TrialPanorama/Dataset huggingface dataset:
Please assess the completion status of the following clinical trial:

Trial Title: Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants~Exclusion Criteria:~1. Children with active systemic illness~2. Children with evidence of active tuberculosis~3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD)~4. Children with recurrent illness/chronic systemic illness

- Gender: ALL
- Minimum Age: 3 Months
- Maximum Age: 24 Months
- Healthy Volunteers: f

Study Arms:
- High dose (Type: EXPERIMENTAL): Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
- Usual dose (Type: ACTIVE_COMPARATOR): Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* ADPKD~* \> 18 y.o. GFR greater than or equal to 25. Willingness to be randomized to any treatment group Willingness to follow protocol requirements-frequent testing and follow-up required at Cleveland Clinic(Cleveland, OH) signed informed consent Willingness to use birth control(male and female)~Exclusion Criteria:~* Pregnancy~* post partum~* lactating~* system illness with renal involvement

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml
- 2 (Type: EXPERIMENTAL): Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml
- 3 (Type: NO_INTERVENTION): Standard Care

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy volunteer between 60-90 days old;~* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;~* Proven legal identity;~* Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;~* Complying with the requirement of the study protocol;~Exclusion Criteria:~* Prior vaccination with Poliovirus Vaccine;~* History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;~* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;~* Autoimmune disease or immunodeficiency/immunosuppressive;~* Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;~* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;~* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;~* Blood product prior to study entry;~* Any other investigational medicine(s) within 30 days prior to study entry;~* Any live attenuated vaccine within 14 days prior to study entry;~* Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;~* Acute disease or acute stage of chronic disease within 7 days prior to study entry;~* Axillary temperature \> 37.0 °C;~* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

- Gender: ALL
- Minimum Age: 60 Days
- Maximum Age: 90 Days
- Healthy Volunteers: t

Study Arms:
- Experimental Group (Type: EXPERIMENTAL): The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.~Intervention: investigational sIPV
- Control Group (Type: ACTIVE_COMPARATOR): The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female patients \> 18 years of age.~2. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.~3. Patients must report a history of heartburn at least two days per week over the past month.~Exclusion Criteria:~1. History of erosive esophagitis verified by endoscopy.~2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.~3. Patients who have a history of Barrett's esophagus or esophageal stricture.~4. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.~5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Oral placebo tablet
- Rabeprazole sodium 10 mg (Type: EXPERIMENTAL): oral rabeprazole 10 mg enteric-coated tablet

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.~* For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period~For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)~Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.~Exclusion Criteria:~* Providers: has \<1 year of experience, and has plans to be transferred to another facility or leave the facility soon~* Other types of participants: none

- Gender: ALL
- Minimum Age: None
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Full - Train/oxy&miso/ B&M/Mentor/Phone (Type: EXPERIMENTAL): Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.
- Partial - Train/oxy & miso/ B&M/Mentor (Type: EXPERIMENTAL): Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.
- Comparison - Train/oxy & miso/ B&M (Type: ACTIVE_COMPARATOR): Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Postoperative Pain Control for Prostatectomy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: TRIPLE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* prostate cancer for radical prostatectomy~Exclusion Criteria:~* chronic pain or opiate use

- Gender: MALE
- Minimum Age: None
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- TAP arm (Type: EXPERIMENTAL): in the experimental arm, the procedure will consist of the staff urologist injecting local anesthetic into the anterior abdominal wall bilaterally from the inside of the abdomen at the end of their surgery
- standard post operative pain control (Type: ACTIVE_COMPARATOR): Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Baby Vaccine Study (Sched3)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Infants due to receive their primary immunisations , aged up to 13 weeks on first vaccinations.~* Written informed consent given by mother who is aged \>= 16 years \[NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known\]~Exclusion Criteria:~* Bleeding disorder~* Fulfil any of the contraindications to vaccination as specified in The Green Book \[https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book\]:~* At risk of invasive pneumococcal disease (IPD) as defined in the Green Book pneumococcal chapter and those born prior to 37 weeks gestation~* Confirmed anaphylactic reaction to a previous dose of the vaccine, or~* Confirmed anaphylactic reaction to any constituent or excipient of the vaccine(s).~* A confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine) and/or kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the MenB vaccine).~* Latex hypersensitivity (the syringe cap of Bexsero may contain natural rubber latex)

- Gender: ALL
- Minimum Age: 8 Weeks
- Maximum Age: 12 Weeks
- Healthy Volunteers: t

