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

Trial Title: TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

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

Eligibility Criteria:
Inclusion Criteria:~Recipient:~Chronical terminal liver failure, age \> 18 years, first organ transplantation~Donor:~* donor age \> 65 Jahre~* macrovesicular steatosis \> 40% (macroscopy or biopsy)~* BMI \> 30~* sodium \>165 mmol/l~* ICU stay and ventilation \> 7 days~* cold ischemia time \> 13 hours~* AST \> 99 U/l~* ALT \> 105 U/l~* bilirubin \> 3 mg/dl (\> 51 µmol/l)~* application of epinephrine~Exclusion Criteria:~Donor:~• Hepatitis B- or Hepatitis C-infection~Recipient:~* Multi organ transplantation~* high urgency listing~* extrahepatic tumor disease~* pregnancy

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

Study Arms:
- Tacrolimus + HTK (Type: EXPERIMENTAL): Ex vivo Tacrolimus Rinse (20 ng/ml solved in 1000 ml HTK) of marginal liver grafts prior to implantation
- HTK (Type: PLACEBO_COMPARATOR): Ex vivo Rinse (1000 ml HTK) of marginal liver grafts prior to implantation

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 Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

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. Recipient of 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) but not more than 1 allo-HSCT.~2. Has primary steroid-refractory graft-versus-host disease (GvHD). Steroid-refractory disease is defined as worsening or no improvement in 5 to 7 days of treatment with methylprednisolone 2 milligram per kilogram (mg/kg) or equivalent or lack of a CR after 14 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. Note that participants who develop intestinal GvHD while receiving systemic therapy for other GvHD are still eligible after 5 to 7 days, even if the intestinal GvHD has not been present for the entire duration. Participants who may have received an increase in their steroid dose treatment (example, increased methylprednisolone from 1 mg/kg to 2 mg/kg) before enrollment will be eligible, provided the participant has met the definition of steroid refractory above. Participants who develop toxicity on corticosteroids or who are otherwise medically unable to be dosed to this level, will also be eligible.~3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.~4. Evidence of myeloid engraftment defined by absolute neutrophil count greater than or equal to (\>=) 0.5\*109/liter (L) on 3 consecutive days.~Exclusion Criteria:~1. Presence of chronic GvHD at Screening (including acute-chronic overlap syndrome).~2. Relapse of underlying malignant disease after allo-HSCT.~3. Hyperacute GvHD defined as onset of GvHD within the first 15 days following hematopoietic stem cell infusion.~4. Received systemic agents other than corticosteroids for treatment of acute GvHD. GvHD prophylaxis agents (example, calcineurin inhibitors) may be continued.~5. Life expectancy of \<3 weeks.

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

Study Arms:
- Vedolizumab 300 mg (Type: EXPERIMENTAL): Vedolizumab 300 mg, intravenous (IV) infusion, once on Days 1, 15, 43, 71 and 99.
- Vedolizumab 600 mg (Type: EXPERIMENTAL): Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.

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: Infliximab Accelerated Induction in Moderate to Severe Pediatric UC

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:~1. Ulcerative colitis~2. PUCAI≥35~3. Age: 6 - 17 years (inclusive)~4. Planned to initiate IFX therapy.~5. Naïve to biologics~6. Informed consent~7. Neg. PPD-Test, negative HBV- S Ag~8. Negative stool culture, parasites and clostridium toxin~Exclusion Criteria:~1. Pregnancy.~2. Acute severe colitis.~3. Renal Failure.~4. Toxic megacolon.~5. Patients whose disease is confined to the rectum (i.e. proctitis).~6. Prior treatment with infliximab or adalimumab.~7. Previous malignancy.~8. Sepsis or active bacterial infection.~9. Known immune deficiency.~10. Positive Hepatitis B surface antigen or evidence for TB.~11. IBD unclassified.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- Accelerated induction (Type: EXPERIMENTAL): Patients in group 1 will receive an accelerated induction of infliximab at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15.
- Per protocol (Type: ACTIVE_COMPARATOR): Patients in group 2 will receive a per protocol induction of infliximab at 0,2,6 weeks (5 mg/kg) and then at week 14.

