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

Trial Title: Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

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

Eligibility Criteria:
Inclusion Criteria:~* Must be \>18, \< 80 years old~* Must be fluent in English, as determined by the PI~* Must not be a member of a vulnerable group (IRB defined)~* Must remain in geographic area during duration of the study~* Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)~* Must have a minimum of 6 posterior teeth remaining in the upper arch (3 teeth per side),third molars are acceptable if healthy, fully erupted and substituting for second molars~Exclusion Criteria:~* Must not be current users of devices such as Baha, CROS or TransEar~* Must not have known active medical causes of SSD:~  * Active middle ear pathology~ * Conductive HL (Otosclerosis, otitis media, otitis externa and others)~ * Sudden hearing loss that is not stable~* Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures~* Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)~* Must not have allergies to polymers~* Must not have known dental abnormalities:~  * Temporary crowns or undergoing dental treatment~ * Poor oral hygiene and/or rampant decay~ * Current orthodontics~ * Active caries in one or more of the possible abutment teeth for the device~ * Active moderate to severe periodontal disease around abutment teeth for the device~ * Suspicious oral/facial lesions or swelling of any type~ * Severe pain on palpation on any area of mouth, face or neck~ * Moderate to severe heat sensitivity on any of the upper teeth~ * Subject currently being treated for temporomandibular joint disorder (TMJ), pain, full mouth reconstruction or posterior dental implants~* Must not have known Audiological conditions:~  * Conductive hearing loss (air-bone gap \>10dB HL at more than 3 frequencies)~ * Word recognition scores inconsistent with pure tone averages~ * Fluctuating hearing loss~* Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- SoundBite Hearing System (Type: EXPERIMENTAL): The objective of this study was to assess the safety and effectiveness of the SoundBite hearing system by Sonitus Medical and to support its intended use for the treatment of unilateral hearing loss. The SoundBite hearing system is a Bone Conduction Device (BCD) and is occasionally referred to as such in the protocol and within this report.

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: 16.0040 Ankylosing Spondylitis Study

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:~* Negative pregnancy test~* Subjects agree to use appropriate contraception throughout study~* Should be able to self-inject study drug or have someone who can do so~* Capable of understanding protocol and willing to provide written informed consent~Exclusion Criteria:~* Any change in NSAID or prednisone dose within 2 weeks of baseline~* Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline~* Use of DMARDs other than those mentioned above, within 4 weeks of enrollment~* Previous receipt of ani-TNF agents, other than etanercept~* Receipt of any other investigational drug within 30 days of baseline~* Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed~* Abnormality in chemistry or hematology profiles or significant concurrent medical events.

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

Study Arms:
- All subjects (Type: EXPERIMENTAL): 257 subjects

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: This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

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:~* Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted~* Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study~* Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected~* Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study~* Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator~Exclusion Criteria:~* Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject~* Poor compliance with the visit schedule or medication intake in the previous brivaracetam study~* Pregnant or lactating women~* Participation in any clinical study of another investigational drug or device during the study

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

Study Arms:
- Brivaracetam (Type: EXPERIMENTAL): Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.

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: Gait Analysis Following Knee Viscosupplementation

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SCREENING
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.~Exclusion Criteria:~* recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for HA joint injection and previous HA or steroid injections in the last six months.

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

Study Arms:
- hyaluronic acid with mannitol (Type: EXPERIMENTAL): None
- hyaluronic acid with sorbitol (Type: EXPERIMENTAL): None
- saline (Type: ACTIVE_COMPARATOR): 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: Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.~* Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg \<180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).~* Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at both Visit 1 and Visit 201.~* Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.~Exclusion Criteria:~* Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).~* History of angioedema, drug-related or otherwise, as reported by the patient.~* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.~* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- LCZ696 200 mg (Type: EXPERIMENTAL): Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
- LCZ696 400 mg (Type: EXPERIMENTAL): Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
- Olmesartan 20 mg (Type: ACTIVE_COMPARATOR): Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.

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: Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Adult subject and pediatric subjects (aged greater than or equal to two (2) years).~* Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.~* Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.~* Has been fully informed about the study, and has consented to participate.~Exclusion Criteria:~* Having acute or chronic grade IV or V renal insufficiency.~* Known class III/IV congestive heart failure.~* Suffering from long QT syndrome.~* Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).~* Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.~* Known allergy to Gadolinium chelates.~* Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.~* Pregnant, breast feeding, or planning to become pregnant during the trial.~* Previously participated in this trial.~* Having participated within 30 days in another clinical trial involving an investigational drug.~* Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.~* Inability or unwillingness to cooperate with the requirements of this trial.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Dotarem (gadoterate meglumine ) (Type: EXPERIMENTAL): Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
- Magnevist (gadopentetate dimeglumine) (Type: ACTIVE_COMPARATOR): Dotarem and Magnevist were randomised as 2:1 ratio
- Dotarem 2 (gadoterate meglumine ) (Type: EXPERIMENTAL): Pediatric patients were assigned to Dotarem group only.

