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

Trial Title: Smith-Lemli-Opitz Syndrome and Cholic Acid

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Ages 2-25 years.~* Participants (or their parents/legally-authorized representative) must provide signed informed consent.~* Assent must be obtained from those participants ages 7-17 years who are intellectually capable of understanding this study.~* Diagnosis of SLOS based on clinical features and biochemical + genetic confirmation.~* Participants are capable of traveling to the STAIR study site.~* Fasting plasma cholesterol ≤125 mg/dL during the Qualification Phase must be established before starting cholic acid therapy.~* Clinically stable at the time of enrollment~* Participants must be on a constant dietary cholesterol intake for at least 3-months prior to treatment with cholic acid.~* Participants must agree to make no changes in cholesterol supplementation during the STAIR study.~* SLOS participants who are taking antioxidants will be included. Participants must agree to make no changes in the antioxidant dose during this study.~* For females of childbearing age (who have begun menstruating), a negative pregnancy test must be documented at the start of the study (week 0/ baseline) and at the end of cholic acid administration (week 8).~Exclusion Criteria:~* Participants are unable to provide signed informed consent and/or verbal assent.~* Participants have an unstable clinical condition that would prevent completion of the study. Medically unstable participants would include those with severe liver disease, complex birth defects such as severe heart disease or renal dysplasia, those with severe respiratory compromise requiring tracheostomy, or those who are not likely to survive longer than 1 year.~* Participants are taking drugs, nutraceuticals, probiotics or other compounds that are known or suspected to affect sterol metabolism.~* Participants have transaminase elevations (\>3-fold above the reference range) at baseline.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 25 Years
- Healthy Volunteers: f

Study Arms:
- Cholic acid (Type: EXPERIMENTAL): Participants will be treated with cholic acid 10 mg/kg body weight.

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 Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

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:~* Diagnosed with acute hepatitis C virus (HCV).~* Normal and Elevated serum alanine transferase (ALT) levels~* Positive serum HCV-RNA.~* Aged between 18 and 65 years.~* Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion~Exclusion Criteria:~* Liver disease unrelated to HCV infection~* Hemoglobin (Hgb) \<12g/dL in women and \<13g/dL in men; white blood cells (WBC) \<3,000/uL; platelets (PLTs) \<100,000/ul~* Women with ongoing pregnancy or who are breast feeding~* History of severe psychiatric disease, especially depression~* History of neurologic disease, especially epilepsy~* History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease~* Positive anti-Human Immunodeficiency Virus (HIV) antibodies~* Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (\>1/80)~* Positive Hepatitis B surface antigen (HBsAg)~* History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months~* History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

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

Study Arms:
- PEG-IFN 24 (Type: EXPERIMENTAL): pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
- PEG-IFN 12 (Type: EXPERIMENTAL): pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
- PEG-IFN + RVB 12 (Type: EXPERIMENTAL): pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 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: Acetaminophen Before Vaccines for Infants Study (AVIS)

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

Eligibility Criteria:
Inclusion Criteria:~1. Child is a current Group Health enrollee.~2. Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.~Exclusion Criteria:~1. If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.~2. If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.

- Gender: ALL
- Minimum Age: 6 Weeks
- Maximum Age: 9 Months
- Healthy Volunteers: t

Study Arms:
- Acetaminophen (Type: ACTIVE_COMPARATOR): Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
- Placebo (Type: PLACEBO_COMPARATOR): Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.

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 UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia

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:~* Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.~* Estimated life expectancy ≥ 12 weeks~* Lansky (age \< 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50~Exclusion Criteria:~* Burkitt leukemia~* CD19-negative B-cell leukemia~* Active Central Nervous System (CNS) leukemia~* Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion~* Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped~* History of CRS grade 4 related to previous CAR T cell therapy~* Contraindication to Alemtuzumab administration

- Gender: ALL
- Minimum Age: None
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- UCART19 (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 Efficacy of BKM120 in Relapsed and Refractory NHL

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.~2. Patient had relapsed or refractory disease and received at least one prior therapy.~3. Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.~4. Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.~5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.~6. Patient had adequate bone marrow and organ function.~Exclusion Criteria:~1. Patient had received previous treatment with PI3K inhibitors~2. Patient had evidence of graft versus host disease (GVHD).~3. Patient had active or history of central nervous system (CNS) disease.~4. Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).~5. Patient had a score ≥ 12 on the PHQ-9 questionnaire.~6. Patient had a GAD-7 mood scale score ≥ 15.~7. Pregnant or nursing women~8. Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.

