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

Trial Title: Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors

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

Eligibility Criteria:
Inclusion Criteria:~* Any solid tumor that failed standard therapy.~* Patient must have evidence for tumor by CT, MRI, PET scan, MIBG scan, serum markers, or tissue sampling.~* Age ≤ 21 years.~* Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age\> 16 years and Lansky score for age ≤ 16 years)~* ANC≥ 1000 at least 24 hours off GCSF~* Platelets ≥ 75k at least one week off platelet transfusions~* Hg≥ 8g/dL at least one week off PRBC transfusion~* AST ≤ 3 x the upper limit of normal~* ALT ≤ 3 x the upper limit of normal~* Total bilirubin ≤ 2.0 mg/dl~* serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.~* ≥ 3 weeks since last non-nitrosourea chemotherapy~* ≥ 6 weeks since last nitrosoureas~* ≥ 4 weeks since last RT~* Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to drug initiation. Females must not be breast feeding.~* Patients must be able to swallow tablets whole~Exclusion Criteria:~* Pregnancy~* Patients must not have active infection or serious intercurrent medical illness.~* HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.~* Patients must not be taking EIAEDs. If patients were previously EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- perifosine (Type: EXPERIMENTAL): This will be a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3-6 patients at each dose level.

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 Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

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:~In order to be included in the study, each subject must:~* be at least 18 years of age;~* be physically able to floss their teeth;~* have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);~* have refrained from performing oral hygiene the morning of the Baseline visit;~* be in good general health;~* have interproximal MGI (Modified Gingival Index) score of \>2.8.~Exclusion Criteria:~Subjects are excluded from study participation where there is evidence of:~* severe periodontal disease;~* discoloration or pigmentation in the gingival tissue;~* meaningful misalignment of front teeth;~* fixed facial orthodontic appliances;~* use of antibiotics within two weeks of the Baseline Visit and at any time during the study;~* any diseases or conditions that could be expected to interfere with the subject safely completing the study.

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

Study Arms:
- Brushing Only (Type: NO_INTERVENTION): Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
- Brushing + Flossing (Type: EXPERIMENTAL): Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss

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: Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

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

Eligibility Criteria:
Inclusion Criteria:~1. Meets DSM-IV criteria for opioid dependence~2. Age \> 18 years~3. Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.~4. Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.~5. No participation in pharmacotherapy trial in the previous 30 days~6. Not pregnant~Exclusion Criteria:~1. Unable to provide informed consent~2. Verbally or physically threatening to research staff~3. Unable to communicate in either English or Spanish~4. Pending trials for a felony~5. Liver failure (Childs-Pugh Class B or C Cirrhosis)~6. Grade IV Hepatitis (liver function tests \> 10X normal)~7. Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.~8. Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency~9. Active opioid withdrawal (within 3-5 days since last opioid ingestion)~10. Pregnancy or unwilling to take contraceptives measures~11. Breast-feeding

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

Study Arms:
- Extended-Release Naltrexone (Type: ACTIVE_COMPARATOR): Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release
- Placebo (Type: PLACEBO_COMPARATOR): Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

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

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

Trial Title: Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* \>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)~* Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)~* Type 2 diabetes mellitus~Exclusion Criteria:~* Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.~* Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Treatment sequence 1: SCH 497079 → Placebo → Metformin (Type: EXPERIMENTAL): Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.
- Treatment sequence 2: Placebo → Metformin → SCH 497079 (Type: EXPERIMENTAL): Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
- Treatment sequence 3: Metformin → SCH 497079 → Placebo (Type: EXPERIMENTAL): Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.
- Treatment sequence 4: SCH 497079 → Metformin → Placebo (Type: EXPERIMENTAL): Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.
- Treatment sequence 5: Placebo → SCH 49709 → Metformin (Type: EXPERIMENTAL): Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.
- Treatment sequence 6: Metformin → Placebo → SCH 497079 (Type: EXPERIMENTAL): Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 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: A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

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:~* Age 18 to 65 inclusive~* Male, non-child-bearing female or fertile female with appropriate contraception.~* Mild to moderate confirmed active ulcerative colitis~* Able and willing to give informed consent~Exclusion Criteria:~* Colitis of other cause~* Pregnancy, inadequate contraception for fertile female patients~* Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.~* Other significant medical condition that preclude participation at investigator criteria~* Allergy or hypersensitivity to salicylates~* Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Dersalazine (Type: EXPERIMENTAL): None
- Mesalazine (Type: ACTIVE_COMPARATOR): None
- 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: The Use of Jet Injection Lidocaine for Blood Draws in Young Children

