bioihbjkbjnl/mcl2 huggingface dataset:
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
Condition: Leukemia; Neoplasms
MeSH terms: Leukemia
Intervention: volasertib
Intervention description: intravenous administration on day 1of a treatment course
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The present trial will be performed according to an open design to determine the maximum
      tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in
      paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than
      18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy
      (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric
      cancer patients
    

Eligibility criteria:

        Inclusion criteria:

          -  paediatric patients with leukaemia or advanced solid tumours including lymphomas (age
             2 - less than 18 years) for whom no further treatment is known

          -  Lansky score > 60 for children 2 to less than 12 years

          -  Karnofsky score > 60 for children aged 12 or older

          -  life expectancy of at least 6 weeks as judged by the investigator

          -  parents or legal guardians have given written informed consent and informed assent
             suitable for the respective age group obtained

        Exclusion criteria:

          -  patient eligible for other anti-leukaemic therapy with curative intent or effective
             therapy known for solid tumour therapy

          -  presence of cardiac disease (LVEF by echocardiography less than 25 %)

          -  symptomatic Central Nervous System involvement of the malignant disease

          -  primary CNS tumour

          -  inadequate lab parameters

          -  inadequate venous access

          -  QTc prolongation

          -  pregnancy, breastfeeding

          -  other diseases or CTs that might interfere with evaluation of safety
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
Condition: Carcinoma
MeSH terms: Carcinoma
Intervention: neck dissection of at least the ipsilateral sub-level 1B
Intervention description: neck dissection of at least the ipsilateral sub-level 1B
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carcinoma; upper; aerodigestive; tract; submandibular; gland

Summary:

      Hypothesis

        1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with
           head and neck cancer despite the presence of metastatic disease in the lymph nodes that
           surround it.

        2. All the lymph nodes in the submandibular triangle can be removed without resection of
           the submandibular gland.

      Study Design

      A better understanding of the frequency of submandibular gland involvement may lead to
      refined treatment strategies for head and neck cancer, which can possibly spare removal of
      the submandibular gland and potentially improve the long term side effects from therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed carcinoma of the oral
             cavity, oropharynx, larynx or hypopharynx

          -  Treatment of the regional lymph nodes to include neck dissection performed as the
             primary modality

          -  No previous treatment to the neck

          -  No previous treatment for the index cancer (surgery, chemotherapy, radiation or
             biological therapy)

          -  No known distant metastatic disease

          -  Age >/= 18

          -  The ability to understand and willingness to sign a study-specific written informed
             consent form

          -  Protocol treatment must begin </= 8 weeks of diagnostic biopsy

        Exclusion Criteria:

          -  Previous or concurrent head and neck primaries

          -  Prior surgery to study site other than biopsy

          -  Patients receiving any other treatment for cancer within 30 days previously

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Known allergy to Lymphazurin®

          -  Pregnant or breast feeding females
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
Condition: Advanced Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: AZD2014; Fulvestrant
Intervention description: Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week; IM monthly after loading dose
Intervention MeSH terms: Fulvestrant
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Estrogen receptor positive; Advanced metastatic breast cancer; Estrogen receptor positive advanced metastatic breast cancer

Summary:

      The purpose of this study is to assess safety and tolerability of AZD2014 when given in
      combination with Fulvestrant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated written informed consent prior to any study specific
             procedures, sampling analysis

          -  Aged at least 18

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain
             X-ray and is suitable for repeated assessment

          -  Histological or cytological confirmation of an ER+ advanced metastatic breast cancer
             tumour that is eligible for treatment with fulvestrant

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Patients must have evidence of non-child-bearing potential.

        Exclusion Criteria:

          -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide,
             immunotherapy, other anticancer agents, and any investigational agents within 14 days
             of starting study treatment (not including palliative radiotherapy at focal sites)

          -  Major surgery within 4 weeks prior to entry to the study (excluding placement of
             vascular access), or minor surgery within 2 weeks of entry into the study.

          -  Patients with severe cardiac condition of ischemia, impaired ventricular function and
             arrhythmias, evidence of severe or uncontrolled systemic or current unstable or
             uncompensated respiratory or cardiac conditions.

          -  Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)
A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
Condition: Health Volunteers, Huntington Disease
MeSH terms: Huntington Disease
Intervention: pridopidine (90 mg)
Intervention description: single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R
      (optional) in the living human brain. No formal statistical analysis will be conducted
    

Eligibility criteria:

        Inclusion Criteria:

          -  In general, good physical health as determined by medical history and psychiatric
             history, suicidality assessment & physical examination

          -  Men who are potentially fertile (not surgically [eg, vasectomy] or congenitally
             sterile

          -  Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after
             18 years of age

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The subject has been previously exposed to ionizing radiation or radioactive
             substances as a result of clinical research or medical treatment in the past 10 years.

          -  The subject has a counterindication to having an MRI

          -  History of alcohol, narcotic, or any other substance dependence in the past 2 years

          -  Additional Exclusion criteria to patients with Huntington's disease:

          -  The patient has a severe motor impairment that might cause artifacts.

