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

Trial Title: Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* male or female~* 10 to 25 years of age~* willing to consent to participation~* able to follow study instructions~* in active orthodontic treatment with fixed orthodontic appliances~Exclusion Criteria:~* unwilling/unable to follow study instructions~* documented/suspected pineapple allergy~* proteolytic enzyme allergy~* food dye allergy~* smoker

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 25 Years
- Healthy Volunteers: t

Study Arms:
- Experimental: Bromelain, Then Placebo (Type: EXPERIMENTAL): Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained. After a 1 week washout period, they received the placebo rinse (powdered sugar), following the same protocol and series of intraoral photographs.
- Experimental: Placebo, Then Bromelain (Type: PLACEBO_COMPARATOR): Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained. After a 1 week washout period, they received the bromelain rinse, following the same protocol and series of intraoral photographs.

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: Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: CASE_ONLY
- Primary Purpose: None
- Time Perspective: RETROSPECTIVE
- Masking: None
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008~* Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained~Exclusion Criteria:~* None

- Gender: ALL
- Minimum Age: None
- 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: Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa

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

Eligibility Criteria:
Inclusion Criteria:~18 years of age or older;~* Diagnosis of any phenotypic variation of RP, confirmed by clinical history, fundus appearance, VF, and electroretinogram;~* Experience of various degrees of VF loss;~* BCVA from light perception of up to 110 letters (equal to 1.6 decimal values) in early treatment of diabetic retinopathy study (ETDRS) chart testing (Topcon CC-100 XP, Japan); \& Mean deviation (MD) values from-33.0 to-5.0 dB with Humphrey or Octopus 900 visual field analysis (threshold 30-2, Sita Standard, Stimulus 3-white);~* Intraocular pressure (IOP) \<22 mmHg.~Exclusion Criteria:~* The presence of cataracts or other media opacity that might affect the VF, MP, or mfERG recordings;~  * The presence of glaucoma, which causes visual field and optic disc changes;~ * The presence of any systemic disorder(e.g.,diabetes,neurological disease, or uncontrolled systemic hypertension) that may affect visual functions;~ * The habit of smoking.

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

Study Arms:
- Before application (Type: ACTIVE_COMPARATOR): Forty-nine eyes belonging to 37 patients before injection aPRP.
- After application (Type: NO_INTERVENTION): Forty-nine eyes belonging to 37 patients after injection aPRP.
- Sham application (Type: SHAM_COMPARATOR): 11 patients before - after aPPP injection

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: Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* BMI≥30 kg/m2.~* Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.~Exclusion Criteria:~* The use of any antilipidemic medication.~* Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).~* Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).~* Clinical or laboratory findings suggestive for thyroid dysfunction.~* Established diagnosis of Diabetes Mellitus.~* History of gout, hyperuricemia, or on hypouricemic agents.~* Active peptic ulcer.~* Pregnancy, or nursing mothers.~* Alcohol or tobacco consumption.

- Gender: FEMALE
- Minimum Age: 20 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
- Fenofibrate Monotherapy (Type: ACTIVE_COMPARATOR): Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
- WMER Niacin Monotherapy (Type: ACTIVE_COMPARATOR): Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
- Combination Therapy (Type: ACTIVE_COMPARATOR): Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven 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 Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder

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:~* Patients with a diagnosis of Bipolar I Disorder, Most Recent Episode Manic, by the criteria in the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)~* voluntarily hospitalized at study initiation for the current manic episode~* history of at least one documented manic or mixed episode that required treatment prior to study initiation~* total score of \>=20 on the Young Mania Rating Scale (YMRS) and total score of \<=20 on the Montgomery Asberg Depression Rating Scale (MADRS) at start of the study~Exclusion Criteria:~* Patients who meet DSM-IV criteria for Schizoaffective Disorder or for rapid cycling~* with borderline or antisocial personality disorder~* history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation~* with seizure disorder~* females who are pregnant or nursing, or those lacking adequate contraception.

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

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

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

Trial Title: Safety Study of Replagal® Therapy in Children With Fabry Disease

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:~Patients must meet all of the following criteria to be enrolled in this study.~1. All patients must be diagnosed with Fabry disease by the following criteria:~   * Male Patients: The patient is a hemizygous male with Fabry disease as confirmed by a deficiency of alfa-galactosidase A activity measured in serum, leukocytes, or fibroblasts or has a confirmed mutation of the alfa-galactosidase-A gene.~  * Female Patients: The patient is a heterozygous female with Fabry disease as confirmed by a mutation of the alfa-galactosidase A gene.~   Note: If the diagnosis of Fabry disease is previously documented in the patient's medical record, screening tests do not need to be repeated.~2. The patient is 7 to \<18 years of age~3. The patient is ERT-naïve~4. 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~5. The minor child must assent to participate in the protocol and the parent(s) or legally authorized representative(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed with the child and the child's parent(s) or legally authorized representative(s)~Exclusion Criteria:~Patients who meet any of the following criteria will be excluded from the study.~1. Patient and/or the patient's parent(s) or legally authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study~2. Patient is unable to comply with the protocol, eg, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the Investigator or the medical monitor.~3. Otherwise unsuitable for the study, in the opinion of the Investigator.

