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

Trial Title: A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~Phase 1~* In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.~* In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.~* Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group \[ECOG\] score of 0 or 1.~* Resolved acute effects of any prior therapy to baseline severity or Grade ≤1~Phase 2~* Adult women (≥ 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.~* Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.~* Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group \[ECOG\] score of 0 to 2.~Exclusion Criteria:~Phase 1~* Active uncontrolled or symptomatic CNS metastases.~* Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse~* Active or unstable cardiac disease or history of heart attack within 6 months~Phase 2~* HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.~* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.~* Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.

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

Study Arms:
- Single-agent PD-0332991 (Type: EXPERIMENTAL): Phase 1 Part 1
- PD-0332991 in combination with letrozole (Type: EXPERIMENTAL): Phase 1 Part 2
- PD-0332991 with letrozole (Type: EXPERIMENTAL): Phase 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: Memantine for Agitation and Aggression in Severe Alzheimer's Disease

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Signed informed consent obtained from a legally acceptable representative~* Male or female \> 65 years of age, residing in long-term care~* Diagnosis and Statistical Manual of Mental Disorders (DSM-IV-TR) diagnosis of Dementia of the Alzheimer's type (code 290.1)~* Mini Mental State Examination total score ≤ 15~* Neuropsychiatric Inventory-Nursing Home Version total score \> 10, and a score \> 1 on the agitation/aggression subscale~* A current order for any prescription medication for behavioral and psychological symptoms of dementia (e.g. benzodiazepine, antipsychotic, trazodone), with at least 1 dose used in the prior 3 months~* Patients with a current order for any regularly administered psychotropic (example, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, trazodone, atypical antipsychotics, typical antipsychotics or cholinesterase inhibitors) must have been on a stable dose for 3 months prior to entry~Exclusion Criteria:~* Current evidence of any uncontrolled medical illness that would interfere with the subject's participation in the study~* Dementia due to any etiology other than Alzheimer's Disease~* Subjects experiencing significant difficulties ingesting oral medications

- Gender: ALL
- Minimum Age: 65 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 Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2~* Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC~* Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate, oral corticosteroids, 6-mercaptopurine and azathioprine~* Participants with current dependency or with a history of corticosteroid dependency (i.e., an inability to successfully taper corticosteroids without a return of the symptoms of UC)~* Not have a diagnosis of active tuberculosis~* Participants with negative stool test for enteric (by way of the intestines) pathogens~Exclusion Criteria:~* Participants with prior exposure to biologic anti-tumor necrosis factor (TNF) agents~* Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry~* Participants having UC limited to the rectum only or to less than 20 centimeter of the colon~* Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula~* Participants with a history of extensive colonic resection

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
- Golimumab 100 mg -> 50 mg (Type: EXPERIMENTAL): Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
- Golimumab 200 mg -> 100 mg (Type: EXPERIMENTAL): Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
- Golimumab 400 mg -> 200 mg (Type: EXPERIMENTAL): Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 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: Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Age: 18-60 years old;~* Diagnostic of major depressive disorder (DSM-IV);~* At least two previous unsuccessful antidepressant medications;~* Current depressive episode (HAM-D \>= 17).~Exclusion Criteria:~* History of psychosis;~* Present or past history of bipolar disorder or schizophrenia;~* Diagnosis of current clinical disease, based on history, physical examination and routine hematologic and biochemical tests;~* Serious and imminent suicidal risk;~* Pregnancy, current drug or alcohol dependence;~* Previous experience with ayahuasca.

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

Study Arms:
- placebo (Type: PLACEBO_COMPARATOR): patients receiving a passive placebo
- Ayahuasca (Type: EXPERIMENTAL): patients receiving Ayahuasca

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 Clino-san on Vaginal Dryness of Breast Cancer Patients

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

Eligibility Criteria:
Inclusion Criteria:~* breast cancer patients~* who are treated with chemotherapy or hormonal therapy~* who experience no menstruation after the previous therapy~* who complain of vaginal dryness~Exclusion Criteria:~* other cancer patients~* other severe disease~* poor compliance

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Clino-san 2ml vaginal application 3 times per week for 12 weeks
- 2 (Type: PLACEBO_COMPARATOR): placebo 2ml vaginal application 3 times per week for 12 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: Olmesartan Pediatric Pharmacokinetic (PK) Study

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

Eligibility Criteria:
Inclusion Criteria:~* Age 12 months to 16 years inclusive~* Signed parental/guardian informed consent and assent from the subject~* Current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension~* Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated using the Schwartz equation~* Sexually active females of child-bearing potential must be practicing an acceptable method of birth control~* Negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)~Exclusion Criteria:~* Clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder~* History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening~* Current treatment with more than 2 antihypertensive medications~* Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney~* Serum albumin \< 2.5 g/dL~* Major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria

- Gender: ALL
- Minimum Age: 12 Months
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- Olmesartan (Type: EXPERIMENTAL): Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg.

