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

Trial Title: Omega-3 Dietary Supplements in Schizophrenia

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

Eligibility Criteria:
Inclusion Criteria:~* Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, psychosis NOS or Bipolar I as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders;~* Does not DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder with psychotic features;~* current positive symptoms rated more than 4 (moderate) on one of these BPRS items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;~* is in a early phase of illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 2 years or less;~* age 15 to 40;~* competent and willing to sign informed consent; and~* for women, negative pregnancy test and agreement to use a medically accepted birth control method.~Exclusion Criteria:~* serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain;~* any medical condition which requires treatment with a medication with psychotropic effects;~* significant risk of suicidal or homicidal behavior;~* cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;~* medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure), omega-3 supplements (e.g. bleeding disorder, seafood allergies) or placebo capsules (e.g. allergies to capsule components);~* contraindications to MRI imaging (e.g. presence of a pacemaker);~* lack of response to a prior adequate trial of risperidone;~* taking omega-3 supplements within the past 8 weeks, and~* requires treatment with an antidepressant or mood stabilizing medication.

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

Study Arms:
- Omega-3 capsules & Risperidone (Type: EXPERIMENTAL): Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
- Placebo & Risperidone (Type: OTHER): Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.

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 Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Males and females, aged 18 and older~* Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging~* Symptomatic carcinoid syndrome (≥4 bowel movements per day)~* Ability to provide written informed consent~Exclusion Criteria:~* ≥ 12 high-volume, watery bowel movements per day~* Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening~* Karnofsky status ≤70% - unable to care for self~* Surgery within 60 days prior to screening~* A history of short bowel syndrome~* Life expectancy \< 12 months~* History of substance or alcohol abuse within 2 years prior to screening~* Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening

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

Study Arms:
- Telotristat etiprate - Core Phase (Type: EXPERIMENTAL): Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
- Telotristat etiprate - Extension Period (Type: EXPERIMENTAL): Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.

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: Replagal Enzyme Replacement Therapy for Children With Fabry Disease

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1a. For Cohort 1 (both phases):~- Patients must have completed all study requirements and assessments for Study TKT023 less than 30 (+/-7) days prior to enrolling in Study TKT029 and must have no safety or medical issues that contraindicate participation.~OR~1b. For Cohort 2:~* The patient is between 7 and 17 years of age at the time of informed consent, inclusive.~* The patient must be ERT-naive.~* The patient is a hemizygous male with Fabry disease as confirmed by a deficiency of alpha-galactosidase A activity measured in serum, leukocytes, or fibroblasts. Male patients who do not already have a documented deficiency of alpha-galactosidase A activity will provide a blood sample during screening for determination of alpha-galactosidase A activity level in their serum.~OR~- The patient is a heterozygous female or hemizygous male with Fabry disease as confirmed by a mutation of the alpha-galactosidase A gene. Patients who do not already have a documented mutation of the alpha-galactosidase A gene will provide a blood sample during screening for genotyping.~2. Adequate general health (as determined by the Investigators) to undergo the specified phlebotomy regimen and protocol-related procedures and no safety or medical contraindications for participation.~3. The minor child must assent to participate in the protocol and the parent(s) or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed concent form after all relevant aspects of the study have been explained and discussed with the child and the child's parent(s) or legal guardian(s).~Exclusion Criteria:~Patients who meet any of the following criteria are not eligible for this study:~* Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the study.~* Patient is unable to comply with the protocol, e.g., uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for safety evaluations, or is otherwise unlikely to complete the study, as determined by the Investigator or the medical monitor.

- Gender: ALL
- Minimum Age: 7 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Agalsidase alfa (Cohort 1) (Type: EXPERIMENTAL): Cohort 1: Patients who completed TKT023.
- Agalsidase Alfa (Cohort 2) (Type: EXPERIMENTAL): Cohort 2: Treatment-naive patients.

