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

Trial Title: Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~1. Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.~2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).~3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.~4. Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.~5. Voluntarily consent to participate in the study.~6. Sexually abstinent or agree to use two approved methods of contraception.~Exclusion Criteria:~1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.~2. Positive urine drug/alcohol testing at screening or check-in (Day -1).~3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).~4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.~5. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.~6. Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.~7. Plasma donation within 7 days prior to Day 1.~8. Participation in another investigational clinical trial within 30 days prior to Day 1.~9. Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

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

Study Arms:
- Single and multiple dose of RPX7009 (Type: EXPERIMENTAL): Single and multiple dose of RPX7009
- Single and multiple dose of RPX2014 (Type: EXPERIMENTAL): Single and multiple dose of RPX2014
- Normal Saline (Type: PLACEBO_COMPARATOR): Single and multiple dose of normal saline
- Combination RPX7009 and RPX2014 (Type: EXPERIMENTAL): Single and Multiple dose of Combination RPX7009 and RPX2014

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, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

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:~* Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline~* Current or ex-smokers who have a smoking history of at least 10 pack years~* Qualifying FEV1 at Visit 2 (day -7)~Exclusion Criteria:~* Patients with a history of asthma or a history of high blood eosinophil count (\>600/mm³)~* Patients with concomitant pulmonary disease~* Patients with lung lobectomy or lung volume reduction or lung transplantation~* Patients with α-1 antitrypsin deficiency~* Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- NVA237 + Fluticasone/Salmeterol (Flu/Sal) (Type: EXPERIMENTAL): NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
- Tiotropium + Flu/Sal (Type: ACTIVE_COMPARATOR): Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
- Flu/Sal (Type: PLACEBO_COMPARATOR): Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

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 Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of major depressive disorder~* Must be able to swallow tablets~* Must be at least 18 years of age.~Exclusion Criteria:~* Clinical diagnosis of other psychiatric disorders~* Significant risk of suicide~* Unstable medical conditions.

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

Trial Title: Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients

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

Eligibility Criteria:
Inclusion Criteria:~1. Chinese subjects aged 18-65, male or female；~2. Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg；~3. Subjects must meet the criteria;~4. No birth planning；~5. Understand and sign informed consent form voluntarily.~Exclusion Criteria:~1. allergic constitution；~2. Pregnant or lactating women；~3. Subjects who have been diagnosed with malignant tumors；~4. Subjects whose laboratory tests meet the conditions；~5. Subjects who have been diagnosed with severe gastrointestinal diseases；~6. Subjects who have been diagnosed with severe cardiovascular disease；~7. Subjects who have been diagnosed with severe cerebrovascular disease；~8. Subjects with history of alcohol and drug abuse；~9. Subjects who have participated in any other clinical trial；~10. Subjects who have any conditions that the investigator considers not suitable for this trial.

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

Study Arms:
- T8 tablet 0.5mg (Type: EXPERIMENTAL): Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week
- T8 tablet 1mg (Type: EXPERIMENTAL): Oral T8 tablet with HARRT, 1mg, once daily for 48 week
- Placebo (Type: PLACEBO_COMPARATOR): Oral Placebo with HARRT, once daily for 48 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: Tranexamic Acid in Surgery of Advanced Ovarian Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.~* Understand and speak Swedish~* Accept participation in the study after written and verbal information and sign informed consent.~Exclusion Criteria:~* Allergy to tranexamic acid~* Having had tranexamic acid within the recent 30 days~* Previous or present episode of thromboembolic events .~* Previous or present treatment within the recent 3 months with anticoagulant.~* Previous or present known coagulopathy~* Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.~* Significant renal failure with serum-creatinine \> 250 µmol/l.~* Severe psychiatric dysfunction or mentally substantially disabled.

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

Study Arms:
- The Tranexamic acid group (Type: ACTIVE_COMPARATOR): The group of women receiving Tranexamic acid intravenously immediately before the surgery
- The placebo group (Type: PLACEBO_COMPARATOR): The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

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 Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

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

Eligibility Criteria:
Inclusion Criteria:~* Men or women of any race or ethnicity who are at least 18 years of age.~* Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.~Exclusion Criteria:~* Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.~* Patients with severe or unstable depression are not eligible.~* Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible~* Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment

