bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
Condition: Vasomotor Symptoms (VMS)
Intervention: MT-8554
Intervention description: MT-8554 Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, long term extension study of MT-8554 in postmenopausal women experiencing
      moderate to severe vasomotor symptoms who completed Study MT-8554-A01
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent to participate in this study.

          -  Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

        Exclusion Criteria:

          -  Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: 25 mg Omecamtiv Mecarbil; Placebo; 37.5 mg Omecamtiv Mecarbil; 50 mg Omecamtiv Mecarbil
Intervention description: oral tablet; oral tablet; oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Heart Failure

Summary:

      -  To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart
           failure (HF) with reduced ejection fraction

        -  To evaluate the safety and tolerability of oral omecamtiv mecarbil
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female ≥ 20 years and ≤ 85 years of age

          -  History of chronic stable heart failure (HF) with reduced ejection fraction, defined
             as requiring treatment for HF for a minimum of 4 weeks prior to screening

          -  Treated for HF with optimal pharmacological therapy

          -  Left ventricular ejection fraction ≤ 40% at screening

        Exclusion Criteria:

          -  Severe uncorrected valvular heart disease

          -  Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive
             pericarditis, or clinically significant congenital heart disease

          -  Acute myocardial infarction, unstable angina, or persistent angina at rest within 30
             days prior to randomization

          -  Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or
             heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

          -  Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase
             (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.
Treating Anorectal Dysfunction in MS
Condition: Constipation; Fecal Incontinence; Multiple Sclerosis
MeSH terms: Fecal Incontinence; Multiple Sclerosis; Sclerosis; Constipation
Intervention: Bisacodyl; Placebo
Intervention description: Rectal suppository; Rectal suppository
Intervention MeSH terms: Bisacodyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10
      mg rectal suppository every other day improves bowel-related symptoms in patients with
      multiple sclerosis. Patients will be randomized to receive either a placebo suppository or
      bisacodyl suppository dosed every other day for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale
             [MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score
             [EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of
             MS disease modifying therapy, or comorbid medical condition AND who also have
             anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.

        Exclusion Criteria:

          -  MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or
             equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal
             anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric
             infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative
             proctitis, ulcerative colitis) will also be excluded.
Psychological Influences on Postoperative Recovery
Condition: Care, Postoperative; Pain, Postoperative; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Tonsillectomy; Adenoidectomy
MeSH terms: Pain, Postoperative
Intervention: Preoperative Preparation Program (Child Life Specialist); Midazolam; Parental Presence during Induction of Anesthesia; PPIA preparation program PLUS Midazolam premedication
Intervention description: This group will receive the standard preoperative visit to the hospital with Child Life intervention; 0.5 mg/kg oral midazolam; One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.; Subjects in this group will receive both interventions 2 and 3.
Intervention MeSH terms: Midazolam
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The primary hypothesis tested in this project is that the preoperative behavioral stress
      response predicts postoperative behavioral and clinical recovery of children undergoing
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient tonsillectomy or tonsils/adenoids

          -  ASA I, II

        Exclusion Criteria:

          -  Developmental delay

          -  ASA III-IV

          -  Psychotropic medication

          -  Meds which interfere with metabolism of midazolam

          -  36 weeks gestation
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Hyperphagia
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Intervention: Intranasal Oxytocin (IN-OXT); Matched Placebo
Intervention description: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).; Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Prader-Willi Syndrome (PWS); Hyperphagia

Summary:

      The investigators propose a randomized double-blind 8 week treatment trial of intranasal
      oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess
      IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3)
      Salivary OXT levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female child outpatients aged 5 to 18 years

          2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history

          3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks
             prior to the study start, and for the duration of the study.

          4. Have a physical exam and laboratory results that are within the norms for PWS

          5. Have a parent/caregiver/guardian that is able to consent for their participation and
             complete assessments regarding the child's development and behavior improvement
             throughout the study.

        Exclusion Criteria:

          1. Exposure to any investigational agent in the 30 days prior to randomization

          2. Prior chronic treatment with oxytocin.

          3. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis,
             schizophrenia, PTSD or major depressive disorder. These patients will be excluded due
             to potential confounding results.

          4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating
             women.

          5. A medical condition that might interfere with the conduct of the study, confound
             interpretation of study results or endanger their own well-being.

          6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the
             course of the study.

          7. Females using an estrogen-based contraceptive. As an alternative to an estrogen based
             contraceptive, subjects will be counseled to use progesterone-based contraceptives;
             cervical caps; cervical sponges; or spermicidal foam in combination with a condom.
             Subjects will need to use a double barrier method to be in the study.
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: PF-00489791; Placebo
Intervention description: Tablet, 20 mg once daily for 12 weeks; Tablet, placebo once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic nephropathy; chronic kidney disease; PF-00489791; phosphodiesterase; PDE5

Summary:

      PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791
      will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,
      improving renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects greater than or equal to 18 years. Female subjects must be of
             non-child bearing potential.

          -  Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on
             an eGFR of 25-59 mL/min/1.73m2.

          -  Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to
             300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

        Exclusion Criteria:

          -  Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

          -  Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.

          -  Subjects on combination ACE inhibitor/ARB therapy.
Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
Condition: Severe Thalassemia
MeSH terms: Thalassemia
Intervention: Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
Intervention description: Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion
Intervention MeSH terms: Fludarabine; Melphalan; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Thalassemia; Alemtuzumab; Hematopoietic cell transplant; non-myeloablative

Summary:

      This study is being done to determine if blood cell transplants, with either bone marrow or
      cord blood from unrelated donors, are effective in children with severe thalassemia and if
      this treatment approach has acceptable risks and side effects.

