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

Trial Title: Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

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:~  * Rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th), and fulfils the intermediate or locally advanced risk category standard of ESMO recal cancer clinical practice guidelines 2013.~ * KPS status no less than 70; Charlson comorbidity no more than 2; Fit status evaluated by CGA.~ * Life expectancy more than 6 months.~ * Hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.~ * Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.~ * Do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment.~ * No previously pelvic irradiation history.~ * Through MDT discussion, the patient is considered to be candidate for preoperative CRT followed by surgery.~ * Informed consent signed.~* Exclusion Criteria:~  * Other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma.~ * Allergy history to analog of quinazoline folate.~ * Active infection existed.~ * Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia, etc.~ * Anticipate other clinical trials in four weeks before enrollment.

- Gender: ALL
- Minimum Age: 71 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- preCRT+surgery (Type: EXPERIMENTAL): Treatment including preoperative chemoradiotherapy (preoperative radiation with concurrent chemotherapy) with Raltitrexed followed by surgery. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy or Volumetric-Modulated Arc Therapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on d1 and d22). Pelvic surgery is planned 6 weeks after completion of CRT based on the decision of MDT.

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 Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

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:~* Newly diagnosed patients with measurable multiple myeloma defined as at least one of the following:~  * Serum M protein ≥1 g/dL (≥10 g/L).~ * Urine M protein ≥200 mg/24 hours.~ * Serum free light chain (sFLC) assay: involved free light chain assay ≥10 mg/dL (≥100 mg/L) and an abnormal sFLC ratio (\<0.26 or \>1.65).~* Patients with ultra-high risk smoldering multiple myeloma fulfilling the International Myeloma Working Group criteria are eligible.~* Patient is not eligible for transplant.~* Patient with no intent for immediate transplant as per investigator's decision are also eligible for VRDI Part B cohort only.~Exclusion criteria:~* Eastern Cooperative Oncology Group performance status \>2.~* Poor bone marrow reserve.~* Poor organ function.~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Study Arms:
- Isatuximab (Type: EXPERIMENTAL): VCDI cohort: Isatuximab (escalating dose) + bortezomib + cyclophosphamide + dexamethasone (VCDI): Induction phase will be 50 weeks (12 cycles). The duration of a cycle will be 42 days (6 weeks) for Cycle 1 (C1) and 28 days (4 weeks) for subsequent cycles. The duration of a cycle of the maintenance phase will be 28 days (4 weeks). After C12, isatuximab will be administered at its initial assigned dose and dexamethasone once every 28 days.~VRDI cohort parts A and B: Isatuximab + bortezomib + dexamethasone + lenalidomide (VRDI): Induction phase will be 24 weeks (4 cycles at 6 weeks/cycle). The duration of a cycle of the maintenance phase will be 28 days (4 weeks). Maintenance therapy may continue until disease progression, unacceptable AE or patient willingness to discontinue.~VRDI Part A: Enrollment to begin after the VCDI cohort is completed.~VRDI Part B: Enrollment to begin after the VRDI part A is completed.

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: Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically or cytologically proven adenocarcinoma of the prostate prior to the initiation of radiotherapy~* Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as primary management~  * More than 30 months since prior brachytherapy with curative intent~* Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the lowest level recorded previously since the end of radiotherapy (i.e., higher than the post-radiotherapy nadir)~* Total testosterone greater than 5 nmol/L~* No definite evidence of metastatic disease~  * Chest x-ray and bone scan negative for metastases~ * Radiological changes compatible with nonmalignant diseases allowed~* Clinical evidence of local disease allowed~PATIENT CHARACTERISTICS:~Age:~* 16 and over (18 and over for participating centers in the United Kingdom)~Performance status:~* ECOG 0-1~Life expectancy:~* More than 5 years~Hematopoietic:~* Not specified~Hepatic:~* Bilirubin no greater than 1.5 times upper limit of normal (ULN)~* AST/ALT no greater than 1.5 times ULN~* LDH no greater than 1.5 times ULN~* No chronic liver disease~Renal:~* Creatinine no greater than 1.5 times ULN~Other:~* Sufficiently fluent and willing to complete the quality of life questionnaire in either English or French~* Fertile patients must use effective contraception~* No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or superficial bladder cancer~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* No prior or concurrent biologic therapy~Chemotherapy:~* No prior or concurrent chemotherapy~Endocrine therapy:~* Prior hormonal therapy administered prior to, during, or immediately after radical radiotherapy or prostatectomy allowed provided duration was no longer than 12 months~  * At least 12 months since prior hormonal therapy~Radiotherapy:~* See Disease Characteristics~* At least 12 months since prior radiotherapy~* No concurrent palliative radiotherapy~Surgery:~* See Disease Characteristics~* See Endocrine therapy~Other:~* No concurrent bisphosphonates

