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

Trial Title: PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

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:~1. Patient is male or female between 18 and 75 years old, inclusive.~2. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization.~3. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour.~4. Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab~5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.~Exclusion Criteria:~1. Patient has taken more than 2 biologic agents.~2. Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study.~3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.~4. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.~5. Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.

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

Study Arms:
- CT-P10 (Type: EXPERIMENTAL): rituximab, CT-P10(experimental drug), 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
- Rituxan (Type: ACTIVE_COMPARATOR): US-licensed referece product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusions
- MabThera (Type: ACTIVE_COMPARATOR): EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusions

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: Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* SSc patients with esophageal symptoms~Exclusion Criteria:~* none

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

Study Arms:
- buspirone (Type: EXPERIMENTAL): 4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement

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: The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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:~* 18 years of age and older~* Subjects has actinic keratoses and qualifies for photodynamic therapy~* Do not meet any of the exclusion criteria~Exclusion Criteria:~* Subjects who smoke~* Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition~* Subjects who have established allergy to topical ALA~* Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

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

Study Arms:
- 10-minute Incubation with Microneedle Roller & Sham (Type: EXPERIMENTAL): 10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
- 20-minute Incubation with Microneedle Roller & Sham (Type: EXPERIMENTAL): 20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

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 Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

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

Eligibility Criteria:
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years~* Current or ex-smoker with a \>= 10 pack-year smoking history~* Use of Combivent® Metered Dose Inhaler (MDI)for \>= 1 month prior to Visit 1~Spirometric criteria (determined at study visits):~* Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \<= 70% (Visit 1)~* Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/Forced Vital Capacity (FVC) \<= 70% (Visit 2)~Exclusion Criteria:~Clinical history of asthma~* History of thoracotomy with pulmonary resection~* History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease~* Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests~* Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1~* Recent history 6 months or less of Myocardial Infarction~* Unstable or life-threatening cardiac arrhythmias~* Hospitalization for Congestive Heart Failure during past year~* Malignancy for which patient is receiving chemo or radiation therapy~* Pregnant or nursing women~* Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose~* Use of SPIRIVA® 3 months prior to Visit 1~* Symptomatic of prostatic hypertrophy or bladder neck obstruction~* Known narrow- angle glaucoma~* Participating in a pulmonary rehab program within 4 weeks of Visit 1

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- 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: Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Diagnosis of breast cancer~* Experiencing 2 or more hot flashes per day for at least 1 week~* Hormone receptor status:~  * Not specified~PATIENT CHARACTERISTICS:~Age:~* Not specified~Sex:~* Female~Menopausal status:~* Not specified~Performance status:~* Not specified~Life expectancy:~* Not specified~Hematopoietic:~* Not specified~Hepatic:~* Bilirubin normal~* SGOT no greater than 2 times upper limit of normal (ULN)~Renal:~* Creatinine no greater than 1.25 times ULN~Cardiovascular:~* No coronary insufficiency~* No myocardial infarction within the past 3 months~* No symptomatic cardiac disease~* No peripheral vascular disease~* No cerebrovascular disease or stroke~* No syncope or symptomatic hypotension~Other:~* No history of allergic or other adverse reaction to gabapentin~* Not pregnant or nursing~* Fertile patients must use effective contraception during and for 1 week after study~PRIOR CONCURRENT THERAPY:~Biologic therapy~* Not specified~Chemotherapy~* Not specified~Endocrine therapy~* Not specified~Radiotherapy~* Not specified~Surgery~* Not specified~Other~* No other concurrent anticonvulsant medication~* No concurrent clonidine or venlafaxine

- Gender: FEMALE
- Minimum Age: None
- Maximum Age: 120 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: Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

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

Eligibility Criteria:
Inclusion Criteria:~* Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months~* Adequate visual accuracy allowing eye testing~* Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age~* Signed informed consent~Exclusion Criteria:~* Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss~* Diagnosis of osteoporosis

- Gender: MALE
- Minimum Age: 30 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
- Denosumab (Type: EXPERIMENTAL): Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.

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 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female patients aged ≥ 18 to ≤ 85 years.~2. Must receive SoC treatment for ITP that has been stable in dose and frequency for at least 4 weeks prior to Screening. SoC may include oral corticosteroids and/or permitted oral immunosuppressants and/or TPO-R agonist.~3. Confirmed diagnosis of ITP with blood platelet counts \< 30 × 109/L and who have not experienced major bleeding in the last 4 weeks prior to Screening.~Exclusion Criteria:~1. Use of anticoagulants, or any drug with antiplatelet effect within 3 weeks prior to Screening.~2. Patients who have received any blood support or transfusion within 4 weeks prior to Screening.~3. Use of Intravenous immunoglobulin G (IVIg) or anti-D immunoglobulin treatment within 4 weeks prior to screening.~4. Use of recombinant thrombopoietin at any time.~5. Use of rituximab within 6 months prior to Screening. Use of any anti-CD20 other than rituximab at any time is not permitted.~6. Use of immunosuppressants is not permitted within 4 weeks prior to Screening, with the exception of the following oral immunosuppressants: azathioprine, danazol, mycophenolate mofetil, mycophenolate sodium which must have been stable for at least 4 weeks prior to Screening.~7. Use of any other biological therapy or investigational drug than those previously indicated within 3 months or 5 half-lives of the drug (whichever is longer) prior to Screening.~8. Received vaccinations within 4 weeks prior to Screening or planned during the study.~9. At Screening, have clinically significant laboratory abnormalities~10. History of any thrombotic or embolic event within 12 months prior to Screening.~11. Known auto-immune disease other than ITP.

