bioihbjkbjnl/mcl2 huggingface dataset:
Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
Condition: Sialorrhea
MeSH terms: Sialorrhea; Parkinson Disease; Parkinsonian Disorders
Intervention: Incobotulinum Toxin A; Placebo
Intervention description: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks; Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: PD

Summary:

      This study is being conducted this study to determine whether injections of Xeomin®, a type
      of botulinum toxin into the glands that produce saliva (one pair just below and in front of
      the ear and the other just under the jaw line) are safe and effective to treat excessive
      saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For PD/ Parkinsonism: 1. PD, Multiple Systems Atrophy (MSA), or Progressive
             Supranuclear Palsy (PSP) diagnosed by clinical criteria, ages 20-80 with troublesome
             sialorrhea as defined below**.

               -  Sialorrhea that patients or their families or treating physicians think is
                  troublesome

                    1. Swallowing function: Functional Oral Intake Scale (FOIS)* of 5 or greater

                    2. If patients have been treated with other medications for sialorrhea earlier,
                       they should be off the medications at least 4 weeks prior to the baseline
                       evaluation.

                    3. If they are on other medications for sialorrhea at the time of the baseline
                       evaluation, the doses will be held stable throughout the period of the
                       study.

                    4. Women of child bearing age will need to be on a reliable method of birth
                       control for the duration of the study.

        Exclusion Criteria:

          -  For PD:

               1. Current use of Coumadin

               2. Concurrent significant medical illness

               3. History of myasthenia gravis or Lambert-Eaton Syndrome

               4. Ongoing substance abuse

               5. History of unreliable follow-up

               6. Past use of Xeomin® or other botulinum toxin preparations

               7. Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712; Placebo; Aripiprazole
Intervention description: oral, once daily; Placebo; oral, once daily
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Relapsed

Summary:

      This will be a multicenter, randomized, double-blind, placebo-controlled study designed to
      assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment
      of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20
      mg) is included as a positive control to confirm the assay sensitivity of the study. A total
      of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to
      obtain approximately 450 randomized subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 65 years of age, with a diagnosis of
             schizophrenia, as defined by DSM-IV-TR criteria

          2. Subjects who have been recently hospitalized or who would benefit from hospitalization
             for an acute relapse of schizophrenia

          3. Subjects experiencing an acute exacerbation of psychotic symptoms

        Exclusion Criteria:

          1. Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug

          2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

               -  Schizoaffective disorder

               -  MDD

               -  Bipolar disorder

               -  Delirium, dementia, amnestic or other cognitive disorder

               -  Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality
                  disorder

          3. Subjects presenting with a first episode of schizophrenia

          4. Other protocol specific inclusion/exclusion criteria may apply
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Condition: Preterm Birth
MeSH terms: Premature Birth
Intervention: Progesterone Cervical Pessary 6.3 g; Progesterone 200 mg vaginal capsules; Progesterone Cervical Pessary 7.7 g
Intervention description: Progesterone Cervical Pessary low dose; Progesterone 200 mg vaginal capsules daily; Progesterone Cervical Pessary high dose
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preterm birth; Short cervix; Cervical Pessaries; Progesterone

Summary:

      Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized
      progesterone for the prevention of preterm delivery, established through spontaneous birth
      before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the
      pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant
      women at high risk of premature birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24
             weeks of gestation, without any previous factors.

          -  Women with a single pregnancy with 10 mm or more cervical length between 16 and 24
             weeks of gestation, and pre-existing risk factors risk factors for preterm birth:

          -  Previous preterm birth before week 35.

          -  Previous rupture of membranes before week 35

        Exclusion Criteria:

          -  Pregnancies with:

               -  Major fetal abnormalities, such as lethal malformations or malformations
                  requiring pre- or post-natal surgery; and fetal death before inclusion into the
                  study.

               -  History of rupture of membranes or prophylactic cerclage before study entry.

          -  Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion
             secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).

          -  Unconscious, severely ill or mentally disabled patients, or under 16 years of age.

          -  Patients for whom use of progesterone is contraindicated.

          -  Patients with history of thrombosis.
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Second line chemotherapy; trastuzumab [Herceptin]
Intervention description: As prescribed; 6mg/kg iv every 3 weeks
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of continuation or discontinuation of
      Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive
      metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus
      Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment
      (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the
      investigator's choice. The anticipated time on study treatment is until disease progression,
      and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >= 18 years of age;

          -  metastatic breast cancer;

          -  HER2 overexpression (IHC 3+ and/or FISH positive);

          -  disease progression during or after previous 1st line chemotherapy + Herceptin;

          -  scheduled to receive 2nd line chemotherapy.

        Exclusion Criteria:

          -  concurrent immunotherapy or hormonal therapy;

          -  anthracyclines as part of previous 1st line chemotherapy or planned 2nd line
             chemotherapy;

          -  cardiac toxicity during previous 1st line chemotherapy + Herceptin;

          -  history of other malignancy within last 5 years.
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Pembrolizumab; Surgery; Radiation Therapy; Cisplatin
Intervention description: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.; gross total surgical resection; 60-66 Gy over 6 weeks; Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and the benefit of adding
      pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of
      care treatment for head and neck cancer. The standard of care treatment will include surgery
      followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of
      care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes
      cancer that was not completely removed (positive margins) or cancer that has invaded through
      the outer lining of your lymph nodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients eligible for resection with one or more of the following

               1. Any T stage with ≥ N2 disease;

               2. T4 disease, any N stage;

               3. T3 Oral Cavity, any N stage; or

               4. Clinical evidence of extra-capsular extension on scans.

          -  Must be willing to undergo definitive resection with neck dissection.

