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

Trial Title: Alemtuzumab to Treat Sporadic Inclusion Body Myositis

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

Eligibility Criteria:
* Only patients who are currently enrolled in protocol 02-N-0121 Study of Immune Dysregulation in Patients with Sporadic Inclusion Body Myositis (s-IBM) will be considered for enrollment in protocol 04-N-0133.~INCLUSION CRITERIA:~Patients with confirmed diagnosis of s-IBM willing to undergo therapy with Alemtuzumab.~Willingness and legal ability to give and sign informed study consent.~Willingness to travel to the Clinical Center for planned studies and treatment as required by protocol.~Men and women of reproductive potential must agree to use an acceptable method of birth control during and for six months after completion of treatment.~Availability of tissue for testing. This will include muscle and peripheral blood lymphocytes isolated through routine lymphocytapheresis or phlebotomy.~EXCLUSION CRITERIA:~Immunosuppressive drug therapy at the time of or 6 months prior to enrollment. Specifically, candidates may not be taking Prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide methotrexate, or other agents whose concomitant use may enhance the toxicity of Alemtuzumab.~Any medical or personal difficulties that precludes serial follow-up visits.~Any active malignancy.~Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol.~Platelet count less than 100,000/mm(3).~Hemoglobin less than 9.0 mg/dl.~Any known immunodeficiency syndrome included HIV infection.~Any history of cardiac insufficiency, major vascular disease, or unstable coronary artery disease.~Any history of systemic or pulmonary edema.~Any history of previous treatment with monoclonal antibodies or sensitivity to the study drug (Alemtuzumab), pre-medication regimen, or prophylactic agents.~History of chronic hypotension (SBP less than 100 mmHg).~Any medical condition that would likely increase the risk of side effects of the study drug or confound the interpretation of the data including active infections.~Pregnancy and active nursing (breast feeding).~History of uncontrolled thyroid disease or a history of autoimmune thyroiditis.

- Gender: ALL
- Minimum Age: 25 Years
- Maximum Age: 80 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: Pramipexole and Morphine for Renal Colic

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

Eligibility Criteria:
Inclusion Criteria:~* Age 19 - 65~* ED presentation with pain associated with suspected renal colic~* Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)~Exclusion Criteria:~* Age \< 19 or ≥ 66~* Allergy to any study medication~* Known pregnancy or breastfeeding~* Received opioid prior to enrollment~* Received IV Lidocaine during current ED visit~* Known chronic renal disease~* Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)~* Unable to consent

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 66 Years
- Healthy Volunteers: f

Study Arms:
- Pramipexole and half-standard dose of morphine (Type: EXPERIMENTAL): 0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine
- Standard dose of morphine and placebo (Type: ACTIVE_COMPARATOR): 0.1mg/kg of IV morphine in combination with a placebo pill

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: Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

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

Eligibility Criteria:
Inclusion criteria:~* Newly diagnosed patients (\< 3years) with type 2 diabetes.~* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.~* No previous treatment with oral or parenteral glucose-lowering therapy.~Exclusion criteria:~* History of lactic acidosis.~* Anemia (\<11g for males, \<10 g for females).~* Unstable or severe NY Heart Association-class 3 or 4.~* Any NY Heart Association congestive heart failure.~* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

- 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: complete
Please assess the completion status of the following clinical trial:

Trial Title: Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Males and females between the ages of 18 to 55 years, inclusive~* Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria~* Subjects who are deemed valid by the State, Assessability, Face, Ecological, and Rule (SAFER) interview~* Subjects who are otherwise healthy on the basis of their physical examination~Exclusion Criteria:~* Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment.~* Subjects taking daily oral risperidone at a dose ≥ 6 mg/day~* Subjects who have received a depot antipsychotic within 120 days of screen~* Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- RBP-7000 90 mg (Type: EXPERIMENTAL): Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
- RBP-7000 120 mg (Type: EXPERIMENTAL): Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
- Placebo (Type: PLACEBO_COMPARATOR): Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.

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: Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Double-blind phases: adults age 18 and above; Open-label extension: Adults and children aged 7 years and older.~* Was diagnosed with Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) based upon clinical signs and symptoms~* Had documented mutation in NLRP-3 (Cold Induced Autoinflammatory Syndrome-1 or CIAS1) in subject or relative, and willingness to have a confirmatory genetic (Deoxyribonucleic acid or DNA) test (cheek swab).~* Was able to understand and comply with study procedures and was able to provide informed consent~* If female, was not currently pregnant and was willing to use contraception during the study~Exclusion Criteria:~* Had evidence of untreated tuberculosis or other conditions/therapies that made the subject inappropriate for this study.

- Gender: ALL
- Minimum Age: 7 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Some subjects were treated with Placebo in the Study. This occurred (if subject randomized to Placebo) either during the first 6 weeks of the study or during the randomized withdrawal (weeks 15-24).
- rilonacept 160 mg (Type: ACTIVE_COMPARATOR): If randomized to rilonacept, subjects received this treatment during the first 6 weeks of the study or during the randomized withdrawal (weeks 15-24). All subjects received rilonacept 160 mg during weeks 6-14 (between Parts A and B).~Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg.
- Open-Label rilonacept 160 mg (Type: OTHER): After week 24 (the end of part B), all subjects went into weekly dosing of open label rilonacept 160 mg. During this phase of the study, adolescents aged 7 and above were entered into the study and rilonacept was dosed as 2.2 mg/kg injections, up to 160 mg, per week.~Study drug is administered as a 2.0 mL subcutaneous injection once a week.

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: Opioid Use Disorder in the Emergency Department: CTN 0069

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

Eligibility Criteria:
Patient Inclusion Criteria:~* Patients who are treated in the ED during study screening hours with Diagnostic and Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid positive urine sample will be eligible to participate.~Patient Exclusion Criteria:~* Patients who test positive for fentanyl only are not eligible due to lack of uniformly available rapid urine tests.~* Patients will be excluded if they have a medical or psychiatric condition requiring hospitalization at the index ED visit, are acutely suicidal or severely cognitively impaired precluding informed consent, present from an extended care facility, require continued prescription opioids for a pain condition, are a prisoner or in police custody at time of index ED visit, are currently (past 30 days) enrolled in formal addiction treatment including by court order, are unable to provide 2 contact numbers, are unwilling to follow study procedures, have been previously enrolled in the current study or do not speak English.~ED and Community Participants Inclusion Criteria:~* ED and community providers and administrators (i.e. physicians, residents, fellows, nursing, nurse practitioners, physician assistants, pharmacists, social workers, counselors, administrative directors, office-based physicians and opioid treatment program representatives) as well as ED patients with OUD.

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

Study Arms:
- Evidenced-based Practice Dissemination (Type: EXPERIMENTAL): Evaluating standard dissemination practice compared with implementation facilitation

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: Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia

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

Eligibility Criteria:
DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose~PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified

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

Study Arms:
- Alemtuzumab (Type: EXPERIMENTAL): 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: Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age 20-74~* PS 0-2~* Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy~* Chid-Pugh A or B~* At least one measurable lesion by RECIST criteria~Exclusion Criteria:~* Large amount of pleural effusion or ascites~* Esophageal varices~* Simultaneously active double cancer

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 74 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Orantinib

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: US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy subjects as established by medical history and history-directed physical examination before entering into the study.~* Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.~* Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.~Exclusion Criteria:~* Administration of a pre-school booster of DTP vaccine within the previous 5 years~* Administration of a diphteria-tetanus (Td) booster within the previous 5 years~* Previous vaccination against N. meningitidis~* Hypersensitivity to latex~* History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines~* History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause~* Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized~* Previous history of Guillain-Barré syndrome

- Gender: ALL
- Minimum Age: 11 Years
- Maximum Age: 18 Years
- Healthy Volunteers: t

Study Arms:
- Boostrix + Menactra Group (Type: EXPERIMENTAL): Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
- Boostrix-Menactra Group (Type: EXPERIMENTAL): Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
- Menactra-Boostrix Group (Type: EXPERIMENTAL): Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.

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: Reduction of Risk for Low Back Injury in Theater of Operations

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-35 years~* Active duty soldiers in the US Army training to become combat medics at Fort Sam Houston~Exclusion Criteria:~* Cardiovascular contraindications to resistance exercise as identified by history and physical examination~* Orthopedic contraindications to resistance exercise as identified by history and physical examination~* History of systemic inflammatory disease or spinal surgery~* Low back pain intensity \> mild~* Disability \>= 50% on the Roland Morris Disability Questionnaire~* Currently receiving care for spinal pain disorder/injury~* Currently disabled due to spinal pain disorder/injury~* Currently diagnosed with or receiving treatment for a psychological or psychiatric disorder~* Currently performing progressive resistance exercises for the lumbar extensor muscles other than those included in standard for military fitness programs~* Active workers' compensation or personal injury case~* Pregnant~* Simultaneously enrolled in another biomedical clinical trial~* Drug or alcohol abuse within the past year~* Any other condition, which in the opinion of the investigators or military medical authority, would put the candidate at increased safety risk or otherwise make the candidate unsuitable for this study~* Unable or unwilling to complete the study procedures

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

Study Arms:
- Strengthening Exercise (Type: EXPERIMENTAL): Lumbar ext. high intensity progressive resistance exercise
- Stabilization Exercise (Type: ACTIVE_COMPARATOR): Low intensity core stabilization exercise

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: Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

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:~* Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma~* Life expectancy \> 12 months~Exclusion Criteria:~* No known history of HIV infection~* No other active infection~* No peripheral neuropathy ≥ grade 2 within the past 14 days~* No uncontrolled hypertension~* None of the following cardiac conditions:~  * Myocardial infarction within the past 6 months~ * No heart failure~ * Uncontrolled angina~ * Severe uncontrolled ventricular arrhythmias~ * Electrocardiographic evidence of acute ischemia~ * Active conduction system abnormalities~* No serious medical or psychiatric illness that would preclude study compliance~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No prior therapy for non-Hodgkins lymphoma~* No prior bortezomib or rituximab~* At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy~* At least 2 weeks since prior investigational drugs~* No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia

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

Study Arms:
- Bortezomib and Rituximab (Type: EXPERIMENTAL): On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.

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: Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with overt signs of upper GIB; fresh hematemesis and/or melena with or with circulatory compromise~Exclusion Criteria:~* Chronic aspirin user,~* Pregnancy,~* Age\<16,~* Allergy to PPI,~* No consent

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

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

Answer: outcome: complete