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

Trial Title: Safety and Efficacy Study of Pregabalin in Fibromyalgia

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

Eligibility Criteria:
Inclusion Criteria:~* At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites~* At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale~Exclusion Criteria:~* Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)~* Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening~* Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)~* Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

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

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

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

Trial Title: Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with endometriosis-associated pelvic pain and/or dysmenorrhea.~* Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice.~Exclusion Criteria:~- Patients participating in an investigational program with interventions outside of routine clinical practice.

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

Study Arms:
- BAY86-5300_YAZ-Flex (Type: None): Patients with endometriosis-associated pelvic pain or dysmenorrhea

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 MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Histologic diagnosis of adenocarcinoma of the prostate~* Metastatic prostate cancer (positive bone scan or measurable disease)~* Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.~* Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.~* Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.~* Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.~* Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.~* No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).~* Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.~Exclusion Criteria:~* Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.~* History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.~* Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.~* Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.~* Active infection requiring therapy.~* Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

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

Study Arms:
- MDX-010 (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: Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age.

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:~* Newborns or infants \< 6 months of age,~* boys and girls,~* premature or not,~* requiring general anesthesia induced by sevoflurane~* who presents during anesthesia a decrease of blood pressure superior to 20% of the basal mBP (measured prior to surgery) despite of vascular filling with sodium chloride 0.9% (10mL/kg during 10 min).~* Written, informed consent obtained from the 2 parents~Exclusion Criteria:~* Allergy to Ephedrine.~* Emergency surgery.~* Patient having previously received other vasopressive amines.~* Use of other indirect sympathomimetic drug such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate.~* Premedication with clonidine~* Congenital heart disease~* IV-induced anesthesia.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 6 Months
- Healthy Volunteers: f

Study Arms:
- Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG (Type: EXPERIMENTAL): Dose escalation: 6 successive cohorts with a maximal increasing dose
- Ephedrine, dose : 0.1 mg/kG, reference dose (Type: ACTIVE_COMPARATOR): Reference dose

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 to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

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

Eligibility Criteria:
Inclusion Criteria:~1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.~2. Has a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and a body weight greater than (\>) 50 kilogram (kg) at the Screening Visit.~3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug/invasive procedure.~Exclusion Criteria:~1. Has a positive alcohol or drug screen.~2. Has had a major surgery, donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 8 weeks of the first dose of study drug.~3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\] per day).~4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.~5. Has a substance abuse disorder.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- TAK-906 maleate 25mg;Itraconazole 200mg + TAK-906 maleate 25mg (Type: EXPERIMENTAL): TAK-906 maleate 25 milligram (mg), capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.

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: Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg in Elderly Patients With ACS

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

Eligibility Criteria:
Inclusion Criteria:~1. Ability to provide written informed consent in a time window 1 to 3 days after successful PCI;~2. Male or female, age ≥ 75 years at screening;~3. ACS at the time of the index hospitalization;~4. Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI;~5. Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose;~6. Successful PCI (Thrombolysis In Myocardial Infarction \[TIMI\] flow 3 and residual coronary stenosis \<30%) for non-ST-segment elevation ACS or ST-segment elevation myocardial infarction~Exclusion Criteria:~1. Use of glycoprotein IIb/IIIa receptor inhibitors;~2. Need for chronic oral anticoagulant therapy;~3. Prior fibrinolysis;~4. Unstable clinical status (hemodynamic or electrical instability);~5. Planned surgery requiring DAPT discontinuation during the study;~6. Prior stroke, transient ischemic attack or intracranial bleeding;~7. Active bleeding;~8. Severe anemia (hemoglobin \< 8g/dL);~9. Platelet count ≤80x103/ml;~10. Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);~11. Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);~12. Known hypersensitivity or contraindication to ticagrelor;~13. Under judicial protection, tutorship or curatorship;~14. Unable to understand and follow study-related instructions;~15. Enrollment in another investigational device or drug study.

