bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope
Condition: Vasovagal Syncope
MeSH terms: Syncope; Syncope, Vasovagal
Intervention: Atomoxetine; Placebo
Intervention description: 40mg PO the night before and the morning of the study tilt table test.; oral placebo capsule designed to blind the atomoxetine intervention
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study drug was encapsulated in opaque capsules by study personnel not involved in the day to day operations of the study.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with
      recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1 or more syncopal spells in the year preceding enrolment

          -  More than -2 points on the Calgary Syncope Symptom Score

          -  Age ≥18 years with informed consent

        Exclusion Criteria:

          -  Other causes of syncope, such as ventricular tachycardia, complete heart block,
             orthostatic hypotension or hypersensitive carotid sinus syndrome

          -  Inability to give informed consent

          -  important valvular, coronary, myocardial or conduction abnormality or significant
             arrhythmia.

          -  hypertrophic cardiomyopathy

          -  a permanent pacemaker

          -  a seizure disorder

          -  hypertension defined as >150/90 mm Hg

          -  pregnancy

          -  glaucoma

          -  medications with known effects on blood pressure

          -  Known hypersensitivity to atomoxetine and derivatives
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
Association Between Body Size and Response to Hydromorphone in ED
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone
Intervention description: a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hydromorphone; acute pain; emergency department

Summary:

      Pain is the most common complaint for patients presenting to the emergency department (ED).
      Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and
      responses to intravenous opioids vary widely and are influenced by multiple factors. The
      objective of the current study is to examine the association between total body weight, BMI
      (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking

          -  Age 18 - 65 years old

          -  Acute pain (less than 7 days in duration)

          -  Pain with sufficient severity to warrant use of intravenous opioids in the judgment of
             ED attending physician

        Exclusion Criteria:

          -  Allergy to hydromorphone

          -  Systolic blood pressure < 90 mm Hg

          -  Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental
             oxygen

          -  Alcohol or other drug intoxication as judged by the attending physician

          -  Suspicion of drug seeking by ED physician

          -  Use of opioids within the past 24 hours

          -  Use of a monoamine oxidase inhibitor

          -  Concurrent use of benzodiazepines

          -  Presence of a chronic pain syndrome (such as sickle cell disease, peripheral
             neuropathy, diabetic neuropathy, or fibromyalgia)

          -  History of COPD, sleep apnea, renal failure, liver disease

          -  Pregnancy or breast feeding

          -  Prior entry of patient in the study

          -  Inability or unwillingness to provide informed consent
A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PF-03187207; Latanoprost 0.005%; PF-03187207 Vehicle; Latanoprost Vehicle
Intervention description: One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To investigate dose response, safety and efficacy of PF-03187207 in patients with primary
      open-angle glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman at least 20 years of age

          -  Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

        Exclusion Criteria:

          -  Closed/barely open anterior chamber angle or a history of acute angle closure in
             either eye

          -  Contraindications to latanoprost and nitric oxide treatment

          -  Known latanoprost non-responders
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Condition: De Novo Kidney Transplantation
Intervention: Alefacept; placebo; Tacrolimus; Mycophenolate Mofetil; Steroids
Intervention description: IV and subcutaneous injection; IV and subcutaneous injection; The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.; Mycophenolic mofetil was administered as 750 mg twice per day orally; Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
Intervention MeSH terms: Mycophenolic Acid; Alefacept; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: kidney transplant; alefacept

Summary:

      The purpose of this study is to determine whether alefacept is effective and well tolerated
      when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a
      combination therapy of placebo, tacrolimus and steroids in the prevention of kidney
      transplant rejection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with end stage kidney disease who is a suitable candidate for primary kidney
             transplantation or retransplantation

          -  Male or female subject at least 18 years of age and younger than 65 years

          -  Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA)
             identical living donor or deceased HLA identical/non-HLA identical donor between 5 and
             59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)

        Exclusion Criteria:

          -  Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or
             had had a previous graft survival shorter than 1 year due to immunological reasons

          -  Subject received a kidney transplant from a non-heart beating donor

          -  Subject has received a kidney transplant from a 50 - 59 year old donor with two of the
             following three factors: history of hypertension, cerebrovascular accident as cause of
             death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ
             sharing [UNOS] expanded criteria donor)

          -  Cold ischemia time of the donor kidney is ≥ 30 hours
Long-term Safety in Atrial Fibrillation Patients
Condition: Persistent or Permanent Nonvalvular Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AZD0837; VKA INR 2-3
Intervention description: Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od; Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 523.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide safety and tolerability data for AZD0837 during
      long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one
      or more additional risk factors for stroke and systemic embolic events (moderate to high risk
      patients).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation
             with one or more additional risk factors for stroke and systemic embolic event

          -  completing treatment with study drug in D1250C00008.

