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

Trial Title: Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 9.0

Eligibility Criteria:
KEY Inclusion Criteria:~1. Male and female patients ≥ 18 years with a body weight ≥ 45 kg.~2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.~3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.~4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.~5. Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.~KEY Exclusion Criteria:~1. Mixed Plasmodium infections.~2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).~3. Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.~4. Clinical or laboratory evidence of any of the following:~5. AST/ALT \> 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin~6. AST/ALT \> 1.0 and ≤ 1.5 x ULN and total bilirubin is \> ULN~7. Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT~8. History of photodermatitis/increased sensitivity to sun.~9. Pregnant or nursing (lactating) women.~10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.~11. Moderate to severe anemia (Hemoglobin level \<8 g/dL).~Other protocol-defined inclusion/exclusion criteria may apply

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

Study Arms:
- Treatment arm 1: KAE609 10 mg Single Dose (SD) (Type: EXPERIMENTAL): KAE609 10 mg once daily (QD) for 1 day
- Treatment arm 2:KAE609 25 mg SD (Type: EXPERIMENTAL): KAE609 25 mg once daily (QD) for 1 day
- Treatment arm 3:KAE609 10 mg 3 Days (Type: EXPERIMENTAL): KAE609 10 mg (QD) for 3 days
- Treatment arm 4:KAE609 50 mg SD (Type: EXPERIMENTAL): KAE609 50 mg once daily (QD) for 1 day
- Treatment arm 5:KAE609 25 mg 3 Days (Type: EXPERIMENTAL): KAE609 25 mg once daily (QD) for 3 days
- Treatment arm 6:KAE609 75 mg SD (Type: EXPERIMENTAL): KAE609 75 mg once daily (QD) for 1 day
- Treatment arm 7:KAE609 50 mg 3 Days (Type: EXPERIMENTAL): KAE609 50 mg once daily (QD) for 3 days
- Treatment arm 8: KAE609 150 mg SD (Type: EXPERIMENTAL): KAE609 150 mg once daily (QD) for 1 day
- Treatment arm 9: Coartem Control (Type: ACTIVE_COMPARATOR): Coartem® 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: Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of 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: None

Eligibility Criteria:
Inclusion Criteria:~* male/female, 18-75 years old, inclusive~* diagnosis of adult-onset RA~* had active disease~* had received methotrexate~* on a stable dose of folic acid~Exclusion Criteria:~* contraindication for methotrexate or anti-TNF

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 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: Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

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:~* Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.~* 18 years of age or more.~* Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.~* Non-HDL-C of 100 mg/dL or greater.~* Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.~* Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).~* No change in weight of more than 5 kg within the prior 3 months.~* On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.~Exclusion criteria:~* Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.~* Currently drinking more than 2 standard alcoholic drinks per day.~* Body Mass Index (BMI) \>45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.~* Glycosylated hemoglobin (HbA1c) 9% or greater.~The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Study Arms:
- Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Type: EXPERIMENTAL): Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapy (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels \>=100 mg/dL (2.59 mmol/L) at Week 8.
- Usual Care (Type: ACTIVE_COMPARATOR): Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 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: Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion criteria:~For COPD subjects: Male or female, age of 40 years or older, smoking history \>10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio \<70%., FEV1 \>/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.~Exclusion criteria:~Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.~Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.~Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

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

Study Arms:
- 18 mcg tiotropium (Type: ACTIVE_COMPARATOR): Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
- Placebo (Type: PLACEBO_COMPARATOR): Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
- Control (Type: NO_INTERVENTION): Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

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: Breathalyzer Validation Study

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Age 21-39 old~* Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months~* Have previously consumed four (women) or five (men) or more standard drinks without problems~* A valid photo ID~* Willing to take public transportation home, via septa or an uber rideshare credit.~Exclusion Criteria:~* Desire alcohol treatment now or received it in the past 6 months~* Alcohol dependence with withdrawal per DSM-V criteria~* Non-English-speaking~* Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 39 Years
- Healthy Volunteers: t

Study Arms:
- Commercial Smartphone-paired breathalyzers-Set 1 (Type: EXPERIMENTAL): All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
- Commercial Smartphone-paired breathalyzers-Set 2 (Type: EXPERIMENTAL): All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.