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: Rifaximin and Norfloxacin for Prevention of SBP in Adults With Decompensated Cirrhosis

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

Eligibility Criteria:
Inclusion Criteria:~1. Low Ascitic fluid protein level \<1gm/dl~2. Advanced liver disease as evidenced by CTP≥9~3. Serum billirubin≥3 mg/dl~4. Impaired renal function defined by serum creatinine≥1.2 mg/dl~5. Blood urea nitrogen 25mg/dl~6. Serum sodium level≤ 1.2 meq/l~Exclusion Criteria:~1. Inability to obtain informed consent from patient or relatives.~2. Acute on chronic liver failure~3. Severe cardiopulmonary disease~4. Pregnancy~5. Age \<18yrs~6. Post liver transplant patients~7. HIV infection~8. Recent abdominal surgery(with in last 6 months)~9. Portal vein thrombosis~10. Splenectomy~11. Patient on immunosuppressive drugs except for alcoholic steatohepatitis~12. Patients on psychoactive drugs, such as antidepressants or sedatives~13. Hypersensitivity to norfloxacin and rifaximin~14. Malignancies including Hepatocellular carcinoma~15. Prior history of hepatic encephalopathy on Rifaximin -

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

Study Arms:
- Primary prophylaxis arm (Type: OTHER): 28 Patients with decompensated cirrhosis without past history of SBP were randomised to receive Rifaximin at dose 550 mg twice daily.29 Patients with decompensated cirrhosis without past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily
- Secondary prophylaxis arm (Type: OTHER): 26 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Rifaximin at dose 550 mg twice daily.33 Patients with decompensated cirrhosis with past history of SBP were randomized to receive Norfloxacin at dose 400 mg once daily

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

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

Trial Title: A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

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:~* adult patients, \>=18 years of age;~* chronic renal anemia;~* regular hemodialysis with the same schedule of dialysis for \>=12 weeks;~* maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.~Exclusion Criteria:~* transfusion of red blood cells during previous 2 months;~* poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;~* acute or chronic bleeding;~* active malignant disease (except non-melanoma skin cancer).

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (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: Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency

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:~* Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with no life-threatening or unmanageable study drug toxicity.~Exclusion Criteria:~* Clinically significant concurrent disease, serious inter-current illness, concomitant medications or other extenuating circumstances~* Clinically significant abnormal values on laboratory screening tests, other than LFTs or lipid panel tests

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

Study Arms:
- Open-Label Sebelipase Alfa (Type: EXPERIMENTAL): Participants were administered sebelipase alfa once weekly (qw) as an intravenous (IV) infusion at the same dose received in Study LAL-CL01 (0.35, 1, or 3 milligrams per kilogram \[mg/kg\]) for 4 weeks. After the initial 4 qw doses, participants transitioned to dosing every other week (qow) at either 1 mg/kg (participants who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (participants who initiated dosing at 3 mg/kg qw). Subsequent modifications to the dose and dosing frequency were permitted for individual participants based on observed safety, tolerability, and clinical response to treatment. Participants could continue to receive treatment with sebelipase alfa for up to 5 years.

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: S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Partial onset seizures, whether or not secondarily generalized;~* at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;~* using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.~Exclusion Criteria:~* Presence of known pseudoseizures within the last year;~* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;~* on felbamate with less than 18 months exposure;~* on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;~* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

- Gender: ALL
- Minimum Age: 16 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: Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)

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

Eligibility Criteria:
Inclusion Criteria: To be included, adolescents must:~1. Be in the age range ≥11 years old and ≤17 years old;~2. Report experiencing weight-related bullying~3. Report current distress about weight-related bullying~4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);~5. Read, comprehend, and write English at a sufficient level to complete study-related materials;~6. Located in the United States and available for participation in the study for 3 months.~Exclusion Criteria: Prospective participants will be excluded if the adolescent:~1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., severe anorexia, neurological disorder, psychotic disorders, suicidality);~2. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);~3. Is pregnant or breastfeeding;~4. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;~5. Is engaged in concurrent treatments that focus on trauma-related stress;~6. Began taking hormonal contraceptives less than 3 months prior;~7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);~8. Has avoidant/restrictive food intake disorder; or~9. Is participating in another clinical research study.

- Gender: FEMALE
- Minimum Age: 11 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- CBT for Weight Bullying (Type: EXPERIMENTAL): Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying

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: Tranexamic Acid in Urologic Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patients~* Patients undergoing open radical prostatectomy~Exclusion Criteria:~* Age \< 18 years~* Patients with drug eluting stent with a double antiplatelet therapy~* Atrial fibrillation~* Thrombophilic diathesis~* Allergy to tranexamic acid

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.
- 2 (Type: PLACEBO_COMPARATOR): Patients belonging to the control group will receive the same volume of saline infusions.

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: Initiating Contraception After Emergency Contraception From Pharmacy

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

Eligibility Criteria:
Inclusion Criteria:~* age \>= 16 yrs~* requesting emergency contraception~* eligible for emergency contraception~* written , informed consent~Exclusion Criteria:~* age \< 16 yrs~* not able to give written , informed consent

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- control (standard care) (Type: NO_INTERVENTION): standard verbal and written advice on contraception from pharmacy
- rapid access (Type: EXPERIMENTAL): rapid access to family planning service
- progestogen only pill (Type: EXPERIMENTAL): one month progestogen only pill

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

Answer: outcome: complete