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

Trial Title: Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Healthy White, male volunteers between 18 and 55 years of age (inclusive).~* BMI between 19 and 28 kg/m\^2 (inclusive)~Exclusion Criteria:~* Previous participation in a clinical study with Rotigotine~* History or current condition of epilepsy and/or seizures~* Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity~* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis~* History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease~* Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations~* Positive HIV, hepatitis B or C test or positive alcohol or drug test~* Relevant hepatic or renal dysfunction~* Intake of medication that might interfere with the test drug within 2 weeks prior to dosing

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

Study Arms:
- Rotigotine PR2.2.1 first (Type: EXPERIMENTAL): Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
- Rotigotine PR2.1.1 first (Type: EXPERIMENTAL): Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days

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 Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

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

Eligibility Criteria:
Inclusion Criteria:~* Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms~* Current or previous smoker with a smoking history of 10 or more pack years~* Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value~Exclusion Criteria:~* History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis~* Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2~* Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

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

Study Arms:
- F 4.5 bid (Type: EXPERIMENTAL): Formoterol 4.5 ug twice daily (bid)
- F 9.0 bid (Type: EXPERIMENTAL): Formoterol 9.0 ug bid
- PBO (Type: PLACEBO_COMPARATOR): 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 to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 8.0

Eligibility Criteria:
Inclusion Criteria:~* Signed written informed consent~* 40 - 80 years of age~* Clinical history of COPD with airflow limitation that is not fully reversible~* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods~* Current/former smokers with at least a 10 pack-year history of cigarette smoking~* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70~* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values~* Able to change COPD treatment as required by protocol~Exclusion Criteria:~* Women who are pregnant or lactating~* Primary diagnosis of asthma~* Alpha-1 antitrypsin deficiency as the cause of COPD~* Active pulmonary diseases~* Prior lung volume reduction surgery~* Abnormal chest X-ray (or CT scan) not due to the presence of COPD~* Hospitalized due to poorly controlled COPD within 3 months of Screening~* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)~* Cancer that has not been in complete remission for at least 5 years~* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives~Other protocol defined inclusion/exclusion criteria may apply

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Inhaled PT003 (Dose 1) (Type: EXPERIMENTAL): PT003 MDI Dose 1
- Inhaled PT003 (Dose 2) (Type: EXPERIMENTAL): PT003 MDI Dose 2
- Inhaled PT005 (Dose 1) (Type: EXPERIMENTAL): PT005 MDI Dose 1
- Inhaled PT005 (Dose 2) (Type: EXPERIMENTAL): PT005 MDI Dose 2
- Inhaled Placebo (Type: PLACEBO_COMPARATOR): Placebo MDI
- Tiotropium bromide 18 μg (Spiriva Handihaler®) (Type: ACTIVE_COMPARATOR): Tiotropium Bromide inhalation powder
- Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (Type: ACTIVE_COMPARATOR): Formoterol fumarate inhalation powder 12 μg
- Inhaled PT001 (Dose 1) (Type: EXPERIMENTAL): PT001 MDI Dose 1

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 the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose

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:~* Essential hypertension (grade 1-2)~Exclusion Criteria:~* Severe hypertension~* Secondary hypertension~* Grade III/IV hypertensive retinopathy~* Type 1 diabetes~* Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.~* Pregnant or lactating females~* History of malignancy.~* shift workers~* intolerant to ABPM

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

Study Arms:
- Valsartan (Type: ACTIVE_COMPARATOR): 160 mg/day on awakening
- Enalapril (Type: ACTIVE_COMPARATOR): 10-20 mg/day on awakening

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: Afatinib in Subjects With Kidney Dysfunction

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

Eligibility Criteria:
Inclusion criteria:~* Despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.~* Glomerular filtration rate (GFR), estimated according to:~  -- MDRD (Modification of Diet in Renal Disease)-formula:~ * eGFR (estimated Glomerular Filtration Rate) \[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 (if male)~ * eGFR\[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)~ * 30 to 59 mL/min for moderate renal impairment group 1~ * 15 to 29 mL/min for severe renal impairment group 2~ * = 90 mL/min for healthy volunteers group 3~* Age =18 and =79 years~Exclusion criteria:~* Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure \< 90 mmHg (millimeter of mercury) or \> 140 mmHg, diastolic blood pressure \< 50 mmHg or \> 90 mmHg, repeated measurement of pulse rate \< 45 bpm (beats per minute) or \> 90 bpm.~* Any evidence of a clinically relevant concomitant disease.~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders.~* Relevant gastrointestinal tract surgery (except appendectomy).~* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders.~* History of photosensitivity or recurrent rash.~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 79 Years
- Healthy Volunteers: t