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

Eligibility Criteria:
Inclusion Criteria:~* Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw~Exclusion Criteria:~* Previous adverse reaction to lidocaine or Pain Ease spray~* Pre-existing skin lesion at site of blood draw~* Needle stick for IV insertion or lab draw that has already occurred at current hospital visit~* Patients who are physically unable to move their arms or legs~* Patients who are unable to cry~* Patients with connective tissue disorders that predispose to easy bruising~* Patients with bleeding disorders

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 6 Years
- Healthy Volunteers: t

Study Arms:
- J tip Noise (Type: SHAM_COMPARATOR): This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray if \> age 1 yr or sucrose if \< 1 yr
- Pain Ease (Type: OTHER): This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
- J tip (Type: EXPERIMENTAL): This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding if \> 1 yr and will receive sucrose is \< 1 yr

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-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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

Eligibility Criteria:
Inclusion Criteria:~* Ages eligible for study: 18 years and above, Genders eligible for study: both~* Patients who have a life expectancy of at least 12 weeks~* Patients with advanced Hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) which has been histologically or cytologically documented~* Patients must have at least one tumor lesion that meets both of the following criteria~  1. Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)~ 2. Not been previously treated with local therapy~* Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan~* Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status of 0, 1, or 2~Exclusion Criteria:~* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: flat tumor\]\&T1 \[Tumor invades subepithelial connective tissue\]). Any cancer curatively treated \> 3 years prior to entry is permitted~* History of cardiac disease~* Active clinically serious infections~* Known history of human immunodeficiency virus (HIV) infection~* Known central nervous system (CNS) tumors including metastatic brain disease~* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

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

Study Arms:
- Sorafenib (Nexavar, BAY43-9006) (Type: EXPERIMENTAL): Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablets matching in appearance were orally administered bid (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: Autologous Fibroblast Transplantation in Facial Deformities

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:~* Available and willing to attend all follow-up visits.~* Age \> 18 years.~* Able and willing to give informed consent.~Exclusion Criteria:~* Known allergy or sensitivity to collagen fillers~* The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.~* Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.~* The subject has received autologous fat transfer in the last 6 months.~* Subject is suffering from facial Kaposi's sarcoma.~* The subject has active skin diseases or inflammation on or near the area of injection~* positive HIV, HBV, HCV

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Fibroblast (Type: EXPERIMENTAL): Injection of autologous cultured fibroblast

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, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

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

Eligibility Criteria:
Inclusion Criteria:~* Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit~Exclusion Criteria:~* Patients on a ketogenic diet~* Seizures too close together to accurately count~* Pseudoseizures~* Status epilepticus 1 month prior Visit 1~* Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

- Gender: ALL
- Minimum Age: 1 Month
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- Levetiracetam (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: Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

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: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Male, 12 - 65 years, with body weight ≥ 30 kg and ≤ 120 kg~* Documented severe Hemophilia B (FIX activity of ≤ 2%) or tested by the central laboratory at screening~* Subjects who have received FIX products for \> 150 exposure days (EDs) (estimated)~* No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as \< 0.6 Bethesda Units \[BU\] by the central laboratory at screening~* Subjects can be treated on-demand or under prophylactic therapy~* Signed Informed Consent/Assent~Exclusion Criteria:~* Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein~* Any known congenital or acquired coagulation disorder other than congenital FIX deficiency~* Platelet count \< 100,000/µL~* Immunocompromised (CD4 count \< 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)~* Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment~* Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration \> 5 times (x) the upper limit of normal (ULN)~* Serum creatinine \> 2 x ULN~* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment~* Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration~* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry~* Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period~* Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance

- Gender: MALE
- Minimum Age: 12 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): 25 IU/kg dose
- Cohort 2 (Type: EXPERIMENTAL): 50 IU/kg dose
- Cohort 3 (Type: EXPERIMENTAL): 75 IU/kg 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: Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19

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

Eligibility Criteria:
Inclusion Criteria:~* Patients must be 18 years of age or older, of either gender~* Patients must be tested positive for SARS-CoV-2 by RT-PCR within 72 hours prior to enrolment~* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.~* Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening~* Patients must be under the care of a Physician for diagnosis of COVID-19~* Patients who have signed informed consent~Exclusion Criteria:~* Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin~* Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis~* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure~* Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.~* Patients with gallstone obstruction~* Hypothyroid suffering patients~* Patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/L);~* Pregnant patients

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

Study Arms:
- Complementary therapy group (Type: EXPERIMENTAL): This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days
- Control group (Type: ACTIVE_COMPARATOR): This arm will receive standard care alone

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

Answer: outcome: complete