- Gender: MALE
- Minimum Age: 16 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- Intermittent Androgen Suppression (Type: ACTIVE_COMPARATOR): None
- Continuous Androgen Suppression (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: A Study of Different Use Regimens Using Two Acne Treatments

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

Eligibility Criteria:
Inclusion Criteria:~* Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;~* Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);~* Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);~* Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline~Exclusion Criteria:~* Known sensitivity to any of the ingredients in the study medication;~* Any nodulocystic acne lesions;~* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;~* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;~* Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;~* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;~* If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;~* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;~* Any significant medical conditions that could confound the interpretation of the study;~* Excessive facial hair that may interfere with evaluations;~* No use of tanning booths, sun lamps, etc.

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

Study Arms:
- Same time of day (Type: EXPERIMENTAL): 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
- Different times of day (Type: ACTIVE_COMPARATOR): 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

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 and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

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

Eligibility Criteria:
Inclusion Criteria:~* Patients must have had ulcerative colitis of at least 3 months' duration at screening, confirmed by the biopsy taken at screening~* Patients must have active colitis confirmed during the screening sigmoidoscopy~* Patients must have active disease.~Exclusion Criteria:~* Patient must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study~* Patient must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

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

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: Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

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 for Phase I:~* Adult lung transplant recipients age 18 or older~* At risk for CMV (donor or recipient serology must be positive for CMV)~* Adequate hematological and renal function,~* On intravenous (IV) ganciclovir within 24 hours of surgery~* Agreement to use effective methods of contraception~* Negative pregnancy~* Tolerate oral medications within 2 weeks of transplant~* Negative baseline CMV PCR~* Able to understand and sign the informed consent~Exclusion Criteria for Phase 1:~* Repeat transplantation~* Mechanical ventilation at study entry~* Oral or intravenous ganciclovir treatment outside the study protocol~* Invasive fungal infection~* Participation in another investigational study~* Acute CMV infection or disease~* Anti-CMV therapy within 30 days before enrollment~* Uncontrolled diarrhea or malabsorption~* Allergic reaction to study drug~* Required use of prohibited medications~* Lactating women~* Pregnancy~* Renal failure~Inclusion Criteria for Phase II:~* Negative serial post transplant PCRs at day 75~* Negative bronchial cultures for CMV~* Adequate hematological and renal function at day 75~* IV ganciclovir for up to 2 weeks post operation and open label up to day 90~* Effective contraceptives~* Negative pregnancy~Exclusion Criteria Phase II:~* Renal failure~* Serious adverse events (SAE) related to study drug~* CMV disease (study endpoint)~* Withdraw consent for Phase II

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): Valganciclovir 900 mg QD for 9 months post lung transplant.
- 2 (Type: PLACEBO_COMPARATOR): placebo for 9 months post lung transplant

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 Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patients both sexes~* Age between 30 and 60 years~* Metabolic Syndrome according to the IDF criteria~* Waist circumference~* Man ≥90 cm~* Woman ≥80 cm~* And two of the following criteria~* High density lipoprotein~* Man ≤40 mg/dL~* Woman ≤50 mg/dL~* Fasting glucose ≥100 mg/dL~* Triglycerides ≥150 mg/dL~* Blood pressure ≥130/85 mmHg~* Informed consent signed~Exclusion Criteria:~* Women with confirmed or suspected pregnancy~* Women under lactation and/or puerperium~* Hypersensibility to SGLT2 inhibitors~* Physical impossibility for taking pills~* Known uncontrolled renal, hepatic, heart or thyroid diseased~* Previous treatment for the metabolic syndrome components~* Body Mass Index ≥39.9 kg/m2~* Fasting glucose ≥126 mg/dL~* Triglycerides ≥500 mg/dL~* Total cholesterol ≥240 mg/dL~* Low density lipoprotein (c-LDL) ≥190 mg/dL~* Blood Pressure ≥140/90 mmHg

