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

Trial Title: Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia

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:~* diagnosed with Diamond Blackfan anemia as published in British Journal of Hematology~* transfusion dependent~* age 2 years and older~* adequate renal function~* adequate liver function~* negative B-HCG if patient is a menstruating female and documentation of adequate contraception~* signed informed consent~Exclusion Criteria:~* Known hypersensitivity to branched chain amino acids~* Diagnosis of an inborn error of amino acid metabolism disorder~* Prior hematopoietic stem cell transplantation~* Pregnancy, or plans to become pregnant during duration of trial

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Leucine (Type: OTHER): No alternative treatment arm

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: Artificial Oocyte Activation Comparing Tow Different Agents

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

Eligibility Criteria:
Inclusion Criteria:~* previous fertilization failure~* poor quality Oocytes~* poor sperms~Exclusion Criteria:~* normal patients

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Ca Ionophore group (Type: EXPERIMENTAL): Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection
- Strontium Chloride group (Type: EXPERIMENTAL): Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection
- Only Intracytoplasmic Sperm Injection (Type: NO_INTERVENTION): after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated

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: Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

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:~* Age \> 18 years and \< 85 years~* Male or female~Exclusion criteria:~* Left dominant circulation~* Heart failure with EF \<40%~* Unstable angina~* MI or angioplasty of the LAD or circumflex with 6 months prior to entry into the study~* Use of radiographic contrast agent within 12 hours of entry into the study~* Use of investigational agents within one month of entry into the study~* Patients who require treatment with positive inotropic agents other than digoxin during the study~* Patients with cerebrovascular accident within 6 months prior to entry into the study~* Significant endocrine, hepatic, renal disorders; local or systemic infectious disease within 4 weeks prior to entry into study~* Pregnancy or lactation~* Mental instability~* Federal Medical Center patients

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- I (Type: ACTIVE_COMPARATOR): Qualifying patients took Atrasentan, 1 pill per day for 6 months, to determine if it had a favorable affect on patients who took it over those who were randomized to placebo.
- 2 (Type: PLACEBO_COMPARATOR): placebo group to be compared to the actual medication

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 Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.~Exclusion Criteria:~* Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb \< 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- tranexamic acid (Type: EXPERIMENTAL): Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language
- Normal saline (Type: PLACEBO_COMPARATOR): Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language

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: Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men

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

Eligibility Criteria:
Inclusion Criteria:~* Male~* Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)~* Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)~* Mexican and/or Mexican American (self-identified)~* Must be able to read and write Spanish fluently~* 18 - 65 years of age~* Planning on living in the area for the next 6 months~* Own a cell phone capable of sending and receiving text messages~Exclusion Criteria:~* Body Mass Index(BMI) greater than 45~* Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise~* Exercise is against advice of doctor~* Heart disease/treatment~* Heart murmur~* Angina/chest pain or Angina/chest pain with exertion~* Palpitations~* Stroke/Transient Ischemic Attacks~* Peripheral Vascular Disease~* Type I Diabetes~* Uncontrolled Type II Diabetes~* Chronic Infectious Disease - HIV, Hepatitis~* Chronic liver disease~* Cystic Fibrosis~* Abnormal EKG on last EKG performed~* Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease~* Seizure in past year~* Surgery in past year on heart, lung, joint, orthopedic surgery~* Surgery pending in next year on lung, joint, orthopedic surgery~* Unusual/concerning shortness of breath~* Asthma (may be able to participate with physician consent)~* High blood pressure/high blood pressure medication (may be able to participate with physician consent)~* Use of beta blockers~* Abnormal Medical Stress Test~* Musculoskeletal problems~* Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance~* Cancer treatment in past 3 months~* Hospitalized for psychiatric disorder in past 3 years or suicidal

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Text-Enhanced Physical Activity Intervention Arm (Type: EXPERIMENTAL): The Spanish-language PA intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).
- Health Education Control Arm (Type: ACTIVE_COMPARATOR): The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.

