined by WHO (weight
             for length/height or weight-for-length/height > 3 z-scores below the median WHO growth
             standards)

          -  Pre-existing severe hematological toxicity:

               1. Hb <4.0 g/dL

               2. Hb <6.0 g/dL AND ARC <100 x 10E9/L

               3. Hb <7.0 g/dL AND ARC <80 x 10E9/L

               4. Platelets <80 x 10E9/L

               5. ANC <1.0 x 10E9/L

          -  Alanine transaminase (ALT) or creatinine >2 times the upper limit of normal for age

          -  Blood transfusion within 30 days prior to enrollment
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel
Intervention description: Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      Multicenter, open-label, long-term extended access treatment protocol in adult patients with
      a primary diagnosis of MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of lead-in study

          -  Adequate therapeutic benefit in the lead-in study to justify continuation of treatment
             with rapastinel in the judgement of the investigator

        Exclusion Criteria:

          -  Suicide risk, as determined by meeting any of the following criteria:

               1. A suicide attempt within the past year

               2. Significant risk, as judged by the investigator, based on the psychiatric
                  interview or information collected in the Columbia- Suicide Severity Rating Scale
                  (C-SSRS) at any visit in the lead-in study

               3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit
                  during participation in the lead-in study where MADRS was conducted.

          -  At imminent risk of injuring self or others or causing significant damage to property,
             as judged by the investigator

          -  Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed
             during participation

          -  Females of childbearing potential and male partners of females of childbearing
             potential, not using a reliable means of contraception
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
Condition: Post-ischemic Stroke
MeSH terms: Ischemic Stroke
Intervention: dalfampridine-ER 7.5 mg; dalfampridine-ER 10 mg
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an extension study to evaluate the long-term safety, tolerability, and efficacy of
      two dose strengths of dalfampridine-ER.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the DALF-PS-1016 study

          -  Providing informed consent to continue into the DALF-PS-1029 long-term extension study

          -  Sufficient ambulatory ability to independently complete the Two Minute Walk Test
             (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension
             study

        Key Exclusion Criteria:

          -  Seizures, new onset strokes (or other significant neurological event precluding
             long-term continuation) occurring during the antecedent DALF-PS-1016 study

          -  Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the
             long-term extension study
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period; Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334

Summary:

      The purpose of this study is to assess the efficacy of etrasimod on clinical remission in
      participants with moderately to severely active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

          -  Active UC confirmed by endoscopy

        Exclusion Criteria:

          -  Severe extensive colitis

          -  Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
             of a fistula consistent with CD

          -  Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: FKB327; Humira®
Intervention description: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.; Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 728.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid; Arthritis

Summary:

      The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison
      to Humira® in rheumatoid arthritis patients who have inadequate disease control on
      methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 18 years or over

          2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months

          3. Patient has active RA

          4. Patient has taken a stable dose of methotrexate for at least 3 months

        Exclusion Criteria:

          1. Patient has been previously treated with adalimumab

          2. Patient has been previously treated or has ongoing treatment with prohibited
             medications

          3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks

          4. Patient has positive result for HIV, HBV, HCV or TB infection

        Other Inclusion/Exclusion criteria may apply.
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: SGLT2 inhibitor (dapagliflozin); Placebo Comparator
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in
      plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP
      following SGLT2 inhibition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM subjects

          -  18 - 70 yrs old

          -  BMI = 25-45 kg/m2

          -  Must be on a stable dose (more than 3 months) of monotherapy or combination therapy
             with metformin and/or a sulfonylurea

          -  HbA1c <10.0%

          -  Stable body weight (± 3 lbs) over preceding 3 months

          -  Do not participate in excessively heavy exercise

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea)

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes
Intervention: Glasdegib; Azacitidine
Intervention description: 25 mg or 100 mg tablet; 100 mg/vial powder for 25 mg/mL suspension for injection
Intervention MeSH terms: Azacitidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label study available to all eligible participants from Study B1371019 and
      participants originating from Study B1371012 continuing on study intervention with
      azacitidine with or without glasdegib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any participant who continues to demonstrate clinical benefit (as determined by the
             Principal Investigator) from study treatment with azacitidine with or without
             glasdegib in this Study or from Study B1371012.

          -  Capable of giving signed informed consent as described in Appendix 1, which includes
             compliance with the requirements and restrictions listed in the ICD and in this
             protocol.

        Exclusion Criteria:

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.

          -  Female participants who are pregnant or breastfeeding (if continuing to receive study
             intervention);

          -  Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason
             (including INT cohort participants required to end study treatment)
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Propolis; Calcium Hydroxide
Intervention description: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.; it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Intervention MeSH terms: Propolis; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Flare up

Summary:

      This study evaluates the role of propolis paste as compared to calcium hydroxide (when used
      as intracanal medication) in prevention and treatment of pain after root canal treatment in
      necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the
      other half will receive propolis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis
             having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and
             4).

          -  Teeth with favorable root morphology.

          -  Teeth with closed apex.

        Exclusion Criteria:

          -  Teeth with PAI index 1 and 5.

          -  Patients who are on antibiotics.

          -  Patient with recent trauma to the jaw.

          -  Teeth with open apex

          -  Multi-rooted teeth.

          -  Vital teeth.

          -  Non-restorable teeth.

          -  Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or
             obliterated).

          -  Teeth associated with soft tissue abscess or swelling.

          -  Teeth with external or internal root resorption

          -  Re-treatment cases.

          -  Periodontally compromised teeth (like mobile teeth and teeth with excessive bone
             loss).

          -  Teeth requiring endodontic surgery.

          -  Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or
             opposing quadrant.

          -  Medically compromised patients (ASA-III and above), patients with special
             communication needs or who doesn't understand Urdu or English language.

          -  Patients allergic to bee pollen or honey products.
Study Of Adults And Adolescents With Vasomotor Rhinitis
Condition: Rhinitis, Vasomotor
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Intervention: GW685698X
Intervention description: Aqueous Nasal Spray 100mcg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 352.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vasomotor Rhinitis; VMR; nonallergic rhinitis; GW685698X

Summary:

      The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg
      once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent
      subjects (12 years of age and older) with vasomotor rhinitis (VMR).
    

Eligibility criteria:

        Inclusion criteria:

          -  Must be outpatients.

          -  Diagnosis of VMR.

          -  Literate in English or native language.

        Exclusion criteria:

          -  Significant concomitant medical condition.

          -  Use corticosteroids or other allergy medications during the study.

          -  Used tobacco products within the past year.
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Condition: Lung Cancer - Non Small Cell Squamous
MeSH terms: Lung Neoplasms
Intervention: Ipilimumab; Placebo; Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1289.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin
      will extend the lives of patients with squamous only non small cell lung cancer more than
      placebo plus Paclitaxel and Carboplatin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Non small cell lung cancer (NSCLC) - squamous cell

          -  Stage IV or recurrent NSCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Brain Metastases

          -  Autoimmune diseases