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

Trial Title: Karma Intervention Study

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

Eligibility Criteria:
Inclusion Criteria:~* Attending the national mammography screening program, i.e. aged 40-74 and has performed a screening mammogram maximum 3 months prior to study inclusion~* Having a measurable mammographic density, i.e. ≥4.5 % density (volumetric) measured by Volpara~* Informed consent must be signed before any study specific assessments have been performed~Exclusion Criteria:~* Pregnancy at start, during time of study medication and up to 3 months after quitting study medication~* Any previous or current diagnosis of breast cancer (including carcinoma in situ)~* Mammographic BI-RADS code 3 or above at baseline mammography, or at a diagnostic mammography during time of treatment (the first 6 months of the study)~* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix~* Currently using oral oestrogen and progesterone based hormone replacement therapy~* Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.~* A history of thrombo-embolic disease such as embolies, deep vein thrombosis, stroke, TIA or cardiac arrest.~* Known APC (Activated protein C )- resistance, an inherited hemostatic disorder~* A history of major surgery of the breast, e.g. reduction or enlargement, which might affect density measurements~* Women who have an increased risk of venous thrombosis due to immobilization, e.g. using wheelchair~* Known uncontrolled diabetes~* Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg~* Use of drugs that interfere with CYP2D6 expression such as Seroxat (paroxetine), Fontex (fluoxetin) and Zyban / Voxra (bupropion)~* Use of Waran (warfarin)~* Non-medical approved drugs against hot-flashes including phytooestrogen~* Not able to understand study information and/or informed consent

- Gender: FEMALE
- Minimum Age: 40 Years
- Maximum Age: 74 Years
- Healthy Volunteers: t

Study Arms:
- 20 mg tamoxifen (Type: ACTIVE_COMPARATOR): None
- 10 mg tamoxifen (Type: EXPERIMENTAL): None
- 5 mg tamoxifen (Type: EXPERIMENTAL): None
- 2.5 mg tamoxifen (Type: EXPERIMENTAL): None
- 1 mg tamoxifen (Type: EXPERIMENTAL): None
- 0 mg tamoxifen (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: A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

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:~1. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).~2. Disease severity Stage III (H\&Y staging) at ON.~3. Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600mg L-DOPA.~4. Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L-DOPA/DDCI dosage), despite optimal anti-PD therapy (based on Investigator's assessment).~Exclusion Criteria:~1. Non-idiopathic PD (atypical Parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome.~2. Severe and/or unpredictable OFF periods, according to Investigator judgment.~3. Average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).~4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last four weeks before screening.~5. Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Opicapone 50mg (Type: EXPERIMENTAL): None
- Levodopa 100mg (Type: ACTIVE_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: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes

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:~* Not previously treated with oral antidiabetic agents as defined by the protocol~* Blood glucose criteria must be met~* Body mass index (BMI) in the range 22-45~Exclusion Criteria:~* Pregnancy or lactation~* Type 1 diabetes~* Evidence of serious diabetic complications~* Evidence of serious cardiovascular complications~* Laboratory value abnormalities as defined by the protocol~* Known sensitivity to pioglitazone~* Other protocol-defined exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- 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: Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib

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

Eligibility Criteria:
Inclusion Criteria~* Subject has undergone previous nephrectomy.~* Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.~* Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.~* ECOG Performance Score of 0-1.~* No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.~* Willing to take adequate measures to prevent pregnancy.~Exclusion Criteria~* Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.~* Subject has untreated brain or meningeal metastases.~* Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.~* Prior use of Avastin is allowed.~* The subject is receiving therapeutic anticoagulation therapy.~* The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).~* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 100 mmHg; or systolic blood pressure (BP) \> 150 mmHg.~* The subject has a history of myocardial infarction within 6 months of Study Day 1.~* The subject has a documented left ventricular (LV) Ejection Fraction \< 50%.~* The subject has known autoimmune disease with renal involvement (eg, Lupus).~* Female subjects who are pregnant or breast feeding.~* Subject is receiving anti-retroviral therapy for HIV.~* Subject has a clinically significant uncontrolled condition(s) including but not limited to:~  * active uncontrolled infection,~ * Class III or IV heart failure as defined by the New York Heart Association functional classification system,~ * unstable angina pectoris or cardiac arrhythmia,~ * history of adrenal insufficiency,~ * psychiatric illness/social situation that would limit compliance with study requirements;~ * Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption.~ * Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.

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

Study Arms:
- Single arm (Type: EXPERIMENTAL): One oral dose 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: A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of \>=220 and \<=450~* In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.~Exclusion Criteria:~* Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated~* Had intra-abdominal surgery within 6 months prior to entering the study~* Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition \[TPN\]) within 6 weeks of baseline

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

Study Arms:
- Population 1: Placebo SC followed by ustekinumab SC (Type: EXPERIMENTAL): Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
- Population 1: Ustekinumab SC followed by Placebo SC: (Type: EXPERIMENTAL): Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
- Population 1: Placebo IV followed by ustekinumab IV (Type: EXPERIMENTAL): Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
- Population 1: Ustekinumab IV followed by Placebo IV: (Type: EXPERIMENTAL): Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
- Population 2: Ustekinumab SC (Type: EXPERIMENTAL): Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
- Population 2: Ustekinumab IV (Type: EXPERIMENTAL): Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.

