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

Trial Title: Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Male and female subjects must be at least 45 years old at the time of consent.~* Subjects must have a pre-established primary clinical diagnosis of COPD.~* Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.~* Subjects must have a FEV1 ≥ 0.70L at Visit 1.~Exclusion Criteria:~* Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.~* Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 1.

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arformoterol 15 mcg twice daily (Type: ACTIVE_COMPARATOR): Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
- Tiotropium 18 mcg once daily (Type: ACTIVE_COMPARATOR): Tiotropium 18 mcg once daily/Placebo Inhalation Solution
- Arformoterol /Tiotropium (Type: EXPERIMENTAL): Arformoterol 15 mcg twice daily/Tiotropium 18 mcg 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: Maintenance Intermittent Therapy for Symptomatic GERD Patients

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

Eligibility Criteria:
Key Inclusion Criteria:~1. Male or female patients, 18 to 65 years of age.~2. If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.~3. Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.~4. Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.~5. Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.~Key Exclusion Criteria:~1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.~2. Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.~3. Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.~4. Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).~5. Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.~6. Patients with a history of endoscopically-proven esophagitis any time in the past.~7. Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Rabeprazole 20 mg (Type: EXPERIMENTAL): None

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

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

Trial Title: A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.~* Eastern Cooperative Group performance score of 0 to 2.~* Adequate hematologic, hepatic and renal function~* Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years~Exclusion Criteria:~* Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.~* Subjects with known history of brain metastases and primary CNS tumors.~* Hypersensitivity reactions to platinum compounds or gemcitabine.~* Clinically significant and uncontrolled major medical conditions~* Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.

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

Study Arms:
- Arm 1 (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: Individualized Obesity Pharmacotherapy

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

Eligibility Criteria:
Inclusion criteria:~* Adults with obesity (BMI \>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.~* Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.~Exclusion criteria~* Abdominal bariatric surgery~* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.~* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.~* Hypersensitivity to any of the study medications.~* No contraindications to all FDA-approved medications

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

Study Arms:
- Intervention group (Type: EXPERIMENTAL): Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
- Control Group (Type: ACTIVE_COMPARATOR): Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine

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: Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

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

Eligibility Criteria:
Inclusion Criteria:~* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria~* tolerate at least 300 mg/day of pregabalin~* have an incomplete response to pregabalin treatment~Exclusion Criteria:~* suicidal risk~* substance abuse~* pulmonary dysfunction~* renal impairment~* active cardiac disease~* liver disease~* narrow angle glaucoma~* autoimmune disease~* cancer~* inflammatory bowel disease~* unstable endocrine disease~* prostatic enlargement

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

Study Arms:
- Milnacipran Added (Type: EXPERIMENTAL): None
- No Treatment Added (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: Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence

Study Design Characteristics:
- Allocation: NON_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:~* Males or females between 21 and 45 years old~* Fulfill DSMIV criteria for cocaine abuse or dependence~* Able to give informed consent and comply with study procedures~* Medically Healthy~Exclusion Criteria:~* Major DSM-IV Axis I disorder other than cocaine abuse or dependence. Subjects with a history of other psychostimulant abuse/dependence or compulsive gambling will be excluded.~* Current use of opiates, sedative-hypnotic, and/or cannabis more than twice a week (use less than twice a week is acceptable).~* Current use of psychotropic medication such as antipsychotics or antidepressants.~* Presence or positive history of severe medical or neurological illness (including epilepsy), or any cardiovascular disease, low hemoglobin (Hb \< 14 gm/dL in males, Hb \< 12 gm/dL in females), or SGOT or SGPT \> 2-3 times normal. Chronic active hepatitis B or C will also be an exclusion criteria.~* Resting SBP \>150, DBP \> 90~* Pregnancy or lactation, lack of effective birth control during 15 days before the scans\*~* Evidence /report of any heart abnormality during intake medical history, EKG or physical exam.~* Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: Guide to MR procedures and metallic objects Shellock, PhD, Lippincott Williams and Wilkins, NY 2001.~* Lifetime exposure to radiation in the workplace, or history of participation in nuclear medicine procedures, including research protocols \*\*~* Positive Allen Test indicating lack of collateral blood flow to hand~* History of sensitivity to methylphenidate

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Contingency Management w/ CRA (Type: ACTIVE_COMPARATOR): Cocaine users: Contingency management w/ Community Reinforcement Approach
- Healthy Control (Type: NO_INTERVENTION): A group of healthy matched comparison subjects with no DSM-IV axis I Disorder was included; they were matched for cigarette smoking, gender, and ethnicity.

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: Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Between 42 and 55 days of age at the time of enrollment.~* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.~* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.~Exclusion Criteria:~* If child has previously had intussusception or abdominal surgery.~* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.~* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.~* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.~* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).~* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).~* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.~* The child has received rotavirus vaccine outside of this study.