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: Aripiprazole in Adolescents With Schizophrenia

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

Eligibility Criteria:
Inclusion Criteria:~* Primary diagnosis of Schizophrenia 1~Exclusion Criteria:~* Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Aripiprazole 10 mg/day Group (Type: ACTIVE_COMPARATOR): Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
- Aripiprazole 30 mg/day Group (Type: ACTIVE_COMPARATOR): Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
- Placebo Group (Type: PLACEBO_COMPARATOR): Participants were given a single pill administered 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 Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

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

Eligibility Criteria:
Inclusion Criteria:~The serum zinc concentrations are under the normal level before registration~Exclusion Criteria:~1. Heavy hepatitis~2. Malignant tumor~3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.~4. The serum albumin under 2.8 g/dL~5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)~6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration~7. Pregnant, suspected pregnant, lactating, patients who wish to have a child~8. Patient who participated in other clinical trials within 12 weeks before registration~9. Unsuitable as a target of this clinical trial judged by doctor

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

Study Arms:
- NPC-02 (Type: EXPERIMENTAL): Oral dose
- Placebo (Type: PLACEBO_COMPARATOR): Oral dose

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

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

Trial Title: Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

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:~1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.~2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained~3. Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg~4. Background antihypertensive treatment of ≥ 2 drugs~5. Serum cortisol ≥ 18 mcg/dL~Exclusion Criteria:~1. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists~3. Subjects with hypokalemia~4. Subjects with hyperkalemia~5. Subjects with serum cortisol \< 3 mcg/dL~6. Subjects with serum sodium \< 135 mEq/L~7. Subjects with estimated glomerular filtration rate \< 60 mL/min/1.73m2~8. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus~9. Subjects with body mass index \> 40 kg/m2~10. Subjects with unstable angina~11. Subjects with SBP ≥ 175 mm Hg or DBP ≥ 100 mm Hg for Part 1 and SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for Part 2 at Pre-Screening, Screening/Start of Placebo Run-in, or Randomization~12. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening~13. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment~14. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms~15. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition~16. Subjects undergoing treatment with any of the following medications:~1. Topical corticoids~2. Sympathomimetic decongestants~3. Theophylline~4. Phosphodiesterase type 5 inhibitors~5. NSAIDs~6. Intramuscular steroids~7. Estrogen~8. Cytochromes~9. Strong CYP3A and CYP3A4 inducers~   17. Subjects with known hypersensitivity to MLS-101 or any of the excipients~   18. Subjects who are night-shift workers

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

Study Arms:
- Placebo (Part I) (Type: PLACEBO_COMPARATOR): Placebo tablet(s) by mouth once or twice daily.
- Dose 1 (Part I) (Type: EXPERIMENTAL): MLS-101 tablet(s) by mouth once or twice daily.
- Dose 2 (Part I) (Type: EXPERIMENTAL): MLS-101 tablet(s) by mouth once or twice daily.
- Dose 3 (Part I) (Type: EXPERIMENTAL): MLS-101 tablet(s) by mouth once or twice daily.
- Placebo (Part II) (Type: PLACEBO_COMPARATOR): Placebo tablet(s) by mouth once daily.
- Dose (Part II) (Type: EXPERIMENTAL): MLS-101 tablet(s) by mouth 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 V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

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

Eligibility Criteria:
Inclusion Criteria:~Participants Age 12 to 15 Years:~* Participant is in good health~* Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up~* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1~* Participant has not received any other HPV vaccine~* Participant is not yet sexually active~Participants Age 16 to 26 Years:~* Participant is in good health~* Participant agrees to provide a primary telephone number for follow-up~* Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1~* Participant has not received any other HPV vaccine~* Participant has never had Papanicolaou (Pap) testing or has only had normal results~* Participant has a history of 0 to 4 lifetime sexual partners at enrollment~Exclusion Criteria:~All participants:~* Participant has a history of severe allergic reaction that required medical intervention~* Participant has any disorder that would contraindicate intramuscular injections~* Participant is pregnant~* Participant is immunocompromised or has an autoimmune condition~* Participant has had a splenectomy~* Participant has received any immune globulin product or blood-derived product~* Participant has participated in a HPV vaccine clinical trial~Participants Age 16 to 26 Only:~* Participant expects to donate eggs during the study~* Participant has a history of abnormal cervical biopsy result~* Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

- Gender: FEMALE
- Minimum Age: 12 Years
- Maximum Age: 26 Years
- Healthy Volunteers: t

Study Arms:
- 9vHPV Vaccine (Type: EXPERIMENTAL): Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- Placebo (Type: PLACEBO_COMPARATOR): Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.

