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

Trial Title: Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation

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

Eligibility Criteria:
Inclusion Criteria:~* Patients who have undergone a hematopoietic stem cell transplantation~Exclusion Criteria:~* Known or suspected allergy to trial product~* Participation in other trials with unapproved drugs or trials with equal or similar objective

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- Low dose (Type: EXPERIMENTAL): None
- High dose (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Pravastatin to Prevent Preeclampsia

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:~1. 16 years or older at time of consent with ability to give informed consent~2. Single or twin gestation with cardiac activity in one or both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.~3. Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.~4. Documented history (by chart or delivery/operative note review) of prior preeclampsia with delivery less than or equal to 34 weeks 0 days gestation in any previous pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0 days gestation and delivered within 48 hours in the same hospitalization, that woman would be eligible.~5. Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.~Exclusion Criteria:~1. Monoamniotic gestation because of the risk of fetal demise~2. Known chromosomal, genetic or major malformations~3. Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from triplets to twins or twins to singleton is not an exclusion.~4. Contraindications for statin therapy:~   1. Hypersensitivity to pravastatin or any component of the product~  2. Active liver disease: acute hepatitis or chronic active hepatitis~5. Statin use in current pregnancy~6. Patients with any of the following medical conditions:~   1. Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because of increased risk of myopathy~  2. HIV positive, because of increased risk of myopathy with use of protease inhibitors~  3. Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because of association with adverse pregnancy outcomes~7. Current use of concomitant medication with potential for drug interaction with statins (i.e.,, cyclosporine, fibrates, niacin, erythromycin). Patients will not be excluded if the drug is discontinued (at least one week) prior to randomization.~8. Participating in another intervention study that influences the primary outcome in this study~9. Plan to deliver in a non-network site~10. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.

- Gender: FEMALE
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Pravastatin (Type: EXPERIMENTAL): 20 mg pravastatin daily
- Placebo (Type: PLACEBO_COMPARATOR): Identical appearing daily placebo

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

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:~* Imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma~* Documentation of previous treatment including conventional chemotherapy and/or radiation therapy as clinically appropriate~* Ages 2 to 30 years of age~* Negative serum pregnancy test if applicable~* Calculated creatinine clearance of greater than 60 mL/minute, serum creatinine of less than 12o micromoles/L, total bilirubin less than 2 mg/dL and aspartate aminotransferase (AST) must be less than twice the upper limit of normal~Exclusion Criteria:~* Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues~* Pregnancy~* Breast-feeding women

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 30 Years
- Healthy Volunteers: f

Study Arms:
- High Dose Conditioning (Type: EXPERIMENTAL): Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age between 10 and 25 years old~* Sickle cell disease with hemoglobin SS, SC or S-B\^0 thalassemia confirmed on hemoglobin electrophoresis~* Tricuspid regurgitant jet velocity (TRJV) equal to or greater than 2.5 m/sec on 2 baseline Doppler echocardiograms at least 3 months apart~Exclusion Criteria:~* Patients already being treated with hydroxyurea~* Patients on a chronic transfusion protocol~* Patients with evidence of hepatic (alanine aminotransferase \[ALT\] equal to or greater than 2 SD above normal) or renal dysfunction (creatinine \[Cr\] equal to or greater than 2 SD above normal)~* Patients who are pregnant~* Patients with documented causes of severe pulmonary hypertension other than from SCD

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 25 Years
- Healthy Volunteers: f

Study Arms:
- Hydroxyurea (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures

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

Eligibility Criteria:
Inclusion Criteria:~* Children aged between 5-16 years with symptomatic planovalgus deformity admitted to the Department of Children's Orthopaedics, Aarhus University Hospital during the period 2012 to 2016. The surgical procedure is performed in about 10 children a year.~Pain and/or callosities. Informed written consent from the child custody/guardianship. Ambulatory function No severe cognitive deficits~Exclusion Criteria:~Reoperation will exclude patients from further follow-up

