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

Trial Title: PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus

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

Eligibility Criteria:
Inclusion Criteria:~* age equal or above 18 years~* keratoconus as defined and classified by~  * presence of corneal thinning and protrusion on slit-lamp examination~ * topographic criteria according to KISA% index (\>100%)~ * mean corneal curvature map~* decreased best corrected visual acuity due to corneal scarring or contact lens intolerance~Exclusion Criteria:~* prior corneal surgery, cross linking, refractive surgery or other treatment modalities~* (localized) corneal thickness \< 200 µm~* associated corneal endothelial disease on specular microscopy as defined by:~  * \<1500 endothelial cells per mm2~ * polymegathism \> 0.3~ * pleomorphism \< 0.6 (all are measurements of endothelial dysfunction)~* gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity~* keratoconus-like disease (keratoglobus, pellucid marginal degeneration)~* associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, ICE-syndrome etc.)

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

Study Arms:
- PET (Type: EXPERIMENTAL): Partial endothelial trepanation in addition to anterior lamellar keratoplasty.~The endothelium en Descemet are paracentrally and circular loosened, but some tissue bridges are left in place. This 'island' is able to mould to the healthy donor curvature.
- DALK (Type: ACTIVE_COMPARATOR): Conventional DALK grafting procedure where the Big Bubble technique is used according to Anwar et al.

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: Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* Good health except for having type 2 diabetes~* Being treated with diet, insulin, or oral hyperglycemic agents~* Male or non pregnant female~* Non-smoker~* HbA1c 8 or above~* Able to provide informed consent~Exclusion Criteria:~* Presence of mental illness~* Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism~* BMI over 35~* Smoker

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- Vitamin C (Type: EXPERIMENTAL): 2 gms vitamin C

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: Molecular Biomarkers for Sepsis

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:~* Admission to the ICU of one of the participating centers.~* Cases: severe community acquired pneumonia with requirement for ICU admission.~* Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever \>38°C, CRP \>100mg/L, no infection focus expected in ≥ 24h.~* All required sample types can most likely be collected within the first 24h visits.~* Expected ICU stay of more than 24h.~Exclusion Criteria:~* Admission to the hospital within the prior 14 days.~* Patients with psychosis~* Evidence of a hospital acquired pneumonia.~* One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.~* Patients with an acute respiratory distress Syndrome (ARDS).~* Patient which can be managed as outpatients and do not require an ICU.~* Patient where a transmission to another institution is likely within the next 24h.~* Documented rejection of the general consent or participation to research in general.~* Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.

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

Study Arms:
- patients with severe community acquired pneumonia (cases) (Type: None): Cases: Patients with severe community acquired pneumonia with required ICU admission.
- patients without pneumonia or sepsis (controls) (Type: None): Controls: Clinical phenotype of inflammation not due to suspected sepsis; patients with fever \>38°C, C reactive Protein (CRP) \>100mg/L, no infection focus expected in ≥ 24h.

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: An ACT Based Application for Young People With Type 1 Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* 13-22 year olds diagnosed with type 1 diabetes or a clinician working in this field~* Understand English~* Android phone~* If a patient to have been diagnosed for at least 6 months~* Ability to give consent~Exclusion Criteria:~• Young people experiencing significant mental health issues. This includes those who are suicidal, experiencing psychosis, or are severely depressed. This will be assessed by the diabetes team which includes psychologists and those potential participants which meet this exclusion criteria will not be asked to participate in the study by the diabetes or research team.

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 22 Years
- Healthy Volunteers: t

Study Arms:
- SweetSpot users (Type: OTHER): Participants will interact with the smartphone application for as long or as little as they wish. They will be asked to complete questionnaires at baseline (pre), 4 weeks (post), and to attend an interview.

