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

Trial Title: Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion criteria:~* All subjects:~  • Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment~* Subjects with hepatic impairment:~  * Subjects must have either mild, moderate or severe hepatic impairment~Exclusion criteria:~* All subjects~  * Hepatic impairment due to non-liver disease~ * Use of other investigational drugs at time of enrollment~ * History of malignancy of any organ system~ * Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing~ * Hemoglobin levels below 10.0 g/dL at screening or baseline~* Subjects with hepatic impairment:~  * Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk~ * Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist~ * Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs~Other protocol-defined inclusion/exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- RLX030: Group 1 mild hepatic impairment (Type: EXPERIMENTAL): Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030
- RLX030: Group 2 moderate hepatic impairment (Type: EXPERIMENTAL): Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030
- RLX030: Group 3 severe hepatic impairment (Type: EXPERIMENTAL): Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030
- RLX030: Group 4 - healthy volunteers (Type: ACTIVE_COMPARATOR): Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3.

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: Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-65~* Less than 16 years of education~* Able to understand, and sign consent~* Smoke \>4 cigarettes/day for at least a year~* No quit attempt in prior 1 month and not planning to quit smoking within next 6 months~* Plan to live in local area for next 8 months~* Able to read and write in English~* Women not pregnant and taking steps to avoid pregnancy~Exclusion Criteria:~* College graduate~* Use of psychotropic drugs~* Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data~* Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months~* Currently pregnant or nursing~* Uncontrolled serious psychotic illness or substance abuse~* History of difficulties providing blood samples-fainting, poor veins, anxiety

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

Study Arms:
- Reduced Nicotine Content Cigarettes (Type: EXPERIMENTAL): the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.
- Same Nicotine Content Cigarettes (Type: PLACEBO_COMPARATOR): The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)

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: Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion criteria:~Healthy subjects.~Exclusion criteria:~Healthy subjects with history or presence of clinically relevant illness.~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

Study Arms:
- alirocumab SAR236553 (REGN727) - Dose A (Type: EXPERIMENTAL): alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen.~alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
- alirocumab SAR236553 (REGN727) - Dose B (Type: EXPERIMENTAL): alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
- alirocumab SAR236553 (REGN727) - Dose C (Type: EXPERIMENTAL): alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.

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: Use Of Fragmin In Hemodialysis

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:~* chronic renal failure on hemodialysis~Exclusion Criteria:~* significant comorbidities that would prevent a patient from completing the trial

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Fragmin (Type: EXPERIMENTAL): Fragmin given according to the flexible dosing regimen outlined in the protocol

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: Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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

Eligibility Criteria:
Inclusion criteria~Inclusion criteria (selected):~* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement~* Written Informed Consent~Exclusion criteria~Exclusion criteria (selected):~* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.~* Active malignant disease or current cytostatic treatment~* Known severe renal insufficiency~* Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal~* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months~* Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control~* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran~* Contraindications to enoxaparin~* Participation in a clinical trial during the last 30 days

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

Study Arms:
- dabigatran etexilate 75 mg (Type: EXPERIMENTAL): daily dose 150 mg once daily, half a dose on the day of surgery
- dabigatran etexilate 110 mg (Type: EXPERIMENTAL): daily dose 220 mg once daily, half a dose on the day of surgery
- enoxaparin (Type: ACTIVE_COMPARATOR): 40 mg once daily

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: SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

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

Eligibility Criteria:
Inclusion Criteria:~* Women aged 18 - 50~* Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles~Exclusion Criteria:~* Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception~* Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Office Hysteroscopy (Type: ACTIVE_COMPARATOR): Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
- Saline Infusion Sonography (SIS) (Type: NO_INTERVENTION): This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.

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: PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy~2. Agreement to provide mandatory archival tissue or fresh biopsy.~3. At least 18 years of age.~Exclusion Criteria:~1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.~2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.~3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.~4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.~5. History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications.~6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.~7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.~8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.

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

Study Arms:
- CX-072 (Type: EXPERIMENTAL): Monotherapy CX-072
- CX-072 with Ipilimumab #1 (Type: EXPERIMENTAL): Combination CX-072 + ipilimumab (Schedule 1)
- CX-072 with Ipilimumab #2 (Type: EXPERIMENTAL): Combination CX-072 + ipilimumab (Schedule 2)
- CX-072 with Vemurafenib (Type: EXPERIMENTAL): Combination CX-072 + vemurafenib
- CX-072 expansion (Type: EXPERIMENTAL): Monotherapy CX-072

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

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

Eligibility Criteria:
Inclusion Criteria:~* All patients between the ages of 18 and 65 having one of three elective procedures as an outpatient. These procedures are associated with moderate to severe postoperative pain (anterior cruciate ligament reconstruction (knee), ankle ligament reconstruction (foot/ankle), or ligament reconstruction with tendon interposition (hand))~* Patients should have operative risk category of American Society of Anesthesiologists (ASA) 1 or 2 .~* Patients weighing between 70-100kg will be included to allow standardization of medication dosing~Exclusion Criteria:~* Allergy to Study Medications~* Previous History of Chronic Opioid Use~* Patient Refusal to Participate~* Known of Suspected History of Sleep Apnea~* Known History of Chronic Pain Syndrome~* Weight less than 70kg or greater than 100kg due to standardization of medication doses.~* Revision Surgery~* Inability to take study medications due to medication incompatibility or co-existing disease~* Patients refusing or unable to receive US guided nerve block for postoperative pain~* Patients unable to read and comprehend written consent document

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

Study Arms:
- multi-modal (Type: EXPERIMENTAL): 3 Different Non-opioid pain medication taken every 6 hours~Celecoxib 100mg~Acetaminophen 325mg~Pregabalin 50 mg~Plus, for breakthrough pain~oxycodone 5-10 mg will be taken every 4 hours as needed for pain.
- Control (Type: ACTIVE_COMPARATOR): 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain.

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: Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica

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

Eligibility Criteria:
Inclusion Criteria:~* Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site~* Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution~* Score of at least 20 on the modified Oswestry Disability Index~* Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc~* MRI study confirms a herniated disc consistent with the signs and symptoms~Exclusion Criteria:~* Onset of sciatica symptoms occurred more than 3 months before study entry~* Cauda equina syndrome~* Active cancer~* Acute spinal fracture~* Currently taking oral steroids~* Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%~* Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg~* Pregnant or breastfeeding~* Active peptic ulcer disease~* History of intolerance to steroid therapy~* Bleeding diathesis or anticoagulant therapy~* Ongoing litigation or workers compensation claim for low back pain or sciatica~* Underwent previous lumbar surgery~* Received epidural steroid injection (ESI) within the 12 months before study entry~* Unable to read or speak English~* Progressive or severe motor loss

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Prednisone (Type: EXPERIMENTAL): Participants will receive a 15-day tapering course of prednisone capsules.
- Placebo (Type: PLACEBO_COMPARATOR): Participants will receive a 15-day course of placebo capsules.

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

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:~* Men or women ≥ 18 and ≤ 80 years old~* Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline~* Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:~  * erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr~ * serum C-reactive protein (CRP) \> 1.0 mg/dL~* Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study~* Subject has no known history of active tuberculosis~Exclusion Criteria:~* Class IV RA, Felty's syndrome or history of prosthetic or native joint infection~* Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome~* Use of commercially available or investigational biologic therapies for RA as follows:~  * anakinra, etanercept within 1 month prior to first dose of IP~ * infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP~ * other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP~* Previous receipt of rituximab or a biosimilar of rituximab~Other Inclusion/Exclusion criteria may apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- ABP 798 / ABP 798 (Type: EXPERIMENTAL): Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
- Rituximab (US) / ABP 798 (Type: ACTIVE_COMPARATOR): Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
- Rituximab (EU) / Rituximab (EU) (Type: ACTIVE_COMPARATOR): Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

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: Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy

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

Eligibility Criteria:
Inclusion Criteria:~* At least 18 years old.~* Idiopathic Membranous nephropathy proved by renal biopsy~* Persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia \< 30g/l for at least 6 months with full dose of NIST~* Patient receiving a non immunosuppressive conventional treatment (antiproteinuric and antihypertensive blocking the rennin-angiotensine system, lipid-lowering statin) since at least 6 months.~* Patient has given its written consent~* Patient with social coverage (excepting AME)~* Use of an efficient contraception method for women in childbearing age.~Exclusion Criteria:~* Secondary membranous nephropathy~* Patient already in a clinical trial~* Patient received an immunosuppressive treatment within 3 months before the study~* Patient with chronic renal disease defined by estimated GFR by MDRD formula under 30ml/mn/1,73m²~* Pregnancy and breastfeeding~* HIV infection, HCV and HBV active infection~* Severe or evolving infections.~* Allergy or hypersensitivity to Rituximab or any component

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

Study Arms:
- active comparator (Type: ACTIVE_COMPARATOR): Non Immunosuppressive Symptomatic Treatment (NIST). No specific treatment Converting Enzyme Inhibitor , Angiotensin II receptor antagonist, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin.
- experimental (Type: EXPERIMENTAL): NIST and Rituximab: 500 Mg and 100Mg in solution to be diluted for IV infusion (Mabthera®)

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

Answer: outcome: complete