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

Trial Title: Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia

Study Design Characteristics:
- Allocation: None
- Intervention Model: None
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: None
- Phase: PHASE1
- Number of Arms: None

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy~  * Presence of lymphoplasmacytic cells~ * CD20+ plasma cell dyscrasia on the majority of malignant cells~ * Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length~* Clinical indication for initiation of treatment, including 1 or more of the following characteristics:~  * Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)~ * Anemia~ * IgM greater than 3 g/L~ * Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months~* No myelodysplastic syndromes or profound hypocellularity of the bone marrow~PATIENT CHARACTERISTICS:~Age~* Over 18~Performance status~* WHO 0-2~Life expectancy~* More than 3 months~Hematopoietic~* Absolute neutrophil count greater than 1,500/mm\^3~* Total B-lymphocyte count less than 5,000/mm\^3~* Platelet count greater than 100,000/mm\^3~* No hyperviscosity syndrome~Hepatic~* Bilirubin no greater than 1.5 mg/dL~Renal~* Not specified~Other~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception during and for 1 year after study completion~* No uncontrolled CNS disease~* No serious nonmalignant disease that would preclude study participation~* No other concurrent active malignancy except controlled skin cancer or prostate cancer~PRIOR CONCURRENT THERAPY:~Biologic therapy~* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)~* More than 4 months since prior rituximab~* No prior radioimmunotherapy~Chemotherapy~* No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)~* More than 6 weeks since prior chemotherapy~Endocrine therapy~* More than 4 weeks since prior corticosteroids~Radiotherapy~* No prior radiotherapy~Surgery~* Not specified

- 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: Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Infants with congenital CMV infection and hearing loss (≥ 20 dB, in one or both ears).~* Age at time of inclusion is \< 13 weeks after birth.~* ≥ 37 weeks gestational age.~* Birth weight ≥ 2500 gram.~* Parental signed informed consent.~Exclusion Criteria:~* Indications for symptomatic congenital CMV infection based on diagnostics carried out prior to the inclusion of the child in the trial.~* In case during the house visit the presence of a symptomatic CMV infection is doubted, inclusion will be discussed. Depending on the medical history taking, physical examination and laboratory tests inclusion will be decided upon.~* Treatment with other antiviral agents or immunoglobulins.~* Leucopenia \< 0,5 x 10\*9/L (blood sample tested at t=0).

- Gender: ALL
- Minimum Age: 3 Weeks
- Maximum Age: 12 Weeks
- Healthy Volunteers: f

Study Arms:
- Valganciclovir (Type: EXPERIMENTAL): Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.
- Control (Type: NO_INTERVENTION): Infants in the control group receive no antiviral therapy. Counseling and treatment assigned by an audiological center remains unchanged.

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 Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001

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:~* At least 18 years old.~* ECOG (performance) status of 0, 1 or 2.~* Histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. Subjects with curative treatment options are not eligible for the protocol.~* No active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and anti-androgens such as; Flutamide, Dutasteride, and Finasteride).~* Adequate organ and bone marrow function.~* Male and female subjects of childbearing potential must agree to use contraception.~Exclusion Criteria:~* Pregnant or breast-feeding.~* Use of anti-coagulant therapy.

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

Study Arms:
- RRx-001 (Type: EXPERIMENTAL): RRx-001 will be administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.

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 6-Month Extension Study of OTO-104 in Meniere's Disease

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:~* Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study.~* Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria~Exclusion Criteria includes, but is not limited to:~* Subject is pregnant or lactating.~* Subject has a history of immunodeficiency disease.~* Subject has experienced an adverse reaction to intratympanic injection of steroids.

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

Study Arms:
- OTO-104 (Type: EXPERIMENTAL): 12 mg dexamethasone

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: Dose of Corticosteroids in COPD

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

Eligibility Criteria:
Inclusion Criteria:~i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital~Exclusion Criteria:~i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices.~vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.

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

Study Arms:
- Low Dose Corticosteroids (Type: ACTIVE_COMPARATOR): 10 mg IV q8hrs x 3 days\*, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop.~\*If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days.
- High Dose Corticosteroids (Type: EXPERIMENTAL): Methylprednisolone 40 mg IV q8hrs x 3 days\*, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \*If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 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: Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy

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

Eligibility Criteria:
Inclusion Criteria:~* Pregnant women who wish to sustain their pregnancy~* Women who have tested positive (blood or urine) for pregnancy in the first trimester~* treated with progestogens or any alternative treatment for early bleeding in pregnancy with evidence of an intrauterine pregnancy / unexplained recurrent OR pregnancy loss (with ≥ 2 previous pregnancy losses) with evidence of an intrauterine pregnancy OR having undergone IVF/ ART embryo transfer and taking progestogen for luteal phase support (LPS), with evidence of an intrauterine pregnancy~* Signed informed consent, allowing consent to contact all treating, or diagnosing HCP~* Able and willing to read and comprehend written instructions; comprehend and complete the questionnaires required by the protocol~Exclusion Criteria:~* Serious disease or disease requiring teratogenic treatment (e.g., Lupus Erythematosus, Multiple Sclerosis, cancer)~* Multifetal pregnancy~* More than four (4) previous IVF embryo transfers~* Previous exposure to dydrogesterone in index pregnancy~* Documented substance abuse~* Treatment with hormones which are known to cause malformations~* Participation in an observational study that might, in the recruiting HCP's opinion, influence the assessment for the current study~* Participation in a randomized clinical trial in the last 3 months~* Previous enrollment in the PEARLY study

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- Cohort A (Type: None): Early Pregnancy Bleeding/Recurrent Pregnancy loss
- Cohort B (Type: None): IVF/ART

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 Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

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:~* Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen~* Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300~* Requires oxygen supplementation at Screening~* Willing to follow contraception guidelines~Exclusion Criteria:~* Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving~* A previous stem cell infusion unrelated to this trial~* Certain medical conditions that pose a safety risk to the subject~* Pregnant or breast feeding or planning to during the study~* Suspected uncontrolled active bacterial, fungal, viral, or other infection~* History of splenectomy, lung transplant, or lung lobectomy~* Concurrent participation in another clinical trial involving therapeutic interventions~* Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days~* Has an existing Do Not Intubate order~* Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing

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

Study Arms:
- COVI-MSC (Type: EXPERIMENTAL): Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
- Placebo (Type: PLACEBO_COMPARATOR): Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

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: Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II

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:~* Recurrent symptomatic paroxysmal atrial fibrillation~* Previously failed one or more antiarrhythmic or beta-blocker medication (treatment \> 30 days) or if any contraindications against treatment with these drug.~* Patient is willing and able to attend the scheduled follow-up visits~* Signed informed consent~Exclusion Criteria:~* Persistent or permanent atrial fibrillation~* Previously atrial fibrillation ablation procedure~* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause~* Severe underlying heart disease (congenital heart disease, significant valvular disease, cardiomyopathy with LVEF \< 35 %, angina pectoris/ ischemic heart disease).~* Severe enlargement of left atrium (\> 45mm)~* Patient with pacemaker~* Failure to obtain informed consent~* Pregnant or breastfeeding women.~* Patient unable to undergo TEE or with documented left atrial thrombus~* Patients with co-morbid conditions who, in the opinion of the investigator, constitute increased risk of general anesthesia or port access, e.g. pleural fibrosis, chronic obstructive pulmonary disease (FEV1 \< 1.5 L/s).~* Known internal carotid artery stenosis (\> 80 %).~* Patients, who are enrolled in another clinical trial~* Life expectancy less than one year~* Previously TIA/stroke

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

Study Arms:
- Mini invasive thoracoscopic radiofrequency ablation (Type: ACTIVE_COMPARATOR): Video-assisted thoracoscopic radiofrequency ablation
- Percutaneous ablation (Type: ACTIVE_COMPARATOR): Percutaneous radiofrequency catheter ablation

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: Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy

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

Eligibility Criteria:
Inclusion Criteria:~* Reproductive aged women: Age 18-48 years old~* Non-pregnant~* Otherwise healthy~* Regular menstrual cycle~* Documented submucosal myomas (one or more)~* Undergoing hysteroscopic myomectomy~* Patients must have signed an informed consent.~Exclusion Criteria:~* Age \< 18 or in menopause~* Undergoing a second uterine surgical procedure~* Other significant uterine pathology (including but not limited to adhesions, septae, or cancerous lesions)~* Hysteroscopic evidence of synechiae at the time of the procedure~* Surgeries complicated by excessive bleeding; defined by estimated blood loss \> 100cc given that the presence of excessive bleeding may predispose a patient to the formation of intrauterine adhesions~* Surgeries complicated by uterine perforation~* Surgeries complicated by postoperative intrauterine infection given that infection may predispose a patient to the formation of intrauterine adhesions (If these patients received Seprafilm Slurry, they will continue to be followed for safety monitoring)

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 48 Years
- Healthy Volunteers: t

Study Arms:
- Seprafilm Slurry (Type: ACTIVE_COMPARATOR): The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.
- Placebo (Type: PLACEBO_COMPARATOR): For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.

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: Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry

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

Eligibility Criteria:
Inclusion Criteria:~* We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.~Exclusion Criteria:~* Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 8 Years
- Healthy Volunteers: t

Study Arms:
- oral placebo (Type: PLACEBO_COMPARATOR): an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen
- Oral Analgesics (Type: ACTIVE_COMPARATOR): 5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen

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: Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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:~* Cirrhosis (any etiology)~* Refractory ascites or hepatic hydrothorax and plan for TIPS placement~Exclusion Criteria:~* Well-documented overt hepatic encephalopathy, either persistent or at the time of screening~* Any contraindication for TIPS placement~  * Except for coagulopathy and thrombocytopenia (decided on an individual basis)~* Uncontrolled depression/anxiety disorder or use of antipsychotic drugs~* Active use of alcohol or illicit drugs~* History of dementia~* TIPS planned for another indication.~* Active alcoholic liver disease.

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

Study Arms:
- TIPS (Type: None): Patients 18-75 year old with refractory ascites or hepatic hydrothorax and cirrhosis, eligible for TIPS placement. All patients will have a baseline oral glutamine challenge and psychometric tests.

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 to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)

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

Eligibility Criteria:
Key Inclusion Criteria:~* Diagnosis of PML confirmed by detection of JCV DNA in CSF.~* Onset of PML symptoms within 6 months prior to study.~Key Exclusion Criteria:~* Other opportunistic infection of the central nervous system.~* Current severe illness or any other conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment.~* Active severe mental illness (e.g., depression, anxiety, psychosis, and schizophrenia).~* Hypersensitivity to mefloquine, quinine, or quinidine, or to any component of these drugs.~* Current treatment with quinine, quinidine, chloroquine, or halofantrine.~Note: Other protocol-defined criteria may also apply.

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

Study Arms:
- Local standard of care (Type: NO_INTERVENTION): All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants in this treatment arm had the option of adding 250 mg mefloquine by mouth at Week 4 (Day 28) or Week 8 (Day 56) daily for 3 days, and then weekly through Week 24.
- Local standard of care plus mefloquine 250 mg (Type: EXPERIMENTAL): All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants received 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.

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

Answer: outcome: terminate
termination_type: lack of efficacy