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 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

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

Eligibility Criteria:
Inclusion Criteria:~* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.~* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.~* Male subject agrees to use an acceptable method for contraception for the duration of the study.~* Day \>100 after allogeneic hematopoietic stem cell transplantation~* Underlying cancer in remission~* Decrease in FEV1 of ≥12% from the pre-transplant baseline (FEV1/FVC ratio \<0.8)~* No evidence of acute infection~* ANC \>1000~* Platelets \>50,000~* Age 18-70~* ECOG performance Status 0-2.~Exclusion Criteria:~* Patient has a platelet count of less than 50,000 within 14 days before enrollment.~* Patient has an absolute neutrophil count of less 1000 within 14 days before enrollment.~* Patient has a calculated or measured creatinine clearance of \< 20 ml/minute within 14 days before enrollment.~* Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.~* Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.~* Patient has hypersensitivity to bortezomib, boron or mannitol.~* Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.~* Patient has received other investigational drugs with 14 days before enrollment~* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.~* Inability of give consent

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

Study Arms:
- Bortezomib (Type: EXPERIMENTAL): Patients will Receive 2 4week cycles of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.

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: Post-Operative Therapy for Nausea or Vomiting

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:~- Patients scheduled for elective surgery requiring general anesthesia~Exclusion Criteria:~* Age less than 18 years~* Adults unable to give primary consent~* Pregnancy~* Prisoners~* Unable to access pericardial 6 acupressure point bilaterally post procedure~* Allergy to Ondansetron

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

Study Arms:
- Acupressure (Type: EXPERIMENTAL): Manual pressure will be applied on the wrists bilaterally.
- Ondansetron (Type: ACTIVE_COMPARATOR): Ondansetron (Zofran) is used for the treatment of nausea and vomiting.

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: Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis

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

Eligibility Criteria:
Inclusion Criteria:~* Patients over the age of 18 receiving chemotherapy~* Mucositis lesions not exceeding grade 2~Exclusion Criteria:~* Patients receiving high load chemotherapy~* Patients receiving radiation therapy~* Patients receiving oral antivirals, oral antifungals or oral antibacterials~* Patients experiencing oral candidiasis

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

Study Arms:
- Oral Defense Toothpaste (Type: EXPERIMENTAL): The experimental group will brush with Oral Defense Toothpaste three times per day during the study
- Crest Toothpaste/Magic Mouth Rinse (Type: PLACEBO_COMPARATOR): The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse.

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: Diclofenac for Submassive PE

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Acute symptomatic PE confirmed by multidetector CT angiography, a high-probability V/Q scan, or by the presence of deep vein thrombosis confirmed by lower limb ultrasound testing in patients with nonconclusive V/Q scan;~2. first symptoms occurring ten days or less before randomization;~3. haemodynamic stability (systolic blood pressure \> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment);~4. right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;~5. signed informed consent.~Exclusion Criteria:~1. Previous diagnosis of chronic thromboembolic pulmonary hypertension;~2. active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE;~3. peptic ulcer;~4. major surgery, or severe trauma in the previous month before diagnosis of PE;~5. indication for chronic anticoagulation;~6. pregnancy or breast feeding;~7. renal insufficiency (serum creatinine \> 2 mg/dL) or severe hepatic impairment;~8. hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid;~9. bronchial asthma;~10. severe congestive heart failure;~11. inflammatory bowel disease.

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

Study Arms:
- Diclofenac (Type: ACTIVE_COMPARATOR): None
- Placebo (Type: PLACEBO_COMPARATOR): 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: Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Men or woman aged \>18 years~2. Diagnosis of DM based on standard criteria~3. Receiving the equivalent of at least 0.4 g/kg IVIg every 4 weeks (IVIg group only)~4. Established response to IVIg or dependence on IVIg to maintain status established either by symptomatic worsening of condition at the end of the inter-dose interval for both groups or by worsening after reduction of the dose within the previous 12 months (IVIg group only)~5. IVIg regimen stable for 12 weeks while on IVIg (minor changes are permitted provided that the dose change is 15% or less) (IVIg group only)~6. Stable dosing with steroids and/or other immunosuppressives for 12 weeks with no changes schedule or intended.~Exclusion Criteria:~1. Pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception~2. Severe concurrent medical conditions which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies~3. Initiation or immunomodulatory treatment other than IVIg in the past 24 weeks or modification of immunomodulatory treatment other than IVIg in the past 12 weeks.~4. Participation in trial of an investigational medicinal product in the past 12 weeks~5. Presence of skin infection unrelated to dermatomyositis, severe skin involvement~Presence of any other medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.

