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

Trial Title: Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:~Key Inclusion Criteria:~* Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4~* Must have a baseline EDSS between 0.0 and 5.0, inclusive.~* Must have relapsing-remitting disease course.~Key Exclusion Criteria:~* Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease~* Pregnant or nursing women~Note: Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- BG00012 240 mg Twice Daily (BID) (Type: EXPERIMENTAL): Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
- BG00012 240 mg 3 Times Daily (TID) (Type: EXPERIMENTAL): Participants received two 120 mg BG00012 capsules orally three times daily (TID)
- Placebo (Type: PLACEBO_COMPARATOR): Participants received two placebo capsules orally three times daily (TID)
- Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) (Type: ACTIVE_COMPARATOR): Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

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: Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer

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:~1. newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade \> 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy~2. HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)~3. ECOG performance status 0 or 1~4. Gender: female~5. Age : \>= 18 years old~6. Negative pregnancy test (females of childbearing potential)~7. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)~8. Signed informed consent~Exclusion Criteria:~1. Metastatic or relapsed disease~2. Major surgery \< 3 weeks prior to enrollment~3. Severe pulmonary obstructive or restrictive disease~4. Uncontrolled inflammatory disease (autoimmune or infectious)~5. Clinically significant cardiac disease (NYHA stadium \> 2)~6. Results of laboratory tests (hematology, chemistry) outside specified limits:~   * WBC ≤ 3 x 109/L~  * ANC \< 1.5 x 109/L~  * Platelets \< 100 x 109/L~  * Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)~  * PTT/ INR \> 1.5 x ULN~  * AST or ALT \> 2.5 x ULN~  * Alkaline Phosphatase \> 2 x ULN~  * Total Bilirubin \> 1.5 x ULN~7. Pregnancy or nursing status~8. Known positive HIV testing~9. Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC formulations~10. History of malignancy other than breast cancer \< 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally~11. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial~12. Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry

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

Study Arms:
- EndoTAG-1 (Type: EXPERIMENTAL): Weekly treatment with EndoTAG-1 (22 mg/m2) plus paclitaxel (70 mg/m2) for 12 weeks (ET+P) followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.

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 on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected)

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:~Individuals who present the following characteristics will be included in this study:~1. Age ≥18 years, regardless of gender;~2. Fluorescence RT-PCR test result of respiratory or blood samples must be positive for COVID-19, or viral gene sequencing of respiratory tract samples must be highly homologous to COVID-19; Individuals with COVID-19 must meet the diagnostic criteria in the latest version of clinical guidelines for COVID-19 issued by the World Health Organization (WHO) on June 4, 2020;~3. Symptomatic patients who meet the case definition for COVID-19, according to WHO, without evidence of bacterial pneumonia or hypoxia (Sat O2 \< 95%) P. \[score 1-3\];~4. Voluntary participation and signing of the informed consent form.~Exclusion Criteria:~Individuals who present one or more of the following characteristics will not be eligible to participate in this study:~1. Know or suspect that you are allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);~2. Individual presenting shortness of breath and Sat O2 \< 95%; or any other symptom requiring treatment through hospital admission;~3. Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);~4. Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);~5. Patients with a history of renal insufficiency (glomerular filtration rate \< 60mL/min/1,73m2);~6. Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;~7. Individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically;~8. Total neutrophil count \<750 cells/L;

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

Study Arms:
- AZVUDINE (Type: EXPERIMENTAL): Experimental:~AZVUDINE 1mg tablet~Interventions:~AZVUDINE 1mg tablet, 5 tablets QD + standard treatment, for up to 14 days
- AZVUDINE placebo (Type: PLACEBO_COMPARATOR): Control:~AZVUDINE placebo~Intervention:~AZVUDINE placebo tablet, 5 tablets QD + standard treatment, for up to 14 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: Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission

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

Eligibility Criteria:
Inclusion Criteria:~* Age: 0-21 years at the time of diagnosis.~* Diagnosis: histologic verification at either the time of original diagnosis or a previous relapse of high risk neuroblastoma.~* Disease Status: Neuroblastoma that is in remission~* First dose of study medication must be greater than 30 days from completion of cytotoxic and antibody therapy and less than 120 days from previous therapy~* A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).~* Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (the pill), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.~* Absolute Neutrophil Count (ANC) \> 500/μl and platelet count \>50,000/μl~* Organ Function Requirements: Subjects must have adequate liver function as defined by:~  * Aspartate Aminotransferase (AST) and Alanine transaminase (ALT) \<10x upper limit of normal~ * Serum bilirubin must be ≤ 2.0 mg/dl~ * Serum creatinine based on age/gender~* Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines~Exclusion Criteria:~* Lansky score \< 60%~* Body Surface Area (BSA) (m2) of \<0.25~* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.~* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects).~* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.~* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.

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

Study Arms:
- DFMO twice daily (Type: EXPERIMENTAL): Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.