Study Arms:
- Afatinib in moderate renal impaired (Type: EXPERIMENTAL): Single Dose Afatinib in moderate renal impaired subjects
- Afatinib in severe renal impaired (Type: EXPERIMENTAL): Single Dose Afatinib in severe renal impaired subjects
- Afatinib in healthy subjects (Type: OTHER): Single Dose Afatinib in healthy subjects matched by gender, race, age and BMI to moderate and severe renal impaired subjects

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: Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab

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

Eligibility Criteria:
Inclusion Criteria:~* Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).~* Male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.~* Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) (ESR) or DAS28 (CRP) \> 3.2~* Biologically treatment naïve and initiated adalimumab at baseline visit~* Availability of clinical data of the previous 12 weeks prior to baseline~* Ability to self-complete patient questionnaires~* Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.~Exclusion Criteria:~* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.~* Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline~* Patients who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization~* Patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Adalimumab (Type: None): Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.

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: Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

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:
Key Inclusion Criteria~1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;~2. Males and females, 18 to 80 years of age inclusive at the time of study screening;~3. Due to undergo large partial / total bowel resection via laparotomy or laparoscopy with primary anastomosis.~Key Exclusion Criteria~1. Scheduled for a colon resection with stoma creation or multi-visceral resection.~2. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures~3. American Society of Anesthesiologists (ASA) Class IV or V~4. History of abdominal carcinomatosis~5. History of radiation enteritis~6. Children \<18 or adults \> 80 years of age~7. Pregnant women~8. Known allergy to caffeine~9. Consumption of more than 800 milligrams of caffeine (8-10 cups of coffee) daily on a regular basis~10. Complete abstention of caffeine consumption on a regular basis~11. Consumption of drugs which are either substrates or inhibitors of CYP1A2 enzyme (Ciprofloxacin, Fluvoxamine or Clozapine( at the time of the study, due to expected change of caffeine metabolism it these patients~12. Postoperative ventilation, pressor requirement or ICU stay~13. Liver failure or/and liver cirrhosis (MELD\>15)~14. Urgent surgery e.g. emergent laparotomy, sepsis, diverting stoma.~15. Opioid treatment for at least a week before surgery.~16. Prior extensive abdominal surgery (not including caesarean section, appendectomy, cholecystectomy or hernia repair).~17. Known impaired mental status or language difficulties.~18. Participation in another interventional trial.

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

Study Arms:
- Treatment (Caffeine Citrate) group (Type: ACTIVE_COMPARATOR): 25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
- Placebo (Water) group (Type: PLACEBO_COMPARATOR): 25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

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 Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women

Study Design Characteristics:
- Allocation: NON_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:~* PCOS defined according to Rotterdam criteria~* Healthy normal menstruating women~Exclusion Criteria:~* Diabetes mellitus~* Cardiavascular disease~* Renal disease~* Any drug usage~* Smoking~* Pregnancy

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

Study Arms:
- women with polycystic ovary syndrome (Type: ACTIVE_COMPARATOR): 36 patients with PCOS
- Healthy women of reproductive age (Type: ACTIVE_COMPARATOR): 30 patients with regular normal menstrual cycle

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

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

Trial Title: Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes 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: None

