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

Trial Title: Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease

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

Eligibility Criteria:
* INCLUSION CRITERIA:~* Adult and pediatric subjects (greater than or equal to 13 years of age and greater than or equal to 49 kg)~* Be registered to an NIH protocol that includes bone marrow, cord, haplo-cord or peripheral blood stem cell transplantation~* Have GI GVHD as determined by the medical team that requires treatment with budesonide and systemic corticosteroids (e.g. methylprednisolone or prednisone)~* Be candidates for antifungal therapy~* Liver function tests:~  * Alanine aminotransferase (ALT) must be \<5 times the upper limit of normal (ULN)~ * Aspartate aminotransferase (AST) must be \<5 times ULN~EXCLUSION CRITERIA:~* Pregnant or breast-feeding~* Prohibited drugs~  --Note: Treatment with corticosteroids and/or immunosuppressants is permitted~* Consumption of grapefruit juice or grapefruit in the past seven days prior to study enrollment~* Inability to take oral medications~* Allergy(ies) to budesonide, fluconazole, micafungin, voriconazole~* ECOG performance status greater than or equal to 4 (adults and children 16 years and older) or Lansky perfomance status less than or equal to 30 (children\< 16 years old)~* Psychiatric disorder or mental deficiency that could interfere with the subject s ability to comply with study procedures and requirements~* Inability to provide informed consent~* Major anticipated illness or organ failure whereby the subject s anticipated survival within 2 weeks is unlikely (PI discretion)~* Current documented or suspected invasive fungal infection~* Intensive care unit (ICU) patient~* Child-Pugh Class C hepatic impairment~* AST greater than or equal to 5 times ULN, ALT greater than or equal to 5 times ULN~* Contraindication to an azole as determined by research team~* Body weight \< 49 kg at the time of study enrollment

- Gender: ALL
- Minimum Age: 13 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Cohort 1 (Type: EXPERIMENTAL): subjects may be on fluconazole or micafungin at study entry or be on no antifungal prophylaxis.
- Cohort 2 (Type: EXPERIMENTAL): subjects are on voriconazole at study entry. Voriconazole will continue throughout days O to 7.
- Cohort 3 (Type: EXPERIMENTAL): subjects are on fluconazole at study entry. Fluconazole will continue throughout days O to 7.

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: Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* A diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (MRI).~* In cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on MRI findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis.~* Karnofsky performance status \>=70~Exclusion Criteria:~* Not able to consent (e.g. severe cognitive impairment)~* Intended biopsy only (meaning: cases not suitable for resection)~* Hypersensitivity to egg protein~* Hypersensitivity to soya or peanut protein~* Hypersensitivity to glycerol~* Pregnancy of breast-feeding~* Intention to become pregnant during the time of the study

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

Study Arms:
- High grade gliomas stage 1 ACF (Type: EXPERIMENTAL): In the first stage 12-15 patients with high-grade gliomas will be included in the trial (acoustic coupling fluid) group.
- Low-high grade gliomas stage 2 ACF (Type: EXPERIMENTAL): If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the trial (acoustic coupling fluid) group of 22-25 patients with both low-grade and high-grade glioma
- High grade gliomas stage 1 control (Type: ACTIVE_COMPARATOR): In the first stage 12-15 patients with high-grade gliomas will be included in the Ringer's acetate (control) group.
- Low-high grade gliomas stage 2 control (Type: ACTIVE_COMPARATOR): If the interim safety assessments validate that the study can continue, the second stage involves inclusion in the Ringer's acetate (control) group of 22-25 patients with both low-grade and high-grade glioma

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: Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells

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

Eligibility Criteria:
Subject and Control Inclusion Criteria~1. Participants have a Body Mass Index (BMI) between 20-25 or 35 and above.~2. Adults aged 18-65~Exclusion Criteria:~1. Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus~2. Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them)~3. Bowel preparation for colonoscopy within the past week~4. Significant bowel surgery other than hysterectomy or appendectomy~5. Pregnancy or plans to become pregnant within the study time frame~6. Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.~7. Age\<18 or vulnerable adults -