- Gender: ALL
- Minimum Age: 5 Years
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- ReproBone (Type: EXPERIMENTAL): calcaneal lengthening
- Autologous bone graft (Type: ACTIVE_COMPARATOR): calcaneal lengthening

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* 3.1 Radiographic evidence of new or progressive metastatic breast cancer by CT chest/abdomen/pelvis and bone scan, or by PET scan.~* 3.2 Patient must have ≥3 sites of disease involving ≥2 organ sites appropriate for biopsy. Treating physician, in consultation with interventional radiologist as needed, will select sites for potential biopsy (see section 5.2.2 for guidance on evaluable sites.)Histologic documentation of metastatic invasive breast cancer with metastasis to a distant organ site (lung, liver, pleural/peritoneal, skin \[if skin, must be determined by treating physician that it is not skin involvement from breast primary or local regional recurrence\], and/or bone) by core needle or excisional biopsy.~* 3.3 The subject must agree to undergo and be able to tolerate the research biopsy(ies) and blood draw.~* 3.4 Prior chemotherapy, endocrine therapy, or radiotherapy with therapeutic intent is allowed in the metastatic setting. However, for patients currently receiving such treatment(s), archived tumor specimens will not count towards the required biopsy of 3 tumors~* 3.5 Women or men \> age 18.~* 3.6 Ability to give informed consent.~* 3.7 Normal Prothrombin Time/International Normalized Ratio within 30 days of any diagnostic biopsies, or if patient is on anticoagulation therapy, approval is required by provider doing the biopsy.~* 3.8 Negative pregnancy test or beyond reproductive potential.~* 3.9 Medical evaluation by medical oncology within 4 weeks.~* 3.10 Previous but not current smokers are eligible if they have not smoked for more than 10 years and have less than 25 pk yr smoking history, see exclusion criterion 3.14.~Exclusion Criteria:~3.12 Poor venous access (unable to tolerate large-gauge needle).~3.13 Unable to tolerate blood draw or research biopsy procedures.~3.14 Current smokers or smoked at all within the last 10 years, or have a lifetime smoking history greater than 25 pack-years. (One pack year is equal to smoking 1 pack per day for 1 year; 5 pack years = one pack/day for 5 yrs, or ½ pack/day for 10 yrs, etc.). There is evidence that smoking increases the likelihood of detecting mutations in cancer-related genes in plasma DNA in healthy individuals (i.e., who do not have detectable cancer) (15, 16). We wish to avoid detecting such genetic lesions in this pilot study by excluding current, recent and heavy smokers

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

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

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:~* Men age 35 or older~* Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia~* No current use (\>1 month) of alpha-blockers~* Community ambulator~* Adequate organ and marrow function as defined below:~leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits~* Ability to understand, and the willingness to sign, a written informed consent~Exclusion Criteria:~* History of radical prostatectomy~* Receiving any other investigational agents~* Revision hip and knee arthroplasty patients~* Severe liver or kidney disease~* Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)~* Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin)~* Being of 5-alpha reductase inhibitors (finasteride, dutasteride)~* History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)~* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements~* Taking Sildenafil,Tadalafil, or Vardenafil

- Gender: MALE
- Minimum Age: 35 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- tamsulosin (Type: EXPERIMENTAL): 0.4 mg daily for five days pre-op through post-op day one (seven total)
- placebo (Type: PLACEBO_COMPARATOR): One capsule daily for five days pre-op through post-op day one (seven total)

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: Carbon Ion Radiotherapy for Hepatocellular Carcinoma

