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

Trial Title: ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)

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

Eligibility Criteria:
Inclusion Criteria:~* Individuals 19-30 years old at enrollment~* History of Type 1 diabetes for greater than one year~* Latest hemoglobin A1c less than 13%~* BMI of 27-39~Exclusion Criteria:~* Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate~* Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months~* Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.~* Individuals unwilling to follow any of the three study diets~* Individuals who monitor blood glucose less than 3 times a day

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 30 Years
- Healthy Volunteers: f

Study Arms:
- Hypocaloric, low carbohydrate (Type: EXPERIMENTAL): Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
- Hypocaloric, moderate low fat (Type: EXPERIMENTAL): Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
- Mediterranean, no caloric restriction (Type: EXPERIMENTAL): Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.

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: DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Age \> 18 years.~* CKD stage 3 or 4 (MDRD-GFR 15-60 ml/min)~* Use of any anti-hypertensive drugs~* No anti-hypertensive drugs but an average office systolic blood pressure \> 140 mmHg (as measured by datascope)~Exclusion Criteria:~* Salt-wasting CKD~* Nephrotic syndrome~* Pregnant or breastfeeding women~* Life expectancy \< 6 months~* Severe heart failure (NYHA III or IV) or liver cirrhosis with ascites and the inability to withdraw diuretics~* Rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months~* Kidney transplant recipients~* Use of immunosuppressive drugs~* Use of non-steroidal anti-inflammatory drugs~* Previous intolerance or allergy to hydrochlorothiazide or amiloride~* Serum sodium \< 135 mmol/l~* Serum potassium \< 3.5 mmol/l or \> 5.0 mmol/l~* Inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)

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

Study Arms:
- Diuretic treatment (Type: ACTIVE_COMPARATOR): Patients receive amiloride and hydrochlorothiazide
- Low-sodium diet (Type: ACTIVE_COMPARATOR): Patients are put on a low-sodium diet (60 mmol/day)

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: Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

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

Eligibility Criteria:
Inclusion Criteria:~* juvenile idiopathic arthritis~* arthritis lasting for at least 6 weeks but not more than 6 months~* polyarticular disease with at least 5 active joints with at least 3 joints with pain or tenderness and limitation of motion~* no previous treatment with DMARDs~Exclusion Criteria:~* systemic JIA~* any abnormality in the hematopoietic or lymphatic system~* any major concurrent medical condition~* inadequate psychosocial situation~* pregnancy~* a non-abstinent female with reproductive capacity without regular contraceptive use

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 15 Years
- Healthy Volunteers: f

Study Arms:
- Infliximab plus Methotrexate (Type: EXPERIMENTAL): infliximab 3-5 mg/kg every 6 weeks, plus methotrexate 15 mg/m2 weekly given orally (dose escalation if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed.
- Combination of DMARDs (Type: EXPERIMENTAL): methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75), plus standard doses of sulfasalazine and hydroxychloroquine. no oral prednisolone. intra-articular steroids allowed.
- Methotrexate alone (Type: ACTIVE_COMPARATOR): Conventional drug therapy: methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed.

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 Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC~* ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test~* NSCLC that has failed crizotinib treatment~* Measurable disease as defined by RECIST v1.1~* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2~* Adequate hematologic, hepatic and renal function~Exclusion Criteria:~* Prior therapy with ALK inhibitor other than crizotinib~* Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment~* History of serious cardiac dysfunction~* History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)~* Clinically significant gastrointestinal abnormality that would affect absorption of the drug~* Pregnant or lactating women

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

Study Arms:
- Alectinib: Phase I (Dose Escalation) (Type: EXPERIMENTAL): Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons.
- Alectinib (Phase II: RP2 dose) (Type: EXPERIMENTAL): Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.

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: Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1.~Exclusion Criteria:~Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent.~-

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Capecitabine (Type: EXPERIMENTAL): Neoadjuvant capecitabine plus RT
- 5-Flourouracil (Type: ACTIVE_COMPARATOR): Neoadjuvant 5-Fluorouracil plus RT

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 Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

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:~* Must be at least 18 years of age~* Chronic plaque PSO for at least 6 months prior to the Screening Visit~* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale~* Subject is a candidate for systemic PSO therapy and/or phototherapy~* Female subject of child bearing potential must be willing to use highly effective method of contraception~Exclusion Criteria:~* Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab~* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections~* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection~* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection~* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study~* Subject has had previous exposure to adalimumab~* Presence of active suicidal ideation or positive suicide behavior~* Presence of moderately severe major depression or severe major depression~* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

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

Study Arms:
- Bimekizumab Arm 1 (Type: EXPERIMENTAL): Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
- Bimekizumab Arm 2 (Type: EXPERIMENTAL): Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
- Adalimumab Arm (Type: ACTIVE_COMPARATOR): Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

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 Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

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

Eligibility Criteria:
Inclusion Criteria:~1. Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).~2. Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:~   * Moderate hot flush: warm sensation with sweating, does not disrupt activity.~  * Severe hot flush: hot sensation with sweating, disrupts activity.~3. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.~Exclusion Criteria:~1. Hypersensitivity to venlafaxine (Effexor or Effexor XR).~2. Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening.~3. History of a seizure disorder other than a single childhood febrile seizure.

