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

Trial Title: Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or Female, age 30 to 85 years at screening~2. Able to provide informed consent and agree to adhere to all study visits and requirements~3. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug~4. Established diagnosis of ILD (clinical, radiographic, or histologic)~5. SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air~6. Free of any active cardiovascular or neuromuscular disease, at PI discretion~7. Clinically stable disease with no major medication changes in the last 4 weeks~8. Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)~9. DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)~10. Sars-CoV-2 negative at screening~Exclusion Criteria:~1. Known allergy to study medication~2. Pregnancy or lactation~3. Current smoker~4. Inability to perform pulmonary function testing~5. Active infection at screening or day of study visit~6. Known pulmonary hypertension (PH) requiring PH-specific treatment~7. AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN~8. Received any investigational medicine (IMP) within past 30 days~9. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.~10. Current alcohol or substance abuse~11. Known active or latent hepatitis B or C~12. History of end-stage liver or renal disease~13. Positive COVID test anytime within 3 months of screening. Note:~    Patients who were previously vaccinated for COVID are allowed~14. History of venous thromboembolic disease~15. History of acute or chronic ophthalmologic conditions currently requiring treatment

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 2.5 mg/kg Trans Sodium Crocetinate (Type: EXPERIMENTAL): Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.
- Placebo (Type: PLACEBO_COMPARATOR): Subjects will receive a single IV bolus dose of 7 mL Normal Saline.

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: A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Have a confirmed diagnosis of type 1 Gaucher disease with a documented gene mutation;~* Clinically stable and on a stable dose of ERT for at least 2 years before study entry, with no changes to dose level or regimen in the last 6 months;~* Willing to stop ERT for the duration of the study;~* Male or female between the ages of 18 to 65 inclusive;~* All subjects of reproductive potential are required to practice an acceptable method of contraception;~* All subjects must have a body mass index of less than 30; and~* Provide written informed consent to participate in the study.~Exclusion Criteria:~* A clinically significant disease, severe complications from Gaucher disease, or serious intercurrent illness that may preclude participation in the study in the opinion of the Investigator;~* During the screening/wash out period, any clinically significant findings, based on physical exam, medical history review, lab assessment, vital sign assessment and/or other significant finding which would compromise the safety of the subject, or preclude the subject from completing the study as deemed by the Investigator;~* Partial or total splenectomy;~* History of pulmonary hypertension or Gaucher-related lung disease;~* History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars;~* Screening or Day 1 (before dosing) 12-lead ECG demonstration QTc \>450 msec in males or \>470 in females;~* Pregnant or breast-feeding;~* Current/recent drug or alcohol abuse within the past 12 months;~* Treatment with any investigational product, including investigational forms of ERT, in the 90 days before study entry;~* Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ;~* Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs; or~* Subject is otherwise unsuitable for the study in the opinion of the Investigator.

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

Study Arms:
- AT2101 (Type: EXPERIMENTAL): None

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: Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

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

Eligibility Criteria:
Inclusion Criteria:~* Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of not applicable~* In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye~Exclusion Criteria:~* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding~* History of nasal or sinus surgery~* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit~* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit~* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

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

Study Arms:
- TrueTear™ Intranasal then Extranasal Application (Type: EXPERIMENTAL): TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.
- TrueTear™ Extranasal then Intranasal Application (Type: EXPERIMENTAL): TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.

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

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

Trial Title: Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed 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:
DISEASE CHARACTERISTICS:~* Histologically confirmed infiltrating carcinoma of the breast~  * Unresected clinical stage T1c, T2, T3, or T4 lesion, any N~* Newly diagnosed disease~  * Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry~ * Mammogram of the contralateral breast within 6 months before study entry~* Clinically measurable disease~* Hormone receptor status:~  * Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material~PATIENT CHARACTERISTICS:~Age~* 18 and over~Sex~* Female~Menopausal status~* Not specified~Performance status~* ECOG 0-2~Life expectancy~* Not specified~Hematopoietic~* Absolute neutrophil count at least 1,500/mm\^3~* Platelet count at least 100,000/mm\^3~* Hemoglobin at least 8 g/dL~Hepatic~* Bilirubin no greater than 1.5 times normal~Renal~* Creatinine no greater than 1.5 times normal~Other~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation~PRIOR CONCURRENT THERAPY:~Biologic therapy~* Not specified~Chemotherapy~* No prior chemotherapy for current breast cancer~Endocrine therapy~* At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention~* No prior endocrine therapy for current breast cancer~Radiotherapy~* No prior radiotherapy for current breast cancer~Surgery~* Not specified

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

Study Arms:
- Docetaxel (Type: EXPERIMENTAL): Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.