- Gender: ALL
- Minimum Age: 42 Days
- Maximum Age: 55 Days
- Healthy Volunteers: t

Study Arms:
- Rotavirus Vaccine at age 6 & 10 weeks (Type: ACTIVE_COMPARATOR): Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 \& 10 weeks of age.
- Rotavirus vaccine at age 10 & 14 weeks (Type: EXPERIMENTAL): Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 \& 14 weeks of age.
- Rotavirus vaccine at age 6,10,&14 weeks (Type: EXPERIMENTAL): Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, \& 14 weeks of age.

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: Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

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:~1. In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.~   - Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks~2. Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.~3. Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.~4. ECOG performance status 0 or 1.~   * Leukocytes \>= 4,000/μL~  * absolute neutrophil count \>= 1,500/ μL~  * platelets \>= 100,000/ μL~  * HCT \> 28% (with or without growth factor support)~  * Creatinine \<= 2.5 mg/dl~  * total bilirubin \< 1.5 x upper limit of normal~  * transaminase \< 2.5 x upper limit of normal~5. Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.~6. Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.~7. Patients must have ability to understand and the willingness to sign a written informed consent document.~Exclusion Criteria:~1. Patients receiving any other investigational agents or devices.~2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).~3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.~4. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.~5. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.~6. Female patients who are pregnant or lactating are ineligible.

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

Study Arms:
- Arm 1: Perifosine + Capecitabine (Type: EXPERIMENTAL): Perifosine 50 mg/d qd + Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks until progression
- Arm 2: Perifosine Placebo + Capecitabine (Type: PLACEBO_COMPARATOR): Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m\^2 BID days 1 - 14 q 3 weeks until progression

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: Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 8.0

Eligibility Criteria:
Inclusion Criteria~* Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen~* Body mass index between 18.0 and 35.0 kg/m2, inclusive~* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1~* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant)during the full duration of the study~* Willing, committed and able to return for all the clinic visits and complete all study-related procedures~* Able to read, and able to sign the informed consent form~Exclusion Criteria:~* History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization~* Pregnant or breast-feeding women~* Blood donation of any volume within 1 month prior to administration of study drug~* Congestive heart failure~* Consumption of greater than 1 quart of grapefruit juice per day~* Previous exposure to any therapeutic or investigational biological agent within 30 days of screening~* History of alcohol or drug abuse within one year to the screening visit~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Group 1 with atorvastatin (Type: EXPERIMENTAL): Dose 1 versus placebo
- Group 2 with atorvastatin (Type: EXPERIMENTAL): Dose 1 versus placebo
- Group 3 with atorvastatin (Type: EXPERIMENTAL): Dose 2 versus placebo
- Group 4 with atorvastatin (Type: EXPERIMENTAL): Dose 2 versus placebo
- Group 5 with atorvastatin (Type: EXPERIMENTAL): Dose 3 versus placebo
- Group 6 with atorvastatin (Type: EXPERIMENTAL): Dose 3 versus placebo
- Group 7 without atorvastatin (Type: EXPERIMENTAL): Dose 3 versus placebo
- Group 8 with atorvastatin (Type: EXPERIMENTAL): Dose4 versus 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: ENB-GS-TBLB for the Diagnosis of PPLs

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

Eligibility Criteria:
Inclusion Criteria:~1. clinical and imaging characteristics suggestive of maligancy~2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.~Exclusion Criteria:~1. The lesion is close to the pleural membrane~2. Refusal of participation~3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

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

Study Arms:
- ENB-GS-TBLB-X-ray Group (Type: EXPERIMENTAL): The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
- GS-TBLB-X-ray group (Type: ACTIVE_COMPARATOR): The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

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

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

Trial Title: A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

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

Eligibility Criteria:
Inclusion Criteria:~1. Confirmed diagnosis of cystic fibrosis (sweat test/genotype)~2. Aged 8 years or older~3. Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease in FEV1 of 20% or more than that recorded 6-12 months previously.~4. As determined by the investigator, are capable and willing to~   * Use the study diary as required for this protocol~  * Able to perform all of the techniques necessary to measure lung function~  * Able to administer the dry powder mannitol~5. Are capable of and have given informed consent~6. Clinically stable at study entry~Exclusion Criteria:~1. Investigators, site personnel directly affiliated with this study, and their immediate families.~2. Subjects under the age of 8 years.~3. Subjects with currently active asthma~4. Subjects using hypertonic saline treatment in the last 2 weeks~5. Considered terminally ill or listed for transplantation~6. Requiring home oxygen or assisted ventilation~7. Colonisation with Burkholderia cepacia~8. Significant episode of hemoptysis (\>60 mls) in the previous 12 months~9. Myocardial Infarction in the six months prior to enrolment.~10. Cerebral Vascular Accident in the six months prior to enrolment.~11. Ocular surgery in the three months prior to enrolment.~12. Abdominal surgery in the three months prior to enrolment.~13. Subjects who are breast feeding or pregnant.~14. Female subjects of reproductive capability, not using a reliable form of contraception~15. Inability to obtain informed consent from the subject or subject's authorised representative.~16. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.~17. Known intolerance to mannitol or beta2 agonists.~18. Uncontrolled hypertension - systolic BP \> 160 and or diastoli

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: None
- Healthy Volunteers: f

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

Answer: outcome: complete