Study Design Characteristics:
- Allocation: None
- 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:~* histologically confirmed HCC or diagnosis of HCC according to AASLD-guidelines~* macroscopic tumor~* liver-confined disease without extrahepatic disease as diagnosed by CT, MRT, ultrasound and bone scan~* minimal distance of tumor edge to the intestines of 1cm~* age ≥ 18 years of age~* Karnofsky Performance Score ³60~* For women with childbearing potential, (and men) adequate contraception.~* Ability of subject to understand character and individual consequences of the clinical trial~* Written informed consent (must be available before enrolment in the trial)~Exclusion Criteria:~* refusal of the patients to take part in the study~* previous radiotherapy of the hepatobiliary system~* margin of \< 1cm between tumor edge and intestines~* Patients who have not yet recovered from acute toxicities of prior therapies~* Known carcinoma \< 2 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy~* Pregnant or lactating women~* Participation in another clinical study or observation period of competing trials, respectively

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

Study Arms:
- Carbon Ion Radiotherapy (Type: EXPERIMENTAL): Increasing Dose of Carbon Ion Radiotherapy 4 x 10 Gy E to 4 x 14 Gy E

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study

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

Eligibility Criteria:
* INCLUSION CRITERIA:~For the pilot study, we will select clean-up workers with thyroid cancer reported in three study areas, Kyiv, Donetsk and Dnipropetrovsk oblasts and controls (with a case-control ratio of 1:3) demographically matched to cases. We estimate the number of these cases will be between 100 and 110. These two oblasts have been chosen to represent an area known, from the leukemia study, to have a high study participation rate (Kyiv and Dnipropetrovsk oblasts) and an area newly added and thus unknown regarding participation rate (Donetsk). All study subjects are males and average about 55 years. In view of the very high survival rate for thyroid cancer, a majority of the subjects are expected to be alive.~EXCLUSION CRITERIA:~Excluded from the study will be those who cannot be located, refuse to participate in the study, or do not provide informed consent.

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Cohort of Chernobyl Cleanup Workers in Ukraine (Type: None): Thyroid cancer cases and matched controls in the cohort

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR~* Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects~Exclusion Criteria:~* Active malignancy~* Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease

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

Study Arms:
- Mesenchymal stromal cell treatment (Type: EXPERIMENTAL): None

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: The Effect of Botox Injection on Postural Stability of Cerebral Palsy (CP) Children

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:~* Cerebral palsy~* BOTOX injection~Exclusion Criteria:~* Not able to stand independently 60 seconds~* Not able to walk independently

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 7 Years
- Healthy Volunteers: f

Study Arms:
- A (Type: None): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Trial of Fistula Versus Graft in Elderly Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Age greater than 65 years old.~* On hemodialysis through a tunneled dialysis catheter.~* In the surgeon's opinion, both a fistula and a graft can be reasonably attempted, based on the patient's anatomy.~Exclusion Criteria:~* Unable to provide informed consent.~* Unable to be medically cleared for surgery~* Does not wish to have surgery.~* Does not wish to be randomized.

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arteriovenous Fistula (AVF) (Type: PLACEBO_COMPARATOR): If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.
- Arteriovenous Graft (AVG) (Type: ACTIVE_COMPARATOR): If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department

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

Eligibility Criteria:
Inclusion Criteria:~* Chief Complaint of nausea or abdominal pain with nausea~* Inability to tolerate oral nausea medication~* Patients with a negative pregnancy test~Exclusion Criteria:~* Patients younger than 18 years of age~* Patient's chief complaint includes headache, chest pain, or dizziness~* Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease)~* Blood sugar greater than 300~* Non-English speaking subjects

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

Study Arms:
- Ondansetron (Type: ACTIVE_COMPARATOR): Ondansetron (4 mg) followed by two 5 ml normal saline flush
- Ondansetron plus dexamethasone (Type: EXPERIMENTAL): Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis 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: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects must give a written, signed and dated informed consent~* Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.~* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.~Exclusion Criteria:~* Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).~* Treatment discontinued subject from CZPL389A2203 study.~* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.

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

Study Arms:
- ZPL389 30mg (Type: EXPERIMENTAL): 30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study
- ZPL389 50mg (Type: EXPERIMENTAL): 50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study

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

Answer: outcome: terminate
termination_type: lack of efficacy