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 PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent must be obtained before any assessment is performed.~* Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.~* patients with Type 2 diabetes, HbA1c \<10% at screening.~* Body mass index (BMI) ≤ 50 kg/m\^2 at screening.~Exclusion Criteria:~* Patients with Type 1 diabetes~* Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase \>3 X ULN; serum bilirubin \> 1.5 X ULN.~* Patients undergoing any method of dialysis~* clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.~* subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 78 Years
- Healthy Volunteers: f

Study Arms:
- Mild (Type: EXPERIMENTAL): Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
- Moderate A (Type: EXPERIMENTAL): Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
- Moderate B (Type: EXPERIMENTAL): Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
- Severe (Type: EXPERIMENTAL): Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
- Normal (Type: EXPERIMENTAL): Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.

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 Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

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

Eligibility Criteria:
Inclusion Criteria:~* All patients with an epidural catheter in situ for labor analgesia, status post a vaginal delivery, and scheduled for a postpartum tubal ligation under epidural anesthesia will be eligible~Exclusion Criteria:~* Allergy/hypersensitivity to morphine~* Allergy/hypersensitivity to ester-linked local anesthetics or para-amino benzoic acid (PABA)~* Body Mass Index \>40 kg/m2~* Patients using chronic opioids~* History of obstructive sleep apnea~* Any contraindication to epidural anesthesia

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: t

Study Arms:
- morphine - 2CP-saline (MCS) (Type: EXPERIMENTAL): morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
- saline-2CP-morphine (SCM) (Type: EXPERIMENTAL): saline will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level;morphine will be administered at skin incision
- saline-lidocaine-morphine (SLM) (Type: ACTIVE_COMPARATOR): Saline will be administered 30 min prior to epidural anesthesia; lidocaine will be used to achieve a T4 level; morphine will be administered at skin incision

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: Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma

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:~* Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.~* Must have relapsed or relapsed/refractory disease~* 18 years of age or older~* All baseline studies must be performed within 21 days of enrollment.~* ECOG performance status of 0 to 2~Exclusion Criteria:~* Renal insufficiency (serum creatinine levels \> 2mg/dL)~* Concomitant therapy medications that include corticosteroids~* Peripheral neuropathy of Grade 3 or greater or painful Grade 2~* Evidence of mucosal or internal bleeding and/or platelet refractory~* ANC \< 1000 cells/mm3~* Hemoglobin \< 8.0 g/dL~* AST (SGOT and ALT) \> 2 x ULN~* Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol~* Known hypersensitivity to thalidomide or the development of erythema nodosum~* Active infection or serious co-morbid medical condition~* Pregnant or breast-feeding women~* Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

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

Study Arms:
- CC-5013 in combination with bortezomib (Type: EXPERIMENTAL): Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.

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 IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

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:~Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.~Exclusion criteria:~Participant participating in another investigational interventional study.~The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Study Arms:
- Alemtuzumab (Type: EXPERIMENTAL): All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).

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 and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

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

Eligibility Criteria:
Inclusion Criteria:~1. Healthy adult subjects 18 to 64 years of age,~2. Individuals willing to provide written informed consent,~3. Individuals in good health,~4. Individuals willing to allow for their serum samples to be stored beyond the study period.~Exclusion Criteria:~1. Individuals not able to understand and follow study procedures,~2. History of any significant illness,~3. History of any chronic medical condition or progressive disease,~4. Presence of medically significant cancer,~5. Known or suspected impairment/alteration of immune function,~6. Presence of any progressive or severe neurologic disorder,~7. Presence of any bleeding disorders or conditions that prolongs bleeding time,~8. History of allergy to vaccine components,~9. Receipt of any other investigational product within 30 days prior to entry into the study,~10. History of previous H5N1 vaccination,~11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,~12. Receipt of any other vaccine within 2 weeks prior to entry into the study~13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,~14. Pregnant or breast feeding,~15. Females of childbearing potential refusing to use acceptable method of birth control,~16. Body mass index (BMI) ≥ 35 kg/m2,~17. History of drug or alcohol abuse,~18. Any planned surgery during study period,~19. Individuals conducting the study and their immediate family members,~20. Individuals with behavioral or cognitive impairment or psychiatric diseases.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: t

Study Arms:
- aH5N1c-High Dose (Type: EXPERIMENTAL): Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
- aH5N1c-Low dose (Type: EXPERIMENTAL): Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.

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: The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patient's weight has been stable for at least 6 weeks~* Patient is in good health based on medical history, physical exam, and laboratory tests~* Patient has dyslipidemia~Exclusion Criteria :~* Patient has a history of stroke, seizures, or major neurological disorders~* Patient has a history of cancer~* Patient is currently taking any lipid-lowering medications or substances except for statins~* Patient consumes excessive amounts of alcohol or caffeine~* Patient has multiple and/or severe allergies to food or drugs

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

Study Arms:
- Panel A (Type: EXPERIMENTAL): Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
- Panel B (Type: EXPERIMENTAL): Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin

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

Answer: outcome: complete