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

Trial Title: Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

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:~* Age 18-70 years, male or female~* High cryptoglandular perianal fistula~* Written approval for the study~* Sufficient co-operation for the study~* Localization of the fistula by ultrasound or MRI~Exclusion Criteria:~* Crohns disease~* Immunosuppressive treatment~* Anovaginal fistula~* Radiation therapy 6 months before study~* Chemotherapy 6 months before study~* Low- or intersphincteric fistula

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Fistula patients (Type: None): Gore-BioA Fistula Plug

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 Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)

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

Eligibility Criteria:
Inclusion Criteria:~1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth~2. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP~3. Clinical course consistent with RDS.~4. Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.~Exclusion Criteria:~1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS~2. Respiratory Distress not secondary to surfactant deficiency~3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.~4. Major congenital anomalies.~5. Evidence of severe birth asphyxia~6. Mothers with prolonged rupture of the membranes~7. Presence of air leaks.~8. Presence of IVH (intraventricular hemorrhage ) ≥ III.~9. Hypotension or evidence of hemodynamic instability.~10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.~11. Participation in another clinical trial

- Gender: ALL
- Minimum Age: 28 Weeks
- Maximum Age: 32 Weeks
- Healthy Volunteers: f

Study Arms:
- nCPAP+ Nebulised Curosurf® (Type: EXPERIMENTAL): Curosurf® administered through nebulization
- nCPAP alone (control) (Type: OTHER): Standard of care, respiratory support used also during experimental arms

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

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

Trial Title: Treating H. Pylori in Parkinson's Patients With Motor Fluctuations

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

Eligibility Criteria:
Inclusion criteria:~* Adults diagnosed with idiopathic Parkinson's disease, Hoehn \& Yahr stage 2-4 in the off state, with no other concomitant neurologic diseases.~* Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy, but with wearing off phenomenon present between levodopa doses (average off time ≥3 hours off time/day).~* Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is acceptable. Parkinson's disease treatment may also include any of the following medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, anticholinergics.~* Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment arms).~Exclusion criteria:~* Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding.~* History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal lesions.~* History of previous gastric surgery.~* History of previous brain surgery for Parkinson's disease.~* Family history of gastric cancer.~* Prior treatment for H. pylori+ status.~* Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or clarithromycin.~* Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole.~* Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide).~* Inability to tolerate or participate in testing in the morning in an off state.~* Inability to communicate effectively with study personnel in English.~* Pregnancy.

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

Study Arms:
- Active-placebo (Type: OTHER): These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
- Placebo-active (Type: OTHER): These subject receive treatment with placebo therapy followed by treatment with active triple therapy.

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: Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

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

Eligibility Criteria:
Inclusion Criteria:~* Meet the indications for therapy~* Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.~* Eligible for AV nodal ablation and permanent pacemaker implantation~* NYHA Class II or III heart failure~* Age ≥ 18 years~* Understand the nature of the procedure~* Ability to tolerate the surgical procedure required for implantation~* Give informed consent~* Able to complete all testing required by the clinical protocol~* Available for follow-up visits on a regular basis at the investigational site~Exclusion Criteria:~* Meet one or more of the contraindications~* Have a life expectancy of less than six months~* Expected to receive heart transplantation within six months~* Enrolled in another cardiovascular or pharmacological clinical investigation~* Patients with an ICD, or being considered for an ICD~* Patients with previously implanted biventricular pacing systems~* Patients with previously implanted single or dual chamber pacing system with \> 50% documented ventricular pacing~* Patients with previous AV node ablation~* Six-minute walk test distance greater than 450 meters~* Any condition preventing the patient from being able to perform required testing~* Presence of another life-threatening, underlying illness separate from their cardiac disorder~* Conditions that prohibit placement of any of the lead systems

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
- 2 (Type: ACTIVE_COMPARATOR): Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
- 3 (Type: ACTIVE_COMPARATOR): Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV 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: Progesterone for the Treatment of Traumatic Brain Injury III