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

Study Arms:
- Replagal 0.2 mg/kg every other week (EOW) (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: Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with newly diagnosed hyperthyroid Graves' disease~Exclusion Criteria:~* If the patient had been treated previously~* diabetes, kidney, or liver disease

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- I (Type: EXPERIMENTAL): Cholestyramine 2g BID, Methimazole 10mg TID, and Propranolol 20mg BID
- II (Type: EXPERIMENTAL): Cholestyramine 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID
- III (Type: PLACEBO_COMPARATOR): Placebo powder 1g BID, Methimazole 10mg TID, and Propranolol 20mg BID

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: Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

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:~* Patients presenting colonic pathology~* The surgery is not contraindicated~* Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..)~* Indication of segmentary resection or total colectomy~* Patients who agree to participate voluntarily in the study and signed an informed consent.~Exclusion Criteria:~* Patients who refuse to participate in the study.~* Patients undergoing mechanical colon preparation the day before surgery.~* Patients with rectal cancer~* Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis).~* Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery.~* Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis)~* Patients presenting allergy to the drugs under study.~* Patients that will not strictly follow the assigned prophylaxis regimen~* Patients undergoing urgent surgery (\<24h)

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

Study Arms:
- Oral + Parenteral prophylaxis (Type: EXPERIMENTAL): None
- Only Parenteral prophylaxis (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: Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)

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

Eligibility Criteria:
Inclusion Criteria:~* Acute Promyelocytic Leukemia (APL)~Exclusion Criteria:~* \> 14

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 14 Years
- Healthy Volunteers: f

Study Arms:
- DNR+Ara-c(Ara-C group) (Type: ACTIVE_COMPARATOR): patients in this group were treated with DNR+Ara-C in consolidation
- DNR(No Ara-C group) (Type: EXPERIMENTAL): patients in this group were treated with DNR alone in consolidation

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 vs Buprenorphine-Naloxone for Opioid Dependence in Norway

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:~* Opioid dependence (DSM-IV TR)~* Age 18 or above~* Applied \& Approved for Norway's national OMT program~* Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility~* Voluntarily seeking treatment for opioid dependence~Exclusion Criteria:~* Pregnant or breast-feeding~* Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality~* Serious debilitation of liver or renal function (e.g. Child-Pugh level C)~* Use of excluded medication~* Known intolerance to study drugs or their ingredients~* Employment in firm manufacturing one of the study drugs or close relation to such person

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

Study Arms:
- Naltrexone intramuscular suspension (Type: EXPERIMENTAL): Extended release naltrexone injections 380mg
- Buprenorphine-naloxone (Type: ACTIVE_COMPARATOR): Flexible oral dose 4-24 mg 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: Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

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

Eligibility Criteria:
Key Inclusion Criteria:~* Patients chronically infected with hepatitis C virus (HCV) genotype 1~* HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening~* Treatment naive~Key Exclusion Criteria:~* Women of child-bearing potential~* Cirrhosis~* Coinfection with HIV or hepatitis B virus

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

Study Arms:
- Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A) (Type: EXPERIMENTAL): Active Comparator
- Daclatasvir, Peginterferon alpha-2a, ribavirin (B) (Type: EXPERIMENTAL): Active Comparator
- Daclatasvir, Peginterferon alpha-2a, ribavirin (C) (Type: EXPERIMENTAL): Active Comparator
- Placebo, Peginterferon alpha-2a, ribavirin (D) (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: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

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

Eligibility Criteria:
Inclusion Criteria:~* Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated obstetric history and plan to deliver either vaginally or by Caesarian section at the University of Utah for their current pregnancy.~Exclusion Criteria:~* Women who have regularly taken carotenoid supplements containing more than 0.5 mg of lutein and/or zeaxanthin daily during the six months prior to screening~* Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).~* Women with conditions associated with high-risk pregnancy such as adolescent pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia, previous premature delivery, drug abuse or other significant medical illness

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

Study Arms:
- Carotenoid group (Type: EXPERIMENTAL): The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.
- Control group (Type: ACTIVE_COMPARATOR): The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.

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: Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

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:~* Diagnosis of Type 2 diabetes mellitus~* Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications \[metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor\]~* Hemoglobin A1c (HbA1c) \>= 7.5% and =\< 9.5% at screening~* Fasting plasma glucose =\<240 mg/dL at randomization (Week 0/Day 1).~* Male or female \>= 18 years of age.~* Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol~* Fasting C-peptide level \>0.5 ng/mL at screening~* Clinically stable in regards to medical conditions other than type 2 diabetes~* Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period~Exclusion Criteria:~* History of Type 1 diabetes and/or history of ketoacidosis~* History of bowel obstruction~* History of hypertriglyceridemia-induced pancreatitis~* Fasting serum triglyceride concentration \>500 mg/dL~* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery~* History of insulin use \>= 2 weeks duration during the previous 3 months or a total of \>2 months insulin therapy at any time prior to screening~* Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening~* Female subject who is pregnant or breastfeeding~* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening

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

Study Arms:
- Colesevelam (Type: EXPERIMENTAL): Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
- Placebo (Type: PLACEBO_COMPARATOR): Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)

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

Answer: outcome: complete