bioihbjkbjnl/mcl2 huggingface dataset:
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: IPN60090; pembrolizumab; paclitaxel; IPN60090 single administration
Intervention description: Oral capsules given daily; An intravenous solution in single-use vial to be diluted for infusion.; An intravenous solution in single-use vial to be diluted for infusion.; Oral capsules given once
Intervention MeSH terms: Paclitaxel; Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to determine safety, tolerability, recommended dose (RD),
      pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090
      as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part
      C) in patients with advanced solid tumours and to evaluate food effect (Part D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥18 years of age

          -  Patients with solid tumours who have received at least one line of therapy for
             advanced disease

          -  Measurable or non-measurable evaluable disease per RECIST 1.1

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1

          -  Standard of care and/or any investigational therapies must have been completed at
             least 3 weeks prior to treatment

        Exclusion Criteria:

          -  Prior malignancy within the previous 2 years except for locally curable cancers that
             have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of
             the cervix, breast or bladder

          -  Known primary central malignancy or symptomatic central nervous system metastasis

          -  Major surgical intervention within 28 days before study drug administration

          -  Significant acute or chronic infections
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Moxifloxacin; Placebo
Intervention MeSH terms: Moxifloxacin; Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period
      crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization
      in healthy adult men and women
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a healthy male or female 18 to 45 years of age. Women were required to be
             postmenopausal (more than 12 months since last period); surgically sterile
             (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an
             intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom)
             non-hormonal contraceptive therapy for the duration of the trial and were required to
             have a negative pregnancy test at screening and upon each check-in to the study
             facility.

          -  Have a BMI within the range of 18-30 kg/m2.

          -  Be able to communicate effectively with the study personnel.

          -  Have no significant disease or abnormal laboratory values as determined by medical
             history, physical examination or laboratory evaluations, conducted at the screening
             visit and on each admission to the clinic.

          -  Have a normal 12-lead electrocardiogram, without any clinically significant
             abnormalities of rate, rhythm or conduction.

          -  Be nonsmokers defined as not having smoked in the past 6 months.

          -  Be adequately informed of the nature and risks of the study and give written informed
             consent prior to study entry.

        Exclusion Criteria:

          -  Known hypersensitivity or allergy to moxifloxacin, eslicarbazepine acetate or related
             compounds such as carbamazepine, oxcarbazepine, or licarbazepine.

          -  Women who were pregnant or breast feeding.

          -  Any disease or condition (medical or surgical) which, in the opinion of the
             investigator, might compromise the hematologic, cardiovascular, pulmonary, renal,
             gastrointestinal, hepatic, or central nervous system; or other conditions that may
             interfere with the absorption, distribution, metabolism or excretion of study drug, or
             placed the subject at increased risk.

          -  A sustained supine systolic blood pressure > 140 mmHg or <100mm Hg or a diastolic
             blood pressure > 95 mmHg at screening or baseline.

          -  A resting ECG heart rate of <50 bpm or >100 bpm.
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Condition: Carcinoma
Intervention: Sorafenib 100 mg (50-mg tablet); Sorafenib 200 mg (50-mg tablet); Sorafenib 400 mg (50-mg tablet); Sorafenib 400 mg (200-mg tablet); Sorafenib 400 mg (Expansion)
Intervention description: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet); Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet); Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet); Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet); Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
Intervention MeSH terms: Sorafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sorafenib; Advanced Solid Tumors; Maximum tolerated dose; Carboplatin and paclitaxel chemotherapy combination

Summary:

      The primary objective of the study was to define the safety profile and maximum tolerated
      dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy
      in patients with advanced, refractory solid tumors.