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

Study Arms:
- ARGX-113 Dose A + SoC (Type: EXPERIMENTAL): Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo
- ARGX-113 Dose B +SoC (Type: EXPERIMENTAL): Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo
- Placebo + SoC (Type: PLACEBO_COMPARATOR): Patients will be randomized in a 1:1:1 ratio to ARGX-113 (Dose A or Dose B) or placebo

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 Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Adult patients ≥ 50years of age with End stage renal disease on dialysis (both hemodialysis and peritoneal dialysis).~* Scheduled to receive pneumococcal vaccine either after 5years of previous vaccination or starting vaccination as part of standard care during the study period~Exclusion Criteria:~* History of S. pneumoniae infection within the last 5 years~* Vaccinated with an influenza- or diphtheria-containing vaccine within the last 6 months~* History of any severe adverse reaction associated with a vaccine~* Received gamma-globulins within the previous 6 months~* Known or suspected HIV or on immunosuppressive medications.~* Functional or anatomic asplenia~* serious chronic medical condition

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Vaccine (Type: EXPERIMENTAL): Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.

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 Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

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:~* Must be ≥18 yrs old on the day of signing informed consent~* Diagnosed with Primary Insomnia~* Good physical and mental health~* Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination~* A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception~* Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)~* Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1~* Regular bedtime is between 9 pm-1 am~* Willing to refrain from napping while in study~* Able to read, understand and complete questionnaires and all diaries~* Willing to limit alcohol, caffeine, and nicotine consumption while in the study~* For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory~Exclusion Criteria:~* Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study~* History or diagnosis of another sleep disorder~* Difficulty sleeping due to a medical condition~* History of a neurological disorder~* History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication~* Ongoing depression~* History of substance abuse or dependence~* History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit~* Taking certain prohibited medications~* Consumption of the equivalent of \>15 cigarettes a day~* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer~* Participant is considered morbidly obese~* Previously randomized in another investigational study of suvorexant

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

Study Arms:
- Suvorexant HD (Type: EXPERIMENTAL): Drug
- Suvorexant LD (Type: EXPERIMENTAL): Drug
- Placebo (Type: PLACEBO_COMPARATOR): Placebo Comparator

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: Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

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:~* Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.~* Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.~* Does not have current active hepatitis B virus infection defined as:~  * positive hepatitis B surface antigen (HBsAg), OR~ * hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface\[HBs\])~* Platelets ≥ 150,000 cells/mm³~* Albumin ≥ lower limit of normal (LLN)~* Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.~* No past history/evidence of cirrhosis.~* No history of hepatocellular carcinoma.~* Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).~* If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

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

Study Arms:
- Glecaprevir/Pibrentasvir (Type: EXPERIMENTAL): Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.

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: Treatment of Chronic Bacterial Prostatitis

Study Design Characteristics:
- Allocation: NON_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:~* patients affected by chronic bacterial prostatitis~* positivity to the Meares-Stamey test~* symptoms duration \> 3 months (dysuria, pelvic pain and/or discomfort)~Exclusion Criteria:~* positivity to Chlamydia trachomatis, Ureaplasma urealiticum, Mycoplasma, Neisseria gonorrhoeae, herpes simplex viruses (HSV 1/2) and human papillomavirus (HPV)~* age less than 18 years~* history of neurological disease, urinary stones or cancer~* allergy to fluoroquinolones~* refusal to sign the informed consent~* incomplete follow-up time.

- Gender: MALE
- Minimum Age: 19 Years
- Maximum Age: 54 Years
- Healthy Volunteers: f

Study Arms:
- Group A, antibiotics (Type: ACTIVE_COMPARATOR): Prulifloxacin 600 mg
- Group B, antibiotics plus nutraceuticals (Type: ACTIVE_COMPARATOR): Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg

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: To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism

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:~* Patients with cirrhosis of liver with signs of parkinsonisms~* Patients consented for the study protocol by signing the informed consent.~Exclusion Criteria:~* Age \< 18 years.~* Patient s with HCC (Hepatocellular Carcinoma).~* Patients diagnosed as Wilsons disease.~* Patient who withdrew or non complaint to the study protocol.~* ALF (Acute Liver failure)~* Classical Parkinsonism~* Atypical Parkinsonism~* Pregnancy~* Hypotension~* Uncontrolled hypertension~* CAD~* Psychiatric illness~* Acute episode of Hepatic encephlopathy

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

Study Arms:
- Lactulose + Rifaximin + Bromocriptine (Type: EXPERIMENTAL): None
- Lactulose+Rifaximin+Placebo (Type: ACTIVE_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: Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

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

Eligibility Criteria:
Inclusion Criteria:~* Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.~* Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.~* Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.~* Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.~* Previous use of Actiq is accepted.

- 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: complete