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Dapagliflozin (Type: EXPERIMENTAL): Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo capsules, 10 mg, one per day before breakfast during 90 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: Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed AML~* Age over 16~* Performance status greater than 60~* Previously untreated~* Peripheral blood white blood cell (WBC) count of less than (\<) 0.5 x109/L, and/or marrow leukemic blasts\< 20 % at 7th day of remission induction treatment~Exclusion Criteria:~* Previously treated~* Acute promyelocytic leukemia~* Age equal or younger than 15

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- control (Type: NO_INTERVENTION): remission induction with cytosine arabinoside amd idarubicine
- G-CSF (Type: EXPERIMENTAL): G-CSF was administered starting on Day 8 until neutrophil recovery

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: An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)~* Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)~Exclusion Criteria:~* Subjects who are known to not respond to methylphenidate~* Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components~* Have marked anxiety, tension or agitation~* Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

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: Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction

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

Eligibility Criteria:
Inclusion Criteria:~* Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.~Exclusion Criteria:~* Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.~* Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.~* The subject has uncontrolled hypotension (SBP\<90mmHg).~* Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.

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

Study Arms:
- Eplerenone plus standard of care (Type: EXPERIMENTAL): None
- Placebo plus standard of care (Type: PLACEBO_COMPARATOR): Matching placebo for eplerenone 25mg film coated tablets.

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 Refractory Chronic Cough With PA101

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of Idiopathic Pulmonary Fibrosis (based on presence of definitive or possible usual interstitial pneumonia UIP pattern on high-resolution computed tomography and after excluding lung diseases associated with environmental and occupational exposure, with connective tissue disease and with drugs; transfer capacity for carbon monoxide corrected for hemoglobin \[TLCOc\] \>25% predicted within 12 months of Screening; and forced vital capacity \[FRC\] \>50% predicted within 1 month of Screening) or Chronic Idiopathic Cough (that is unresponsive to targeted treatment for identified underlying triggers including post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease)~* Refractory chronic cough for at least 8 weeks~* Daytime cough severity score \>40 mm on Cough Severity VAS at Screening~* Daytime average cough count ≥15 per hour at Screening~* Willing and able to provide written informed consent~Exclusion Criteria:~* Current or recent history of clinically significant medical condition, laboratory abnormality or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator~* Upper or lower respiratory tract infection within 4 weeks of Screening~* History of malignancy treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ~* Current or recent history (within 12 months) of excessive use or abuse of alcohol~* Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances~* Participation in any other investigational drug study within 4 weeks of Screening~* Use of prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium within 2 weeks of Screening~* Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study

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

Study Arms:
- PA101 (Type: EXPERIMENTAL): PA101, 40 mg administered via inhalation three times daily for 14 days
- Placebo (Type: PLACEBO_COMPARATOR): Placebo PA101, administered via inhalation three times daily for 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: Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)

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:~* Biopsy proven NASH~* Circulating fasting leptin \<9 ng/mL (staggered criteria for different BMI levels)~Exclusion Criteria:~* Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal prothrombin time or albumin)~* Presence of clinical lipodystrophy~* Presence of other liver disease~* Presence of clinical diabetes (fasting \>126 mg/dL or 2 hour post 75 g-glucose \>200 mg/dL or random glucose \>200 mg/dL with presence of diabetes symptoms or known history of diabetes)~* Any medication for treatment of NASH or obesity~* Presence of HIV~* Inability to give informed consent~* Presence of end-stage renal disease, any type of active cancer, or \>class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination~* Presence of any other condition that limits life expectancy to \<2 years~* Active infection (may be transient)~* Any other condition in the opinion of the investigators that may impede successful data collection

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

Study Arms:
- Metreleptin treatment group (Type: EXPERIMENTAL): Treatment group

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

Answer: outcome: complete