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: Adrenaline for the Treatment of No-Reflow in Normotensive Patients

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:~* All patients with acute coronary syndrome who developed No-reflow during PCI.~* Patients with systolic blood pressure of \> 100 mmHg.~Exclusion Criteria:~* Hypotensive patients~* Patients with Valvular or congenital heart disease.~* Patients with Atypical chest pain~* Patients with Cardiomyopathy~* Patients with Pericarditis~* Patients with Myocarditis~* Patients refused to give consent

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

Study Arms:
- Treatment group (Type: EXPERIMENTAL): Patients receiving intracoronary adrenaline
- Control group (Type: ACTIVE_COMPARATOR): Patients receiving intracoronary adenosine

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: NMDA Antagonists in Bipolar Depression

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:~* Male and female patients with Diagnostic and Statistical Manual, Version 4 (DSM-IV) diagnosis of bipolar disorder I or II, current major depressive episode without psychotic features, 18-60~* Insufficient therapeutic response during the current episode~* Medically stable for study participation~* Judged clinically not to be at significant suicide or violence risk~* Subject is off all psychotropic and other types of drugs likely to interact with glutamate for at least 14 days before starting the study. One exception is chloral hydrate or short acting benzodiazepines for distressing anxiety or insomnia (up to 72 hours prior to each MRI scan). In addition, subjects will be off antipsychotics for 1 month and off fluoxetine for 6 weeks prior to the study.~* Subject is likely to be able to tolerate a medication washout. Only subjects who have failed their current medication regiment will be washed off medications.~Exclusion Criteria:~* History of chronic psychosis or drug induced psychosis of any kind~* Current DSM-IV diagnosis of drug abuse/dependence in the last six months. Subjects must have a negative drug screen at baseline.~* Women will be excluded if they are pregnant lactating, or not either surgically-sterile or using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test~* Taking any medication contraindicated with ketamine or DCS (ethionamide, isoniazid)~* History of seizures, renal insufficiency or congestive heart failure~* History of clinically significant violence~* History of ketamine abuse/dependence or prior clinically significant adverse reaction to ketamine~* Current alcohol abuse or dependence~* Untreated hypertension~* Clinically abnormal liver function tests (LFTs), thyroid, renal function or anemia~* Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan.~* Medicinal patch, unless removed prior to the MR scan

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Ketamine and DCS treatment (Type: EXPERIMENTAL): Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.

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: Pharmacogenomics of Antiplatelet Response

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

Eligibility Criteria:
Inclusion Criteria:~* 45-75 years~* GeneSTAR participant~* No personal History of Coronary Artery Disease~* Women who are post-menopausal~* Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP~Exclusion Criteria:~* Taking aspirin prescribed by physician~* weight \< 60 kg~* History of recent or current bleeding~* allergy to aspirin or history of adverse events to aspirin~* serious comorbid conditions (such as AIDS, active cancer)~* high blood pressure (\>160/95)~* History of gastrointestinal ulcer/bleeding~* Mental incompetence to make decision to participate.

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Aspirin (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: Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Male or Female ages 30 to 80~* Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening~Exclusion Criteria:~* Participant has human immunodeficiency virus (HIV), Hepatitis B or C~* Participant uses illegal drugs~* Participant has Type I diabetes~* Participant has a history of claustrophobia

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- 10 mg Atorvastatin (Type: ACTIVE_COMPARATOR): 10 mg atorvastatin + placebo
- 80 mg Atorvastatin (Type: ACTIVE_COMPARATOR): 80 mg atorvastatin + placebo

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: Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* age 8 - 30,~* duration of diabetes 4 - 12 months,~* weight greater than 27.5 kg,~* stimulated C-peptide \>= 0.2 pmol/ml~Exclusion Criteria:~* asthma,~* history of hepatitis C, hepatitis B, HIV

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 30 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
- 2 (Type: PLACEBO_COMPARATOR): Normal saline infusion

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: Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~1. 2-21 years old~2. Biopsy proven FSGS or minimal change with steroid resistance~3. Presence of FSPF (defined as permeability activity \>0.5)~4. Presence of nephrotic range proteinuria (urine protein: creatinine ratio \>2) at the time of enrollment.~5. Persistent nephrotic range proteinuria despite being on stable immunosuppressive medications (cyclosporine, tacrolimus or mycophenolate mofetil) for at least 12 weeks and/or persistent nephrotic range proteinuria despite being on stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for 12 weeks.~6. Stable serum creatinine (change of less than 0.3 mg/dl) in the prior 3 months.~7. Schwartz estimated (e) glomerular filtration rate (GFR) \>60ml/min/1.73m2~Exclusion Criteria:~1. Secondary FSGS~2. Onset of nephrotic syndrome in infancy.~3. Presence of acute renal failure (as defined by acute kidney injury criteria) at the time of enrollment. These children can be enrolled 1 month after resolution of acute renal failure (ARF).~4. Decreasing renal function (persistent increase in serum creatinine of greater than 0.3 mg/dl over baseline in the prior 3 months).~5. Use of another investigational drug~6. Pregnant or unable to comply with contraceptive measures in females of child bearing age~7. eGFR \< 60 ml/min per 1.73 m2~8. Children with Galactosemia~9. Children with type 1 or 2 diabetes

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- Galactose (Type: EXPERIMENTAL): Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.

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

Answer: outcome: complete