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

Study Arms:
- Flexible Sigmoidoscopy (Type: OTHER): Participants will undergo an unsedated Flexible Sigmoidoscopy in order to obtain 12 mucosal biopsies. Serum cholesterol, triglyceride and HBA1C levels will be determined. Plasma, serum and whole blood will be stored for future use for next generation sequencing and metabolomics to determine the effect of different genetic loci on composition and function of gut microbiota

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: Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Patients aged 65 years old and over~* Severe acute pain (NRS score greater than 6)~Exclusion Criteria:~* Contraindication of premixed 50% nitrous oxide and oxygen

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- Premixed 50% nitrous oxide and oxygen (Type: ACTIVE_COMPARATOR): The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. Premixed 50% nitrous oxide and oxygen is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN \<3/10.
- Medical air (Type: PLACEBO_COMPARATOR): The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. The medical air is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN \<3/10.

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: Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

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:~* Patient with respiratory failure due to primary pulmonary pathology.~* Patient who is selected for BiPAP or CPAP by the health care provider~Exclusion Criteria:~* Age \<18 years.~* Respiratory failure due to non-pulmonary pathology.~* Impaired consciousness (Glasgow coma scale \<10).~* Patients with contraindications of NIV.~* Severe upper gastrointestinal bleeding.~* Chest trauma.~* Agitated or violent patient.

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

Study Arms:
- Aerosol-reducing Mask (Type: None): The participant will be placed on BIPAP using the aerosol-reducing mask. In the case where the patient is located in a care area where BIPAP is prohibited with a standard mask, they will assigned the aerosol-reducing mask.
- Standard Mask (Type: None): The patient will be placed on BIPAP using the standard mask. In the case where the patient is located in a care area where BIPAP is prohibited with a standard mask, they will assigned the aerosol-reducing mask.

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: A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

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:~1. LAP-BAND® System placed in a facility in the United States~2. BMI ≥ 30 kg/m2 and \< 40 kg/m2 prior to LAP-BAND® placement~3. Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement~4. Aged 18 or older~Exclusion Criteria:~1. Prior bariatric surgery.~2. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.~3. Vulnerable patients or those unable to exercise free informed consent.~4. Inability to complete the questionnaires.~5. Patients who are addicted to alcohol and/or drugs.

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

Trial Title: Knee Injection RCT

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

Eligibility Criteria:
Inclusion Criteria:~* Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.~Exclusion Criteria:~* Prior injections into the same knee within the past 6 months,~* Pregnant and/or lactating women,~* Inflammatory joint disease including rheumatoid or psoriatic arthritis,~* Concurrent use of anti-rheumatic drugs,~* Allergy or hypersensitivity to the study medications,~* Patients on an active pain management contract,~* Patients with insurance that requires pre-certification for any of the study drugs,~* Inability to make own decisions regarding the informed consent,~* Inability to read and/or understand English,~* Patients who are unable to return for follow-up or be reached by phone.

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

Study Arms:
- Ketorolac (Type: EXPERIMENTAL): One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
- Corticosteroid (Type: ACTIVE_COMPARATOR): One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
- Hyaluronic Acid (Type: ACTIVE_COMPARATOR): One knee injection of Hylan G-F 20 (Synvisc-One)

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: Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients must have confirmed malignancy for which standard regimens of anthracyclines or trastuzumab are being offered as treatment at the University of Maryland Greenebaum Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.~2. Age \> 18 years~3. Ability to understand and willingness to sign a written informed consent document.~4. Women of childbearing potential may participate in this study only if they have a negative pregnancy test and agree not to become pregnant during the study. Woman of childbearing potential must use an effective method of birth control such as hormonal contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly, surgical (hysterectomy or tubal ligation) or intrauterine device.~Exclusion Criteria:~1. Patients who have established dilated or restrictive cardiomyopathy with EF \< 40 %.~2. Patients with severe mitral or aortic valve disease (valve area \<1cm squared).~3. Patients who have any contraindication to metoprolol, in particular bradycardia with HR \< 50, or severe reactive pulmonary disease such as asthma. Patients who take mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and thioridazine) will also be excluded from the study as they have serious interactions with beta-blockers~4. Patients who have untreated thyroid function disorder.~5. Pregnant and nursing women are excluded from this study because of potential risk for adverse events to the fetus.~6. Patients with any impediment to swallowing tablets would be excluded.

