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

Trial Title: Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

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:~1. Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.~2. Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.~3. A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).~4. Age 6 years to 17 years, 4 months.~5. Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.~6. Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.~Exclusion Criteria:~1. History of intolerable adverse effects with metformin.~2. Prior history of an exposure to metformin of sufficient dose or duration to determine response status.~3. History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.~4. Use of cationic drugs excreted by the kidneys.~5. Planned surgery or procedure requiring contrast.~6. Pregnant at screening contact.~7. On other psychotropic concomitant medications for less than 2 months.~8. Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.~9. Unable to tolerate blood work.~10. Current use of medication for target symptoms of appetite or weight loss.~11. Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Placebo Hydrochloride Oral Solution (Type: PLACEBO_COMPARATOR): None
- Metformin (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: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria

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

Eligibility Criteria:
Inclusion Criteria:~* Children between 6 months and 12 years old, with a body weight of ≥5 kg;~* Living in the catchment area of the study (within a radius of \~10 km from St. Jude's Clinic, Mbita, Kenya);~* Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1).~Exclusion Criteria:~* Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;~* Mixed Plasmodium infection;~* Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);~* Having anaemia with an Hb \<6 g/dL;~* Evidence of severe malnutrition (severe wasting: z-score weight for age \<-3 and severe stunting: z-score height for age \<-3 (WHO 2009b));~* Having received anti-malarial therapy in the previous two weeks;~* Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;~* Participating in other anti-malarial drug intervention studies;~* Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);~* Not being available for follow-up.

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- Pyronaridine-artesunate (Type: EXPERIMENTAL): pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
- Artemether-lumefantrine (Type: ACTIVE_COMPARATOR): artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

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: Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Key Inclusion Criteria:~* Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)~* Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.~Key Exclusion Criteria:~* Clinically significant cirrhosis with or without portal hypertension~* Lung infection with organisms associated with a more rapid decline in pulmonary status.~* Solid organ or hematological transplantation.~Other protocol defined Inclusion/Exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 11 Years
- Healthy Volunteers: f

Study Arms:
- Part A: ELX/TEZ/IVA (Type: EXPERIMENTAL): Participants in Part A received ELX 100 milligrams (mg) once daily (qd)/TEZ 50 mg qd/IVA 75 mg every 12 hours (q12h) in the treatment period for 15 days.
- Part B: ELX/TEZ/IVA (Type: EXPERIMENTAL): Participants in Part B weighing less than (\<) 30 kilograms (kg) at Day 1 received ELX 100 mg qd/TEZ 50 mg qd/IVA 75 mg q12h and participants weighing greater than equals to (\>=) 30 kg at Day 1 received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 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: Establishing the Vitamin D Requirements During Lactation

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:~* Mother plans to breastfeed exclusively for at least six months~* Mother is in good health~* Infant is 35 weeks' gestation or greater~* Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).~Exclusion Criteria:~* Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months~* Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours~* Infant is less than 35 weeks' gestation~* Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern~* Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal~* Mother has history of hypercalciuria

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- Control 400 IU vitamin D3 (Type: ACTIVE_COMPARATOR): 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
- 2400 IU vitamin D3 (cholecalciferol) (Type: EXPERIMENTAL): 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
- 6400 IU vitamin D3 (cholecalciferol) (Type: EXPERIMENTAL): 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant

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: Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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:~* Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.~Exclusion Criteria:~* Prior treatment of current cSSSI with an antimicrobial.~* Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

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

Study Arms:
- Ceftaroline for Injection (Type: EXPERIMENTAL): None
- IV Vancomycin and IV Aztreonam (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: Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

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

Eligibility Criteria:
Main Inclusion Criteria:~* History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit~* FEV1/FVC ratio (post-bronchodilator) ≤ 70%~* FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted~* Treated with tiotropium for at least 3 months before enrollment~* At least 28 puffs of rescue medication during last week prior to randomization~Main Exclusion Criteria:~* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Roflumilast (Type: ACTIVE_COMPARATOR): Roflumilast 500 µg~underlying medication: tiotropium 18 µg, once daily, inhaled
- Placebo (Type: PLACEBO_COMPARATOR): Placebo~underlying medication: tiotropium 18 µg, once daily, inhaled

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 With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.