      The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these
      patients being treated with sorafenib in combination with paclitaxel and carboplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed solid tumors

          -  Evaluable disease

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

          -  Life expectancy minimum 12 weeks

        Exclusion Criteria:

          -  Congestive heart failure

          -  Serious arrhythmias

          -  Coronary artery disease (CAD) or ischemia

          -  HIV (human immunodeficiency virus)

          -  Hepatitis B or C

          -  Serious active infection

          -  Metastatic brain or meningeal tumors
Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
Condition: Vaccine
Intervention: CoVaccine HT
Intervention description: intramuscular injection, dose escalation
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine, hypertension

Summary:

      The study is being conducted to explore the safety and tolerability of CoVaccine HT in
      healthy male and female volunteers. In this study volunteers will receive intramuscular
      injections of CoVaccine HT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males or females of non child-bearing potential aged 25 to 65 years inclusive
             and between 19 and 35 kg/m2 body mass index (BMI)

          -  Generally healthy as determined by pre study medical history, physical examination, 12
             lead ECG.

          -  Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human
             immunodeficiency virus (HIV) I and II tests at screening and rapid influenza
             diagnostic test at admission.

        Exclusion Criteria:

          -  History of alcohol abuse in the last 5 years or drug abuse at any time, current
             significant alcohol consumption.

          -  Fever, active infections (such as influenza) and acute gastrointestinal symptoms
             following prior to first dosing

          -  Subjects with a previous serious reaction to a vaccine, such as angioedema or
             anaphylaxis
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: BI 655075; BI 655075; Placebo; BI 655075; Placebo; Placebo; Placebo; BI 655075
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 46.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075
      dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and
             =29.9 kg/m2

          -  Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5
             and = 32 kg/m2

          -  Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in
             relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate
             renal impaired (CLcrd =30 to <60 mL/min according Cockcroft&Gault formula in
             relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2

        Exclusion criteria:

          -  Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance

          -  Any evidence of a clinically relevant concomitant disease (other than mild renal
             impairment in the respective group) A significant disease is defined as a disease
             which in the opinion of the investigator

          -  put the volunteer at risk because of participation in the study

          -  may influence the results of the study

          -  may influence the volunteer¿s ability to participate in the study

          -  is not in a stable condition Diabetic, hypercholesterolemia or hypertensive subjects
             can be entered in this trial if the disease is not significant according to these
             criteria

          -  Surgery of the gastrointestinal tract (except appendectomy)

          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          -  History of relevant orthostatic hypotension, fainting spells or blackouts.

          -  Chronic or relevant acute infections

          -  History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)
Home Safety Clinical Trial for Alzheimer's Disease
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Intervention: Home Safety Toolkit
Intervention description: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; Dementia; Safety; Home Care Services

Summary:

      The purpose of this study was to test the effectiveness of a new multimodal educational
      intervention to improve home safety for persons with dementia of the Alzheimer's type and
      their home caregivers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are dyads of primary caregivers and persons with a progressive DAT who live
             in the community, are willing to have home visits for home safety education, and who
             read and speak English.

          -  Inclusion criteria for care recipients are: diagnosis of DAT, score of 24 or less on
             the Mini-Mental State Exam (MMSE), is expected to continue living in the community for
             the next 6 months, and has the ability to ambulate without help from the caregiver.

          -  Inclusion criteria for the primary informal caregiver are: lives in the home with the
             care-recipient, provides a minimum of 4 hours of care-giving or supervision per day,
             and has no known cognitive impairment as judged by the primary care provider who
             refers the subject dyad for study recruitment.

        Exclusion Criteria:

          -  Care-recipient MMSE score of 25 or greater.

          -  A previous home safety visit.

          -  Admission to a long-term care facility. - Persons with DAT who are living alone will
             be excluded because their safety issues are more complex and there is no primary
             informal caregiver who can make consistent observations about risky behaviors and
             accidents.
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Comparator: amlodipine besylate; Comparator: Placebo
Intervention description: Two 5 mg tablets amlodipine daily for 6 weeks.; Two 5 mg tablets placebo to amlodipine daily for 6 weeks
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate methodologies for measuring pedal edema associated with calcium
      channel blockers in middle-aged and elderly subjects and patients with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient does not have hypertension or has Stage I or II hypertension and is taking < 3
             anti-hypertension medications

