bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of DHA on Periodontitis
Condition: Periodontitis; Gingivitis; Inflammation
MeSH terms: Gingivitis; Periodontitis; Inflammation
Intervention: Aspirin; Docosahexaenoic acid; Placebo (for Docosahexaenoic acid)
Intervention description: Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Docosahexaenoic acid; DHA; Periodontitis; Gingivitis; Omega-3 fatty acid; Fish oil

Summary:

      The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in
      the treatment of periodontitis in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >40 years

          -  >20 natural teeth (excluding third molars)

          -  no orthodontic appliances

          -  periodontitis defined as >4 teeth with pocket probing depths >5 mm

        Exclusion Criteria:

          -  pregnancy

          -  diabetes

          -  severe chronic diseases

          -  gastrointestinal bleeding

          -  uncontrolled chronic diseases

          -  autoimmune disorders

          -  conditions requiring antibiotic prophylaxis

          -  warfarin

          -  clopidogrel

          -  antimicrobial therapy within 30 days

          -  chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)

          -  omega-3 fatty acid use within 6 months

          -  loose teeth

          -  painful teeth

          -  periodontal abscess

          -  pocket depths >10 mm in >1 tooth

          -  periodontal therapy within the past two years

          -  allergy to aspirin

          -  allergy to fish oil

          -  allergy to corn oil

          -  allergy to soybean oil
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Intervention: Sodium Nitrite
Intervention description: Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: subarachnoid hemorrhage; vasospasm; nitrite; sodium nitrite

Summary:

      The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the
      reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral
      aneurysm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained from a patient or legal representative before enrollment;

          -  Admission to hospital following subarachnoid hemorrhage;

          -  Aneurysm confirmed by digital subtraction angiography or CT-angiography after
             admission;

          -  Development of the clinical symptoms and /or signs of cerebral vasospasm and
             CT-angiography results warranting cerebral angiography.

        Exclusion Criteria:

          -  Rupture of a fusiform, traumatic, or mycotic aneurysm;

          -  Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast
             feeding;

          -  Methemoglobin > 2%

          -  History of sickle cell disease, thalassemia, or other hemoglobinopathy;

          -  Anemia with hemoglobin level less than 6 g/dL;

          -  Significant acute or chronic concomitant diseases (including renal, hepatic,
             cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary
             embolism) that would be inconsistent with survival for at least 6 months;

          -  History of allergy to nitrites or allergy to other substances that could interfere
             with nitrite metabolism, within 30 days before screening;

          -  History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;

          -  Treatment with allopurinol, a medication that could interfere with nitrite metabolism,
             within 30 days before screening;

          -  Other investigational drug within the past 30 days;

          -  other cerebral injury within the past 30 days including previous subarachnoid
             hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial
             surgery, radiation therapy to the head.
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Condition: Leukemia; T-cell Prolymphocytic Leukemia (T-PLL); Cancer
MeSH terms: Leukemia; Leukemia, Prolymphocytic; Leukemia, Prolymphocytic, T-Cell
Intervention: Venetoclax; Ibrutinib
Intervention description: Venetoclax tablets taken orally once a day (QD). Initially, venetoclax was administered utilizing a 5-step dose ramp-up over 5 days. Subjects were hospitalized and closely monitored for 7 days. The venetoclax ramp-up was administered in a daily manner: 20 mg on Week 1 Day 1, 50 mg on Week 1 Day 2, 100 mg on Week 1 Day 3, 200 mg on Week 1 Day 4, and 400 mg on Week 1 Day 5 and thereafter, once daily, until the end-of-treatment. The dose of venetoclax may have been increased to 600 mg QD at Week 8 or thereafter.; Ibrutinib capsules taken orally once a day, 420 mg/day until the end-of-treatment.
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-cell Prolymphocytic Leukemia (T-PLL); Cancer; Venetoclax; Venclexta; Venclyxto; Ibrutinib; Imbruvica; Relapsed or Refractory T-lymphoid malignancy

Summary:

      The main objective of this study is to evaluate the efficacy of the combination of venetoclax
      plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate liver, kidney and hematology function per laboratory values as described in
             the protocol.

          -  Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

          -  Received prior alemtuzumab (unless unsuitable or unavailable).