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: Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 8.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent obtained before any trial related procedures~* Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy~* ECOG score to be equal to or above 2~* Testosterone level within age-specific normal range~* PSA value equal to or above 2 ng/ml~* Life expectancy of at least 6 months~Exclusion Criteria:~* Previous or current hormonal treatment of prostate cancer~* Recent or current treatment with any drugs modifying the testosterone level~* Candidate for curative treatment such as prostatectomy or radiotherapy~* History of severe asthma, anaphylactic reactions or Quincke's Oedema~* Hypersensitivity towards any component of FE200486~* Cancer disease within the last ten years except for prostate cancer and some skin cancers~* Signs of liver impairment shown as elevated serum ALT or serum bilirubin~* Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results~* Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator~* Mental incapacity or language barrier~* Having received an investigational product within the last 12 weeks preceding the trial~* Previous participation in this trial

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

Study Arms:
- Degarelix 120 mg (20 mg/mL) (Type: EXPERIMENTAL): Degarelix 120 mg (20 mg/mL)
- Degarelix 120 mg (40 mg/mL) (Type: EXPERIMENTAL): Degarelix 120 mg (40 mg/mL)
- Degarelix 160 mg (40 mg/mL) (Type: EXPERIMENTAL): Degarelix 160 mg (40 mg/mL)
- Degarelix 200 mg (40 mg/mL) (Type: EXPERIMENTAL): Degarelix 200 mg (40 mg/mL)
- Degarelix 200 mg (60 mg/mL) (Type: EXPERIMENTAL): Degarelix 200 mg (60 mg/mL)
- Degarelix 240 mg (40 mg/mL) (Type: EXPERIMENTAL): Degarelix 240 mg (40 mg/mL)
- Degarelix 240 mg (60 mg/mL) (Type: EXPERIMENTAL): Degarelix 240 mg (60 mg/mL)
- Degarelix 320 mg (60 mg/mL) (Type: EXPERIMENTAL): Degarelix 320 mg (60 mg/mL)

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: Induction With Foley OR Misoprostol (INFORM) Study

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:~* Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not.~* Women age ≥18 years~* Signed informed consent form~Exclusion Criteria:~* • Women with previous caesarean sections~  * Those unable to give informed consent~ * Multiple pregnancy~ * History of allergy to misoprostol~ * Ruptured membranes~ * Chorioamnionitis (by clinical diagnosis)

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

Study Arms:
- Misoprostol (Type: ACTIVE_COMPARATOR): Group 2 will be induced using oral misoprostol tablets (25 mcg) every 2 hours for a maximum of 12 doses or until active labour commences. In primigravid women, if contractions have not commenced after 2 doses, the dosage may be increased to 50mcg every 2 hours. Once in labour (regular painful contractions with a cervical dilatation of at least 4cm) no more misoprostol will be used and artificial membrane rupture and/or oxytocin infusion will be used as clinically indicated. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of repeat misoprostol, Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate).
- Foley Catheter (Type: ACTIVE_COMPARATOR): Group 1 will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) which will remain until active labour starts, the Foley catheter falls out, or 12 hours have elapsed. If the Foley catheter falls out within 12h, membranes will be ruptured and/or oxytocin infusion started. If the Foley catheter does not fall out within 12h, it will be removed at 12h and oxytocin commenced with an artificial rupture of membrane when possible. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of misoprostol, repeat Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate).

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

Answer: outcome: complete