        Exclusion Criteria:

          -  Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism

          -  Presence of a valvular heart disease, mechanical heart valves, active endocarditis,
             left ventricular aneurysm or thrombus, atrial myxoma or any condition other than
             Atrial Fibrillation requiring chronic anticoagulation treatment

          -  Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI)
             within the previous three months prior to inclusion; Stroke and/or systemic embolism
             within the previous 30 days prior to inclusion

          -  Conditions associated with increased risk of major bleeding.
Efficacy and Safety Study of SUNPG1622
Condition: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: SUNPG1622 I dose; Placebo dose
Intervention description: Injection; Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the
      efficacy and safety of SUNPG1622.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed written consent

          -  Subject is ≥ 18 years of age at time of Screening

          -  Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of
             investigational product

          -  Subject has a negative test for TB within 4 weeks before initiating IMP

        Exclusion Criteria:

          -  Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes

          -  Active uveitis or symptomatic inflammatory bowel disease requiring therapy at
             screening

          -  Radiographic evidence of total ankylosis of the spine

          -  Subject has a planned surgical intervention between Baseline and the Week 24
             evaluation for a pre-treatment condition
Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate

Summary:

      Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat
      hydrochloride (HCl) (migalastat) in participants with Fabry disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have completed another Phase 2 study of migalastat in Fabry Disease

          -  Women of childbearing potential must have had a negative result on their pregnancy
             test

          -  Male and female participants agreed to use a reliable method of contraception during
             study treatment and for 4 weeks after study treatment termination

          -  Were willing and able to provide written informed consent

        Exclusion Criteria:

          -  Had not completed a Phase 2 study of migalastat in Fabry Disease

          -  Had a major protocol violation in the preceding migalastat trial and was discontinued

          -  Had undergone or was scheduled to undergo kidney transplantation or was currently on
             dialysis

          -  Had been treated with another investigational drug (except migalastat) within 30 days
             of study start

          -  Had been treated with Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa),
             Glyset® (miglitol), or Zavesca® (miglustat) within 2 weeks prior to enrollment
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
Condition: Uterine Cervical Neoplasms; Endometrial Neoplasms; Anus Neoplasms; Rectal Neoplasms; Prostatic Neoplasms
MeSH terms: Neoplasms; Prostatic Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Pelvic Neoplasms; Anus Neoplasms
Intervention: fluorothymidine F 18
Intervention description: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiotherapy; Positron-Emission Tomography and Computed Tomography; chemotherapy; bone marrow

Summary:

      [F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan
      to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone
      marrow will help maintain blood counts. This would impact chemotherapy administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and willingness to sign a written informed consent document.

          -  Recommended to undergo pelvic irradiation with concurrent chemotherapy.

          -  At least 18 years of age. Pediatrics would be best served by a protocol designed for
             their specific needs.

          -  Karnofsky Performance Status of at least 60% at time of screening.

          -  Life expectancy of greater than 6 months.

          -  Subject must have normal organ and marrow function (as defined below) within 30 days
             of study enrollment:

               -  leukocytes at least 3,000 / µL

               -  absolute neutrophil count of at least 1500 / µL

               -  platelets of at least 100,000 / µL

               -  creatinine equal to or less than the upper limit of normal

          -  not pregnant (as applicable)

        Exclusion Criteria:

          -  history of allergic reactions attributed to compounds of similar chemical or biologic
             composition to FLT

          -  an oncology research protocol requiring full pelvic radiation (i.e., 4 field box
             technique)

          -  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.

          -  subjects taking nucleoside analog medications such as those used as antiretroviral
             agents.
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Ofatumumab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone, Prednisone or equivalent
Intervention description: ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given; Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start; Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start; Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start; 100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Intervention MeSH terms: Prednisone; Prednisolone; Cyclophosphamide; Doxorubicin; Vincristine; Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone); ofatumumab

Summary:

      To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP
      (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients
      with Follicular Lymphoma (FL)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with Follicular Lymphoma (FL)

          -  Confirmed diagnosis of Follicular lymphoma

          -  18 years or above

          -  Verbal and written information about the study

        Exclusion Criteria:

          -  No previous treatment for Follicular Lymphoma

          -  Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma

          -  Several diseases such as malignancies etc.

          -  Screening laboratory values

          -  Current participation in any other interventional clinical study

          -  Breast feeding women or pregnant women

          -  Women of childbearing potential not willing to use adequate contraception
Treatment of Acute Pericarditis With Anakinra
Condition: Acute Pericarditis
MeSH terms: Pericarditis
Intervention: Anakinra; Placebo
Intervention description: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days; Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: anakinra; Kineret; pericarditis

Summary:

      The goal of this study is to determine the safety and efficacy of anakinra for the treatment
      of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7
      days.

        1. to determine the efficacy of anakinra with respect to chest pain resolution

        2. to determine the safety of anakinra with respect to adverse drug events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥12 years in presence of a parent able to provide consent or age >18 years

          -  First or recurrent episode of acute pericarditis, defined as the presence of at least
             2 of the following:

          -  Chest pain (suggestive of pericarditis and not explained by another condition)

          -  Pericardial friction rub on physical exam

          -  ST-segment elevation and/or PR depression on ECG

          -  New or worsening pericardial effusion

          -  Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no
             pain at all and 10 is the worst pain ever experienced) at time on enrollment

          -  Ability to provide written informed consent if 18 years or older or to provide assent
             in presence of parental consent if 12-17 years of age

        Exclusion Criteria:

          -  Pericarditis due to known bacterial or fungal infection

          -  Pericarditis due to known malignancy

          -  Pericarditis after cardiac surgery

          -  Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes

          -  Pregnancy or breastfeeding

          -  Hypersensitivity to anakinra, latex or products derived from Escherichia coli

          -  Chronic pain syndrome or chronic use of analgesic drugs