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: Impact of Metabolic Syndrome on Flu Vaccine Efficacy

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

Eligibility Criteria:
Inclusion criteria for the METABOLIC SYNDROME COHORT( Participants must have 3 or more of the following 5 risk factors):~* Abdominal Obesity, given as a waist circumference: Men \>102 cm (\>40 in) Women \> 88 cm (\>35 in)~* Triglycerides \>150 mg/dl~* HDL Cholesterol: Men \< 40 mg/dl Women \< 50 mg/dl~* Blood Pressure \>130/ \>85 mm Hg - or controlled on antihypertensive medication~* Fasting Glucose \> 100 mg/dl~Inclusion criteria for the HEALTHY CONTROLS (Participants must have all of the requirements below) :~* body mass index 18.5 - 25 kg/m2~* HDL female \> 50 mg/dL, male \> 40 mg/dL~* fasting glucose \< 100 mg/dL~* triglycerides \<150 mg/dL,~* waist circumference of a female \< 88 cm, male \< 102 cm)~* - Blood pressure \< or = to 120/80 (based on an average of 3 readings taken 5 minutes apart after the consent form has been signed)~Exclusion criteria :~* Currently undergoing treatment for the metabolic syndrome~* The average of 2 BP readings \> 150/90 (based on 2 B/Ps taken at screening visit 1).~* Hepatitis A, B and C~* NSAIDs and/or Aspirin ingestion within the last 14 days~* Self-reported history of any active autoimmune diseases~* Self-reported ingestion of statins within the last 3 months~* Self-reported antibiotic use within the last 3 months~* Anti-inflammatory drugs including biologics and corticosteroids within last 3 months( nasal spray and topical applications are OK)or Omega 3 Fatty Acids.~* Self-reported hx of cancer treatment within the last year~* Allergy to eggs~* History of Guillain-Barre syndrome~* Pregnant ( determined by point of care testing at screening visit 1).~* HIV positive~* Self-reported history of flu vaccination within the past 3 months.~* Any self-reported infection in the week of the visit except the first two visits (Screening visit 1 and Screening visit 2) and the last visit (Study visit #5) that could be rescheduled.~* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.~Study Population Description The population from which the groups will be selected are resident of New York City.

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

Study Arms:
- Influenza vaccine in metabolic syndrome (Type: EXPERIMENTAL): Influenza vaccine
- Influenza vaccine in healthy controls (Type: EXPERIMENTAL): Influenza vaccine

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 Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

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:~* Age \> 18 and ≤ 85 years~* Histologically confirmed prostate cancer~* Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of \>1 on the Bruera global fatigue severity scale OR~* Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2~* Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy.~* Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine \< 2 x ULN)~* Able to swallow and retain oral medication~* Life expectancy of at least 1 year~* Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent.~Exclusion:~* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer)~* Previous chemotherapy within the last 5 years~* Anemia (Hemoglobin \< 100 g/L)~* Myocardial infarction within past 6 months~* Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders~* Severe depression as defined by CES-D score \>27~* History of motor tics, seizures or a family history of Tourette's syndrome~* Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C)~* Evidence of drug or alcohol abuse~* Known hypersensitivity to methylphenidate~* Possess any other contraindications to methylphenidate use

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): None
- 2 (Type: PLACEBO_COMPARATOR): 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: Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* 18 years old \< Age \< 75 years old with prior diagnosis of achalasia via manometry and/or radiographically~Exclusion Criteria:~* \< 18 years old or \> 75 years old~* History of hypertension not controlled on oral medications (blood pressure \> 160/100 mm Hg)~* No prior history of hypertension with a blood pressure \> 160/100 mm Hg~* History of bladder outlet obstruction~* History of angioedema~* Pregnant or breast-feeding women: Women between 18 and 40 years old who are enrolled in the study will be required to use a form of birth control during the study~* Patients currently receiving certain medications (digoxin, warfarin, any overactive bladder medications, thioridazine, flecainide, propafenone, phosphodiesterase inhibitors)~* Patients with prolonged QTc interval or risk factors to develop it:~  * Baseline QTc on EKG of \> 450 milliseconds~ * History of additional risk factors for Torsades de Pointes (heart failure, family history of long QT syndrome)~ * Concomitant medications that prolong the QTc interval: ranolazine, sotalol, dofetilide, procainamide, disopyramide, propafenone, azole antifungals, fluoroquinolones, macrolide antibiotics, HIV antiretrovirals, chemotherapy, beta-2 agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors~* Prior surgeries for achalasia~* \< 2 months since last endoscopic botulinum toxin injection into LES or endoscopic dilation~* Stage 4 Chronic kidney disease (severe renal impairment with GFR 15-29 ml/min), Stage 5 Chronic Kidney disease (GFR \< 15 ml/min or on dialysis)~* Childs Pugh B (moderate) or C (severe) Cirrhotic (hepatic impairment)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Mirabegron (Type: EXPERIMENTAL): Patients will receive 50 mg of oral Mirabegron daily for 4 weeks and then switch to placebo by mouth daily for an additional 4 weeks.
- Placebo (Type: PLACEBO_COMPARATOR): Patients will receive placebo by mouth daily for 4 weeks and then switch to oral Mirabegron 50 mg daily for an additional 4 weeks.

