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

Trial Title: Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision

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

Eligibility Criteria:
INCLUSION CRITERIA:~To participate in the screening portion of this study, an individual must meet all of the following criteria:~1. Have a diagnosis or suspected diagnosis of any genetically based condition causing low vision to the level specified in criteria 2.~   If the genetic condition is CLN3-related, the individual must have one of the following:~  * a. Two CLN3 pathogenic variants, OR~  * b. One CLN3 pathogenic variant AND~     * i. clinical presentation suggestive of CLN3, OR~    * ii. characteristic electron microscopy (EM) findings (such as curvilinear body, fingerprint profile, granular osmiophilic deposits).~2. Have an estimated visual acuity in the better seeing eye \< 20/200, without the use of an assistive or augmentative device.~3. Is between 6 to 18 years of age.~To participate in the intervention/device use portion of this study, an individual must meet the above screening criteria and the following criteria:~* Have an appropriate cognitive developmental ability to participate based on Investigators screening assessment.~EXCLUSION CRITERIA:~An individual who meets any of the following criteria will be excluded from participation in this study:~* Has any of the following auditory dysfunctions: non-reversible or non-correctable hearing loss, tinnitus that is chronic or occurring daily, auditory hallucinations that occur daily.~* Uses an optic-to-audio assistive device at the time or within 3 months of screening and enrollment.~* Is unable to travel to the NIH because of medical condition for required in-person portions of the study.~* Is unable to comply with or have medical conditions that would potentially increase the risk of participation.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Children with CLN3 disease (Type: EXPERIMENTAL): Children with CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
- Children with Low vision without CLN3 (Type: EXPERIMENTAL): Children with low vision not related to CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

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

Eligibility Criteria:
Inclusion Criteria:~* Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.~* ST-segment elevation \>=2mm in \>=3 adjacent leads.~* Presence of severe hypokinesia and/or akinesia in \>=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.~* Age between 20 and 75 years.~Exclusion Criteria:~* Pregnant or lactating.~* Prior history of myocardial infarction before index event.~* Decompensated congestive heart failure.~* Pre-existent LV dysfunction (EF \<45% prior to admission)~* Cardiomyopathy.~* Previous cardiac surgery.~* Congenital heart disorder.~* Serum creatinine \>200 Mmol/L.~* Presence of permanent pacemaker or implantable defibrillator.~* Contraindication to bone marrow aspiration.~* History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.~* Sustained or inducible VT \>48 hours post primary PCI.~* Three vessel coronary artery disease necessitating intervention within 4 months.~* Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.~* Presence of chronic systemic inflammatory disorders.~* Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.~* Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.~* Any condition associated with a life expectancy of less than 6 months.~* Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.~* Current alcohol or drug abuse.~* Inability to provide written informed consent.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries
- 2 (Type: PLACEBO_COMPARATOR): Control group patients will receive 3 injections of 0.3 mL each of buffered normal saline (the vehicle used for cell suspension) into comparable vessels. Subjects will have an identical intra-coronary injection procedure to those randomized to autologous CD133+ progenitor cell injections.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* 6 months or more since cardiac transplant~* Clinically stable from a transplant perspective~* Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid~* Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.~Exclusion Criteria:~* Clinical instability from a cardiac transplant perspective~* Contraindications to aliskiren therapy~* Conditions that may increase the risk of aliskiren adverse effects~* Severe hypertension~* Concomitant medications known to increase or decrease aliskiren plasma exposure.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: OTHER): Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion~* Patients must have undergone a matched related donor, matched unrelated donor or cord blood Hematopoietic Stem Cell Transplant (HSCT) over 6 months ago~* Patients currently on Desferal (desferrioxamine) therapy will require a one day wash out prior to the first dose of study drug~* Serum ferritin \>= 1500 ng/mL on two occasions two weeks apart at screening; samples must be obtained in the absence of concomitant infection~* Normal C-reactive protein level at screening~* Patients must be red cell transfusion independent for 2 months prior to enrollment~* Sexually active women must use an effective method of contraception, or must have undergone clinical documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)~* Written informed consent by the patient~Exclusion~* Chronic hepatic GVHD with serum total bilirubin over 2 mg/dL~* Known hypersensitivity to deferasirox~* Serum creatinine above the upper limit of normal~* AST or ALT \> 200 U/L during screening~* Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)~* History of HIV positive test result (ELISA or Western blot)~* History of drug or alcohol abuse within the 12 months prior to enrollment~* ECOG Performance Status \> 2~* Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation~* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment~* Pregnancy (as documented in required screening laboratory test) or breast feeding~* Patients who received treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or are planning to receive other investigational drugs while participating in the study~* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug~* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative

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

Study Arms:
- Arm I (Type: EXPERIMENTAL): Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Histopathologically confirmed extracranial primary malignancy~  * Multiple (i.e., \> 3) brain metastases OR \< 3 metastases with at least 1 metastasis \> 4.0 cm in diameter~ * Not eligible for radiosurgery~* No requirement for immediate whole-brain radiotherapy~* No metastases to the midbrain or brainstem~Exclusion Criteria:~* Zubrod performance status 0-2~* Life expectancy ≥ 8 weeks~* Platelet count \> 100,000/mm\^3~* ANC \> 1,500/mm\^3~* Hemoglobin ≥ 10 g/dL~* BUN \< 25 mg/dL~* Creatinine \< 1.5 mg/dL~* Bilirubin \< 1.5 mg/dL~* ALT ≤ 2 times normal~* Sodium \> 136 mg/dL~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* Neurologically stable~  * No seizure disorders or seizures due to brain metastases~* No medical illnesses or psychiatric conditions that would preclude completion of study treatment~* No sensory neuropathy ≥ grade 2~* No bipolar disorder~* No thyroid disease~* No QTc interval prolongation~PRIOR CONCURRENT THERAPY:~* More than 2 weeks since prior and no concurrent chemotherapy~* At least 2 weeks since prior and no concurrent NSAIDs, angiotensin-converting enzyme inhibitors (e.g., enalapril or captopril), calcium channel blockers, diuretics, selective cyclooxygenase-2 inhibitors, acetazolamide, urea, xanthine, or alkalinizing agents (e.g., sodium bicarbonate)~* No prior radiotherapy to the head and neck area~* No prior radiosurgery~* No concurrent radiotherapy to other sites~* No concurrent anticonvulsants due to brain metastases~* No concurrent psychoactive drugs~* No concurrent thyroid medications~* No concurrent amifostine

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

Study Arms:
- Therapeutic Intervention (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty

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

Eligibility Criteria:
Inclusion Criteria:~1. Both genders~2. Age between 30 and 75 years~3. Early type 2 diabetes, defined as FPG \>7.0 mmol/l or a PPG of 11.1 mmol/l or greater or a previous diagnosis of diabetes~4. Treatments accepted~   * Diet without pharmacological treatment~  * One or more oral antidiabetic drug (OAD: sulfonylureas, biguanides, meglitinides) at half-maximum dose or greater~  * Once daily insulin and OAD~5. Angiographic documentation of infrapopliteal arterial disease (stenosis \>70% or occlusion)~6. Critical limb ischemia (CLI) defined as~   * Persistent, recurring rest pain requiring analgesia and an ankle systolic pressure \<50 mm Hg and/or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg~  * Ulceration, gangrene, or nonhealing wounds of the foot with ankle systolic pressure \<50 mm Hg or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg~  * Fontaine stages III-IV and rutherford categories IV-VI~  * Lifestyle-limiting claudication defined as Rutherford category II to III associated with jeopardized single vessel runoff or complete trifurcation vessel occlusion.~7. Subject able to provide a signed and dated written informed consent~Exclusion Criteria:~1. Type 1 diabetes, defined as positivity for GAD antibodies measured by radiobinding assay~2. Unwilling to inject insulin or to perform a correct self monitoring of blood glucose~3. Acute limb ischemia~4. Buerger disease~5. Severe contrast allergy~6. Hypersensitivity to aspirin and/or clopidogrel~7. Systemic coagulopathy contraindicating antiaggregation therapy~8. Hypercoagulation disorder~9. Serum creatinine\>2.0 mg/dl at screening~10. Active liver disease, or ALT or AST \>2.5 times upper limit of normal at screening~11. Chronic or recurrent treatment with systemic corticosteroids~12. Malignant diseases~13. Psychiatric diseases which make participation impossible~14. Alcohol abuse