          -  Has no malignancies other than T-PLL that:

               -  currently require systemic therapies;

               -  were not previously treated with curative intention (unless the malignant disease
                  is in a stable remission due to the discretion of the treating physician); or

               -  developed signs of progression after curative treatment.

        Exclusion Criteria:

          -  History of or current decompensated cirrhosis including Child-Pugh class B or C,
             ascites, hepatic encephalopathy, or variceal bleeding.

          -  Has human T-cell lymphotropic virus, type 1.

          -  Prior allogeneic stem cell transplant within 6 months of study drug administration and
             requirement for graft versus host therapy.

          -  Has an uncontrolled or active infection including severe acute respiratory syndrome-
             coronavirus-2 (SARS-COV-2).

          -  Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.

          -  Received a prohibited therapy within the specified time frame as described in the
             protocol.
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Danoprevir; Ritonavir; peginterferon alfa-2a; Ribavirin (RBV)
Intervention description: Danoprevir (DNV) 100mg tablet administered orally twice daily; Ritonavir 100mg tablet administered orally twice daily; PegIFN subcutaneous injection at 180 mcg weekly; Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Danoprevir; SVR12; Chinese HCV G1; non-cirrhotic

Summary:

      The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of
      Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive
      Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection (≥ 6 months) ;

          -  Positive HCV antibody

          -  Serum HCV RNA of ≥ 1 × 104 IU/mL

          -  Hepatitis C virus GT1

          -  Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or
             host-targeting antivirals for HCV

          -  The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂
             4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not
             obtained a liver biopsy or Fibroscan in the last 1 years will have a study related
             Fibroscan performed in order to confirm the diagnosis

          -  Others as specified in the detailed protocol

        Exclusion Criteria:

          -  Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for
             liver cirrhosis patients

          -  Presence or history of non-hepatitis C chronic liver disease, including but not
             limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous
             hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease,
             alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and
             porphyria cutanea tarda causing liver pathology or requiring phlebotomy

          -  Patients with a history of liver cell cancer, screening before or screening suspected
             hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules,
             or AFP > 50 ng/mL

          -  Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody
             or HIV antibody at screening

          -  Others as specified in the detailed protocol
A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
Condition: Cushing Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Intervention: ATR-101; Placebo
Intervention description: During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.; During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Endogenous Cushing's Syndrome; ATR-101; CS

Summary:

      This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101
      to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous
      Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an
      open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a
      double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets
      randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if
      the subject does not meet randomization criteria).It is anticipated that the overall duration
      of the study per subject will range from approximately 16-22 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of endogenous Cushing's syndrome

          -  Baseline UFC 1.3 to 10 × upper limit of normal (ULN)

          -  If previous pituitary surgery, participants must be at least 3 months since surgery at
             the time of screening

          -  BMI between 18 and 60 kg/m2, inclusive

        Exclusion Criteria:

          -  Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's
             syndrome

          -  Candidates for surgical treatment of Cushing's syndrome, unless surgery is not
             anticipated to occur during the study

          -  Normal late night salivary cortisol or 24-hr urine free cortisol

          -  Radiotherapy of the pituitary within 6 months
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Intervention: External beam radiation; Oxaliplatin; Leucovorin; 5-FU; Capecitabine
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at
      or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while
      maintaining response rates comparable to what would be expected with radiotherapy and
      concurrent chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven adenocarcinoma of the rectum

          -  Patient evaluated by surgeon and found to be a potential surgical candidate. Since the
             primary objectives are response to chemoradiation and acute toxicity, lesions which
             are initially unresectable are eligible-provided the surgeon feels that, if there is
             sufficient response, surgery could become feasible.

          -  Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by
             physical findings (tethering on palpation for T3 lesions or invasion of a neighboring
             organ for T4 lesions)

          -  Karnofsky Performance Status at >60

          -  Laboratory criteria:

          -  Absolute neutrophil count >= 1.5 K

          -  Platelets >= 100 K

          -  Total Bilirubin <= 2.0;

          -  SGOT and Alkaline Phosphatase <= 2 x upper limit of normal

          -  Creatinine < 2.0

          -  Hemoglobin >= 8.0

          -  Informed consent signed

          -  Tumor measurable in at least one dimension. This may be, e.g. length and/or width
             measured endoscopically or on digital rectal examination, and maximum rectal wall
             thickness determined by imaging studies.

          -  Estimated longevity at least 12 months

          -  Patients with distant metastatic disease will be eligible if they satisfy all other
             conditions

        Exclusion Criteria:

          -  Pregnant women, children < 18 years, or patients unable to give informed consent

          -  Patients with a past history of pelvic radiotherapy.

          -  Patients with any other malignancy within the past 5 years except: skin cancer or
             in-situ cervical cancer

          -  Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine

          -  Prior chemotherapy for colorectal cancer.

          -  Grade >= 2 peripheral neuropathy

          -  Any condition which, in the opinion of the treating medical oncologist, renders the
             patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin,
             Oxaliplatin chemotherapy
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Condition: Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Paclitaxel; CB-839
Intervention description: standard weekly paclitaxel in 28-day cycles; CB-839 administered as oral tablets twice daily (BID)
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to one of 4 arms depending on the number of prior lines of therapy they have received and whether or not they have African ancestry
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: African ancestry; African American; CB-839; Glutaminase Inhibitor; Glutaminase; TNBC; Tumor Metabolism; Glutamine

Summary:

      CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in
      participants of African ancestry and non-African ancestry with advanced triple negative
      breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID)
      CB-839 will be administered in combination with the full approved dose of paclitaxel.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets criteria for 1 of the 4 defined study cohorts

          -  TNBC, defined as estrogen receptor (ER) and progesterone receptor (PR) negative (< 1%
             by immunohistochemistry) and human epidermal growth factor receptor 2 (HER2)-negative
             (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization [FISH] negative)

          -  Metastatic disease or locally-advanced disease not amenable to curative intent
             treatment

          -  Adequate hepatic, renal, cardiac, and hematologic function

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events
             (CTCAE) version.4.0

        Key Exclusion Criteria:

          -  Known brain metastases or central nervous system (CNS) cancer unless adequately
             treated with radiotherapy and/or surgery and stable for ≥ 2 mo

          -  Unable to receive oral medications

          -  Known hypersensitivity to Cremophor®-based agents

          -  Major surgery within 28 days of Cycle 1 Day 1
Acitretin and Etanercept in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: acitretin
Intervention description: Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
Intervention MeSH terms: Acitretin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: psoriasis; etanercept; acitretin

Summary:

      To determine whether acitretin plus etanercept is more effective than etanercept alone in
      clearing psoriasis plaques in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having
             a physician global assessment score of 3 [moderate] or higher) who are on etanercept
             50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment
             with etanercept

          -  All patients on etanercept have been tested for TB before initiation of etanercept

        Exclusion Criteria:

          -  Patients < 18 years old or > 80 years old

          -  Patients who are not on etanercept 50 mg SQ once weekly

          -  Women of childbearing potential (Note: women of non-childbearing potential, meaning
             surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal
             ligation] or post-menopausal for at least 2 years, are eligible)

          -  Inability to understand consent or comply with study requirements

          -  Uncontrolled hypertriglyceridemia

          -  Patients with severely impaired hepatic function

          -  Patients without health insurance or who are not willing to pay out-of-pocket for
             etanercept and laboratory tests

          -  Systemic psoriasis therapies or PUVA within the past 2 weeks

          -  UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC
             shampoos) within the past 1 week

          -  Patients with epilepsy or multiple sclerosis
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ZPL389 30mg; ZPL389 50mg; TCS and/or TCI
Intervention description: 30mg of ZPL389; once daily; 50mg of ZPL389; once daily; Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; AD; eczema; itch; pruritus; H4R; ZPL389

Summary:

      This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the
      core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the
      short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant
      or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors
      (TCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Subjects with atopic dermatitis who have participated in and completed 16 weeks of
             treatment in CZPL389A2203 study.

          -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
             diary completion and other study procedures.

        Exclusion Criteria:

          -  Inability to use TCS and/or TCI due to history of important side effects of topical
             medication (e.g., intolerance or hypersensitivity reactions).

          -  Treatment discontinued subject from CZPL389A2203 study.

          -  Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis
             disease activity.