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

Trial Title: Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

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:~Male or non-pregnant, non-lactating female patients at least 18 years of age~Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS:~* Active AS assessed by BASDAI ≥4 (0-10) at Baseline~* Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline~* Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline Patients should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent~Exclusion Criteria:~* Chest X-ray or MRI with evidence of ongoing infectious or malignant process~  * Patients taking high potency opioid analgesics~ * Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor~ * Pregnant or nursing (lactating) women

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

Study Arms:
- Secukinumab (Type: EXPERIMENTAL): Secukinumab 150 mg s.c.~Arm includes all patients who received at least 1 dose of study drug including placebo switchers at Week 16
- Placebo (Type: PLACEBO_COMPARATOR): Placebo s.c.

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: Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

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:~* Willing and able to provide written informed consent~* HCV RNA ≥ 10\^4 IU/mL at screening~* HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory~* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy~* Classification as treatment naive or treatment experienced~* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception~Exclusion Criteria:~* Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.~* Screening ECG with clinically significant abnormalities~* Laboratory results outside of acceptable ranges at Screening~* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor~* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Study Arms:
- SOF/VEL (Type: EXPERIMENTAL): SOF/VEL for 12 weeks
- Placebo (Type: PLACEBO_COMPARATOR): SOF/VEL placebo 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: Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

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:
Key Inclusion Criteria~Medically stable HIV-1 infected women who meet the following criteria:~* Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.~* Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit~* Documented plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA \< 50 copies/mL, single values of HIV-1 RNA~  ≥ 50 copies/mL followed by re-suppression to \< 50 copies/mL is allowed~* HIV-1 RNA \<50 copies/mL at screening~* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit~Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Arms:
- B/F/TAF (Type: EXPERIMENTAL): Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks.
- Baseline Regimen (Type: ACTIVE_COMPARATOR): Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks.
- Extension Phase (Type: EXPERIMENTAL): Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional 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: Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.~* Fibrous ring capable of holding the cell implantation, demonstrated by Magnetic resonance imaging (MRI) image (stages 2, 3 and 4 of Adams).~* Decrease of disc height of more than 20% (radiographic measurement in side image).~* Absence of spinal infection.~* Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.~* The patient is able to understand the nature of the study.~* Informed written consent of the patient.~Exclusion Criteria:~* Age over 75 or under 18 or legally dependent~* Allergy to gentamicin, or to bovine, cattle or horse serum.~* Congenital or acquired diseases leading to spine deformations that may upset cell application.~* Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study~* Modic III changes on MRI images (31).~* Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).~* Pregnancy or breast-feeding~* Neoplasia~* Immunosuppression~* Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.~* Other conditions that may, according to medical criteria, discourage participation in the study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Allogenic Mesenchymal Stromal Cells (Type: EXPERIMENTAL): Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intradiscal injection of 25 millions MSC in 2 ml of saline
- Mepivacaine (Type: ACTIVE_COMPARATOR): Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine

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: Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* International Prognostic Scoring System (IPSS) low, intermediate -1, intermediate-2, or high risk MDS (including chronic myelomonocytic leukemia; CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label~* Eastern Cooperative Oncology Group (ECOG) 0 to 2~* No major surgery within 2 weeks of starting study treatment~* No cytotoxic chemotherapy within 2 weeks of starting study treatment~* Able to swallow pills~Exclusion Criteria:~* Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)~* Treatment with investigational therapy within 2 weeks of study treatment~* Uncontrolled medical disease(s) or active, uncontrolled infection~* Diagnosed with acute myeloid leukemia (AML)~* Active uncontrolled gastric or duodenal ulcer~* Known history of HIV or hepatitis C or B

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

Study Arms:
- Phase 1 Dose Escalation (Type: EXPERIMENTAL): Starting cohort was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- Phase 2 Dose Confirmation (Type: EXPERIMENTAL): Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (E7727) (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
- Phase 2 Fixed-Dose Combination (Type: EXPERIMENTAL): Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine (E7727)/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the 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: Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

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:~* Male or female adults aged ≥ 40 years with a diagnosis of COPD~* Current smokers or ex-smokers~* A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post- bronchodilator FEV1/FVC \< 0.7~* At least one exacerbation in the 12 months preceding the screening visit~Exclusion Criteria:~* Pregnant or lactating women~* Diagnosis of asthma or history of allergic rhinitis or atopy~* Patients treated with non-cardioselective β-blockers in the month preceding the screening visit~* Patients treated for exacerbations in the 4 weeks prior to screening visit~* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN~* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia~* Known respiratory disorders other than COPD~* Patients who have clinically significant cardiovascular condition