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

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: TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

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:~* Patient has 3 or more primary protease inhibitor mutations~* documented genotypic evidence of resistance to currently available NNRTIs by having at least 1 NNRTI (non-nucleoside reverse transcriptase inhibitors) resistance-associated mutation~* on a stable antiretroviral therapy for at least 8 weeks~* plasma viral load at screening visit \> 5000 HIV-1 RNA copies/mL.~Exclusion Criteria:~* Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)~* Any grade 3 or grade 4 toxicity according to the DAIDS grading scale~* Use of disallowed concurrent therapy~* Any active clinically significant disease

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

Study Arms:
- 002 (Type: PLACEBO_COMPARATOR): Placebo 2 tablets b.i.d.96 weeks
- 001 (Type: ACTIVE_COMPARATOR): TMC125 2 X100 mg tablets b.i.d.96 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: Study of PEG-Intron for Plexiform Neurofibromas

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:~* Age \> or equal to 18 months to 21 years~* Diagnosis Patients with NF1 and progressive, symptomatic or life-threatening plexiform neurofibromas which are not surgically resectable. Patients without biopsy-proof of plexiform must have at least one other diagnostic criteria for NF1: 6 or more cafe-au-lait spots, freckling in the axilla or groin, optic glioma, 2 or more Lisch nodules, distinctive bony lesion, first degree relative with NF1.~* Only eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery.~* Patients may be treated on this trial without having received prior therapy. If patients have received prior therapy, they must have recovered from all toxic effects prior to entering this study.~* Must have life expectancy of at least 12 months and a performance score (Karnofsky or Lansky) of \> or equal to 50.~* Must have adequate liver, kidney and bone marrow function~Exclusion Criteria:~* Clinically significant unrelated systemic illness.~* Received an investigational agent within the past 30 days.~* Evidence of active visual pathway glioma~* History of malignant peripheral nerve sheath tumor or ther cancer other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ~* Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, or immunotherapy.~* Inability to return for follow-up visits or obtain follow-up studies~* Severe cardiovascular disease~* Pre-existing sever psychiatric condition or history of psychiatric disorder requiring hospitalization or a history of suicidal ideation or attempt.~* Thyroid dysfunction not responsive to therapy.~* Uncontrolled diabetes mellitus~* History of seropositivity for HIV~* Subjects who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.~* Any medical condition requiring chronic systemic corticosteroids.~* Subjects who are known to be actively abusing alcohol or drugs.

- Gender: ALL
- Minimum Age: 18 Months
- Maximum Age: 21 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: The Study Of Fluconazole For Vulvovaginal Candidiasis

Study Design Characteristics:
- Allocation: None
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with clinical symptoms and signs of vulvovaginal candidiasis.~* Patients tested positive for Candida by fungal culture.~* Patients who can agree not to have intercourse up to 28 days after dosing.~Exclusion Criteria:~* Patients with a history of hypersensitivity to fluconazole.~* Patients with severe renal dysfunction.~* Patients with liver disorder.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Fluconazole (Type: EXPERIMENTAL): 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 Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg~Exclusion Criteria:~* History of or current medical illness deemed clinically significant by the Investigator (study physician)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- 001 (Type: EXPERIMENTAL): Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

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 on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program

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:~* Body Mass Index (BMI) \>= 33 and \< 50 kg/m2~* BMI \>=30 and \< 50 kg/m2 if patients have controlled hypertension or abnormal blood lipids~* Stable weight~* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)~* Randomization criteria: Weight reduction of more than 8% of enrollment body weight during the eight week run-in phase~Exclusion Criteria:~* Prior exposure, known contraindication, or hypersensitivity to topiramate~* Exposure to any other experimental drug or device within last 30 days~* A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed)~* History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels~* History of obesity with known cause~* History or family history of kidney stones~* History of weight loss surgery or liposuction~* History of malignancy within last 5 years~* History of an eating disorder

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

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

Answer: outcome: complete