          -  Patient is willing to discontinue all anti-hypertensive medications during study

          -  Patient is willing to refrain from drinking alcohol for 24 hours prior to each study
             visit and is willing to limit intake at other times during the study to 2 drinks per
             day

          -  Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other
             times during study, daily caffeine intake should not exceed 4 cups of coffee (or
             equivalent)

          -  Patient will avoid strenuous physical activity during study

          -  Patient is a nonsmoker or has not smoked for the last 3 months

        Exclusion Criteria:

          -  Patient has metal implants in the leg or artificial limbs

          -  Patient has had a lower limb amputation, malformation, alterations in leg muscles, or
             a history of musculoskeletal disease

          -  Patient has used oral contraceptive pills or hormone replacement therapy within 3
             months of screening

          -  Patient has a history of stroke or seizures

          -  Patient has a history of cancer, except that which was treated at least 10 years prior
             to screening and shows no evidence of recurrence
Rehabilitation of Patients After THR - Based on Patients´Selfrated Health
Condition: Total Hip Replacement
Intervention: counselling and support after discharge from hospital
Intervention description: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 65 Years
Maximum age: 97 Years
Healthy volunteers: No
Keywords: Rehabilitation; RCT; User Involvement; Self-Rated Health

Summary:

      Objective: The investigators hypothesized that all areas of health status after total hip
      replacement could be improved in patients aged over 65 years and over by using telephone
      support and counselling 2 and 10 weeks after surgery compared with a control group receiving
      conventional care and treatment.

      Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4
      weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65
      and over were randomised 4 weeks preoperatively to either control or intervention groups.
      Measurements: Both groups received conventional surgical treatment, but the intervention
      group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given
      counselling within eight main dimensions with reference to their postoperative situation.

      Key-words: THR - elderly patients - health status - postoperative support - counselling
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients enrolled to THR

          -  Being able to read and understand Danish

        Exclusion Criteria:

          -  Patients not being able to participate or refused

          -  Any condition that makes the subject unable to participate in the opinion of the
             investigator.
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Condition: Diabetes Type 2; Dementia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Estradiol patch
Intervention description: transdermal 17β-estradiol patch
Intervention MeSH terms: Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Primary Objective: The primary objective is to determine whether the effects of glucose and ketone body uptake to the brain in response to 8-week administration of transdermal 17β-estradiol differ in postmenopausal women with and without type 2 diabetes.
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: women's health; estradiol; postmenopausal

Summary:

      The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on
      brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism
      using positron emission tomography before and after short-term administration of transdermal
      17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to provide written informed consent

          2. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          3. Female, postmenopausal, aged 60-80

          4. Normal results on recommended healthcare screenings (e.g., mammogram, pap smear,
             colonoscopy)

          5. BMI 20-35 kg/m2

          6. No evidence of dementia or mild cognitive impairment (MoCA score >25)

          7. Able to access reliable transportation to study and intervention visits

        Exclusion Criteria:

          1. Use of hormone replacement therapy within the past 3 months

          2. History of renal, heart, liver, or neurological disease; head injury with loss of
             consciousness in the past 5 years; chronic pain, anxiety or depression

          3. Presence of medical conditions that might contraindicate estrogen use (e.g.,
             unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)

          4. Currently taking insulin, metformin, or any other drug or medication judged by the
             study physician to affect safety or research outcomes of interest

          5. Involved in another research study

          6. Contraindications for MRI or PET scanning

          7. Current smoker
A Study of LY3323795 in Healthy Participants
Condition: Healthy
Intervention: LY3323795; Itraconazole; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to investigate the safety of LY3323795 and the effects it
      has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy
      participants. The study has three parts. Each participant may only enroll in one part. The
      study will last 14 to 43 days, depending on the part. Screening must be completed prior to
      study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of non-childbearing potential at time of screening

          -  Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0
             kg/m², inclusive

        Exclusion Criteria:

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product.

          -  Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of
             greater than 450 millisecond (msec) (males) or greater than 470 msec (females)