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

Study Arms:
- Metoprolol (Type: ACTIVE_COMPARATOR): Receiving metoprolol
- Control (Type: NO_INTERVENTION): Not receiving metoprolol

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: DETERMINATION OF THE CELL OF ORIGIN (COO) in LDCGB

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:~* Patients diagnosed with LDCGB in the Spanish GELTAMO sites, without previous treatment and who decide to join the program.~* Age over or equal to 18 years old.~* Having voluntarily given informed consent for the sending and processing of biological samples, as well as for the analysis and reporting of the LDCGB COO results~Exclusion Criteria:~* Absence of histological material available to review histology and determine COO~* Patients with LDCGB from any other low-grade lymphoma

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

Trial Title: Safety Study of Autologous Stem Cell in Liver Cirrhosis

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

Eligibility Criteria:
Inclusion Criteria:~* Liver cirrhosis of any origin~* Moderate liver disfunction (Child-Pugh Score=7-10)~Exclusion Criteria:~* Waiting time expectancy of liver transplant shorter than 12 months~* Ongoing hepatic encephalopathy~* Clinically detectable ascitis~* Severe coagulation disorder (INR\>2,0 or platelets count \< 40.000)~* Diagnosis or strong suspicion of cancer (except basocellular)~* Pregnancy or intention to become pregnant during the next 12 months~* Moderate or severe co-morbidity~* Current participation in another clinical trial

- 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: terminate
termination_type: safety issues
Please assess the completion status of the following clinical trial:

Trial Title: Multimodal Analgesia in Cardiac Surgery (Pilot Study)

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

Eligibility Criteria:
Inclusion Criteria:~* Elective CABGs and/or Valve replacements, ≥ 18 years old~Exclusion Criteria:~* Re-do cardiac surgery, Acute endocarditis, Circulatory arrest, Emergent cases, Shock, Left Ventricular Assist Device, Transplantation, Transcatheter Aortic Valve Replacement, contraindications for Spinal including coagulopathy and Clopidogrel \<7days, psychosis, known allergy to any of the study drugs, Preoperative liver dysfunction (AST/ALT \> 2 times normal) and Renal dysfunction (Cr \> 2 mg/dL), inability to administer spinal anesthetic, preoperative opioid use, patients who are unable to give their own consent, expected prolonged intubation postoperatively (\>12 hrs), prisoners, pregnancy

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

Study Arms:
- Unrestricted Fentanyl (Type: ACTIVE_COMPARATOR): Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.~Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.
- Lidocaine, Dexmedetomidine and Ketamine (Type: EXPERIMENTAL): Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to \<250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.

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: CO2 as a Stress Agent for Perfusion Imaging

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

Eligibility Criteria:
Inclusion Criteria:~For all participants~* Age ≥ 18 years old~* BMI ≤ 40 kg/m2~* Able and willing to comply with the study procedures~* Written informed consent~* Participants with documented coronary artery disease~* Stable coronary artery disease on a stable medication regime.~* Healthy volunteers without known heart disease~* Low risk of coronary artery disease (CAD)~Exclusion Criteria:~* History or risk of severe bradycardia (heart rate \< 50 beats per minute) not related to chronotropic drugs~* Known second- or third-degree Atrio-ventricular block without pacemaker~* Atrial flutter or atrial fibrillation~* Dyspnea (NYHA III/IV), wheezing asthma or Chronic Obstructive Pulmonary Disease (COPD)~* Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or at any time after consent~* Percutaneous coronary intervention (PCI) within 30 days prior to screening or at any time following consent~* Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent~* Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)~* Known hypersensitivity to adenosine~* Breastfeeding or pregnancy~* Claustrophobia or inability to lie still in a supine position~* Unwillingness or inability to provide informed consent

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

Study Arms:
- Myocardial blood flow quantification (Type: OTHER): The RA-MR™ Virtual Sequential Gas Delivery System. : delivery of CO2 in increasing levels.~Rubidium Elution System: delivery of Rb-82 through an automated pump system for myocardial PET perfusion imaging.~Persantine stress myocardial PET perfusion imaging: as a standard for comparison.

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

Answer: outcome: terminate
termination_type: enrollment issues