bioihbjkbjnl/mcl2 huggingface dataset:
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: TRV130; Morphine; Placebo
Intervention description: TRV130 1 - 4 mg will be administered every 4 hours; Morphine 4 mg will be administered every 4 hours; Placebo will be administered every 4 hours
Intervention MeSH terms: Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: moderate to severe acute pain; bunionectomy

Summary:

      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain after bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and
             internal fixation) with no additional collateral procedures.

          -  Experiences a pain intensity rating of ≥ 4 on an 11 point NRS

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
Condition: HIV Infections; Lipodystrophy; Metabolic Diseases; Nutrition Disorders
MeSH terms: Lipodystrophy; Metabolic Diseases; Nutrition Disorders
Intervention: NucleomaxX; Tenofovir Disoproxil Fumarate
Intervention description: NucleomaxX 36 grams TID every other day; Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate
Intervention MeSH terms: Tenofovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lipoatrophy; mitochondria; HIV; treatment experienced

Summary:

      HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking
      antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors
      (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage
      the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce
      energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in
      nucleosides, which are building blocks that may counteract the negative effects of NRTIs.
      Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other
      drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is
      to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for
      ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV
      infected adults.

      Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy
      will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and
      peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in
      mitochondrial function as assessed by electron transport chain (ETC) and oxidative
      phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat
      apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with
      uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat
      content.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HIV lipoatrophy

          -  Receiving a stable stavudine- or zidovudine-containing ARV regimen

          -  HIV-1 RNA viral load less than 50 copies/ml

        Exclusion Criteria:

          -  Coagulopathies or other bleeding disorders

          -  Diabetes requiring medication

          -  Creatinine clearance less than 50 ml/min

          -  Pregnancy or breastfeeding
Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Condition: Healthy Subjects
Intervention: 0.12% chlorhexidine mouthrinse; Cosmetic mouthrinse; Sterile water
Intervention description: commercially available 0.12% chlorhexidine mouthrinse; Commerically available cosmetic mouthrinse; Sterile water
Intervention MeSH terms: Chlorhexidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tooth plaque

Summary:

      A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general and oral health

          -  At least 20 natural gradable teeth

          -  Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or
             equal to 2.00 at the first baseline visit
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
Condition: Menopause; Hot Flashes; Night Waking
MeSH terms: Hot Flashes
Intervention: Elinzanetant (BAY3427080); Placebo
Intervention description: BAY3427080 capsules; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken
      once a day, in the treatment of troublesome post-menopausal symptoms.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Postmenopausal

          -  Body mass index between 18 and 38 kg/m2, inclusive

          -  Subject experiences moderate or severe hot flashes

        Key Exclusion Criteria:

          -  Inability to comply with the use of prohibited and allowed medications as described in
             the protocol.

          -  Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12
             months of Screening.

          -  Any clinically significant prior or ongoing history of arrhythmias, either determined
             through clinical history or on ECG evaluation.

          -  Any clinically significant abnormal laboratory test result(s) measured at Screening.

          -  Any active ongoing condition that could have caused difficulty in interpreting
             vasomotor symptoms.

          -  Uncontrolled hypertension.

          -  A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at
             Screening. Treated hypothyroidism with normal thyroid function test results at
             Screening is acceptable.
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 2%; SB204 4%; Vehicle Gel
Intervention description: Applied topically twice daily; Applied topically daily; Applied topically twice and once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a randomized, multi-center, double-blinded study in subjects with moderate to severe
      acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  25-70 non-inflammatory lesions at Baseline

          -  20-40 inflammatory lesions at Baseline

        Exclusion Criteria:

          -  Subjects with known allergy to any component of the test material or vehicle

          -  Women who are pregnant or nursing
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Condition: Pneumococcal Vaccine
Intervention: 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention description: 13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.; 7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention; against; pneumococcal; disease; Vaccine

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal
      conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old-infants (42 to 98 days)

          -  Available for the entire study period (14 months)

        Exclusion Criteria:

          -  Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib
             vaccine

          -  A previous severe reaction to any vaccine or vaccine-related component
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
Condition: Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Erlotinib; Pemetrexed
Intervention description: 150 mg Given orally; 500mg/m2 Given IV
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cancer; Non-small-cell lung cancer; Adenocarcinoma; EGFR gene mutation; Chemotherapy; Pemetrexed; Erlotinib

Summary:

      Both pemetrexed and erlotinib are second-line treatment options for patients with advanced
      non-small cell lung cancer. It is controversial that whether it is necessary to detect
      epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after
      the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive
      marker remains controversial. Therefore, we investigate the efficacy of erlotinib and
      pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR
      FISH-positive advanced lung adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Lung adenocarcinoma

          -  Wld-type EGFR

          -  Stage IIIB/IV

          -  Failure to prior chemotherapy

          -  Life expectancy of more than 3 months

          -  Tissue sample desired for genomic study

          -  Age ≥ 18 years

          -  Performance status (WHO) < 3

          -  Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count >
             100000/mm^3, hemoglobin > 9gr/mm^3)

          -  Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
             upper limit of normal) and renal function (creatinine < 2mg/dl)

