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

Trial Title: A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation

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:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com~Inclusion Criteria:~* Males and Females, 28 days to \< 18 years of age, inclusive~* Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)~* Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis~* Able to tolerate enteral medication \[eg, by mouth, nasogastric tube, or gastric tube\]~* Participants 28 days to \< 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization~Exclusion Criteria:~* Recent thromboembolic events less than 6 months prior to enrollment~* Weight \< 3 kg~* Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment~* Artificial heart valves and mechanical heart valves~* Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)~* Active bleeding at the time of enrollment~* Any major bleeding other than perioperative in the preceding 3 months~* Known intracranial congenital vascular malformation or tumor~* Confirmed diagnosis of a GI ulcer~* Known antiphospholipid syndrome (APS).~Other protocol defined inclusion/exclusion criteria apply

- Gender: ALL
- Minimum Age: 28 Days
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Apixaban (Type: EXPERIMENTAL): None
- LMWH/VKA (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: A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

Study Design Characteristics:
- Allocation: 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:~Subjects to be included in the study are:~* Outpatients of either gender, age 18 or older~* Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)~* Hyperuricemic: screening serum uric acid must be \>=8 mg/dL.~* The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)~* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide~Exclusion Criteria:~Subjects to be excluded are those for whom any of the following apply:~* Unstable coronary artery disease or uncontrolled hypertension~* History of end stage renal disease requiring dialysis~* History of liver disease, as defined by baseline serum transaminase elevation \>3X the upper limit of normal in the absence of any other known cause~* Organ transplant recipient requiring immunosuppressive therapy~* Concurrent use of prednisone at a dose \>10 mg qd (or equivalent) at or within one week before dosing~* Concurrent use of uric acid-lowering agents~* Prior treatment with Puricase® or other recombinant uricase~* An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol~* glucose-6-phosphate dehydrogenase deficiency~* A history of anaphylactic reaction to a recombinant protein or porcine derivatives~* Lactation~* Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study~* Known allergy to urate oxidase or PEGylated products~* Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 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: Daily Zinc Supplement Effect on Prevention of Diarrhea and Acute Respiratory Infections in Children Less Than Five Years

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

Eligibility Criteria:
Inclusion Criteria:~* Apparently healthy child with good general health~Exclusion Criteria:~* Children with severe malnutrition requiring hospital admission,~* Cases of chronic and metabolic diseases as diabetic children~* Children suffering from any type of cancer or any other debilitating disease.

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 5 Years
- Healthy Volunteers: t

Study Arms:
- zinc group (Type: ACTIVE_COMPARATOR): The children were randomized to receive daily zinc sulphate. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more.
- placebo group (Type: PLACEBO_COMPARATOR): The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, consistency and taste. Zinc and placebo syrups were packaged in similar bottles.

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: Sirolimus and Familial Adenomatous Polyposis (FAP)

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:~* ≥ 18 years~* A genetically confirmed APC mutation~* Classical FAP phenotype (100-1000 colorectal adenomatous polyps)~* Subtotal colectomy with ileorectal anastomosis (IRA) or total colectomy with ileo-anal pouch anastomosis (IPAA)~* Severe rectal or pouch polyposis, defined as having \>25 polyps amenable to complete removal (InSiGHT 2011 Staging System score of 3)~* Fertile patients must use effective contraception during study treatment and until 12 weeks after study treatment~Exclusion Criteria:~* Inability to give informed consent~* Participation in another interventional clinical trial~* Subjects who are pregnant or breast-feeding, proved with a negative pregnancy test if female of child-bearing potential~* Prior pelvic irradiation~* Invasive malignancy in the past 5 years~* Subjects who are HIV positive~* Subjects with severe systemic infections, current or within 2 weeks prior to study start~* Subjects with known severe restrictive or obstructive pulmonary disorders~* Known sucrase insufficiency, isomaltase insufficiency, fructose intolerance, glucose malabsorption, galactose malabsorption, galactose intolerance or Lapp-lactase deficiency~* History of pulmonary embolism or deep venous thrombosis~* Major surgery less than or equal to 2 weeks prior to enrollment or any planned surgery within treatment period~* Active post-operative complication, e.g. infection, delayed wound healing~* History of hypersensitivity to sirolimus or to drugs of similar chemical classes~* Regular NSAID use (defined as more than twice a week for 4 consecutive weeks) within 3 months prior to baseline~* Use of other FAP directed drug therapies (accepted if discontinued 3 months prior to start of the study)~* Subjects requiring systemic anticoagulation~* Co-medication that could interact with sirolimus~* Abnormal laboratory results (assessed within 14 days prior to start of study drug)

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

Study Arms:
- Sirolimus (Type: EXPERIMENTAL): All patients will receive sirolimus for the duration of the study, with a trough level target range of 5-8 ng/ml.