Eligibility Criteria:
Inclusion Criteria:~* Type 1 or Type 2 diabetes mellitus~* Age\>= 18 years~* Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones~* Study wound located on the foot or lower leg~* Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years~* Adequate circulation to the foot, evidenced by a palpable pulse on the study foot~* Study wound \> 1.0cm2 but \< 20.0cm2~* Written informed consent~Exclusion Criteria:~* Pregnancy, lactation or absence of adequate contraception for fertile women~* Ankle/Brachial Index \< 0.7~* Severe malnutrition~* Clinical evidence of gangrene on any part of the foot with the study wound~* Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0~* One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study~* Active osteomyelitis of the foot with the study wound~* Necrotic toes on the foot with the study wound~* Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening~* Study wound over a Charcot's joint~* Evidence of deep tissue infection of the study wound at day 0~* Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0~* Random blood sugar reading \> 450 mg/dL~* Alcohol or drug abuse~* Participation in other clinical studies in the last 4 weeks

- 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: Deposition of Inhaled Prolastin in Cystic Fibrosis Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Patient with diagnosis of CF~* Age \>= 8 years~* Forced expiratory volume at one second (FEV1) \> 25 % of predicted value~* Free elastase activity checked at visit 1 must be positive (free elastolytic activity in the sample, 2 standard deviations above of the negative blank samples in the assay.) .~* Patient must be positive at least 3 times for pseudomonas in the last 2 years~* Patient must be positive for pseudomonas at Visit 1~* Patient must be able to perform reliable spirometry~* Patient must be on stable concomitant therapy at least 2 weeks prior to visit 1 and during the study~* Written informed consent of the patient or legal representative(s)~Exclusion Criteria:~* FEV1 \< 25% of predicted value post-bronchodilator~* History of lung transplant~* Any lung surgery within the past 2 years~* On any thoracic surgery waiting list~* Severe concomitant disease (serious malignant disease, congestive heart failure New York Heart Association (NYHA) III/IV, cor pulmonale with the need of oxygen therapy)~* Severe liver cirrhosis with ascites, hypersplenism or grade III/IV esophageal varices.~* Known selective immunoglobulin A (IgA) deficiency with known antibody against IgA (anti-IgA antibody)~* Active pulmonary exacerbation within the 4 weeks prior to screening~* Current Smoking~* Pregnancy or lactation~* Women of child-bearing age without adequate contraception~* Any medical condition which the investigator feels will prohibit the patient from completing the trial~* Participation in another clinical trial within 30 days prior to inclusion at visit 1

- Gender: ALL
- Minimum Age: 8 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Group 1 (Type: EXPERIMENTAL): Bronchial Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 weeks
- Group 2 (Type: EXPERIMENTAL): Peripheral Deposition Intervention: Alpha1-Proteinase Inhibitor (Human) Dosage: 25 mg in lungs, one inhalation per day over 4 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: High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma

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

Eligibility Criteria:
Inclusion Criteria:~* One of the following clinical criteria:secondary CNS NHL; synchronous CNS NHL; relapsed PCNSL; relapsed IOL; PCNSL or IOL which has only achieved a PR after adequate initial therapy~* Must have CNS or intraocular involvement by NHL~* Subjects with secondary CNS NHL, relapsed PCNSL, or relapsed IOL will have received Salvage therapy for their CNS disease~* Subjects with synchronous CNS NHL will have received primary therapy including CNS-directed therapy~* Must demonstrate a partial or complete response of the CNS and systemic disease to pre-enrollment therapy, and must be in PR or CR at the time of enrollment~* Age \>/= 18 and \</= 75 years~* Life expectancy \>/= 3 months~* ECOG performance status \</= 2~* Must have adequate organ function as defined by the protocol~Exclusion Criteria:~* Stable or progressive CNS or systemic disease (SD orPD) at the time of enrollment~* Systemic or intrathecal chemotherapy or radiotherapy within 2 weeks prior to starting therapy on study~* Actively receiving any other study agents aimed to treat their disease~* A prior HDT-ASCT or allogeneic stem cell transplant (myeloablative or nonmyeloablative)~* Burkitt's lymphoma or acute lymphoblastic lymphoma~* A history of severe allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, thiotepa, busulfan, cyclophosphamide, or rituximab~* Serious uncontrolled concurrent illness~* Any evidence of prior exposure to Hepatitis B virus~* HIV-positive~* Pregnant or lactating~* A history of malignancy other than NHL or PCNSL unless disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

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

Study Arms:
- High-dose chemotherapy with autologous stem cell transplant (Type: EXPERIMENTAL): None

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

Answer: outcome: complete