          -  Presence of two-dimensional measurable disease. The measurable disease should not have
             been irradiated

          -  Informed consent

        Exclusion Criteria:

          -  Have previously received pemetrexed or TKIs

          -  Other concurrent uncontrolled illness
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Condition: Gastric Cancer; Chemotherapy Effect
MeSH terms: Stomach Neoplasms
Intervention: FLOT Chemotherapy; SOX Chemotherapy
Intervention description: 5-FU+Leucovorin+Docetaxel+Oxaliplatin; Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly assigned(1:1) either to FLOT or SOX group.
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neoadjuvant chemotherapy; perioperative chemotherapy; Systemic chemotherapy; FLOT; SOX; Gastric cancer

Summary:

      Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer
      patients in high volume center of China
    

Eligibility criteria:

        Inclusion criteria:

          -  Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric
             junction.

          -  Clinical stage: cTNM: stage III or above

          -  Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to
             symptomatic but in bed less than half the day)

          -  Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate
             renal, hepatic, hematologic, and pulmonary function.

          -  Written informed consent

        Exclusion criteria:

          -  Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e.
             uncontrolled cardiac disease, or other clinically significant uncontrolled
             comorbidities, unable to undergo general anesthesia

          -  Confirmed distant metastases

          -  Locally advanced inoperable disease (Clinical assessment)

          -  Relapse of gastric cancer

          -  Malignant secondary disease

          -  Prior chemo or radiotherapy

          -  Inclusion in another clinical trial

          -  Known contraindications or hypersensitivity for planned chemotherapy
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: rhIGF-1/rhIGFBP-3
Intervention description: Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.
Intervention MeSH terms: Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 40 Weeks
Maximum age: 108 Weeks
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the long-term efficacy and safety outcomes
      following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study
      ROPP-2008-01 (NCT01096784).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).

          -  Participants parent or legally authorized representative(s) must provide written
             informed consent prior to performing any study-related activities. Study-related
             activities are any procedures that would not have been performed during normal
             management of the participant.

        Exclusion Criteria:

          -  Any other condition or therapy that, in the Investigator's opinion, may pose a risk to
             the Participant or interfere with the participants ability to be compliant with this
             protocol or interfere with the interpretation of results.

          -  The participant or participants parent or legally authorized representative(s) is
             unable to comply with the protocol as determined by the Investigator.
A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: ACH-0144471
Intervention description: ACH-0144471 will be administered to all participants enrolled in the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal; Hemoglobinuria; ACH-0144471; ALXN2040; Danicopan

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in
      participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical
      benefit from ACH-0144471 in Study ACH471-100. This study is designed to include up to 12
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study designed to include up to 12 participants who completed treatment in Study
             ACH471-100 and demonstrated clinical benefit from ACH-0144471 with no significant
             safety or tolerability concerns.

          -  Negative pregnancy test for females prior to dosing and throughout the study.

        Exclusion Criteria:

          -  Have developed any clinically relevant co-morbidities while participating in Study
             ACH471-100 that would make the participant inappropriate for the continuation of
             treatment with ACH-0144471, in the opinion of the Investigator.

          -  Have developed any clinically significant laboratory abnormalities while participating
             in Study ACH471-100 that, in the opinion of the Investigator, would make the
             participant inappropriate for the study or put the participant at undue risk.

          -  Females who are pregnant, nursing, or planning to become pregnant during the study or
             within 90 days of study drug administration or participants with a female partner who
             is pregnant, nursing, or planning to become pregnant during the study or within 90
             days of study drug administration.
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Condition: Opioid Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: placebo; NKTR-118
Intervention description: placebo, oral, once daily (QD); 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Intervention MeSH terms: Naloxegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar

Summary:

      Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized,
      dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of
      NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical
      manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to
      evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  18 years of age or older, male or female

          -  Receiving a stable opioid regimen

          -  Documented opioid-induced constipation

          -  Willingness to stop all laxatives and other bowel regimens. The use of constipation
             rescue medication will be allowed during the study.

        Main Exclusion Criteria:

          -  Life expectancy less than 6 months

          -  Active substance abuse

          -  Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other
             active medical disorders associated with diarrhea or intermittent loose stools or
             constipation

          -  Pregnant or breast-feeding

          -  Any receipt of an investigational medication within 30 days of screening

          -  History or presence of specific cardiac, neurologic, endocrine and/or psychiatric
             conditions
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Rituximab; Bendamustine; Cytarabine
Intervention MeSH terms: Cytarabine; Rituximab; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Newly diagnosed

Summary:

      Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to
      improve upon standard of care in newly diagnosed, untreated MCL patients who were
      transplant-eligible using drugs already established as active in MCL. The combination of
      Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize
      pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with
      tolerable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's
             Hospital or Massachusetts General Hospital

          -  Measurable disease

          -  Candidate for ASCT

        Exclusion Criteria:

          -  Prior anti-lymphoma therapy

          -  Pregnant or breastfeeding

          -  Hypersensitivity to rituximab

          -  Uncontrolled intercurrent illness

          -  Receiving other study agents

          -  HIV positive on combination antiretroviral therapy