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 the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

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:~* Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.~* For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).~* Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).~Exclusion Criteria:~* Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.~* Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.~* Subjects with a known hypersensitivity to study drugs or their components.~* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.~* Uncontrolled diabetes mellitus.~* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.~* Current diagnosis of immunocompromising conditions.~* Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.~* Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.~* Extremely severe tinea pedis (incapacitating).~* Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- NAFT-600 ( naftin 2 % gel) (Type: EXPERIMENTAL): Topical; applied once daily for two weeks
- Placebo (Type: PLACEBO_COMPARATOR): Topical; applied once daily for two 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 Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

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

Eligibility Criteria:
Inclusion Criteria:~* Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season~* Patient is a non-smoker~* Patient is in good mental and physical health~Exclusion Criteria:~* Patient is hospitalized~* Patient is a woman who is \<8 weeks postpartum or is breast feeding~* Patient intends to move or vacation away during the study~* Patient is a current or past abuser of alcohol or illicit drugs

- Gender: ALL
- Minimum Age: 15 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): montelukast
- 2 (Type: ACTIVE_COMPARATOR): loratadine
- 3 (Type: PLACEBO_COMPARATOR): 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: Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction

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

Eligibility Criteria:
Inclusion Criteria:~* ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:~* ischemic symptoms;~* ECG variations: ST-elevation (\>0,05 mV) in two or more contiguous leads;~* Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT). • Indication to urgent coronary angiography and primary or rescue PCI~Exclusion Criteria:~* Patients with history of allergic reaction to NAC~* Chronic hemodialysis~* Age \>= 90 years

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 89 Years
- Healthy Volunteers: f

Study Arms:
- Sodium bicarbonate plus NAC (Type: None): Sodium bicarbonate plus NAC
- Saline hydration plus NAC (Type: None): Saline hydration plus NAC

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 to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

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:~* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures~* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL~* No prior use of any approved or investigational antiretroviral drug for any length of time~* Screening genotype report must show sensitivity to FTC, TDF, and EFV~* Normal electrocardiogram (ECG)~* Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)~* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 5 x the upper limit of the normal range (ULN)~* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin~* Adequate hematologic function~* Serum amylase ≤ 5 x ULN~* Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug~* Age ≥ 18 years~* Life expectancy ≥ 1 year~Exclusion Criteria:~* A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening~* Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C~* Subjects experiencing decompensated cirrhosis~* Females who are breastfeeding~* Positive serum pregnancy test (female of childbearing potential)~* Implanted defibrillator or pacemaker~* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance~* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma~* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline~* Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla tablets~* Participation in any other clinical trial without prior approval~* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

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

Study Arms:
- Stribild (Type: EXPERIMENTAL): Stribild plus placebo to match Atripla
- Atripla (Type: ACTIVE_COMPARATOR): Atripla plus placebo to match Stribild

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: Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

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:~1. Aged 19 to 70 years~2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia~3. Written informed consent~Exclusion Criteria:~1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit~2. Uncontrollable diabetes with HbA1c ≥ 8.5%~3. Fasting LDL-C ≤ 70 mg/dL~4. Fasting triglyceride ≥ 400 mg/dL~5. Total cholesterol ≥ 300 mg/dL~6. History of muscular disease or rhabdomyolysis due to use of statin~7. Hypersensitive to rosuvastatin or ezetemibe~8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:~   ① Severe renal disease (estimated GFR(MDRD) \< 30mL/min/1.73m2)~   ② ALT, AST \> 3x ULN or history of active liver disease~   ③ CPK \> 3x ULN~9. Administration of other investigational products within 30 days prior to screening visit~10. Other than the above who is deemed to be ineligible to participate in the trial by investigator

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Rosuvamibe® Tab (Type: EXPERIMENTAL): Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
- Monorova® Tab (Type: ACTIVE_COMPARATOR): Monorova® Tab (rosuvastatin 10mg) qd for 8 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: Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent provided for the subject by a parent or legal guardian~* Children age 6-35 months~Exclusion Criteria:~* Allergies to eggs, thimerosal, gentamicin sulphate or latex~* Life-threatening reaction to previous Flu vaccine~* Bleeding disorder~* Pregnancy~* Receipt of blood or blood products in past 3 months~* Chronic illness that could interfere with trial participation~* Compromised immune system~* Previous lab-confirmed H1N12009 infection~* Receipt of H1N12009 vaccine~* Receipt of Seasonal Influenza vaccine since March 2009

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 35 Months
- Healthy Volunteers: t

Study Arms:
- Adjuvanted Arepanrix 2 doses (Type: ACTIVE_COMPARATOR): Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart

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 Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

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

Eligibility Criteria:
Inclusion Criteria:~* All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up~* Patients must have received at least 1 dose of study agent to be eligible for participation in the study~Exclusion Criteria:~- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation

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

Study Arms:
- Infliximab 5 mg/kg (Type: None): This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
- Infliximab 10 mg/kg (Type: None): This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
- Placebo (Type: None): This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.

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

Answer: outcome: complete