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

Trial Title: A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* 18 to 50 years of age at the time of enrollment.~* Signed the informed consent document.~* Subject judged to be healthy by a qualified physician~Exclusion Criteria:~* Abnormal physical findings of clinical significance at the screening examination~* Significant abnormal laboratory values at the Screening Visit.~* Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.

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

Study Arms:
- STS101 5.2 mg (Type: EXPERIMENTAL): STS101 (dihydroergotamine nasal powder), 5.2 mg
- STS101 7.0 mg (Type: EXPERIMENTAL): STS101 (dihydroergotamine nasal powder), 7.0 mg
- STS101 8.6 mg (Type: EXPERIMENTAL): STS101 (dihydroergotamine nasal powder), 8.6 mg
- DHE intramuscular injection (Type: ACTIVE_COMPARATOR): Dihydroergotamine mesylate
- DHE nasal spray (Type: ACTIVE_COMPARATOR): Dihydroergotamine mesylate

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 Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

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:~* Current cigarette smoker of at least 10 cigarettes per day~* Interested in quitting at some time~* Not currently interested in quitting smoking~* Access to telephone (home or work) for 6 month study period~Exclusion Criteria:~* Monthly cigar, pipe, or smokeless tobacco use~* Current pregnancy or breastfeeding~* Recent cardiovascular distress~* Phenylketonuria (PKU)~* Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Practice Quit Attempt plus Nicotine Replacement Therapy
- 2 (Type: ACTIVE_COMPARATOR): Practice Quit Attempt only

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: Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria :~* Aged 18 to 40 years on day of inclusion~* Informed consent form signed~* Able to attend all scheduled visits and to comply with all trial procedures~* For a woman, inability to bear a child or negative urine pregnancy test.~Exclusion Criteria :~* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.~* Planned participation in another clinical trial during the present trial period.~* Previous participation in a clinical trial involving an investigational flu pandemic vaccine.~* Vaccination with an influenza vaccine during the past 6 months~* Any vaccination in the 4 weeks preceding the first trial vaccination~* Vaccination planned in the 4 weeks following any trial vaccination~* Breast-feeding.~* For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.~* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.~* Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.~* Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.~* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.~* Chronic illness at a stage that could interfere with trial conduct or completion.~* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.~* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.~* Blood or blood-derived products received in the past 3 months.~* Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.~* Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Group 1 (Type: EXPERIMENTAL): Dose 1 with Adjuvant
- Group 2 (Type: EXPERIMENTAL): Dose 2 with adjuvant
- Group 3 (Type: EXPERIMENTAL): Dose 3 with adjuvant
- Group 4 (Type: EXPERIMENTAL): Dose 4 with adjuvant
- Group 5 (Type: ACTIVE_COMPARATOR): Control

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: Paricalcitol Effect on Anemia in CKD

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:~* age \> 18~* written informed consent~* CKD stage 3-5 (eGFR \<60 ml/min/1,73 m2)~* PTH 30-300 pg/ml~* Hb \<10 g/dl \>3 consecutive months~* Ferritin \> 100 ng/ml~* transferrin saturation (TSAT) 20-40%~* mean corpuscular volume (MCV) 85-95%~* for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable \>3 months~* for patients treated with erythropoiesis-stimulating agents (ESA), dose stable \>3 months~Exclusion criteria:~* anemia due to non renal cause~* presence of malignancies, inflammatory or infectious disease \>3 months~* pregnancy~* bleeding \>6 months~* C-reactive protein (CRP) \>1 mg/dl~* poorly controlled hypertension (PAS \> 170 mmHG and PAD \>100 mmHg)~* severe malnutrition~* hypercalcemia (\>10,5 mg/dl)~* hyperphosphatemia (\>5,5 mg/dl)~* surgical interventions \>3 months~* acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure \>3 months

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

Study Arms:
- Control (Type: ACTIVE_COMPARATOR): Patients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose of 0.5 mch every other day and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
- Paricalcitol (Type: EXPERIMENTAL): Patients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines.

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: Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements

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:~* Postoperative Total joint replacement with osteoarthritis as the underlying pathology~* Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for \>12 months post-op)~* Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa Health System TJAs (7/1/08-6/30/2009).~Exclusion Criteria:~* An infection of any kind (prior to, or during the study)~* Rheumatoid arthritis as the underlying pathology~* Cortisone injection received \<6 months prior to study enrollment~* Insulin dependent diabetes~* Diagnosed immunodeficiency~* On dialysis or have poor kidney function~* Anti-coagulant medication (e.g., Coumadin or \>100mg of Aspirin daily)~* Anti-seizure medication (e.g., Dilantin)~* Steroidal medication (e.g., Prednisone, Advair or Symbicort)~* NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed~* bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)~* hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)~* Cancer (active or in remission)~* Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour wash out period will be allowed~* A glucose-6-phosphate dehydrogenase (G6PD) deficiency~* Pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy~* Lactose intolerant~* Citric acid intolerant

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 85 Years
- Healthy Volunteers: t

Study Arms:
- oral Apatone®B (Type: EXPERIMENTAL): An amalgam of Vitamins C \& K3
- Placebo (Type: PLACEBO_COMPARATOR): Oral capsule of similar appearance and taste without Apatone®B

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: Dysport® Pediatric Lower Limb Spasticity Follow-on Study

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:~Subjects were eligible for participation in the study if they met the following criteria:~1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.~2. Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.~3. Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.~Exclusion Criteria:~Subjects were excluded from entering the study for the following reasons:~1. Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed \<80° (TS angle) in the most affected leg to be injected.~2. Unwillingness or inability to comply with the protocol.~3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.~4. Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.~5. Be pregnant and/or lactating.~6. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.~7. An infection at the injection site(s).~8. Planned treatment with any new investigational drug or device during the study period.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Dysport (Type: EXPERIMENTAL): Dysport was injected into either one or both lower limbs in up to 4 cycles of treatment, a minimum of 12 weeks apart and up to a maximum of 40 weeks apart. Doses varied from 5 Units (U)/Kg to 20 U/kg for one leg, or from 10 U/Kg to 30 U/kg for two legs, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever was reached first.

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: Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age~* Body mass index (BMI) between 18 and 35 kg/m\^2~* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma~* Used only inhaled short-acting β2-agonists infrequently to treat asthma~* No current exposure to allergens to which subject experiences asthmatic responses~* No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening~* Positive skin prick test to common aeroallergens at screening~* Additional inclusion criteria apply~Exclusion Criteria:~* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;~* History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm~* Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks~* Subject has know type I/II diabetes~* History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization~* Subject who has history of malignancy of any type within 5 years prior to enrollment~* Subjects tested positive for drugs/alcohol or nicotine use at screening~* Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C~* Additional exclusion criteria apply

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Participants received placebo to tezepelumab administered by intravenous infusion on study days 1, 29, and 57.
- Tezepelumab 700 mg (Type: EXPERIMENTAL): Participants received 700 mg tezepelumab administered by intravenous infusion on study days 1, 29, and 57.

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: Mother-Infant Psychoanalysis Project of Stockholm

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:~* The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score \< 80 (perturbed relation) on the PIR-GAS or, alternatively, \> 2.5 on the SPSQ).~* Infant of any gender, age below 18 months.~* Duration of worries exceeding two weeks.~* Domicile in Stockholm.~* Reasonable mastery of Swedish.~Exclusion Criteria:~* Maternal psychosis.~* Substance dependence according to DSM-IV, to an extent precluding collaboration.~No mothers met these criteria.

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

Study Arms:
- Mother-Infant Psychoanalytic treatment;MIP (Type: EXPERIMENTAL): MIP intervention
- TAU at Child Health Centres (Type: ACTIVE_COMPARATOR): Regular nurse visits at Child Health Centres according to Swedish infant health care.

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: Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

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

Eligibility Criteria:
Inclusion Criteria:~1. Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.~2. Subject is ≥18 years of age at the time of informed consent and assent (as applicable).~3. Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements if. discharged from the hospital prior to completing the study.~4. Subject has a diagnosis of COVID-19 infection through an approved testing method.~5. Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung injury defined as diffuse bilateral radiographic infiltrates with partial pressure of arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) \>100 and \<300.~6. Subject's oxygen saturation at rest in ambient air \<93%~Exclusion Criteria:~1. Subject is intubated.~2. Subject is currently taking immunomodulators or anti-rejection drugs.~3. Subject has been administered an immunomodulating biologic drug within 60 days of baseline.~4. Subject is in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.~5. Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.

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

Study Arms:
- CERC-002 (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): 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: Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

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:~- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.~Exclusion Criteria:~- Patients who are contraindicated based on the product label and have already received Xarelto treatment.

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

Study Arms:
- Rivaroxaban (Xarelto, BAY59-7939) (Type: None): Rivaroxavban administration group

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: Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Type 1 diabetes (WHO criteria)~* Diabetic nephropathy (2 out of 3 consecutive 24 hour urinary samples with albumin excretion \> 300 mg/24hour and diabetic retinopathy in the absence of signs of other kidney or urinary tract disease) 27 or diabetic glomerulosclerosis verified by biopsy.~* Hypertension: Blood pressure \> 135 mmHg systolic and/or 85 mm Hg diastolic repeatedly.~* Age from 18 to 70 years.~Exclusion Criteria:~* Age \< 18 years or \> 70 years.~* Pregnancy or fertile women not using adequate anticonceptive (intrauterine device, sterilization, or oral anticonceptive)~* Malignant hypertension.~* Blood pressure \> 180/105 mm Hg~* Known renal artery stenosis~* GFR \< 30 ml/min/1.73 m²~* Serum potassium \> 4.8 mmol/ l~* Heart failure, myocardial infarction, unstable angina or coronary bypass operation within the previous three months.~* Abuse of drugs or alcohol.~* Not able to understand the written information.~* Known intolerance to ACE inhibitors.~* Chronic use of non steroid inflammatory drugs or aspirin (above 1 g/day)

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

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

Answer: outcome: complete