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

Eligibility Criteria:
Inclusion Criteria:~* Moderate to severe brain injury (GCS 12-4)~* Age 18 years or older~* Blunt, closed head injury~* Study drug initiated within 4 hours of injury~Exclusion Criteria:~* Non-Survivable injury~* Bilateral dilated unresponsive pupils~* Severe intoxication (ETOH \> 250 mg %)~* Spinal cord injury with neurological deficits~* Inability to perform activities of daily living prior to injury~* Cardiopulmonary arrest~* Status epilepticus on arrival~* Systolic blood pressure (SBP) \< 90 on arrival or for at least 5 minutes prior to enrollment~* O2 Sat \< 90 on arrival or for at least 5 minutes prior to enrollment~* Prisoner or ward of state~* Pregnant~* Active breast or reproductive organ cancers~* Known allergy to progesterone or intralipid components (egg yolk)~* Known history of clotting disorder~* Active thromboembolic event~* Concern for inability to follow up at 6 months~* Anyone listed in the Opt out registry

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

Study Arms:
- Progesterone (Type: EXPERIMENTAL): Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone will be combined with a 20% Intralipid mixture for infusion.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour loading dose of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The placebo will be combined with a 20% Intralipid mixture for infusion.

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: FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease

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

Eligibility Criteria:
Inclusion Criteria:• Males and female between 40 and 85 years of age~* subjects referred to The Cleveland Clinic Foundation for a catheter-based revascularization procedure as treatment of intermittent claudication~* Leg symptoms consistent with intermittent claudication for a period of at least 3 months~* Ankle-brachial index (ABI) in the leg to be revascularized must be \< 0.90 or demonstration of post exercise fall in ABI to \< 0.9 for subjects with aortoiliac disease~* Subjects scheduled for both aortoiliac and/or femoropopliteal revascularization procedures will be eligible~* Subjects with bilateral leg symptoms may be enrolled, as long as bilateral revascularization procedures are planned~Exclusion Criteria:~* • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies~  * Critical limb ischemia (rest pain, non-healing ulcer, gangrene)~ * Contraindication to contrast arteriography~ * Vascular surgery or prior catheter-based vascular intervention within the preceding 6 months~ * Patients with suspected or confirmed graft stenoses or occlusions~ * Myocardial infarction or hospitalization for unstable angina, coronary artery bypass grafting or percutaneous coronary intervention, within the preceding one month~ * Stroke or transient ischemic attack within the preceding one month~ * Pregnancy or planned pregnancy during the one year of participation in the trial.~ * Any active chronic inflammatory condition,including autoimmune disorder or active malignancy.Subjects unable to walk, amputees, and subjects with a contraindication to treadmill exercise.~ * Patients with dementia or other significant cognitive impairment~ * Patients who are non-English speaking, (due to the need for subjects to complete standardized questionnaires)

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

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: The Influence of Ambulation on the Return of Bowel Function After Colorectal Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Subject patients are those who will undergo colorectal surgeries at NMCP. Colorectal surgery is defined as any surgery involving the gastrointestinal tract from the ileocecal valve to the dentate line and includes all laparoscopic approaches. This surgery includes, but is not limited to:~  * Ileocecetomy~ * Partial colectomy (including right, left, and sigmoid colectomies)~ * Hartmann procedure~ * Total abdominal colectomy~ * Proctocolectomy~ * Colostomy formation or takedown~ * Low anterior resection~ * Abdominoperineal resection~Exclusion Criteria:~* Reasons for subject exclusion are non-ambulatory conditions are conditions whereby a subject cannot walk or move from place to place. Examples of non-ambulatory conditions include but are not limited to: severe vasculopathy with limiting claudication (leg pain when ambulating due to poor blood flow) of less than 100 meters, all wheelchair bound conditions (anatomically missing both legs without adequate prosthesis, severely limiting pulmonary disease, neurologic disorders - Amyotrophic Lateral Sclerosis, severe multiple sclerosis, paraplegia), fractured leg bones requiring temporary and/or permanent use of a walking aid or any congenital disorders limiting ambulation (osteogenesis imperfecta, muscular dystrophy, cerebral palsy). Any patient who takes Alvimopan (Entereg ®) will be excluded or terminated from the study. Alvimopan is an FDA-approved drug that accelerates bowel motility and is used to prevent and/or treat post-operative ileus. In addition, patients with underlying gastrointestinal motility issues, gastroparesis, chronic constipation, etc or who may have complications who may not be able to ambulate during the hospital course (i.e. prolonged intubated postoperatively) will be excluded as well. Pregnant women will also be excluded from the study.

