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

Trial Title: Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum~* Inoperable metastatic disease~* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue~* Presence of at least 1 bi-dimensionally measurable index lesion~Exclusion Criteria:~* Previous irinotecan-based chemotherapy~* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment~* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment~* Brain metastasis

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

Study Arms:
- Cetuximab Plus FOLFIRI (Type: EXPERIMENTAL): None
- FOLFIRI Alone (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: Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female 18 years of age or older.~* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.~* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.~* Informed consent is provided.~Exclusion Criteria:~* Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B \[or their respective genes, tcdA and/or tcdB\] of C. difficile in the stool) or current treatment for CDAD.~* Undergoing cord blood transplants.~* Has fulminant colitis, toxic megacolon, or ileus.~* A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).~* Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug).~* Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).~* Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.~* Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.

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

Study Arms:
- Fidaxomicin (Type: ACTIVE_COMPARATOR): 200 mg Fidaxomicin tablet once daily for no longer than 40 days
- Placebo (Type: PLACEBO_COMPARATOR): Placebo tablet once daily for no longer than 40 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: Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

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:~* Age \>18 years~* Patients with painful exuding wounds \>1 cm2 that includes painful exuding ulcers and pressure ulcers grade II \[according to National Pressure Ulcer Advisory Panel (NPUAP) classification\]~* Patients available and able to return to the study site for the scheduled visits~* Patients who gave written informed consent to take part into the study~Exclusion Criteria:~* Patients with ulcer infected, discoloured, odorous, pressure ulcer grade I, III, or IV (according to NPUAP classification)~* Diabetic foot ulcer~* Patients with contraindication or known allergy to drug's components~* Patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies~* Patients who are pregnant or lactating.~* Patients with vascular disorders (mainly arteriopathies)~* Patients known as alcohol or drug abusers.~* Patients currently participating in a clinical study

- 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: Achilles Tendinopathy Treated With Training and Injections

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:~* Midsubstance pain in the achilles tendon~* Symptoms for at least 3 months~* Ultrasound scanning at the first visit shows thickness of the achilles tendon above 7 mm or 20% thicker than the contralateral.~* Patient can read and understand danish~Exclusion Criteria:~* Earlier operations in the foot and leg, that is judged to complicate training~* known arthritis.~* known diabetes~* Leg ulcerations or infections in the foot.~* Judged unable to comply with the training protocol.~* Daily use of pain killers~* Glucocorticosteroid injection to the diseased achilles tendon within the last 6 months.~* Earlier allergic reactions to glucocorticosteroid or local anesthetic.~* Pregnancy or planning to become pregnant~* BMI above 30.

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

Study Arms:
- Training and glucocorticosteroid (Type: ACTIVE_COMPARATOR): Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.~All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.~Ultrasound guided injection with glucocorticosteroid: 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
- Training and local anesthetic (Type: ACTIVE_COMPARATOR): Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.~All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.~Ultrasound guided injection with local anaestethic: 1ml Lidocain 5 mg/ml and 1 ml intralipid (for blinding) in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).

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 Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

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

Eligibility Criteria:
Inclusion criteria~1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb~2. location of injury such that pain-on-movement (POM) is elicited on by specified exercises~3. enrollment within 6 hours of the injury~4. baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS~5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2~6. adult male or female patients~7. age 18 to 60 years~8. having given written informed consent~9. satisfactory health as determined by the Investigator based on medical history and physical examination.~Exclusion criteria~1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound~2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion~3. current skin disorder or shaving hair at application site~4. history of excessive sweating/hyperhidrosis inclusive of application site~5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study~6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)~7. participation in a clinical study within 30 days before inclusion in the study or concomitantly~8. drug or alcohol abuse in the opinion of the investigator~9. Pregnant and lactating women~10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:~    * Surgical sterilization~   * Hormonal contraception~   * Intra Uterine Device~   * Double barrier method~   * Total abstinence throughout the study at the discretion of the Investigator.

