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

Trial Title: Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias

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

Eligibility Criteria:
Inclusion criteria:~* Endoscopically diagnosed angiodysplasias~* Transfusion dependency: at least 4 red blood cell transfusions (per 500 ml or packed cells) and/or parental iron infusions (per 500 mg) in the year before inclusion~* Failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures~* Providing informed consent~* Older than 18 years~Exclusion Criteria:~* Liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension~* Previous treatment with octreotide for the same indication (refractory anemia due to angiodysplasias)~* Current thalidomide treatment which is effective (no transfusion dependency)~* Life expectancy \< 1 year~* Left ventricular assist devices (LVAD's)~* Hereditary hemorrhagic diseases or hematological disorders with active treatment~* Pregnancy or nursing women~* Uncontrolled diabetes as defined by HbA1C \>64 mmol/ml, despite adequate therapy~* Known hypersensitivity to somatostatin analogs~* Symptomatic cholecystolithiasis~* Systemic cancer under active treatment (chemotherapy or radiation therapy)

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

Study Arms:
- Octreotide (Type: ACTIVE_COMPARATOR): Drug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection
- Standard of care (Type: NO_INTERVENTION): Patients receive standard of care without a 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: Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)~Exclusion Criteria:~* Subjects with risks of hemorrhage~* Subjects with thrombolic risks~* Subjects who weigh less than 40 kg~* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

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

Study Arms:
- DU-176b (Type: EXPERIMENTAL): DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery
- Enoxaparin sodium (Type: ACTIVE_COMPARATOR): Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery

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: Cetuximab + Gemox in Biliary Tract Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)~* age ≥ 18 years~* ECOG performance status ≤ 2~* bidimensionally measurable disease per RECIST criteria~* no prior chemotherapy or targeted therapy for advanced disease~* adequate bone marrow reserve (neutrophil count \> 1500 /µL, platelet count \> 100,000 /µL)~* adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)~* adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)~* written informed consent~Exclusion Criteria:~* prior palliative treatment~* resectable disease~* brain metastases~* serious or uncontrolled concurrent medical illness~* pregnancy or nursing~* history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma~* peripheral neuropathy (grade \> 1)

- 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: Clofarabine Bone Marrow Cytoreduction

Study Design Characteristics:
- Allocation: None
- 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:~* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.~* Adequate hepatobiliary function as indicated by the following laboratory values:~  * SGOT/SGPT \<=2.5 x upper limit of normal~ * Alkaline phosphatase \<=2.5 x upper limit of normal~ * Serum bilirubin \< 1.5 mg/dl~ * Adequate renal function as indicated by the following laboratory values:~ * Creatinine Clearance \>50 ml/min~* Age \>/=18 years~* Zebroid performance status \</= 2 (See Appendix A)~* Life expectancy is not severely limited by concomitant illness (i.e. \< 3months life expectancy from non-leukemic conditions).~* No evidence of chronic active hepatitis or cirrhosis.~* HIV-negative~* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.~* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.~Exclusion Criteria:~* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.~* Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .~* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.~* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).~* Pregnant or lactating patients.~* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

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

Study Arms:
- Clofarabine (Type: EXPERIMENTAL): Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive 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: A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.~* Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.~* Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit~Exclusion Criteria:~* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.~* Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).~* Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.~* History of psoriasis unresponsive to topical treatments.~* History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

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

Study Arms:
- DFD01 Spray (Type: EXPERIMENTAL): DFD01 Spray twice daily for 28 days
- Vehicle Spray (Type: PLACEBO_COMPARATOR): Vehicle Spray twice daily for 28 days
- Comp01 Lotion (Type: ACTIVE_COMPARATOR): Comp01 Lotion twice daily for 14 days
- Vehicle Lotion (Type: PLACEBO_COMPARATOR): Vehicle Lotion twice daily for 28 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: Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

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:~* Clinical diagnosis of type 1 diabetes for one year or more~* Age 18 years or older~* Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)~* Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1~* As determined by the investigator, are capable and willing to do the following:~  * perform self monitoring of blood glucose (SMBG),~ * complete patient diaries as required for this protocol,~ * use the insulin injection device(s) according to the instructions provided,~ * are receptive to diabetes education,~ * comply with the required study visits.~Exclusion Criteria:~* Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.~* Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study~* Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding~* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.~* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