          -  Patients with a known history of Long QT Syndrome or a first degree relative with this
             condition.

          -  Treatment with any investigational product within 6 weeks of screening or patients
             planning to participate in another clinical study assessing any investigational
             product during the study.

               -  Additional criteria apply, please contact the investigator for more information
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: CVX-096
Intervention description: Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 1 Type 2 diabetes CVX-096 diabetes mellitus; adult-onset diabetes mellitus; non-insulin dependent

Summary:

      The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2
      diabetic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female patients (females will be women of non-childbearing potential) with
             an historical diagnosis of type 2 diabetes mellitus, who are currently being treated
             with metformin at a dose at or near maximum.

          -  Hb A1c between 7-10%.

          -  Fasting C-peptide >0.4 nmol/L.

        Exclusion Criteria:

          -  History of clinically significant chronic conditions other than T2DM not well
             controlled by either diet or medications.

          -  Patients with pancreatitis or considered a high risk for pancreatitis.

          -  History of contraindications to metformin therapy.

          -  Previous treatment with an approved or investigational GLP 1 mimetic.
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: metformin (Diabex); metformin (Glucophage™); metformin (Glucophage™); metformin (Diabex)
Intervention description: Tablets, Oral, 500 mg, Once daily, single dose; Tablets, Oral, 500 mg, Once Daily, single dose; Tablets, Oral, 1000 mg, Once daily, single dose; Tablets, Oral, 1000 mg, Once daily, single dose
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by
      BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in
      Australia by Alphapharm in the fed state
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 18 to 55 inclusive

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, electrocardiograms (ECGs), and clinical
             laboratory determinations

          -  Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  History of allergy or intolerance to metformin or other similar acting agents

          -  Prior exposure to metformin within 3 months of study drug administration

          -  Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
Condition: Healthy
Intervention: Metformin; Linagliptin; Metformin; Linagliptin
Intervention description: Free combination; Fixed dose combination; Combination; Free combination
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to demonstrate bioequivalence of two 2.5 mg
      linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination
      of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice and the local legislation

          -  Healthy males and females according to the following criteria:

        Based upon a complete medical history, including physical examination, vital signs (BP,
        PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and
        urinalysis).

          -  Age 18 to 45 years (incl.)

          -  Body mass index by Quetelet between 18.50 to 24.99 kg/m2 (incl.)

          -  Female subjects of childbearing potential who agree on using double-barrier
             contraception during the study. If a female is postmenopausal (no menses for at least
             2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
             hysterectomy) she will be exempt from the requirement. In case of using oral
             contraceptives, these should be withdrawn at least 2 months before the first drug
             dosing.

          -  Male subjects who agree on using effective contraception during the study (barrier
             contraceptive methods)

        Exclusion criteria:

          -  Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance

          -  Any laboratory value outside the reference range that is of clinical relevance

          -  Any evidence of a clinically relevant concomitant disease

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C)

          -  A positive urine drug screening test at screening and on admission to the trial site
             in each treatment period.

          -  A positive alcohol breath test at screening and on admission to the trial site in each
             treatment period.

          -  Surgery of the gastrointestinal tract (except appendectomy)
Effects of RLIC on Motor Learning in Middle-aged and Older Adults
Condition: Adults; Older Adults
Intervention: RLIC; Sham conditioning; Balance training
Intervention description: See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.; See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.; All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded, randomized, controlled trial
Masking: Single (Participant)
Masking description: Participants are masked to their group assignment.
Enrollment: 82.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: remote ischemic conditioning, motor learning

Summary:

      The purpose of this research is to determine if the beneficial effects of remote limb
      ischemic conditioning on learning seen in young adults are found in middle-aged and older
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 40-80 years old

          2. Had sufficient cognitive skills to provide informed consent and actively participate.

        Exclusion Criteria (determined by self-report):

          1. History of a neurological condition, balance impairment, or vestibular disorder.

          2. History of attentional disorders (ADD/ADHD) that could affect learning.

          3. History of sleep apnea which could confound the effects of RLIC.

          4. Presence of lower extremity condition, injury, or surgery that would compromise
             performance on the balance task.

          5. Learning disability, sensory, or communication problem that would prevent completion
             of the study.

          6. History of epilepsy, peripheral vascular disease, or blood diathesis which could
             contraindicate RLIC.

          7. Current intensive weight lifting or interval training exercise which could confound
             the effects of RLIC.

          8. Current substance abuse or dependence.
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
Condition: Multiple Myeloma (MM)
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: acalabrutinib
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bruton tyrosine kinase inhibitor; Btk; Multiple Myeloma; MM; ACP-196; acalabrutinib; Calquence

Summary:

      To characterize the safety profile of acalabrutinib with and without dexamethasone in
      subjects with relapsed or refractory Multiple Myeloma (MM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior
             therapy for MM, and is progressing at the time of study entry.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

          -  Agreement to use contraception during the study and for 30 days after the last dose of
             study drugs if sexually active and able to bear or beget children.

        Exclusion Criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function,
             gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory
             bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant