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

Trial Title: Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

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

Eligibility Criteria:
Inclusion Criteria:~* Age \>= 18 years old~* Moderate or severe risk of prematurity~* Mono-fetal pregnancy~* And a term of pregnancy \> = 24 weeks and \<34 weeks of gestation at diagnosis~* subjects affiliated with an appropriate social security system~* written signed informed consent form~Exclusion Criteria:~* Age \< 18 years old~* Major under trusteeship or curatorship~* Maternal refusal and / or Incapacity to understand the benefits and potential risks of the protocol and to sign an informed consent form.~* A sonographic cervix ≥ 20 mm~* Mothers WITH:~  * A Body mass index less than 18 kg/m2 and greater than 40 kg/m2 before pregnancy~ * Type I, II diabetes~ * Epileptic disorders~ * A history of asthma~ * A hemorrhagic pathology~ * Maternal infection (HIV, hepatitis B and C) other than chorioamnionitis~* Patients in labour treated with magnesium sulphate~* Multiple pregnancy~* A known allergy/ hypersensitivity to N-acetylcysteine~* Fetal pathology other than intrauterine growth retardation (such as: karyotype abnormality, malformation, intrauterine growth retardation \<10th percentile)~* Current high doses of antioxidants treatments (vitamin supplements, ...)~* Patient with proven pre-eclampsia~* Patient with heart failure~* Patient with nephropathy~* Patient with medically known lactose intolerance~* Patient not affiliated with an appropriate social security system

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

Study Arms:
- N-acetylcysteine (NAC) (Type: EXPERIMENTAL): High risk of prematurity: 9g intravenously then 6g (per os) a day until day 7, then 1,8g (per os) a day until 37 weeks of gestational age.~Moderate risk of prematurity: 6g (per os) a day until day 7 then 1,8g ( per os) a day until 37 weeks of gestational age.
- Placebo (Type: PLACEBO_COMPARATOR): High risk of prematurity: 9g intravenously then 6g (per os) a day until day 7, then 1,8g (per os) a day until 37 weeks of gestational age.~Moderate risk of prematurity: 6g (per os) a day until day 7 then 1,8g ( per os) a day until 37 weeks of gestational age.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female patient, aged at least 18 years.~* Patient presenting with at least one autonomous hyperfunctioning thyroid nodule~  * TSH 0,1 mU/ml~ * Hyperfunctioning at thyroid scintigraphy with partial or total extinction of parenchyma~* Targeted nodules visible with ultrasonography~* Volume to be treated 15 cc~* Targeted area located at least at 2 mm from the trachea, the esophagus, and the carotid artery.~* Composition of the targeted nodule: no more than 75% cystic.~* Absence of abnormality at laryngoscopy in recurrent nerves~* Voluntary consent (patient or legal guardian) to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent document at the eligibility assessment visit~* Patients for whom iodine therapy is contra-indicated or unfeasible and surgery is contra-indicated or refused~* Patients refusing iodine therapy~* Willingness and availability to return for all required follow-up visits and to undergo all required study procedures.~* Patient affiliated to the French Health Insurance System~Exclusion Criteria:~* For the targeted nodule(s): presence of signs evidencing a nodule malignancy (compression or curvature of the surrounding organs, positive or suspicious previous FNAB).~* Suspicious cervical lymph nodes at US~* \> 75% Cystic nodule~* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment~* Pregnant or lactating woman. Female patient of childbearing age will be screened for pregnancy prior to enrollment in the study and will be included only if having a suitable contraception method.~* Known latex or lidocaine hypersensitivity~* History of neck irradiation or subtotal thyroidectomy~* Non controlled evolutive cardiothyreosis~* Patients treated with antithyroid medications within the month before the pre-treatment visit~* Subjects whose concurrent illnesses, disability, or geographical residence would hamper regular attendance at required study visits~* Patients who have received any investigational drug or device within the last 30 days and/or patients who are currently participating in another clinical trial

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

Study Arms:
- Hifu (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: High Volume Lactated Ringer's Solution and Pancreatitis