          -  Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.

          -  Adequate labs

          -  Appropriate staging imaging.

        Exclusion Criteria:

          -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or
             immunosuppressive therapy within 7 days prior to planned first dose of trial
             treatment.

          -  Nasopharyngeal or sinonasal carcinoma

          -  Confirmed metastatic disease

          -  Human Papillomavirus (HPV)+ disease of the oropharynx

          -  Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection,
             HIV, Hepatitis B, or Hepatitis C
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: VX-814; Placebo
Intervention description: Tablet for oral administration.; Placebo matched to VX-814 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ
      subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects must have a PiZZ genotype confirmed at screening

          -  Plasma AAT levels indicating severe deficiency at screening

        Key Exclusion Criteria:

          -  History of a medical condition that could negatively impact the ability to complete
             the study

          -  Solid organ, or hematological transplantation or is currently on a transplant list

          -  History of use of gene therapy or RNAi therapy at any time previously

        Other protocol defined Inclusion/Exclusion criteria may apply
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Condition: Paranasal Sinus Disease
MeSH terms: Paranasal Sinus Diseases
Intervention: Bacitracin
Intervention description: Bacitracin soaked nasopore sponge
Intervention MeSH terms: Bacitracin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a
      sponge soaked in Saline / and the administration of oral antibiotics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must
             have middle meatus easily identified. The type of surgery will not be influenced by
             the participation in this study.

        Exclusion Criteria:

          -  Age less then 18

          -  Known sensitivity to Bacitracin

          -  Pregnancy
Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Intervention: Capecitabine; Oxaliplatin
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capecitabine; oxaliplatin

Summary:

      There are limited treatment options available for patients with advanced pancreatic ductal
      adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety
      of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced
      and metastatic PDAC treated in the first and second lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  At most one prior chemotherapy regimen for unresectable or metastatic disease. Any
             adjuvant chemotherapy must have been completed more than 12 months prior to beginning
             protocol therapy

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  At least one measurable lesion according to RECIST criteria that has not been
             irradiated

          -  Adequate laboratory parameters as outlined in protocol

          -  Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely,
             given the drug-drug interaction between coumadin and capecitabine

          -  Negative serum pregnancy test within 14 days prior to registration

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Life expectancy < 3 months

          -  Serious, uncontrolled, concurrent infection(s)

          -  Any prior oxaliplatin or fluoropyrimidine therapy

          -  More than one prior chemotherapy regimen for unresectable or metastatic disease

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
             to 5-fluorouracil or platinum compounds

          -  Any active second malignancy

          -  Clinically significant cardiac disease or myocardial infarction within the last 12
             months

          -  Evidence of CNS metastases or history of uncontrolled seizures, central nervous system
             disorders or psychiatric disability

          -  Other serious uncontrolled medical conditions

          -  Major surgery within 4 weeks of the start of study treatment, without complete
             recovery

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  Known, existing uncontrolled coagulopathy
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3502970; Dulaglutide; Placebo; Placebo
Intervention description: Administered orally; Administered subcutaneously; Administered orally; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 30
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of
             metformin

          -  Have a stable body weight for the 3 months prior to randomization

          -  Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)

          -  Males must agree to use highly effective methods of contraception

          -  Women not of childbearing potential (WNOCBP) may participate in this trial

          -  Note: Hormone replacement therapy in post-menopausal women is allowed but women must
             be on stable therapy for 3 months prior to day 1.

        Exclusion Criteria:

          -  Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma

          -  Have a history of diabetic retinopathy, diabetic maculopathy, or severe
             non-proliferative diabetic retinopathy that requires immediate treatment intervention

          -  Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms

          -  Have acute or chronic pancreatitis

          -  Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi
             syndrome)

          -  Have gastric emptying abnormality or chronically take medications impacting GI
             motility

          -  Have poorly controlled hypertension

          -  Have the following heart conditions within the last 6 months: myocardial infarction
             (MI), unstable angina, coronary artery bypass graft, percutaneous coronary
             intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA),
             cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV
             heart failure

          -  Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease
             (NAFLD)

          -  Have HIV, or Hepatitis B or Hepatitis C
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001 3 μg/ QS-21 50 μg; ACC-001 10 μg/ QS-21 50 μg; Placebo- Phosphate buffered saline (PBS)
Intervention description: ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Early Alzheimer's disease; active immunization; amyloid imaging

Summary:

      This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and
      tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as
      measured by positron emission tomography (PET) scans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Concern about a change in cognition expressed by the subject or by an informant that
             knows the subject well

          -  Mini-Mental State Examination (MMSE) score ≥ 25

          -  Global Clinical Dementia Rating = 0.5.

          -  General cognition and functional performance sufficiently preserved such that a
             diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time
             of screening.

          -  Amyloid burden detected on screening brain PET scan.

          -  Other inclusion criteria apply.

        Exclusion Criteria:

          -  Significant neurological disease other than early Alzheimer's disease

          -  Major psychiatric disorder or symptom

          -  Contraindication to undergo brain MRI

          -  Unstable medical conditions

          -  Other exclusion criteria apply