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: Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.~Exclusion Criteria:~* Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Anagrelide Hydrochloride (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: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.~* Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.~Exclusion Criteria:~* Cancer~* Medicines that suppress the immune system~* Dialysis

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

Study Arms:
- A (Type: ACTIVE_COMPARATOR): None
- B (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: Treating Postmenopausal Dyspareunia Where it Hurts

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:~1. Postmenopausal women aged 40 to 70 years old.~2. Postmenopausal, demonstrated by at least one of the following:~   i. Cessation of menses for ≥1 years if age is \>50 ii. Bilateral oophorectomy iii. A history of climacteric symptoms if below age 50, having an ovary and scarred or absent uterus.~3. Onset of dyspareunia after menopause.\*~4. Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.~5. No estrogen product use, local or systemic, for 6 months.\*~6. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).\*~7. Willingness to enter a study where she will receive low-dose local estrogen.\*~8. Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. \*~9. Willingness to evaluate the progress of therapies by use of the Tampon Test as many as 2 times per week, and willingness to attempt intercourse if the Tampon Test indicates tolerable penetrative pain.\*~   * n/a for reference group~Exclusion Criteria:~1. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).~2. Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.~3. Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)~4. Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.~5. Constant burning pain localized to the vulva.~6. Allergy to local estrogen products or lidocaine numbing agents.~7. Previous estrogen receptor positive breast cancer or endometrial cancer.~8. Endometrial thickness ≥5mm on screening via transvaginal ultrasound.

- Gender: FEMALE
- Minimum Age: 40 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- 50mcg estradiol cream (Type: ACTIVE_COMPARATOR): Subjects randomized to 50mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump
- 100mcg estradiol cream (Type: ACTIVE_COMPARATOR): Subjects randomized to 100mcg of study medication will be issued a pump that will dispense 0.5gm of cream with each pump

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 Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Study Design Characteristics:
- Allocation: NON_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: - Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records) - Documented history of at least 150 EDs (exposure days) to other FVIII products - At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired coagulation disorders other than haemophilia A - Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - Ongoing immune modulating or chemotherapeutic medication

- Gender: MALE
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Prophylaxis (Type: EXPERIMENTAL): None
- On-demand (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: Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering

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

Eligibility Criteria:
Inclusion Criteria:~* on 300 patients aged 18-60 years~* of the American Society of Anesthesiologists (ASA) physical status I or II~* and underwent gynecological surgeries under spinal anesthesia.~* A written informed consent was obtained from all patients to participate in the study.~Exclusion Criteria:~* Patient's refusal,~* duration of surgery more than 120 min,~* obesity with body mass index (BMI) \>35 kg/m2,~* generalized infection or localized infection at level of blockade,~* neurologic disease,~* coagulation disorder,~* patients with hypo- or hyperthyroidism,~* cardiopulmonary disease,~* psychological disorders,~* a need for blood transfusion during surgery,~* an initial body temperature \>38.0C or \<36.0C,~* a known history of alcohol or substance abuse,~* or receiving vasodilators, or medications likely to alter thermoregulation

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

Study Arms:
- M (Mirtazapine) (Merta) group:(n=100) (Type: ACTIVE_COMPARATOR): None
- D (Dexamethasone) (Dex) group: (n=100) (Type: ACTIVE_COMPARATOR): None
- C (Control) group: (n=100) (Type: PLACEBO_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: Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging

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:~* Experienced a heart attack in the 2 to 4 weeks before study entry~* Lives in the greater Boston area or adjacent regions (within a 50-mile radius of Boston)~Exclusion Criteria:~* Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an implantable cardioverter defibrillator \[AICD\]) at time of study entry~* Active cancer or any other terminal illness with an expected survival rate of less than 6 months after study entry~* Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60 mL/min in the 2 weeks before study entry~* Inability to follow study procedures~* Pregnant~* Hemodynamic instability~* Urgent clinical need for a pacemaker or AICD~* Inaccessibility of medical records

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Omega-3 Fatty Acids (Type: EXPERIMENTAL): Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
- Placebo (Type: PLACEBO_COMPARATOR): Participants will receive placebo for 6 months.

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 of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

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:~* Informed Consent~* BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)~* 70 years of age or less~* Have 2 or more of the following obesity-related co-morbid conditions:~  * Systolic blood pressure 140-160 mmHg (130-160 if diabetic);~ * Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);~ * Requirement for 2 or more medications to achieve control (\<140/90 mmHg)~* Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (\<200 mg/dL)~* At lease one of the following metabolic criteria:~  * Fasting blood glucose level \> 100 mg/dL~ * Glucose level \> 140 mg/dL~ * Diagnosis of type 2 diabetes~* Waist circumference ≥ 102 cm for men or ≥88 cm for women~Exclusion Criteria:~* Stroke/MI/unstable cardiovascular disease within 6 months~* Clinically significant renal, hepatic or psychiatric disease~* Unstable thyroid disease or replacement therapy~* Nephrolithiasis~* Obesity of known genetic or endocrine origin~* Participation in a formal weight loss program or lifestyle intervention~* Glaucoma or intraocular pressure~* Pregnancy or breastfeeding~* Drug or Alcohol abuse~* Smoking cessation within previous 3 months or plans to quit smoking during study~* Eating disorders~* Cholelithiasis within past 6 months~* Excluded medications~* Type 1 diabetes or use of any antidiabetic medication other than metformin~* Previous bariatric surgery~* Bipolar disorder or psychosis~* Steroid hormone therapy~* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg~* Creatinine clearance \< 60 mL/minute

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

Study Arms:
- VI-0521 Top (Type: EXPERIMENTAL): high dose experimental treatment
- VI-0521 Mid (Type: EXPERIMENTAL): mid dose experimental treatment
- Placebo (Type: PLACEBO_COMPARATOR): Placebo

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

Answer: outcome: complete