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

Trial Title: A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease

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:~* Age \>18 years~* Patients must have clinical evidence\* of steroid-refractory acute Graft vs Host Disease (any organ) defined as one of the following:~  * No change or progression in the stage of skin GvHD after at least 1 week of 2mg/kg/day methylprednisolone (or po equivalent)~ * lack of response of visceral (liver, GI) GvHD despite treatment with 2mg/kg/day methylprednisolone for at least 72h.~ * progression of visceral GvHD despite treatment with 2mg/kg/day methylprednisolone for at least 48h~ * visceral GvHD progressing to stage 4 after 24h of 2mg/kg/d methylprednisolone~ * Patients with protracted acute GvHD who have not responded to at least 0.5mg/kg/d of prednisone are considered eligible.~* Ability to understand and the willingness to sign a written informed consent document.~* \* As GvHD is a clinical diagnosis, and patients will have already been initiated on steroid therapy at the discretion of the attending physician, tissue confirmation of refractory GvHD by biopsy is not required for entry to this study. It is anticipated that most, but not all, patients will have undergone tissue confirmation of the initial diagnosis of GvHD; however lack of tissue confirmation for this clinical syndrome is not exclusionary.~Exclusion Criteria:~* As patients with steroid refractory acute GvHD are quite ill with multiple abnormal labs and organ dysfunction, there are no explicit laboratory values or degree of organ dysfunction that specifically preclude enrollment on this study. Baseline lab studies will be obtained and followed throughout this trial as the standard of care for patients with GvHD.~* Pregnancy or Nursing Mother~* Vasopressor requirement~* Patients may not be receiving any other investigational agents for the treatment of GvHD at time of study entry or at any time while on study or be on another investigational agent that can impact on the primary clinical outcome analyses or has known pharmacodynamics or pharmacokinetic effects on AAT.~* Patients with known antibodies to IgA

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

Study Arms:
- Treatment arm (Type: EXPERIMENTAL): Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.

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: Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

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

Eligibility Criteria:
Inclusion Criteria:~1. Female~2. Last menstrual period at least one year prior and not more than eight years prior.~3. 19 years of age and older.~4. BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.~5. Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).~6. Able to understand spoken and written English.~7. Capable and willing to follow all study-related procedures.~Exclusion Criteria:~1. BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.~2. A 10-year probability of hip fracture of \> 3% or major fracture of \> 20% based on results of DXA using the FRAX tool (see attached).~3. Weight \> 300 lbs.~4. Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.~5. Active cancer or cancer treatment.~6. Any change in exercise in the past 3 months.~7. Fractures or major surgery within the past 6 months.~8. Medical Implants (excluding dental implants).~9. Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.~10. Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.~11. Hip circumference is greater than 42 inches

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

Study Arms:
- Sham Wearable belt (Type: SHAM_COMPARATOR): Device will be worn but not turned on for 30 minutes.
- Wearable vibration belt (30) (Type: EXPERIMENTAL): Device will be worn and turned on for 30 minute treatment.

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 Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* Male~* Healthy based on medical examination/history at the inclusion~* Age between 18 and 55 years~* Signed informed consent~* Prepared to grant authorized persons access to the medical records~* The volunteer is likely to comply with instructions~Exclusion Criteria:~* Known exposure to TB before (or expected during) the trial~* Prior BCG vaccination~* Granulomatous disease (by chest X-ray, autoimmune screen)~* Vaccinated with live vaccine 3 months before first vaccination~* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination~* HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)~* Participation in other clinical trials~* Positive Mantoux or QuantiFERON-TB Gold~* Known hypersensitivity to any of the vaccine components~* Laboratory parameters outside of normal ranges considered clinically relevant

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: t

Study Arms:
- Antigen group + high adjuvans (Type: EXPERIMENTAL): The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
- Antigen group (Type: EXPERIMENTAL): The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
- Antigen + low adjuvans group (Type: EXPERIMENTAL): The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.