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

Eligibility Criteria:
Inclusion Criteria:~Patients to be included in the study are those undergoing ERCP with the following:~* Clinical suspicion of sphincter of Oddi dysfunction~* History of post-ERCP pancreatitis (at least one episode)~* Pancreatic sphincterotomy~* Pre-cut (access) sphincterotomy~* Ampullectomy~Exclusion Criteria:~* Age \< 18 years old~* Intrauterine pregnancy or breastfeeding mother~* Congestive heart failure~* Advanced/symptomatic coronary artery disease~* Known ascites~* Renal failure~* Active or recent gastrointestinal hemorrhage~* Acute pancreatitis within 72 hours prior to ERCP

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

Study Arms:
- High Volume Group (Intervention Arm) (Type: EXPERIMENTAL): Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~* LR fluid infusion during the procedure at 5 cc/kg/hr~* Post-procedure bolus of 20 cc/kg over 90 minutes
- Low Volume Group (Control Arm) (Type: ACTIVE_COMPARATOR): Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy

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: None

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Cytologically or pathologically confirmed colorectal adenocarcinoma~  * Advanced or metastatic disease~* Refractory to ≥ 1 line of prior therapy~  * Not amenable to potentially curative surgical resection~* Mutations in the PI3K gene in tumor tissue~* Tumor tissue available for genetic testing OR willing to undergo baseline tumor biopsy~  * Tumor amenable to sequential biopsies~ * Willing to undergo 2 sequential tumor biopsies, and 2 sequential skin biopsies~* Measurable lesion with ≥ 1 diameter ≥ 2 cm by conventional CT scan (1 cm by spiral CT scan) in a nonirradiated area~* No known brain metastases~PATIENT CHARACTERISTICS:~* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%~* Life expectancy \> 12 weeks~* WBC ≥ 3,000/mm³~* Absolute neutrophil count ≥ 1,500/mm³~* Platelet count ≥ 100,000/mm³~* Bilirubin normal~* AST and ALT ≤ 2.5 times upper limit of normal (ULN)~* Creatinine normal OR creatinine clearance ≥ 60 mL/min~* Cholesterol and triglycerides ≤ 2.5 times ULN~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus~* No uncontrolled intercurrent illness, including, but not limited to, any of the following:~  * Hypertension~ * Ongoing or active infection~ * Symptomatic congestive heart failure~ * Unstable angina pectoris~ * Cardiac arrhythmia~ * Psychiatric illness or social situation that would preclude study compliance~* No evidence of bleeding diathesis~* Able to swallow tablets~PRIOR CONCURRENT THERAPY:~* See Disease Characteristics~* At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered~* No prior targeted therapy against mTOR~* No other concurrent investigational agents~* No concurrent therapeutic anticoagulation~  * Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided the requirements for PT, INR or PTT are met.~* No concurrent combination antiretroviral therapy for HIV-positive patients~* No other concurrent anticancer therapy, including chemotherapy, hormonal therapy, immunotherapy, alternative therapy, or radiotherapy~* No concurrent live vaccination

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

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Cell Therapy in Chronic Ischemic Heart Disease

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 chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG.~* Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule).~* Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy.~* Abnormal myocardial perfusion tests:~  i. Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram~* Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:~  i. High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease~* Non-candidates for a complete CABG, or candidates for a complete CABG in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.~* To provide a signed, written informed consent, according to the National Guidelines for Clinical Trials.~Exclusion Criteria:~* Severe valve heart disease requiring surgical repair.~* Serologic diagnostic of Chagas' disease.~* Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.~* Malignant ventricular arrhythmias (like VT), unless an ICD have been placed.~* Any acute coronary syndrome in the past 3 months.~* End-stage renal disease requiring maintenance dialysis.~* History of neoplasia.~* Drug or alcohol abuse.~* Life expectancy below 2 years.~* Enrollment in any cell therapy trial in the past 2 years.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

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:~* Patients newborn to 18 years old.~* Patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, EBR, or enucleation would be considered for this study.~Exclusion Criteria:~* Patients over the age of 18.~* Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy).~* Patients with extraocular disease evident on MRI (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination.~* Documented hypercoagulable disorders or vasculopathies.~* Laboratory exclusion criteria: GFR \< 60 mL/min/1.73 m2