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: Efficacy and Safety of IL-11 in DDAVP Unresponsive

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:~* Males or females \>= 18 years of age.~* A diagnosis of hemophilia A, moderate (FVIII:C 0.01-0.04 U/ml) or mild (FVIII:C \>= 0.05 U/ml); or a diagnosis of VWD, defined by a low VWF:RCo and past bleeding history.~* For those with VWD, an inability to use DDAVP due to i) unresponsiveness defined as VWF:RCo or FVIII:C level lower than 50 IU/dl or less than a 3-fold increase after 0.3 microgram/kg DDAVP; ii) allergic reactions or seizures; or iii) a contraindication to DDAVP.~* Willingness to have blood drawn.~* Willingness to sign informed consent.~Exclusion Criteria:~* Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia.~* Use of immunomodulatory or experimental drugs, or diuretics.~* Pregnant or lactating women.~* Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis.~* Past allergic reaction to Neumega.~* Surgery within the past 8 weeks.~* Inability to comply with study protocol requirements.~* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.~* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study.~* Baseline safety and/or hematology lab values outside the normal limits and/or an EKG indicating an arrhythmia.

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

Study Arms:
- Neumega (Oprelveken, Interleukin 11) (Type: EXPERIMENTAL): Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega

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: CAndesartan vs LIsinopril Effects on the BRain

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

Eligibility Criteria:
Inclusion Criteria:~1. age: 55 years or older;~2. Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications.~3. Executive MCI will be defined using these criteria:~   1. The Montreal Cognitive Assessment (MoCA) score less than or equal to 26~  2. Executive dysfunction: A performance at the 10th percentile or below on at least one of four screening tests for executive function: Trail Making Test, Part B (TMT-B), modified Stroop interference, Digit Span and Digit Sequencing, and Letter fluency.~  3. Minimal Functional limitation as reflected by the Functional Assessment Questionnaire (FAQ)≤7~Exclusion Criteria:~1. Intolerance to study drugs;~2. SBP \>200 or DBP \>110 mm Hg;~3. Renal disease or hyperkalemia~4. Active medical or psychiatric problems~5. Uncontrolled congestive heart failure;~6. History of stroke in the past 3 years;~7. Inability to perform the study procedures~8. Women of childbearing potential~9. diagnosis of dementia~10. In those who lack decision capacity, a study surrogate who can sign on their behalf will be required. Since we are enrolling only those with MCI, we anticipate that most participants will have decision capacity~11. Current use of Lithium, as most antihypertensive classes may lead to increased lithium toxic levels.

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Candesartan (Type: ACTIVE_COMPARATOR): To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
- Lisinopril (Type: ACTIVE_COMPARATOR): To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

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 Exenatide in Obese Patients With Accelerated Gastric Emptying

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

Eligibility Criteria:
Inclusion Criteria:~* Obese subjects with BMI\> 30 Kg/m\^2: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.~* Women of childbearing potential will have negative pregnancy test before initiation of medication.~* Gastric emptying (GE): Accelerated GE T1/2 \< 79 minutes or GE 1h\>35 %~Exclusion Criteria:~* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria~* Unstable heart disease as evidenced by ongoing angina~* Congestive heart failure~* Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)~* Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)~* Use of anti-diabetic drugs including metformin,~* History of nephrolithiasis,~* Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire (PHQ-9) total score ≥10).~* Gastroparesis~* Inflammatory bowel disease or irritable bowel syndrome~* Malignancy treated with chemotherapy within the past 3 years~* History of pancreatitis~* Renal insufficiency (eGFR less than 50 ml/min)~* Concomitant use of monoamine oxidase inhibitors (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants~* Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale (HADS) self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.~* Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.

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

Study Arms:
- Exenatide (Type: EXPERIMENTAL): Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
- Placebo (Type: PLACEBO_COMPARATOR): Participants randomized to this arm received placebo subcutaneously twice daily for 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: (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-65 years~* Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles~* Patient is capable and willing to provide informed consent~* Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox~* Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves.~* Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery.~Exclusion Criteria:~* Patient has hypersensitivity reactions or other intolerance to Botox~* Patient is pregnant or trying to become pregnant with the timeframe of the study.~* Infection at proposed injection sites.

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

Study Arms:
- Botulinum toxin type A injection arm (Type: EXPERIMENTAL): All patients will be injected with Botulinum toxin on one side of the back of the head.

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 Vitamin D Requirements During Pregnancy

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

Eligibility Criteria:
Inclusion Criteria:~1. Women who are within the ages of 16-45 years~2. In good general health~3. Less than 12 weeks pregnant (based on last menstrual period)~Exclusion Criteria:~1. Mothers with preexisting type I or type II diabetes~2. Mothers with preexisting hypertension~3. Mothers with preexisting parathyroid disease or uncontrolled thyroid disease~4. Mothers with multiple fetuses (e.g., twins, triplets, etc.)

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- cholecalciferol-400 IU (Type: ACTIVE_COMPARATOR): Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
- cholecalciferol 2000 IU (Type: EXPERIMENTAL): Experimental group receiving 2000 IU total vitamin D3/day.
- cholecalciferol 4000 IU (Type: EXPERIMENTAL): Experimental group receiving 4000 IU/day cholecalciferol

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: Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting~* insidious onset of symptoms not related to trauma~* pain with compression of the patella~* pain on palpation of the patellar facets~Exclusion Criteria:~* symptoms present for less than one month~* clinical evidence of other knee pathology~* history of recent knee surgery within past one year~* history of patellar dislocations or subluxations~* current significant injury affecting other lower extremity joints

- Gender: FEMALE
- Minimum Age: 15 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- Hip Progressive Resistive Exercises (Type: EXPERIMENTAL): Exercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach.
- Quad Progressive Resistive Exercises (Type: ACTIVE_COMPARATOR): Exercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach..

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

Answer: outcome: complete