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: Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

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:~* Has Type 2 diabetes mellitus~* Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy~* Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation~Exclusion Criteria:~* History of type 1 diabetes mellitus or a history of ketoacidosis~* History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime~* Currently has a urinary tract infection or genital infection with subjective symptom

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

Study Arms:
- Ipragliflozin (Type: EXPERIMENTAL): Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.

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: Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)

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

Eligibility Criteria:
Inclusion Criteria:~* Age over 18 years~* Polyuria of \> 50 ml/Kg/day~* Polydipsia of \> 3 liters/day~Exclusion Criteria:~* Known or probable central or nephrogenic Diabetes insipidus, expected from patient's history~* Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia~* Pregnancy~* Previous treatment with GLP-1 agonists within the last 3 month~* History of pancreatitis~* Severe renal insufficiency (eGFR (CKD EPI) \<30 ml/min/1,73 m2)~* Cancer

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

Study Arms:
- Verum first (Type: EXPERIMENTAL): Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.
- Placebo first (Type: PLACEBO_COMPARATOR): Placebo: 0.5 ml normal saline (0.9% sodium chloride \[0.9% sodium chloride (NaCl)\]), injection sc via syringe once weekly for 3 weeks.

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: Somatuline Autogel: Acromegaly Self/Partner Injection Study

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

Eligibility Criteria:
Inclusion Criteria:~* The patient must have a clinical diagnosis of acromegaly~* The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit~* The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening~* The patient must be able to store study medication in a refrigerator in their own home~Exclusion Criteria:~* The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening~* The patient has received pituitary radiotherapy within one year prior to screening~* The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period~* The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

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

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

Answer: outcome: complete
Please assess the completion status of the following clinical trial:

Trial Title: Metformin to Treat Obesity in Children With Insulin Resistance

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:~Good general health.~Age greater than or equal to 6 and less than 13 years.~Pre-pubertal or having at most early puberty (breast Tanner I, II or III for girls, testes size less than or equal to 8 mL for boys).~Hyperinsulinemia, defined as fasting insulin concentration greater than or equal to 15 mIU/mL. The insulin level must be greater than or equal to 15 at either the NIH Clinical Center lab or the NIDDK lab at PIMC in Phoenix.~Obesity, defined as body mass index greater than or equal to 95th percentile determined by NHANES I age and sex specific data.~Subjects must have fasting plasma glucose less than 126 mg/dl~Subjects must have glycosylated hemoglobin (HgbA1C) of less than or equal to 6.5%.~Females who begin menstruating (or who are at risk for pregnancy) during the study must have a negative pregnancy test and must use an effective method of contraception if they are engaging in sexual intercourse.~EXCLUSION CRITERIA:~Baseline creatinine greater or equal to 1.0 mg/dl.~Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.~Hepatic disease with elevated liver function tests (ALT or AST) greater than or equal to 1.5 the upper limits of normal.~An alcohol history concerning for development of hepatic toxicity.~Pregnancy.~Evidence for Type 2 diabetes, including fasting plasma glucose greater than or equal to 126 mg/dl or HgbA1C greater than 6.5%.~Weight loss of greater than 2% of bodyweight within the past 6 months.~Presence of other endocrinologic disorders leading to obesity (e.g. Cushing's Syndrome).~Individuals who have, or whose parent or guardians have current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.~Recent use (within six months) of anorexiant medications.~Individuals receiving medical treatment other than diet for hypertension or dyslipidemia.~Individuals with evidence of precocious puberty.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 12 Years
- Healthy Volunteers: f

Study Arms:
- 1 - Metformin HCL (Type: ACTIVE_COMPARATOR): Subjects receive metformin plus a weight loss program
- 2 - Placebo (Type: PLACEBO_COMPARATOR): Subjects receive placebo plus a weight loss program

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: Use of Pedometers to Measure and Increase Walking Among Patients With ESRD

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:~* on hemodialysis for ≥ 3 months~* able to walk~* able to give informed consent and willing to participate~Exclusion Criteria:~* unable to walk~* unable to understand directions or give informed consent