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

Study Arms:
- Standard dose of ticagrelor (90 mg twice daily). (Type: EXPERIMENTAL): Standard dose of ticagrelor (90 mg twice daily) followed by lower dose of ticagrelor (60 mg twice daily).
- Low dose of ticagrelor (60 mg twice daily). (Type: EXPERIMENTAL): Low dose of ticagrelor (60 mg twice daily) followed by standard dose of ticagrelor (90 mg twice 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: Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment

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

Eligibility Criteria:
Inclusion Criteria:~* Consecutive patients \> 18 years of age admitted to participating internal and family medicine teams during the 1 year study period will be eligible to receive the pharmacist intervention. For the purposes of data analysis, patients with a most responsible or primary diagnosis of HF, COPD, CAP, T2DM, and CAD will be included.~Exclusion Criteria:~* Residence outside the Capital Health catchment~* Admitted for ≤ 2 days~* Palliative care~* Transferred to another team

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

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

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

Trial Title: A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

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:~1. Helicobacter pylori (HP)-positive participants as determined by \^13C-urea breath test (\^13C-UBT) at the start of the study (Visit 1 \[screening\]) and who require HP eradication in Physician judgment.~Exclusion Criteria:~1. Participant had any of the following conditions at the start of the study (Visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or duodenal ulcer (DU) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis, gastric or duodenal erosion are permitted to participate.~2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.~3. Participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).~4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface antigen \[HBsAg\] or hepatitis C virus \[HCV\]- antibody-positive).

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

Study Arms:
- Vonoprazan 20 mg (Type: EXPERIMENTAL): Vonoprazan 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.
- Esomeprazole 20 mg (Type: ACTIVE_COMPARATOR): Esomeprazole 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.

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: Insulin Glulisine in Type 2 Diabetic 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:~* Diabetes Mellitus, Type 2~* 25 \< BMI \< 45 kg/m²~* 7,5% \< HbA1c \< 9%~* Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months~Exclusion Criteria:~* Type 1 diabetes mellitus~* Treatment with OADs only~* Treatment with thiazolidinediones, with exenatide or with pramlintide~* Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)~* Active proliferative diabetic retinopathy,~* Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)~* Breast-feeding~* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.~* Treatment with systemic corticosteroids in the 3 months prior to study entry~* Treatment with any investigational product in the 2 months prior to study entry~* Previous treatment with insulin glulisine~* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol~* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult~* Impaired hepatic function~* Impaired renal function~* History of drug or alcohol abuse~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: 75 Years
- Healthy Volunteers: f

Study Arms:
- insulin glulisine+insulin glargine+metformin+glimepiride (Type: OTHER): Bolus arm
- insulin glargine+metformin+glimepiride (Type: OTHER): Control arm

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: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Genetically-confirmed Prader-Willi syndrome~* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of participant); provide voluntary, written assent (participants, as appropriate)~* PWS Nutritional Phase 3 (hyperphagic, rarely feels full)~Exclusion Criteria:~* Living in a group home~* Genetically diagnosed Schaaf-Yang syndrome or other genetic, hormonal, or chromosomal cognitive impairment~* New food-related interventions, including environment or dietary restrictions, within 1 month of screening~* Dose of any allowed chronic concomitant medications or supplements that have not been stable for ≥3 months prior to the study or is not expected to remain stable while participating in the study; adjustments in growth hormone dose ≤10% are not exclusionary~* Presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma~* More than 3 episodes of sinusitis in the 12 months prior to Screening Visit or presence of nasal diseases that may affect deposition of intranasal medication~* Unwilling to abstain from nasal saline, other nasal irrigation, or other intranasal medications for 2 weeks prior to the Baseline visit and during the 8-week, placebo-controlled period of the study~* Use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 months prior to screening~* Participation in an interventional research study involving another investigational medication or device in the 6 months prior to screening or during the study~* Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable medical condition, inability to comply with the protocol, or other risk to subject or to the integrity of the study

- Gender: ALL
- Minimum Age: 7 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): matched placebo during first 8-weeks; prospectively randomized 1:1 to either one of the two doses of carbetocin during 56-week follow-up and optional extension periods
- 3.2 mg of LV-101 (Type: EXPERIMENTAL): 3.2 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods
- 9.6 mg of LV-101 (Type: EXPERIMENTAL): 9.6 mg of LV-101 during first 8-weeks; remain on same dose during 56-week follow-up and optional extension periods

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 Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

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:~* The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.~* The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.~Exclusion Criteria:~* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.~* Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.~* Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.~* Past or planned surgery affecting gastric acid secretion.~* Clinically significant hepatic or renal disorder.~* Serious cardiac dysfunction, hypertension, or hematological disorder.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Lansoprazole 15 mg QD (Type: EXPERIMENTAL): None
- Gefarnate 50 mg BID (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: complete