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

Trial Title: Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

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

Eligibility Criteria:
Inclusion Criteria:~Diagnosis of tuberousclerosis Angiomyolipoma \>2cm age\>10 years~Exclusion Criteria:~Creatinine \>4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit\<27% Thrombocytopenia (\<100.000/mm3) Leukopenia (\<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(\>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

- Gender: ALL
- Minimum Age: 10 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: An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female patients ≥ 18 years of age~2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2~3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)~4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol~5. CML-CP patients initiated on any dose of imatinib~6. Ability to provide written informed consent prior to any study related screening procedures being done~Exclusion Criteria:~1. Loss of CHR or cytogenetic response~2. Prior accelerated phase or blast phase CML~3. Previously documented T315I mutation~4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.~5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.~6. Treatment with other investigational agents within 30 days of Day 1.~7. History of non-compliance to medical regimens or inability to grant consent.~8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- nilotinib (Type: EXPERIMENTAL): Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).

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 of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain~Exclusion Criteria:~* allergy in fentanyl or morphine~* abnormal cognitive function patient

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

Study Arms:
- Injectable Fentanyl in Sublingual Route (Type: EXPERIMENTAL): Injectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
- Oral Morphine Syrup (Type: ACTIVE_COMPARATOR): Oral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred

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

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

Trial Title: Safety Study Looking at the Effects of Stendra on Vision

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy adult males 18 to 45 years of age, inclusive~* Non-tobacco user for at least 6 months prior to first dose~Exclusion Criteria:~* History or presence of retinal disease or any vision defects including color vision~* Intraocular pressure value ≥ 22mm Hg~* Resting heart rate \< 45 or \> 90 beats per minute (3 rechecks)~* Systolic blood pressure \< 90 or \> 140 mm Hg or Diastolic blood pressure \< 50 or \>90 mm Hg (3 rechecks)~* Initiation or change in dose of any α-blockers 14 days prior to randomization

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Active (Type: EXPERIMENTAL): Stendra 200 mg
- Placebo (Type: PLACEBO_COMPARATOR): 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: Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy men or women between the ages of 18 and 45 years old~Exclusion Criteria:~* History (including family history) or symptoms of, or risk factors for bleeding~* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition~* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants~* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Module 2 (210 mg) (Type: EXPERIMENTAL): 210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min)
- Module 2 (420 mg) (Type: EXPERIMENTAL): 420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min)
- Module 2 (600 mg) (Type: EXPERIMENTAL): 600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min)
- Module 2 (720 mg bolus + 240 mg infusion) (Type: EXPERIMENTAL): 720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min)
- Module 2 (800 mg bolus + 960 mg infusion) (Type: EXPERIMENTAL): 800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\]
- Module 2 Placebo (Type: EXPERIMENTAL): Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous fusion.

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: Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

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

Eligibility Criteria:
Inclusion Criteria:~* ASA status I-11~* patients performing colonoscopy~* sign the informed consent~Exclusion Criteria:~* BMI\>30, pregnant~* diabetes~* depression~* patients dependent on opioids~* hypertension poorly controlled~* serious complications of important organs~* obvious abdominal pain before colonoscopy

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

Study Arms:
- Butorphanol group (Type: EXPERIMENTAL): None
- control group (Type: PLACEBO_COMPARATOR): None

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

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

Trial Title: Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids

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

Eligibility Criteria:
Inclusion criteria:~* fasting plasma TG levels between 150 and 500 mg/dL~* C-reactive protein (CRP) levels ≥2 µg/mL~* at least one of the following criteria for the definition of metabolic syndrome:~  * abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women),~ * hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and~ * fasting glucose ≥110 mg/dL.~Exclusion criteria:~* high-fish diets (\>2 fish meals/week)~* taking fish oil supplements or supplements containing EPA or DHA~* allergy to sardines~* allergy to sunflower oil~* regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)~* anticoagulant therapy~* alcohol consumption \>7 drinks/week~* uncontrolled thyroid dysfunction~* insulin-dependent type 2 diabetes mellitus~* kidney or liver disease~* smoking~* alterations in coagulation~* use of lipid altering medications

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 75 Years
- Healthy Volunteers: t

Study Arms:
- EPA intervention (Type: EXPERIMENTAL): Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
- DHA intervention (Type: EXPERIMENTAL): Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): 3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.