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

Study Arms:
- Beclometasone/Formoterol/Glycopyrrolate (Type: EXPERIMENTAL): CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
- Beclometasone/Formoterol (Type: ACTIVE_COMPARATOR): Foster® 100/6 mcg 2 inhalations bid

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

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

Trial Title: Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

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:~* Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality~* Age 6 or above but under 16 regardless of gender~* Out-patient~* Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week~* Deemed healthy by the investigator~* Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol~* Consent from the pediatric patient's legally acceptable representative~* Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility~* Show no possibility of being a nursing mother or pregnant, or becoming pregnant~* If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment~Exclusion Criteria:~* Suffer from enuresis with an underlying disease~* Participated in another clinical trial within six months preceding consent~* Used an intranasal Desmopressin in the past~* Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder~* Have an anomaly or a disease that may affect the oral absorption of drug products~* Hard to get cooperation from subject by school refusal, punishment or bullying~* Deemed by the investigator to be inappropriate to participate in this trial~* Unable to be placed on water-intake restriction starting from two hours before bedtime~* Evidence of hepatic, renal, cardiac, or pulmonary dysfunction

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 15 Years
- Healthy Volunteers: f

Study Arms:
- Desmopressin (Type: EXPERIMENTAL): During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of \<75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
- Placebo (Type: PLACEBO_COMPARATOR): Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.

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: Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

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:~* Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)~* Diagnosis with cyanosis at baseline (pre-operative PaO2 of less than 50mmHG) due to:~  * Complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with VSD)~ * Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)~ * Right-to-left shunt (example: Tetralogy of Fallot, double outlet right ventricle with subaortic VSD and pulmonary stenosis)~Exclusion Criteria:~* Corrected gestation at time of surgery less than 37 weeks~* Prior cardiac arrest~* Current or prior history of extracorporeal membrane oxygenation (ECMO) support~* Current or prior history of needing renal replacement therapy with dialysis~* Prior cardiac surgery requiring cardiopulmonary bypass~* Diagnosis of Ebstein's Anomaly~* Known genetic syndrome other than Trisomy 21 or DiGeorge Syndrome

- Gender: ALL
- Minimum Age: None
- Maximum Age: 29 Days
- Healthy Volunteers: f

Study Arms:
- Normoxia (Type: EXPERIMENTAL): On bypass, goal PaO2 on cardiopulmonary bypass of 60-100 mm Hg using lower fraction of inspired oxygen (FiO2) (blended sweep gas) via oxygenator~Post-bypass, goal of PaO2 \<100 mm Hg by anesthesia and in ICU via oxygen titration via mechanical ventilator for 24 hours post-op.
- Standard of care (Type: ACTIVE_COMPARATOR): Frequent blood gases will be checked per protocol on bypass and correlated with the blood parameter monitoring system to maintain a PaO2 of 200-300 per standard practice

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: Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

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:~* HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive polymerase chain reaction for HIV-1 ribonucleic acid (RNA).~* Adult patients (over 18 years of age).~* Current HAART regimen containing zidovudine + lamivudine at usual doses for at least 6 months.~* Viral load \< 50 copies/mL on the last two consecutive determinations, under zidovudine + lamivudine containing HAART regimen.~* For women of childbearing potential, negative urine pregnancy test at screening visit.~* Agreement to take part in the study and sign the informed consent.~* Patients on lipid lowering treatment were allowed to participate in the study only if the lipid-lowering treatment (either statins or fibrates) was stable for at least 8 weeks prior to screening and it was not expected to change during the first 3 months of the study.~Exclusion Criteria:~* Patients on current FTC or TDF therapy.~* Patients with previous history of virological failure on an FTC or TDF-containing regimen.~* Patients receiving a non-registered antiretroviral drug.~* Patients receiving a triple-nucleoside antiretroviral combination.~* Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of those drugs.~* Known history of drug abuse or chronic alcohol consumption~* Women who were pregnant or breast feeding, or female of childbearing potential who did not use an adequate method of contraception according to the investigator's judgment.~* Active opportunistic infection or documented infection within the previous 4 weeks.~* Documented active malignant disease (excluding Kaposi sarcoma limited to the skin).~* Renal disease with creatinine clearance \< 50 mL/min.~* Concomitant use of nephrotoxic or immuno-suppressive drugs which could not be stopped without affecting the safety of the patient.~* Receiving on-going therapy with systemic corticosteroids, Interleukin-2 or chemotherapy.~* Patients who were not to be included in the study according to the investigator's criterion.

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

Study Arms:
- Truvada (Type: EXPERIMENTAL): Truvada + NNRTI or PI.
- Zidovudine/lamivudine (Type: ACTIVE_COMPARATOR): Zidovudine/lamivudine + NNRTI or PI.

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

Answer: outcome: complete