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

Study Arms:
- Pregabalin (Type: EXPERIMENTAL): Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
- Placebo (Type: PLACEBO_COMPARATOR): Group 2 as placebo vs. pregabalin (cross over study in which period two will have this 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: WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion criteria:~* All patients (both genders) with a clinical diagnosis of BUD (categories: I and II, cross-sectional diameter ≤ 10cm) as agreed by study site treatment team led by the lead clinicians~Exclusion criteria:~1. Patients with lesion sizes \>10cm in cross-sectional diameter~2. Children \< 5 years, or \< 20 kilograms body weight~3. Pregnancy (self-reported, clinically diagnosed, or urine test (beta-hCG) positive~4. Patients with previous treatment of Buruli ulcer, tuberculosis or leprosy with at least one of the study drugs (rifampicin, streptomycin, clarithromycin)~5. Patients with history of hypersensitivity to rifampicin and/or streptomycin and/or clarithromycin~6. Patients with previous treatment with macrolide or quinolone antibiotics, or antituberculosis medication, or immuno-modulatory drugs including corticosteroids within one month~7. Patients with current treatment with any drugs likely to interact with the study medication, e.g, anticoagulants, cyclosporin, phenytoin, and phenobarbitone. Users of oral contraceptives should be notified that such contraceptive is less reliable if taken with rifampicin; alternative (mechanical) contraceptive methods will be discussed with the study participant~8. Patients with co-infection with HIV~9. Patients with history or having current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or evidence of (previous) tuberculosis, Buruli ulcer or leprosy; or terminal illness (e.g., metastasized cancer)~10. Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption~11. Patients with known or suspected bowel strictures who cannot tolerate macrolide antibiotics such as clarithromycin~12. Patients with mental condition, including addiction with substance abuse (alcohol, qat, etc) likely to interfere with possibility to comply with the study protocol~13. Patients who are not willing to give informed pre-consent, and consent (patient and/or parent/legal representative), or withdrawal of consent

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- SR8 (Type: ACTIVE_COMPARATOR): Streptomycin (S: 15 mg/kg per day, intramuscularly) in combination with rifampicin (R: 10 mg/kg per day, orally) for 8 weeks
- CR8 (Type: EXPERIMENTAL): Clarithromycin (C: 15 mg/kg per day, oral extended release formulation) in combination with rifampicin (10 mg/kg per day, orally) 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: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

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

Eligibility Criteria:
Inclusion Criteria:~* Type 1 or type 2 diabetes mellitus at screening~* Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)~Exclusion Criteria:~* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0% at screening~* Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization~* Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP~* Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP~* Major psychiatric disorders at screening or randomization~* Creatinine clearance (using the Cockcroft-Gault equation) \< 60 mL/min at screening

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

Study Arms:
- Mirogabalin (Type: EXPERIMENTAL): Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (14-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: PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

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:~* adult patients, \>/= 18 years of age~* chronic hepatitis C~* HIV HCV co-infection allowed~* informed consent to data collection~Exclusion Criteria:~* co-infection with Hepatitis B Virus (HBV)~* previous treatment with peginterferon and/or ribavirin

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

Study Arms:
- Cohort (Type: None): Participants chronically infected with the hepatitis C virus including genotypes 1 to 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: Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Type 1 diabetes mellitus~* Male or female aged 18-50 years inclusive~* Body weight between 50-100kg and BMI between 18 and 30 kg/m2~* Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia~* No other medical problems~Exclusion Criteria:~* History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug~* Positive pregnancy test or lactation~* Lack of family support~* Unwilling or unable to follow the study protocol~* Concurrent medical problems

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 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: A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

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

Eligibility Criteria:
Inclusion Criteria:~* Signed informed consent prior to any study-mandated procedure.~* Male and female subjects aged between 18 and 75 years (inclusive) at screening.~* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.~* Women of non-childbearing potential.~* Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.~* For healthy subjects: Normal renal function confirmed by a creatinine clearance at screening according to Cockroft and Gault adjusted to age of:~  1. ≥ 80 mL/min/1.73 m2 for subjects ≤ 50 years of age.~ 2. ≥ 70 mL/min/1.73 m2 for subjects 51-60 years of age.~ 3. ≥ 60 mL/min/1.73 m2 for subjects 61-75 years of age.~* For subjects with hepatic impairment: Degree of liver function impairment due to liver cirrhosis according to the Child-Pugh classification:~  1. Group A: Mild hepatic impairment, Child-Pugh score 5-6.~ 2. Group B: Moderate hepatic impairment, Child-Pugh score 7-9.~ 3. Group C: Severe hepatic impairment, Child-Pugh score 10-15.~Exclusion Criteria:~* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.~* For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).~* For healthy subjects:~  1. History of alcoholism or drug abuse within the 3-year period prior to screening.~ 2. Relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.

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

Study Arms:
- Group A: ACT-541468 in subjects with mild hepatic impairment (Type: EXPERIMENTAL): Single oral dose administered on Day 1.
- Group B: ACT-541468 in subj. with moderate hepatic impairment (Type: EXPERIMENTAL): Single oral dose administered on Day 1.
- Group C: ACT-541468 in subjects with severe hepatic impairment (Type: EXPERIMENTAL): Single oral dose administered on Day 1.
- Group D: ACT-541468 in healthy subjects. (Type: EXPERIMENTAL): Single oral dose administered on Day 1.

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

Answer: outcome: complete