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: Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

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

Eligibility Criteria:
Inclusion Criteria:~* Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;~* Subject was 18 years of age or older at the time of NIPT;~* Subject provides signed and dated informed consent in English;~Exclusion Criteria:~* Subjects' treating physician is not located in the United States.

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

Study Arms:
- Multiple gestations (Type: None): Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).

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: Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment

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

Eligibility Criteria:
Inclusion Criteria:~* All subjects - non-smoking, male and female volunteers 18-65 years of age weighing at least 60kg with BMI between 18- 40kg/m2. Females of childbearing potential sexually inactive or using acceptable birth control method for 14 days prior to through 3 days following dosing or postmenopausal with amenorrhea for at least 2 years, adequate venous access~* Healthy subjects - medically healthy based on designated clinical criteria including CLcr\>80 ml/min and hemoglobin 11g/dL or greater~* Renally-impaired subjects - medically acceptable based on designated clinical criteria including good glucose control if diabetic, CLcr 30 to 80 ml/min, hemoglobin 10 g/dL or greater, anticipation that medications necessary for treatment of renal disease and/or other coexisting disease will remain stable for 14 days prior to and throughout the study period~Exclusion Criteria:~* Pregnant or lactating; history of presence of significant cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, musculoskeletal, dermatologic, neurologic, or psychiatric disease; positive at screening for HIV, HbsAg, or HCV; QTc \>440 msec (male) or 450 msec (female) or PR \>200 msec, sitting BP \< 90/55, sitting radial pulse \< 45 bpm at screening or baseline; history of G6PD deficiency, myasthenia gravis, or optic neuritis; hypersensitivity or idiosyncratic reaction to mefloquine or quinidine; recent/ongoing use of drugs or substances known to inhibit or induce CYP P450 enzymes and/or P-glycoprotein or quinine; hx of alcoholism or drug abuse within previous 2 years; donation of blood or plasma within 56 days prior to dosing; receipt of study medication in another clinical trial within 30 days of dosing

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

Study Arms:
- 1 (Type: EXPERIMENTAL): quinine sulfate 648mg in subjects with normal renal function (CLcr \> 80mL/min)
- 2 (Type: EXPERIMENTAL): quinine sulfate 648mg in subjects with mildly impaired renal function (CLcr \> 50 to 80 mL/min)
- 3 (Type: EXPERIMENTAL): quinine sulfate 648mg in subjects with moderately impaired renal function (CLcr 30 to 50mL/min)

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: Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles

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:~* Women~* 30-38 years old (inclusive)~* with regular menstrual cycles (25-35 days)~* AntiMülleriana Hormone \>5 pmol/L.~* Undergoing IVF treatment~Exclusion Criteria:~* BMI \>30 kg/m2~* repeated miscarriages~* implantation failure~* uterine or adnexal pathology~* Unable to be treated with gonadotrophins for the ovarian hyperstimulation~* history of low response to ovarian hyperstimulation~* participation in another study with PGS for monogenic pathology~* Cryptozoospermia in male partner

- Gender: FEMALE
- Minimum Age: 30 Years
- Maximum Age: 38 Years
- Healthy Volunteers: None

Study Arms:
- Natural Cycle (Type: None): The patient will not undergo hyperstimulation rather a natural cycle
- Stimulated Cycle (Type: None): The 80 patients will undergo hyperstimulation cycle as per the clinical practice planned for the patient.

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: Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

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:~* Patients who meet criteria for tympanoplasty procedure~* Willing to comply with the protocol and attend all study visits~* Able to provide written informed consent~Exclusion Criteria:~* Patients who have previously undergone middle ear or lateral skull base surgery~* Patients who would not qualify for a tympanoplasty~* Any type of platelet disorder, cancer, or ongoing systemic infection~* Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums~* Type I diabetes or other autoimmune pathology

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

Study Arms:
- PRP Treatment (Type: EXPERIMENTAL): Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise.

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 and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

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

Eligibility Criteria:
Inclusion Criteria:~* Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete~* Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season~Exclusion Criteria:~* Has had any hospital admissions for asthma~* Has smoked within the past year, or has a ≥10-pack per year smoking history~* Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™~* Has used Xolair within the past 12 months~* Has a history of anaphylaxis

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): TOLAMBA™ dose-intense regimen
- 2 (Type: EXPERIMENTAL): TOLAMBA™ lower-dose regimen
- 3 (Type: PLACEBO_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: safety issues