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

Study Arms:
- Active Arm (Type: EXPERIMENTAL): Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
- Control Drug (Type: PLACEBO_COMPARATOR): Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch

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 of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

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

Eligibility Criteria:
Inclusion Criteria:~* Men and non-pregnant or sterile women ages 45 and older~* Hypertriglyceridemia~* On statin therapy for at least four weeks~* Either having established cardiovascular disease or at high risk for cardiovascular disease~Exclusion Criteria:~* Severe heart failure~* Any life-threatening disease other than cardiovascular disease~* Active severe liver disease~* Hemoglobin A1c \>10.0%~* Poorly controlled hypertension~* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure~* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)~* Known hypersensitivity to the study product, fish and/or shellfish, or placebo~* History of acute or chronic pancreatitis~* Patients are excluded if using the following medications:~  * PCSK9 inhibitors~ * niacin \>200 mg/day or fibrates;~ * any omega-3 fatty acid medications ;~ * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);~ * bile acid sequestrants

- Gender: ALL
- Minimum Age: 45 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- AMR101 (Type: EXPERIMENTAL): AMR101 (icosapent ethyl) + statin therapy, daily
- Placebo (Type: PLACEBO_COMPARATOR): Placebo + statin therapy, daily

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: Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement

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

Eligibility Criteria:
Inclusion Criteria:~* Scheduled for elective aortic valve replacement surgery via right anterolateral thoracotomy~* Adult patients (minimally 18 years old)~* EuroScore ii \< 3%~* Bodyweight \> 50 kg~Exclusion Criteria:~* Refusal to participate~* Inability to communicate due to language or neurologic barriers~* Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties~* Chronic use of opioids~* Chronic use of analgesic antidepressants and/or antiepileptics~* History of major trauma or surgery to right chest wall~* History of chronic pain at right chest wall~* Allergy to opioids and/or local anesthetics~* Allergy to acetaminophen~* Morbid obesity (BMI \> 35)~* Pregnancy~* Peroperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)

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

Study Arms:
- Experimental group (Type: ACTIVE_COMPARATOR): Patients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide.
- Control group (Type: SHAM_COMPARATOR): Patients in the control group will receive postoperative PCIA with Piritramide.

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: Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

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:~1. Adults aged 18 or older~2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol~3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)~4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.~Exclusion Criteria:~1. Severe UC~2. Acute flare with onset greater than \>6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.~3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)~4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses \>3.2 g/day~5. Acute flare on a 5-ASA maintenance therapy of \>3.2 g/day~6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening~7. History of biologic (anti-TNF agent) use~8. Antibiotic use or repeated use (\>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted~9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments

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

Study Arms:
- MMX mesalamine/ mesalazine (Type: EXPERIMENTAL): 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 Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy

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 must weigh at least 36 pounds (16 kilograms)~* patients must have partial onset seizures (with or without secondarily generalized seizures) being treated with at least one, but no more than two antiepileptic drugs (AEDs)~* patients must have at least 6 partial onset seizures during the 8-week baseline phase, with at least one seizure during each 4-week period~* an electroencephalogram (EEG) with features consistent with partial epilepsy performed prior to study initiation or during the baseline phase~Exclusion Criteria:~* Females who are pregnant, nursing, or those not using adequate birth control if capable of having children~* patients with a treatable cause of seizures (for example, infections)~* patients with a progressive disorder of the nervous system~* patients with a clinical diagnosis of Lennox-Gastaut syndrome~* patients with a history of generalized status epilepticus (repeated or prolonged seizures) while on appropriate anti-epileptic therapy

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 16 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: Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Study Design Characteristics:
- Allocation: None
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/\[height(m)\]2.~* Subjects are fully informed and voluntarily consent to participate in this study.~Exclusion Criteria:~* History of allergy or hypersensitivity.~* Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs.~* During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc.~* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.~* Lost blood or donated more than 400 mL of blood within 3 months prior to the screening.~* Participation in a clinical drug study 30 days prior to present study.~* Use of any other drugs within 2 weeks prior to the screening.~* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.~* The partner of the subject is unwilling to take effective contraceptive measures.~* Other unfavorable factors diagnosed by investigators.

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

Study Arms:
- ABCD (Type: EXPERIMENTAL): Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg

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 Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer

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:~1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer~2. Inoperable metastatic or locally advanced ovarian cancer~3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug~4. Platinum-resistant patients who have progressed after receiving PLD (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive PLD therapy.~5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated.~6. ECOG performance score of 0 or 1.~7. Adequate organ and bone marrow functions at Screening.~Exclusion Criteria:~1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity prior to Day 1 of Cycle 1~2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1~3. Patients who have received CYP3A4 inducers or inhibitors.~4. Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.).~5. Patients with CNS metastases.

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

Study Arms:
- NKTR-102 q14d (Type: EXPERIMENTAL): NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.
- NKTR-102 q21d (Type: EXPERIMENTAL): NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients.

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

Answer: outcome: complete