      This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,
      Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.
      The primary hypothesis is that this regimen will promote stable engraftment of unrelated
      donor hematopoietic cells, support normal erythropoiesis, and result in an event free
      survival of > 75% of children with thalassemia major.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1-16.00 years old

          -  Have transfusion dependent thalassemia major

          -  Shall not have an HLA-matched family donor

          -  Must have a suitably matched unrelated marrow donor or UCB product

          -  Lansky score >/= 70

          -  Adequate pulmonary, renal, liver, and other organ function as defined in protocol

          -  Negative pregnancy test

          -  Adequate total nucleated cell or CD34+ dose of product as defined in protocol

          -  Iron chelation must be discontinued >/= 48 hours prior to conditioning regimen

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  HIV positive

          -  Prior allogeneic marrow or stem cell transplantation
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: CoQ10
Intervention description: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10
      in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants will be positive for the CAGn expansion in the Huntingtin gene (>36
             repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence
             level (Question 17 of the UHDRS)

          -  Participants will have received genetic testing prior to enrollment through a standard
             pre-manifest testing protocol.

          -  18 years of age or older.

          -  Concomitant medications are permitted with the exception of CoQ10, creatine > 5g/day
             and warfarin.

        Exclusion Criteria:

          -  History of intolerability to CoQ10.

          -  CoQ10 use within 60 days prior to randomization.

          -  Unstable medical or psychiatric illness;

          -  Substance abuse within one year of the baseline visit.

          -  Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing
             age.

          -  Subjects with known allergy to FD&C #6 yellow food coloring.
Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: emixustat hydrochloride; Placebo
Intervention description: Tablet for oral administration; Placebo tablets for oral administration contain only inactive ingredients
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor
      biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to provide written informed consent

          -  Documented diagnosis of type 1 or type 2 diabetes mellitus

          -  Meets specific ocular criteria for the study eye including but not limited to, the
             presence of PDR with or without diabetic macular edema in study eye for which
             treatment can be deferred for at least 4 weeks after Day 1 visit

          -  Media clarity, pupillary dilation, and subject cooperation sufficient to obtain
             adequate assessments

        Exclusion Criteria:

          -  Any condition that would preclude participation in the study (e.g., unstable medical
             status including blood pressure, cardiovascular disease or glycemic control)

          -  History of myocardial infarction or other acute cardiac event

          -  History of chronic renal failure requiring dialysis or kidney transplant

          -  Prior participation in any clinical study of emixustat

          -  Treatment with any investigational study drug within 30 days of screening

          -  Known allergy to fluorescein sodium for injection in angiography

          -  Treatment with specific prohibited medications or therapy beginning 4 weeks prior to
             screening and throughout the duration of the study

          -  History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to
             randomization

          -  Pre-specified laboratory abnormalities at screening

          -  Specific ocular characteristics in the study eye

          -  Male subjects who are not surgically sterile and are not willing to practice a
             medically accepted method of birth control with their female partner of childbearing
             potential from screening through 30 days following completion of the study

          -  Female subjects of childbearing potential who are not willing to practice a medically
             accepted method of birth control with their non-surgically sterile male sexual partner
             from screening through 30 days following completion of the study

          -  Female subjects who are pregnant or lactating
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
Condition: Glaucoma Open-angle
MeSH terms: Glaucoma, Open-Angle
Intervention: Travoprost Intraocular Implant, high elution; Travoprost Intraocular Implant, low elution; Timolol Maleate Ophthalmic Solution, 0.5%
Intervention description: Surgical implant placed within the eye to elute travoprost.; Surgical implant placed within the eye to elute travoprost; Instillation of one drop of timolol in the study eye twice daily
Intervention MeSH terms: Timolol; Travoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant
      to timolol ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open angle glaucoma

        Exclusion Criteria:

          -  Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular
             disorders.

          -  Functionally significant visual field loss, including severe nerve fiber bundle
             defects.

          -  Prior glaucoma surgery.

          -  Uncontrolled systemic disease, pregnant females or those planning a pregnancy.

          -  Other ocular status conditions, etc.
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Condition: Healthy
Intervention: RSV Vaccine; Placebo
Intervention description: Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.; Participants will receive a single IM injection of placebo on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to explore the dose-response relationship of immune responses
      induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess
      the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine
      (Cohorts 2 and 3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the investigator's clinical judgment, participants must be either in good or stable
             health. Participants may have underlying illnesses such as hypertension, type 2
             diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and
             symptoms are stable and medically controlled in the judgment of the investigator.
             Participants will be included on the basis of medical history and of physical
             examination and vital signs performed at screening (all cohorts), and of physical
             examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)

          -  A woman must be postmenopausal (defined as no menses for 12 months without an
             alternative medical cause) and not intending to conceive by any methods

          -  Agree to not donate blood from the time of vaccination until 3 months after
             vaccination

          -  Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)

          -  Be willing to provide verifiable identification and have means to be contacted and to
             contact the investigator during the study

        Exclusion Criteria:

          -  Has a contraindication to intramuscular injection (IM) injections and blood draws
             (example, bleeding disorders)

          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
             or vaccine components (including any of the constituents of the study vaccine)

          -  History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis

          -  Has hepatitis B or C infection, including history of treated hepatitis C infection

          -  Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored
             vaccine at any time prior to randomization