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

Study Arms:
- IVIg naive (Type: ACTIVE_COMPARATOR): Patients naïve to IVIg who have active disease responding to corticosteroids or are corticosteroid-dependent, will be also included. Before these patients enter the study, they will receive 3 monthly infusions of IVIg starting with the standard dose of 2gram/kg/month and followed with monthly maintenance of 1 or 2gram/kg according to their response.
- non-IVIg naive (Type: ACTIVE_COMPARATOR): Participants already on IVIg will be observed for 12 weeks under their existing IVIg regimen and will undergo measurements of their muscle strength, skin changes, assessments of their daily activities and quality of life (QoL) every 4 weeks at scheduled visits for monthly maintenance IVIg infusions (weeks 0,4,8,12).

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: Perceval S Aortic Heart Valve Study- North America

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. Subjects of age \>= 18 years.~2. Subjects with aortic valve stenosis or steno-insufficiency.~3. The subject is willing to sign the informed consent.~4. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.~5. The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).~6. Subject will be available to the investigator(s) for postoperative follow-up beyond one year.~Exclusion criteria:~1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.~2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.~3. The subject has a previously implanted PERCEVAL valve that requires replacement.~4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.~5. The subject has active endocarditis.~6. Subjects with active myocarditis~7. The subject is or will be participating in a concomitant research study of an investigational product.~8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.~9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.~10. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.~11. Subjects with known hypersensitivity to nickel alloys.~12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.~13. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.~14. Subject is known to be noncompliant or is unlikely to complete the study.~15. Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.

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

Study Arms:
- Perceval S Aortic Heart Valve (Type: EXPERIMENTAL): Treatment with the Perceval S Aortic Heart Valve

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)

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

Eligibility Criteria:
Inclusion Criteria:~1. Sign a consent form that has been approved by the Institutional Review Board.~2. Be at least 18 years of age.~3. Scheduled to undergo coronary artery bypass grafting with EVH.~4. Be able to return to Duke University Medical Center for post-operative visit.~Exclusion Criteria:~1. Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.~2. Reported allergy to FloSeal Matrix™

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

Study Arms:
- Arm A (Type: EXPERIMENTAL): Arm A has FloSeal Matrix applied to EVH wound bed.
- Arm B (Type: NO_INTERVENTION): Arm B does not have FloSeal Matrix applied to EVH wound bed.

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: Improving the Care of Diabetic Patients: A Randomized Trial of a Family Physician Office-Based Chronic Disease Care Model for Patients With Type 2 Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with type 2 diabetes (2003 classification by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus) receiving any therapy with HbA1c of \> or = 7.0% between the ages of 40 - 75 years.~Exclusion Criteria:~* Type 1 diabetes~* Pregnancy~* Severe diabetic complications that include end stage renal disease requiring dialysis~* Proliferative retinopathy (growth of new vessels on the retina and posterior surface of the vitreous that requires laser therapy)~* Uncontrolled cardiovascular disease (CVS event within 1 year of enrollment)~* Psychiatric disease or cognitive impairment that would interfere with treatment compliance~* Cancer or terminally ill patients with less than 6 months life expectancy~* Blindness~* Other severe co- morbid diseases~* Participation in another intense multifactorial intervention for the management of type 2 diabetes~* Participation in another study

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Usual Care Group (Type: ACTIVE_COMPARATOR): The 'usual care' study arm (control) will reflect current patterns of care for patients with thpe 2 diabetes in the Capital Health region
- Enhanced Care Group (Type: EXPERIMENTAL): In the enhanced care group(intervention arm) the participants will receive a multifactorial intervention with three main components that include: optimized medical management, 2) support for development of enhanced patient self management skills, and 3) organized proactive follow-up by chronic disease management teams to support improvement in care.

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

Answer: outcome: terminate
termination_type: enrollment issues