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

Study Arms:
- Insulin Lispro Protamine Suspension (Type: EXPERIMENTAL): Insulin Lispro Protamine Suspension twice daily
- Detemir (Type: ACTIVE_COMPARATOR): Insulin Levemir (detemir) subcutaneous (SC) 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: A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~* 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2~* Informed Consent~* Females of child-bearing potential must be using adequate contraception~Exclusion Criteria:~* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months~* Clinically significant renal, hepatic or psychiatric disease~* Unstable thyroid disease or replacement therapy~* Nephrolithiasis~* Obesity of known genetic or endocrine origin~* Participation in a formal weight loss program or lifestyle intervention~* Glaucoma or elevated intraocular pressure~* Pregnancy or breastfeeding~* Drug or Alcohol abuse~* Smoking cessation within previous 3 months or plans to quit smoking during study~* Eating disorders within past year~* Cholelithiasis within past 6 months~* Type 2 diabetes~* Previous bariatric surgery~* Bipolar disorder or psychosis~* Steroid hormone therapy not stable for 3 months~* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg

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

Study Arms:
- VI-0521 Top (Type: EXPERIMENTAL): VI-0521; high dose phentermine/topiramate
- VI-0521 Mid (Type: EXPERIMENTAL): VI-0521; mid dose phentermine/topiramate
- TPM 46 (Type: ACTIVE_COMPARATOR): mid dose topiramate
- TPM 92 (Type: ACTIVE_COMPARATOR): high dose topiramate
- PHEN 7.5 (Type: ACTIVE_COMPARATOR): mid dose phentermine
- PHEN 15 (Type: ACTIVE_COMPARATOR): high dose phentermine
- Placebo (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 Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Is a pre-menopausal female, between 18 and 47 years~* Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids~* Confirmed uterine fibroid(s) at screening~* Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).~* A Body Mass Index (BMI) between 18 and 45 inclusive~Exclusion Criteria:~* Participant is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period~* Received an investigational drug in the 30 days prior to the screening for this study~* Has an intrauterine device in place~* Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia~* Participants with abnormally high liver enzymes or liver disease

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 47 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
- Telapristone Acetate 6 mg (Type: EXPERIMENTAL): Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
- Telapristone Acetate 12 mg (Type: EXPERIMENTAL): Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.

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: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia

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:~* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.

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

Study Arms:
- Group 1 (Type: None): 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: Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

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:~* Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive)~* Measurable disease (breast and/or lymph nodes)~* No prior surgery other than biopsy and no prior chemotherapy or radiation therapy~* Age ≥18 years and age ≤70 years~* Karnofsky Performance score ≥70%~* Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material~* In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study)~* Her2/neu receptor analysis performed on the primary tumour in the biopsy material~* Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l~* Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL~* Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min~* Patients must be accessible for treatment and follow-up~* Written informed consent according to the local Ethics Committee requirements~Exclusion Criteria:~* Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy \> grade 2 whatever the cause~* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias~* Evidence of distant metastases (M1)~* Patients with a history of breast cancer~* Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception

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

Study Arms:
- A (Type: EXPERIMENTAL): Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel
- B (Type: EXPERIMENTAL): Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel

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: Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

Study Design Characteristics:
- Allocation: None
- 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:~* Have participated in and complied, to the best of their ability, with the protocol for AMB112529 and have met one of the following:~  1. Completed the Week 24 visit in AMB112529;~ 2. Required additional targeted treatment for PAH due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in AMB112529;~ 3. Required reduction in dose of baseline targeted treatment for PAH after ambrisentan was added to the treatment regimen;~ 4. In the opinion of the investigator, continued treatment with ambrisentan is warranted.~* A female is eligible to participate in this study, as assessed by the investigator, if she is of:~  1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,~ 2. Child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug (reliable methods of contraception are listed in Appendix 2).~* Subject or subject's legal guardian is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.~Exclusion Criteria:~* Subjects who were withdrawn from ambrisentan in Study AMB112529;~* Subjects who did not comply with the protocol in Study AMB112529;~* Female subjects who are pregnant or breastfeeding;~* Subjects with severe renal impairment (estimated creatinine clearance \<30 mL/min assessed within the previous 45 days) at the point of transition from Study AMB112529 into this study;~* Subject with clinically significant fluid retention in the opinion of the investigator;~* Subject with clinically significant anaemia in the opinion of the investigator;~* Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB112529.

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Ambrisentan (Type: EXPERIMENTAL): Open label, flexible dosing from 2.5 mg to 10 mg (not to exceed 0.25 mg/kg) per day

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

Answer: outcome: complete