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: TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

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:~* Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening~* Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy~* Genotype 1 HCV infection with plasma HCV RNA of \>10,000 IU/mL (both confirmed at screening)~* Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)~Exclusion Criteria:~* Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases~* Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C~* Liver disease not related to hepatitis C infection~* Previous chronic hepatitis C treatment, other than PegIFN and RBV

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

Study Arms:
- TMC435/PR (Type: EXPERIMENTAL): None
- TVR/PR (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: Contingency Management for Smoking Cessation in Homeless Smokers

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

Eligibility Criteria:
Inclusion Criteria:~* must be a Veteran who is eligible for care within the VA system;~* must be currently homeless or have been homeless more than twice in the past year period;~* must have current smoking status of at least 10 cigarettes per day for at least 1 year (verified with breath carbon monoxidemeasurement);~* must be aged 18 to 70;~* must be English speaker~Exclusion Criteria:~* Pregnancy;~* Any substance use disorder in any of the following drug categories: opioids, cocaine, alcohol, sedatives, stimulants, hallucinogens, or drugs categorized as other per the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.~* Urine drug screen results positive for cocaine, amphetamines, stimulants, opioids, or hallucinogens;~* Not stable on medications for the study period;~* Use of any other forms of nicotine such as cigars, pipes, or chewing tobacco;~* Participants may be excluded if they have a seizure disorder, uncontrolled diabetes or an eating disorder;~* Prior history of hepatitis or cirrhosis; current hepatitis or cirrhosis~* Score less than 80 on Kaufman Brief Intelligence Test

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

Study Arms:
- Active Contingency Management (Type: EXPERIMENTAL): All participants are assigned to a single arm, active contingency management. In this arm, participants are provided monetary rewards for remaining abstinent from smoking.

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 Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

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:~* Patients with uncomplicated, essential hypertension~Exclusion Criteria:~* Severe hypertension~* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm~* Liver, kidney, or pancreas disease~* Insulin dependent diabetes~* Allergy to certain medications used to treat high blood pressure~Other protocol-defined exclusion criteria may apply.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: 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: A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

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

Eligibility Criteria:
Key Inclusion Criteria:~* Provision of signed and dated, written informed consent prior to any study-specific procedures.~* Healthy male and female (of non-child bearing potential) Chinese subjects, with suitable veins for cannulation or repeated venipuncture~* BMI 19 to 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.~Key Exclusion Criteria:~* Any clinical condition requiring the regular use of any medication.~* Consumption of alcohol, drug, tobacco (cigarettes).~* Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other β-lactam antibiotics.~* Severe medical or psychiatric condition or laboratory abnormality.~* Blood donation.~* 12 lead ECG abnormal.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): IV infusions of 0.9% normal saline
- CAZ-AVI (Type: EXPERIMENTAL): IV infusion of AVI 500 mg + CAZ 2000 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 Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan

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

Eligibility Criteria:
Inclusion Criteria:~1. Patient is male or female older than 18 years.~2. Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.~3. Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:~   * greater than 1.5 cm in the longest dimension or~  * between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis~4. Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)~5. Patient has Ann Arbor stage III or IV disease.~Exclusion Criteria:~1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.~2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.~3. Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.~4. Patient has known central nervous system involvement.~5. Patient has received previous treatment for NHL:~   * Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)~  * All doses of corticoid therapy for treatment of NHL~  * Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone \>20 mg per day for the treatment for any purpose

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

Study Arms:
- CT-P10 (Type: EXPERIMENTAL): Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
- Rituxan (Type: ACTIVE_COMPARATOR): Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.~Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

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: Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus

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

Eligibility Criteria:
Inclusion Criteria:~* Biopsy proven symptomatic vulvar lichen sclerosus~* Ability to understand the study, accept randomization and logistically follow-up with scheduled visits~* English Speaking~Exclusion Criteria:~* Known vulvar malignancy~* Pregnancy or planning pregnancy or less than 3 months postpartum~* Premenopausal~* Current or prior diagnosis of any gynecologic malignancy~* Previous pelvic radiation therapy~* Allergy to topical steroid~* Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial vaginosis, trichomoniasis or other infection)~* Pelvic organ prolapse \> than Stage 2~* Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus, pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of enrollment~* History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)~* IUD (Intrauterine Device)~* Skindex-29 overall score \<21, below mildly impaired health related quality of life threshold

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

Study Arms:
- Prior Clobetasol Exposure (Type: EXPERIMENTAL): Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate
- No Prior Clobetasol Exposure (Type: ACTIVE_COMPARATOR): Patients with biopsy proven lichen sclerosus never previously treated with clobetasol propionate.

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

Answer: outcome: complete