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

Study Arms:
- pedometer (Type: EXPERIMENTAL): Patients will be given pedometers and instructions to increase physical activity based on pedometer output
- usual care (Type: NO_INTERVENTION): No intervention

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 Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of a hemato-oncological disorder~* Scheduled to undergo a lumbar puncture~* Aged 4-11 years~* Male or female~* Unpremedicated~* Willing and able to provide informed consent (or informed consent by parents)~Exclusion Criteria:~* Children who are known or suspected to be difficult to ventilate by face mask~* Children who are deemed medically unfit to receive either of the two study medications~* Children who are obese (weight for height \> 95th percentile,~* Children who do not have an indwelling intravenous line

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 11 Years
- Healthy Volunteers: f

Study Arms:
- Propofol 4 mg/kg group (Type: EXPERIMENTAL): First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
- Propofol 2 mg/kg group (Type: EXPERIMENTAL): First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

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: Does the Order in Which Vaccines Are Administered Affect Pain Response?

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:~* Healthy infant~* 2 - 6 months of age~* receiving primary DPT and PCV vaccinations~Exclusion Criteria:~* chronic illness~* immune deficiency~* immunosuppression~* a history of allergy to DPT or PCV or any of its components~* fever~* any acute illness that prevents the administration of the vaccine

- Gender: ALL
- Minimum Age: 2 Months
- Maximum Age: 6 Months
- Healthy Volunteers: t

Study Arms:
- Pentacel (Type: ACTIVE_COMPARATOR): The subjects in this arm will be vaccinated with Pentacel
- Prevnar (Type: ACTIVE_COMPARATOR): The subjects in this arm will be vaccinated with Prevnar

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: Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

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

Eligibility Criteria:
Inclusion Criteria:~* Chinese participant~* Female of reproductive potential with a serum hCG level consistent with a nongravid state and agree to use 2 acceptable methods of birth control throughout the study~* Body Mass Index (BMI) \>=15 and \<=30 kg/m\^2~* Anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (AML); b)chemotherapy for AML in first relapse; or c) therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) or chronic myelogenous leukemia in blast crisis~* Free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations~Exclusion Criteria:~* Pregnant, intends to become pregnant during the study, or has been nursing~* Mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years~* Received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis~* Known or suspected invasive or systemic fungal infection~* Taken posaconazole within 10 days prior to study enrollment~* Major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study~* Type 1 hypersensitivity or idiosyncratic reactions to azole agents~* Significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food~* Moderate or severe liver dysfunction~* Chronic active hepatitis, cirrhosis, Hepatocellular Carcinoma (HCC), or other hepatic disease caused by a virus~* Previous electrocardiogram with a prolonged QTc interval~* Prior enrollment in this study or other posaconazole studies within 90 days of study entry~* Eastern Cooperative Oncology Group (ECOG) performance status was \>2 prior to induction chemotherapy for the underlying disease~* Known or suspected Gilbert's disease

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

Study Arms:
- Posaconazole (Type: EXPERIMENTAL): Posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28

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: Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma~* Subjects must be able to take orally~* Measurable lesion and/or non-measurable lesion defined by RECIST~* ECOG performance status ≦ 1~* Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3~* Creatine ≦ upper normal limit (UNL)~* Total bilirubin ≦ 1.5 X UNL~* AST, ALT and ALP ≦ 2.5 x UNL~* No prior chemotherapy~* Life expectancy estimated than 3 months~* Written informed consent~Exclusion Criteria:~* Active double cancer~* Gastrointestinal bleeding~* Excessive amounts of ascites require drainage~* Known brain metastases~* Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0~* Pulmonary fibrosis, Intestinal pneumonitis~* History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80~* Any previous chemotherapy or radiotherapy for AGC~* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant~* Treatment with any investigational product during the last 4 weeks prior to study entry~* Definite contraindications for the use of corticosteroids~* Any subject judged by the investigator to be unfit for any reason to participate in the study

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Docetaxel + S-1
- 2 (Type: ACTIVE_COMPARATOR): S-1

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

Answer: outcome: complete