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

Study Arms:
- Intraocular Retinoblastoma Patients (Type: OTHER): Single group assignment of patients with intraocular retinoblastoma, unilateral or bilateral.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Prehabilitation for PAD Revascularization Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Documented lower extremity PAD~* Ability to walk at least 1 block~* Sedentary~* Medical clearance from the surgical team~* Competent to provide consent~Exclusion Criteria:~* Life expectancy \< 6 months~* Co-morbidities which limit walking to a severe degree~* Signs of critical limb ischemia~* Recent or current enrollment in a formal exercise program~* Recent cardiovascular events including stroke, TIA, severe valve disease, etc.~* Current substance abuse~* Psychiatric disorder which limits ability to participate in study procedures~* Non-English speaking

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

Study Arms:
- Prehabilitation (Type: EXPERIMENTAL): Participants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health
- Usual Care (Type: NO_INTERVENTION): Participants will follow the pre-operative instructions provided by their surgical team.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Males or females with type 2 diabetes mellitus (T2DM)~* Are current users of U-100, U-200 and/or U-300 insulin/analog as, basal, premixed and/or basal/bolus delivered with any injection device (pens and/or syringe/vial but excluding continuous subcutaneous infusion (CSII)/insulin pump use in the preceding 3 months), taking a total daily dose (TDD) of greater than or equal to (≥) 150 units (U) or at least one dose greater than (\>) 100 U as part of a multiple daily injection (MDI) regimen and TDD less than or equal to (≤)3.0 units per kilogram (U/kg)~* Concomitant antihyperglycemic agent(s) (AHA) therapy may include: metformin (MET), dipeptidyl peptidase 4 inhibitors, pioglitazone (doses ≤30 milligrams per day (mg/day)), glucagon like peptide (GLP)-1 receptor agonists, sodium-glucose co-transporter-2 (SGLT2) inhibitors, except in combination with GLP-1 receptor agonists~* Participant's antihyperglycemic agent (AHA) therapy must have been stable for ≥3 months (except for weekly GLP-1 receptor agonists which must have been stable for ≥4 months)~* Have hemoglobin A1c (HbA1c) 7.5-11.5 percent (%)~Exclusion Criteria:~* Have type 1 diabetes mellitus (T1DM), or other types of diabetes mellitus apart from T2DM~* Have known hypersensitivities or allergies to insulin, excipients contained in insulin products, or related compounds~* Have used U-500R within 3 months prior to screening~* Have used rosiglitazone, pramlintide, once weekly or twice daily exenatide, or other injectable or oral antihyperglycemic agent(s) not listed in the inclusion criterion; or are taking oral antidiabetic medications at doses exceeding the respective product labels~* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia which may affect reliability of HbA1c measurements

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- Part A: U-500R Single Injection (Type: EXPERIMENTAL): Bolus of U-500R administered via single subcutaneous (SC) injection.
- Part A: U-500R CSII (Type: EXPERIMENTAL): Bolus of U-500R administered via continuous subcutaneous insulin infusion (CSII).
- Part B: U-500R TID (Type: EXPERIMENTAL): U-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days
- Part B: U-500R BID (Type: EXPERIMENTAL): U-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of HS for at least 1 year prior to screening~* HS lesions must be present in at least 2 distinct anatomic areas~* A total AN count (sum of abscesses and inflammatory nodules) \> 6 across all anatomical sites at both the screening and baseline visits~* Willing to use contraception for the duration of the study~Exclusion Criteria:~* Presence of other skin conditions which may interfere with study assessments~* Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening~* Body Mass Index (BMI) \>48kg/m2~* Breastfeeding or pregnant

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

Study Arms:
- RIST4721 400 mg (Type: EXPERIMENTAL): RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Placebo: 4 placebo tablets once daily for 12 weeks

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

Answer: outcome: terminate
termination_type: safety issues
Please assess the completion status of the following clinical trial:

Trial Title: Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:~* Presence of bone marrow clonal plasma cells (more than 10%)~* Presence of an M-protein in serum and/or urine (no concentration specified)~* Serum calcium \< 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey~* No symptoms of hyperviscosity, amyloidosis or recurrent infection~* Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration~* Negative pregnancy test~Exclusion Criteria:~* No previous treatment with bisphosphonates~* No disorders of the parathyroid or thyroid glands~* No current breastfeeding~* No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason \< grade 7 prostate cancers

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
- B (Type: NO_INTERVENTION): Patients will be randomly assigned by study number to observation only.

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

Answer: outcome: terminate
termination_type: enrollment issues