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 Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

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:~* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.~* Subject is 18 years of age or older.~* Subject must be receiving hemodialysis 3 times weekly for at least 3 months~* Subject agrees to not participate in another study of an investigational agent during the study.~* Other Inclusion Criteria may apply~Exclusion Criteria:~* Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.~* Other investigational procedures while participating in this study are excluded.~* Anticipated or scheduled parathyroidectomy during the study period.~* Subject has received a parathyroidectomy within 3 months prior to dosing.~* Anticipated or scheduled kidney transplant during the study period.~* Subject has known sensitivity to any of the products or components to be administered during dosing.~* Subject has participated in a prior clinical trial of AMG 416 (also referred to as KAI-4169).~* Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).~* Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.~* Other Exclusion Criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- Etelcalcetide (Type: EXPERIMENTAL): Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 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: Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

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

Eligibility Criteria:
Inclusion Criteria:~* Subject is aged ≥ 21 years.~* Subject is Caucasian.~* Subject is healthy, as judged by the Investigator.~* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.~* Subject has smoked at least for the last 3 years.~* Subject does not plan to quit smoking in the next 3 months.~Exclusion Criteria:~* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).~* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.~* Female subject is pregnant or breast feeding.~* Female subject does not agree to use an acceptable method of effective contraception.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- CHTP 1.0 (Type: EXPERIMENTAL): Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
- Conventional cigarette (CC) (Type: ACTIVE_COMPARATOR): Ad libitum use of subject's own preferred brand of CC for 5 days in confinement

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: Replacement GH Therapy After Bariatric Surgery in Patients With Very Severe Obesity

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:~* Age between 18-50 yrs~* Normal glucose tolerance during standard oral glucose tolerance test (OGTT)~* Inclusion criteria for bariatric surgery proposed by the 1991 National Institutes of Health Consensus Development Panel Report.~Exclusion Criteria:~* Liver or renal failure, cancer, acute or chronic inflammatory diseases~* Chronic treatment with any type of medications~* organic pituitary deficiency~* Bulimia Nervosa of the DSM-IV~* Ulcers or malignancies excluded by oesophagus-gastro-duodenoscopy.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): The clinical examination will determine anthropometric indexes (weight, height, BMI, waist circumference). The biochemical evaluation will include the measurement of lipid profile, fasting plasma glucose and insulin, liver test function, FT3, FT4, GHRH + Arginine test to detect GHD, plasma IGF-I levels. The instrumental evaluation will include DEXA Total Body and bioimpedance analysis to determine body composition, and liver ultrasounds.
- 2 (Type: PLACEBO_COMPARATOR): PHASE II: In the medical treatment protocol very severe obese patients with persistent GHD after LASGB will be inclosed. Starting from 15-day, GHD patients were re-evaluated by GHRH + Arginine test. After evaluation, the patients with persistent GHD will be randomized to be treated with Recombinant GH replacement therapy (Group A: Recombinant GH replacement therapy at the initial dose 0.15-0.30 mg/die; dose adjustment will be made according to IGF-I levels; Group B: no GH treatment).

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 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL

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

Eligibility Criteria:
Inclusion criteria :~* Male or Female.~* Age ≥ 18 years.~* With Type 1 diabetes mellitus.~* Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.~* Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.~* Patients who have signed an Informed Consent Form.~Exclusion criteria:~* Type 2 diabetes mellitus.~* Known hypoglycemia unawareness~* Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.~* End-stage renal failure or being on hemodialysis.~* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.~* Known hypersensitivity / intolerance to insulin glargine or any of its excipients.~* Patients treated with glucagon like peptide agonists.~* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.~* Pregnant or lactating women.~* Women of childbearing potential with no effective contraceptive method.~* Participation in another clinical trial.~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: None
- Healthy Volunteers: f

Study Arms:
- Insulin glargine (U300) (Type: EXPERIMENTAL): Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.

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: Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Children \>6 years of age and \< 12 years of age, who snore and have an apnea hypopnea index (AHI) \< or equal 7 or Respiratory arousal index \> or equal 2~Exclusion Criteria:~* Hypersensitivity to budesonide~* Recent nasal trauma~* Nasal surgery or nasal septum perforation~* Current therapy with drugs interacting with budesonide (erythromycin clarythromycin, ketoconazole and cimetidine)~* Immunodeficiency or immunosuppressant therapy~* Craniofacial, neuromuscular, syndromic or defined genetic abnormalities~* Acute upper respiratory tract infection~* Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and~* Children who already had adenotonsillectomy in the past 12 months.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- Budesonide (Type: EXPERIMENTAL): Budesonide for 6 weeks followed by crossover to placebo
- Placebo (Type: PLACEBO_COMPARATOR): Placebo for 6 weeks followed by crossover to treatment.

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: Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed OSA (moderate-to-severe; apnea hypopnea index \>15 events/hr)~Exclusion Criteria:~* Cardiovascular disease other than well controlled hypertension~* Depression

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

Study Arms:
- Desipramine First, Placebo Second (Type: ACTIVE_COMPARATOR): Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
- Placebo First, Desipramine Second (Type: EXPERIMENTAL): Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.

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

Answer: outcome: complete