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

Eligibility Criteria:
Inclusion Criteria:~1. Presence of a renal mass.~2. Scheduled for surgical resection of renal mass.~3. Expected survival of at least 3 months.~4. Karnofsky performance scale ≥70.~5. The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:~   * Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L~  * Platelet count ≥ 100 x 10E9/L~  * Serum bilirubin ≤ 2.0 mg/dL~  * Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)~  * Alanine aminotransferase (ALT) ≤ 2.5 x ULN~  * Serum creatinine ≤ 2.0 mg/dL~6. Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.~7. Recovered from toxicity of any prior therapy.~8. Able and willing to give valid written informed consent.~Exclusion Criteria:~1. Intercurrent medical condition that may limit the amount of antibody to be administered.~2. Intercurrent medical condition that renders the patient ineligible for surgery.~3. New York Heart Association Class III/IV cardiac disease.~4. History of autoimmune hepatitis.~5. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.~6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.~7. Lack of availability for immunological and clinical follow-up assessments.~8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.~9. Women who are pregnant or breastfeeding.~10. Allergy to iodine.

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

Study Arms:
- 124I-cG250 (Type: EXPERIMENTAL): Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

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: To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy subject (male or female) between the ages of 18 and 55 years.~* Subject with a body weight of \> 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).~* Subject with a total IgE level of ≤ 100 IU/mL.~Exclusion Criteria:~* Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.

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

Study Arms:
- CT-P39 (Part 1) (Type: EXPERIMENTAL): 150 mg/mL, Solution for injection in PFS
- EU-approved Xolair (Part 1) (Type: ACTIVE_COMPARATOR): 150 mg/mL, Solution for injection in PFS
- CT-P39 (Part 2) (Type: EXPERIMENTAL): 150 mg/mL, Solution for injection in PFS
- EU-approved Xolair (Part 2) (Type: ACTIVE_COMPARATOR): 150 mg/mL, Solution for injection in PFS
- US-licensed Xolair (Part 2) (Type: ACTIVE_COMPARATOR): 150 mg/mL, Solution for injection in PFS

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: Website for Adolescents About Pediatric Clinical Trials

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

Eligibility Criteria:
Inclusion Criteria:~* Adult participant is a parent or legal guardian of adolescent participant;~* Adolescent participant is within the ages of 12-17 years;~* Parent-adolescent pair has access to a computer or tablet with internet connection~* Parent-adolescent pair is fluent in English~Exclusion Criteria:~* Adolescent participant has previously participated in a clinical trial after kindergarten.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 17 Years
- Healthy Volunteers: t

Study Arms:
- Educational website intervention (Type: EXPERIMENTAL): Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research.
- Wait-List Control (Type: NO_INTERVENTION): Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen).

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 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening~* Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications~* Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)~* Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2~Exclusion Criteria:~* History of Type 1, brittle diabetes or secondary forms of diabetes~* History of repeated severe hypoglycemic episodes~* History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis~* History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant

- Gender: ALL
- Minimum Age: 25 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): JNJ-28431754 30 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
- Cohort 2 (Type: EXPERIMENTAL): JNJ-28431754 100 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
- Cohort 3 (Type: EXPERIMENTAL): JNJ-28431754 300 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
- Cohort 4 (Type: EXPERIMENTAL): JNJ-28431754 600 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
- Cohort 5 (Type: EXPERIMENTAL): JNJ-28431754 at 30 mg/day, 100 mg/day, or 300 mg/day or placebo (the dose level to be determined from the prior cohort of patients tested and considered to be well tolerated).

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 Usage Of Statins In A Community Heart Failure Population

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:~* Mild to moderate HF (NYHA class II-III) of any aetiology and documented left ventricular systolic dysfunction (LVEF \< 45%) by echocardiography within 3 months of randomization. These patients were clinically stable, on optimal HF medical therapy which had remained unaltered for at least four weeks prior to recruitment. All had normal fasting total cholesterol.~Exclusion Criteria:~* Those receiving lipid lowering agents; those with absolute or relative contraindications to statins; those with known chronic inflammatory conditions; patients with medical conditions requiring anti-inflammatory or immuno-suppressive therapies.

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Atorvastatin titrated from 10-40 mg/day over 3 months and maintained at 40mg/day for a further 3 months
- 2 (Type: NO_INTERVENTION): Usual medical care of heart failure

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 Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

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

Eligibility Criteria:
Inclusion Criteria:~* Female,~* 20-40 years of age,~* If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),~* Normal menstruation cycle,~* Male partner 20-70 years of age,~* Male partner,~* Normal sperm sample within 5 years (\>20x106/mL, total sperm count \>30x106, normal morphology 5%),~* Duration of infertility more than one year,~* Signed informed consent~Exclusion Criteria:~* Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,~* Clinical signs of PID,~* Known hypersensitivity to local anesthetics,~* Non-patent fallopian tubes,~* Pathological uterine cavity,~* Pathological PCT, myoma \> 2 cm diameter,~* Any disease or laboratory finding considered of importance by the investigator not to include the patient

- Gender: FEMALE
- Minimum Age: 20 Years
- Maximum Age: 40 Years
- Healthy Volunteers: f

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

Answer: outcome: complete