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

Study Arms:
- DLBCL Cohort (Type: EXPERIMENTAL): Diffuse large B-cell lymphoma cohort
- MCL Cohort (Type: EXPERIMENTAL): Mantle cell lymphoma cohort
- FL Cohort (Type: EXPERIMENTAL): Follicular lymphoma cohort

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: Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
General Inclusion Criteria:~* The patient's legal representatives must have given their informed and signed consent~* The patient must be insured or beneficiary of a health insurance plan~* Sexual maturation of at least Tanner stage 2~Inclusion criteria for the patient population~* The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)~* Absence of at least 5% of total weight over the last 3 months~Inclusion criteria for the control population~* The subject has a body mass index \< 90th percentile~Exclusion Criteria:~* The patient is participating in another study~* The patient is in an exclusion period determined by a previous study~* The patient is under judicial protection~* The patient's legal representative(s) refuse(s) to sign the consent~* It is impossible to correctly inform the patient or his/her legal representative(s)~* The patient has a contraindication for physical activity (joint, heart or other)~* The subject does at least 3 hours of extracurricular physical activity per week~* The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).~* Active smoking~* Known dyslipidemia (particularly hypercholesterolemia).~* The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).~* BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.~* Secondary or known genetic obesity.~* Known hypersensitivity to vitamin D.~* Hypercalcemia, hypercalciuria, calcium lithiasis

- Gender: ALL
- Minimum Age: 11 Years
- Maximum Age: 17 Years
- Healthy Volunteers: t

Study Arms:
- Non-Obese group (Type: OTHER): Non-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation.~Intervention: Normal control
- Obese group, Vitamin D (Type: EXPERIMENTAL): Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.~Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation
- Obese group, placebo (Type: PLACEBO_COMPARATOR): Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.~Intervention: 3 months lifestyle and dietary management Intervention: Placebo

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: Metadoxine as a Therapy for Severe Alcoholic Hepatitis

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.~Exclusion Criteria:~* Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.

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

Study Arms:
- Prednisone (Type: NO_INTERVENTION): Prednisone 40 mg daily by mouth during 30 days.
- Pentoxifylline (Type: NO_INTERVENTION): Pentoxifylline 400 mg thrice in day by mouth during 30 days
- Prednisone plus metadoxine (Type: EXPERIMENTAL): Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
- Pentoxifylline plus metadoxine (Type: EXPERIMENTAL): Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 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: Add-On Therapy to Risperidonein Schizophrenia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female patient aged ≧18 and ≦60 years.~2. A diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria made by a specialist in psychiatry.~3. Acute exacerbation of schizophrenia.~4. A total of PANSS score of at least 60 at screen.~5. History of schizophrenia ≦ 15 years (from onset of prodromal symptoms).~6. Signed informed consent by patient or legal representative~7. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.~Exclusion Criteria:~1. Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.~2. Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic~3. Females who are pregnant or nursing.~4. Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.~5. Axis-I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder.~6. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that in the judgement of the investigator, would compromise patient safety or preclude study participation.~7. History of intolerance to risperidone or dextromethorphan or other Cox-2 inhibitors.~8. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.~9. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of double-blind medication.~10. Diagnosis of or treatment for oesophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.~11. Inclusion in another schizophrenia study or study for another indication with psychotropics within the last 30 days prior to start of study.~12. Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).~13. History of idiopathic or drug-induced agranulocytosis.~14. Alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by DSM-IV criteria.

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

Study Arms:
- dextromethorphan (Type: EXPERIMENTAL): Research clinical trial of double-blind, stratified randomized, parallel group, double-centre study

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

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

Trial Title: Can Group Visits Improve Outcomes of Veterans With Diabetes

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:~* Primary care at one of two participating sites,~* HbA1c \>= 7.5%, Systolic BP \> 140 OR Diastolic BP \> 90 on 2 consecutive measurements~Exclusion Criteria:~-Primary care provider excludes patient from study, -Patient states that primary care is shared with non-VA primary care provider, -New enrollment in endocrine clinic within the last 6 months, -Patient is reluctant to participate in group visit for any reason, -Reduced life expectancy, as determined by any of the following: -New York Heart Association Class IV congestive heart failure, -Lung disease requiring supplemental oxygen, -End-stage renal disease on dialysis, -Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy, -Cirrhosis of the liver, or -AIDS (HIV disease does not exclude a patient in the absence of an AIDS diagnosis), -Five or more errors on Short Portable Mental Status Questionnaire, Psychotic illness with hospitalization within three years prior to enrollment

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

Study Arms:
- Medical group visits (Type: EXPERIMENTAL): Medical group visits
- Treatment as Usual control (Type: NO_INTERVENTION): control

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: Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

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

Eligibility Criteria:
Inclusion Criteria:~* Women who are within the ages of 18-45 years~* In good general health~* 12 weeks pregnant (based on last menstrual period)~Exclusion Criteria:~* Mothers with preexisting type I or type II diabetes~* Mothers with preexisting hypertension~* Mothers with preexisting parathyroid disease or uncontrolled thyroid disease~* Mothers with multiple fetuses (e.g., twins, triplets, etc.)

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

Study Arms:
- Prenatal Vitamin D3 (Type: PLACEBO_COMPARATOR): Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
- 2 (Type: EXPERIMENTAL): Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
- 3 (Type: EXPERIMENTAL): Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).

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 Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy subjects 3 to 64 years of age~Exclusion Criteria:~* Receipt of other investigational products within 3 months or other vacine within 1 month;~* Allergy to eggs, egg products, or any other vaccine component;~* Laboratory confirmed influenza disease within 6 months;~* Have previously received an influenza vaccination (3 to 8 years only);

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 64 Years
- Healthy Volunteers: t

Study Arms:
- Influenza virus vaccine (Type: EXPERIMENTAL): None
- Comparator influenza vaccine (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: complete