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: COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

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:~* All patients admitted to the ICU in septic shock~* All patients that develop septic shock while in the ICU~Exclusion Criteria:~* Age less than 18 years~* Pregnancy~* Cardiopulmonary resuscitation~* Cerebral coma~* Metastatic cancer~* Presence of relative or absolute contraindications to CPFA~* Estimated life expectancy less than 2 weeks~* Already included in the study~* Admission from an other ICU where the patient remained for more than 24 hours~* Absence of informed consent

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

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: NO_INTERVENTION): None

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: Co-culture and Advanced Maternal Age in PGS Program

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

Eligibility Criteria:
Inclusion Criteria:~* Advanced maternal age (\>39) undergoing PGS cycle~Exclusion Criteria:~* Other PGS indication~* Altered karyotype

- Gender: FEMALE
- Minimum Age: 40 Years
- Maximum Age: 47 Years
- Healthy Volunteers: f

Study Arms:
- Control Group (Type: None): sequential culture system
- Co-culture system (Type: None): None

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: Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed pancreatic cancer.~* Measurable disease.~* Absence of ascites or obstructive jaundice.~* ECOG Performance Status 0-2.~* Adequate liver kidney and bone marrow function.~* Written informed consent.~Exclusion Criteria:~* Chronic diarrheic syndrome.~* Uncontrolled brain metastases after radiation.~* Liver infiltration over 50%.~* Peripheral neuropathy ≥ 2.~* No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.~* No active uncontrolled infection.~* Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.~* Women who are pregnant or lactating.

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

Study Arms:
- 1 (Type: EXPERIMENTAL): GEM/TAR
- 2 (Type: EXPERIMENTAL): GEM/OX/TAR

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: Behavioral Effects of Kuvan in Children With Mild Phenylketonuria

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

Eligibility Criteria:
Inclusion Criteria:~* Willing and able to provide informed consent and/or assent.~* Willing and able to comply with study procedures.~* Between 6 and 18 years of age, inclusive.~* Intention of physician to prescribe Kuvan.~* Phenylalanine levels between 360μmol/L and 600μmol/L, inclusive, when untreated with dietary restrictions.~* Negative pregnancy test if of childbearing potential.~* Willing to use contraception if sexually active.~Exclusion Criteria:~* Treatment with Kuvan within the past 6 months.~* Pregnant, breastfeeding, or planning to become pregnant during study.~* Use of investigational product less than 30 days prior to or during study.~* Concurrent condition that could interfere with participation or safety.~* Any condition creating high risk of poor compliance with study.~* History of major medical disorder unrelated to phenylketonuria.~* Perceived to be unreliable or unavailable for study.~* Use of L-Dopa, methotrexate, or other drugs that inhibit folate metabolism.~* Known hypersensitivity to sapropterin or excipients.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Phenylketonuria (Type: None): Individuals with mild phenylketonuria/hyperphenylalanemia who are beginning treatment with Kuvan.

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: Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture

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

Eligibility Criteria:
The inclusion criteria are:~1. Adult men or women aged 18 years and older.~2. Acute open or closed fracture(s) of the appendicular skeleton. Patients with multiple fractures may be included.~3. Fracture treated operatively with internal fixation.~4. Screened for eligibility within 6 weeks of their fracture.~5. Cognitive ability and language skills required to participate in the CBT intervention (in the judgement of site research personnel).~6. Able to start the CBT within 8 weeks of their fracture surgery.~7. Provision of informed consent.~8. Screen positive for unhelpful illness beliefs (SPOC scores ≥74), as assessed at 6 weeks' post-surgical fixation.~The exclusion criteria are:~1. Fragility fracture.~2. Stress fracture.~3. Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture.~4. Active psychosis.~5. Active suicidality.~6. Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the study.~7. Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).~8. Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.~9. Incarceration.~10. Other reason to exclude the patient, as specified.

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

Study Arms:
- intervention - CBT (Type: EXPERIMENTAL): Participants in this arm will receive 6 weekly one-on-one, 1-hour sessions of Cognitive Behavioural Therapy session (intervention) in addition to receiving standard of care treatment for their fracture(s).
- control (Type: NO_INTERVENTION): Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.

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

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

Trial Title: Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian 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:~* Patient has platinum-sensitive, recurrent ovarian, fallopian-tube or peritoneal cancer. Platinum sensitivity is defined as complete clinical remission after frontline chemotherapy lasting greater than 6 months~* Patient has completed at least 2 courses of platinum-based chemotherapy with a PR or CR as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.139 or a CA-125 response, according to Gynecological Cancer InterGroup (GCIG) criteria40~* BRCA testing required (results not needed for registration)~* ECOG performance status score of 0, 1, or 2 (See Appendix A)~* Life expectancy greater than 6 months~* Normal organ and marrow function as defined: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin (Hgb) ≥ 8 g/dL (blood transfusions to reach this amount are allowed); Serum creatinine ≤ 1.5 mg/dL; Total serum bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN~* Able to take oral medication~* Not pregnant and not breastfeeding~* Able to understand and willingness to sign a written informed consent document~* Patients must be enrolled within 8 weeks of completing last cycle of chemotherapy~Exclusion Criteria:~* Patient has had a prior invasive malignancy diagnosed within the last five years (except \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix or breast \[3\] has been without evidence of invasive disease for greater than 3 years)~* Patients receiving any other investigational agents~* History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib~* Uncontrolled intercurrent illness that could affect their participation in the study including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements~* Impairment of gastrointestinal function or disease that may significantly alter the absorption of olaparib~* Patients who have received prior treatment with a PARP inhibitor~* History of noncompliance to medical regimens

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

Study Arms:
- Olaparib (Type: EXPERIMENTAL): Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value.

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: Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia

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

Eligibility Criteria:
Inclusion Criteria:~* Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).~* Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.~Exclusion Criteria:~* Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.~* Creatinine Clearance \< 30 milliLitres/minute.~* Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.~* Participating in a clinical trial with an investigative drug for CLL.

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

Study Arms:
- Participants Treated With Venetoclax + Obinutuzumab (Type: None): Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.

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

Answer: outcome: terminate
termination_type: enrollment issues