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

Study Arms:
- Traditional Ambulation regimen (Type: PLACEBO_COMPARATOR): All patients will receive pedometers to record the total amount of ambulation. These patients will ambulate without limitations or goals. Most surgeons request that post-operative patients ambulate at least 2 to 3 times a day.
- Walkers (Type: ACTIVE_COMPARATOR): All patients will receive pedometers to record the total amount of ambulation. Patients in the experimental group will have assigned nursing staff assisting in ambulation in these patients at least three times a day.

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: Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port

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:~* male or female ages 18 and up~* utilizing a regimen of at least two injections daily of insulin and at least two injections daily of Symlin~* able to understand and sign an informed consent form and HIPPA form~* agrees to all study visits and procedures~* HbA1c between \>6.5 and \<9.0 (inclusive)~Exclusion Criteria:~* history or current diagnosis of chronic disease which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study~* history of malignancy with in the last five years of study entry (other than basal cell carcinoma)~* current use of any drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine), agents that slow intestinal absorption of nutrients (e.g. a-glucosidase inhibitors) or promotility agents (e.g. metaclopromide)~* any contraindication of Symlin or I-PORT according to the package labeling~* are female and pregnant, lactating or planning to become pregnant during the duration of the trial~* are poorly compliant with their current insulin and/or Symlin regimen, as defined by their HCP~* has history of known hypersensitivity to plastics or polymers~* treatment with any investigational drug within one month prior to enrollment~* myocardial infarction or stroke within six months prior to screening~* initiated use of Symlin pen or any Insulin pen in lieu of a vial in last 4 weeks (pen use is okay as long as they have been using it for at least 4 weeks prior to screening visit)~* female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, double barrier methods, Intrauterine devices, surgical sterilization or vasectomized partner)~* have confirmed diagnosis of gastroparesis~* have hypoglycemia unawareness

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

Study Arms:
- I-PORT (Type: ACTIVE_COMPARATOR): Treatment group
- standard injections (Type: ACTIVE_COMPARATOR): control group

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: Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)

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:~* written informed consent from the patient or his/her legal representative~* ventral hernia requiring elective surgical repair~Exclusion Criteria:~* no written informed consent~* 'hostile' abdomen; open abdomen treatment~* contraindication to pneumoperitoneum~* emergency surgery (incarcerated hernia)~* parastomal hernia

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Laparoscopic Ventral hernia repair by heavy weight mesh
- 2 (Type: EXPERIMENTAL): Laparoscopic Ventral hernia repair by lighter weight mesh

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: Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis

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:~* elective CABG, valvular procedure~Exclusion Criteria:~* non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- TEE report (Type: None): Cardiac surgery patients requiring TEE

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: Effects of Bosentan on Respiratory Mechanics

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients with World Health Organization (WHO) functional class II-III.~* A systemic pulse oximetry (SpO2) between 70% and 90% at rest with room air and a baseline 6-minute walk distance between 150 and 450 m were required for inclusion.~* PAH confirmed by cardiac catheterization as mean pulmonary arterial pressure greater or equal to25 mm Hg, pulmonary capillary wedge pressure lower 15 mm Hg,~Exclusion Criteria:~* Patients were excluded if they had patent ductus arteriosus (for hemodynamic assessment difficulties)~* complex congenital heart defect~* left ventricular dysfunction (left ventricular ejection fraction lower 40%)~* restrictive lung disease (total lung capacity lower 70% predicted)~* obstructive lung disease (forced expiratory volume in 1 second \[FEV1\] lower 70% predicted~* with FEV1/forced vital capacity lower 60%)~* or previously diagnosed coronary artery disease.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): treatment with Bosentan

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

Answer: outcome: terminate
termination_type: enrollment issues