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- long-acting insulin plus analogues (Type: ACTIVE_COMPARATOR): three administrations of regular insulin or short acting insulin analogues before meals combined with long-acting insulin analogue glargine in the evening.
- long-acting insulin and oral agents (Type: ACTIVE_COMPARATOR): treatment will be once-daily long-acting insulin and oral antidiabetic agents

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Cytokines and the Risk of Infection in Liver Cirrhosis

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: COHORT
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Patients with clinical, radiological and/or histological evidence of liver cirrhosis~* Age above 18 (inclusive) at the time of screening~* Able and willing to give written informed consent and to comply with the requirements of the study~Exclusion Criteria:~* Infection during the last 14 days before screening~* Gastrointestinal bleeding within the last 14 days before screening~* Antibiotic therapy at the time of screening (except prophylaxis of spontaneous bacterial peritonitis)~* Shock or cardiac failure requiring inotrope treatment at the time of screening~* Hepatic encephalopathy grade \>2~* Findings suggestive of organic nephropathy or a serum creatinine level of more than 2 mg/dl~* Human immunodeficiency virus infection at time of inclusion~* Use of immunomodulating agents within one month prior to screening (e.g. steroids)~* Any disease (e.g., advanced neoplasia) that could affect the short-term prognosis~* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

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

Study Arms:
- Liver Cirrhosis (Type: None): Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_CONTROL
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months~* Subject must have documented detrusor overactivity~* Subject must not be taking any OAB medication for at least 14 days~* Subject has no sleep related conditions (other than nocturia)~Exclusion Criteria:~* Subject has active urinary tract infection (UTI)~* Subject has significant stress incontinence or mixed stress/urge incontinence~* Subject has nocturnal polyuria~* Subject has history of sleep apnea~* Subject has indwelling urinary catheterization within 4 weeks~* Subject using medication that effects urinary and sleep function~* Subject is unable to refrain from alcohol or smoking during the sleep night stay~* Subject has an unstable medical or psychiatric disorder~* Subject has a history of cardiovascular concerns~* Subject is pregnant, breastfeeding or plans to become pregnant

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

Study Arms:
- Group 1 - OAB with DO+ (Type: None): Subjects that DO+ nocturia
- Group 2- OAB with DO- (Type: None): Subjects that DO- nocturia

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Anesthetic Effects in Mitochondrial Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.~Exclusion Criteria:~* Patients more than 16 years of age.~* Patients with concurrent acute infectious disease.~* Patients not tolerating a slow induction for emotional reasons.~* Initial BIS measurement of less than 95.~* Documented pulmonary disease.

- Gender: ALL
- Minimum Age: 12 Months
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- slow induction with sevoflurane (Type: EXPERIMENTAL): Only children with a BIS greater than 95 prior to inhalation of sevoflurane will be included in the study. Inductions will be done using a tight fitting mask with continuous monitoring of end tidal gas concentrations. During induction, concentration of inspired sevoflurane will begin at .5%, and slowly increased by 0.5% every two minutes, until a Bispectral Index (BIS) of 60 or less is reached. Inspired sevoflurane will be increased only after end tidal concentration of sevoflurane is constant for at least one minute. Each induction (except for the patients requiring very low doses of sevoflurane) will take approximately 10 minutes.

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: Hypertension in Breast Cancer Patients Receiving Bevacizumab

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_ONLY
- Primary Purpose: None
- Time Perspective: PROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed breast cancer~* Must be starting combination treatment with bevacizumab and chemotherapy. Treatment may not have already started. Patients may receive therapy either on or off of a clinical trial.~* Any number of prior chemotherapy or biological therapy regimens is acceptable.~* Either no history of hypertension, defined as Blood Pressure \<140/90mm Hg on no antihypertensive therapy, or medically controlled pre-existing hypertension, defined as Blood Pressure \< 140/90mm HG on one non-angiotensin converting enzyme inhibitor (ACE-I) or non-angiotensin receptor blocking (ARB) medication.~Exclusion Criteria:~* History of uncontrolled hypertension within the previous 6 months~* Inability to assess blood pressure or have prolonged blood pressure cuff inflation due to history of bilateral lymph node dissections, presence of an indwelling venous access device, or other condition~* Concurrent use of a statin medication~* Systolic blood pressure \< 100mm Hg

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

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

Answer: outcome: terminate
termination_type: enrollment issues