Study Arms:
- Group 1 (Type: OTHER): Group 1 will receive the following interventions:~* DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months~* 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 2, 4 and 12 months~* Rotavirus vaccine oral 1.5ml at 2 and 3 months~* 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months~* Meningococcal C/Hib vaccine IM 0.5ml at 12 months~* Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months
- Group 2 (Type: OTHER): Group 2 will receive the following interventions:~* DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months~* 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 3 and 12 months (instead of current routine schedule of 2,4 and 12 months)~* Rotavirus vaccine oral 1.5ml at 2 and 3 months~* 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months~* Meningococcal C/Hib vaccine IM 0.5ml at 12 months~* Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Clinical symptoms or signs suggestive of myotonic disorders~* Presence of myotonic potentials on electromyography (EMG)~* Participant in the Non-Dystrophic Natural History study (RDCRN 5303) or a new patient with confirmed non-dystrophic myotonia~Exclusion Criteria:~* Other neurological condition that might affect the assessment of the study measurements~* Genetic confirmation of DM1 (more than 50 repeats of CTG) or DM2~* Existing cardiac conduction defects, as evidenced on EKG, including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (e.g., second degree AV block, third degree AV block, or prolonged QT interval)~* Existing permanent pacemaker~* Current use of any of the following antiarrhythmic medications for a cardiac disorder: flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone, or mexiletine~* Use of medications for myotonia, such as phenytoin and flecainide acetate, within 5 days of study entry; carbamazepine and mexiletine within 3 days of study entry; or propafenone, procainamide, disopyramide, quinidine, and encainide within 2 days of study entry~* Use of medications that produce myotonia, which may include fibrate acid derivatives, hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicines~* Kidney or liver disease~* Heart failure~* Seizure disorder~* Pregnant or breastfeeding

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.
- 2 (Type: EXPERIMENTAL): Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, or pure autonomic failure, (i.e. neurogenic orthostatic hypotension).~* At screening, subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a ≥ 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.~* Impaired autonomic reflexes, as determined by absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performed, as appropriate.~* For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Part A.~Exclusion Criteria:~* Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.~* Concomitant use of vasoconstricting agents for the purpose of increasing BP such as ephedrine, dihydroergotamine, or midodrine must be stopped at least 2 days or five half lives (whichever is longer) prior to dosing on Day 1 of Part A and C, and throughout the duration of Part C. Subjects previously enrolled in Part A under previous versions of the protocol will continue taking fludrocortisone during the washout period and in Part C at the dose and regimen used in Part A. For new subjects enrolling in Part A under Amendment 3, fludrocortisone use in both Parts of the study and during the washout period will be limited to 0.1 mg QD.~* Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.~* Known or suspected alcohol or substance abuse within the past 12 months.

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- TD-9855 Part A (Type: EXPERIMENTAL): Subjects will receive placebo and escalating single doses of TD-9855
- TD-9855 Part B (Type: EXPERIMENTAL): Subjects will receive a single dose of TD-9855 or placebo.
- TD-9855 Part C (Type: EXPERIMENTAL): Subjects will receive once daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Males or females 17 years of age or older.~* Stable cancer-related pain.~* Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.~* Experiencing 1-4 episodes of breakthrough pain per day.~* Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.~Exclusion Criteria:~* Have previously been exposed to EN3267.~* Are pregnant or lactating.~* Have uncontrolled or rapidly escalating pain.~* Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.~* Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.~* Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.~* Are scheduled to receive an investigational drug other than EN3267 during the course of the study.~* Have hypersensitivity, allergy or contraindication to fentanyl.~* Have significant prior history of substance abuse or alcohol abuse.~* Would have difficulty complying with the protocol, as assessed by the investigator.~* Are unable to read, write, or comprehend the English language in order to complete diaries.

- Gender: ALL
- Minimum Age: 17 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- sublingual fentanyl tablet (Type: EXPERIMENTAL): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patients scheduled for knee arthroscopy~Exclusion Criteria:~* Inadequate intravenous (IV) access.~* History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.~* Less than 18 years of age.~* Use of analgesics less than 8 hours prior to surgery.~* Patients with active, clinically significant anemia.~* History or evidence of asthma or heart failure.~* Pregnant.~* Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.~* Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.~* Refusal to provide written authorization for use and disclosure of protected health information.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- IV ibuprofen (Type: ACTIVE_COMPARATOR): Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure
- IV ketorolac (Type: ACTIVE_COMPARATOR): A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete