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

Trial Title: Balanced Crystalloid vs. Saline in Children With Septic Shock

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

Eligibility Criteria:
Inclusion Criteria:~* Children 2 month to ≤ 15 years with features of septic shock - defined as children who have a suspected infection manifested by hypothermia or hyperthermia and have at least two clinical signs of decreased perfusion with or without hypotension~Exclusion Criteria:~* Children receiving fluid boluses before enrollment~* Children with cardiogenic shock~* Known patient with chronic kidney disease with baseline deranged renal function (eGFR \< 90 ml/1.73 m2/min)~* Severe malnutrition~* Children whose parents refuse to give an informed consent

- Gender: ALL
- Minimum Age: 2 Months
- Maximum Age: 15 Years
- Healthy Volunteers: f

Study Arms:
- Balanced crystalloid or multiple electrolyte solution group (Type: EXPERIMENTAL): After enrollment, a fluid bolus comprising of 'multiple electrolyte solution (Plasma-Lyte P)' solution at a dose of 20 ml/kg over 15-20 minutes (recommended) with careful monitoring for features of fluid overload would be administered to each child. Fluid resuscitation will be targeted at achieving the therapeutic end points as given in study definitions. After this the management protocol will be as per recommendations of the American College of Critical Care Medicine 2017 for septic shock in children.
- 0.9% saline or saline group (Type: ACTIVE_COMPARATOR): After enrollment, a fluid bolus comprising of 'saline' solution at a dose of 20 ml/kg over 15-20 minutes (recommended) with careful monitoring for features of fluid overload would be administered to each child. Fluid resuscitation will be targeted at achieving the therapeutic end points as given in study definitions. After this the management protocol will be as per recommendations of the American College of Critical Care Medicine 2017 for septic shock in children.

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: Outlook Quality of Life Intervention

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

Eligibility Criteria:
Inclusion Criteria:~Patients with advanced cancer, CHF or COPD.~Exclusion Criteria:~Cognitive impairment, inability to speak, non-English speaking

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

Study Arms:
- Preparation and Completion (Type: EXPERIMENTAL): Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
- Attention Control (Type: ACTIVE_COMPARATOR): The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
- True Control (Type: NO_INTERVENTION): Subjects in the third group (true control) were exposed to no intervention or attention control.

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: The Rosuvastatin In TrAnsplant Recipients Study

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Renal transplant recipients with stable renal function (plasma creatinine \< 200 µmol/L)~* Renal transplant recipients on an everolimus and fluvastatin based therapy for minimum 3 months prior to inclusion~* \> 18 years of age~* Male patient or female patient without childbearing potential (surgically sterilized or postmenopausal) or if female of childbearing potential; is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs~* Signed informed consent~Exclusion Criteria:~* Patients experiencing an acute rejection episode within 2 weeks before or after inclusion, whether proven by biopsy or not~* Patients with a known hypersensitivity to rosuvastatin~* Change in enzyme inducing or inhibiting drugs within the last 2 weeks prior to and throughout the study \[e.g. barbiturates, rifampicin, ketoconazole, erythromycin, cimetidine and similar drugs\]~* Pregnant or nursing mothers

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

Study Arms:
- Rosuvastatin (Type: EXPERIMENTAL): Rosuvastatin treatment for 4 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: Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer

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 over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV~* ECOG score ≤ 2~* Candidates for first-line chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks~* Signed informed consent (and ethical scientific committee No. (010/023 (IMO) (CB/618~Exclusion Criteria:~* Patients who withdraw their consent and not want to continue with the evaluation of the study~* Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa~* People diagnosed with epilepsy or some other neurological disorders associated~* Concomitant radiotherapy in head and neck.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- BASELINE (Type: None): Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study

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: Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* metastatic renal cell carcinoma (kidney cancer) with clear cell component~* no prior systemic therapy (including no prior adjuvant or neoadjuvant)~* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1~* Blood Pressure \< or = 140/90mmHg~Exclusion Criteria:~* brain/CNS metastasis~* using more than 2 blood pressure medications

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

Study Arms:
- A (Type: OTHER): Randomized arm
- B (Type: OTHER): Randomized arm
- C (Type: OTHER): Non-randomized arm

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: Baclofen for Rumination

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical suspicion of rumination syndrome and/or supra-gastric belching.~* Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.~* 18 to 75 years old.~* Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.~Exclusion Criteria:~* Systemic diseases, known to affect esophageal motility.~* Surgery in thorax or in the upper part of the abdomen.~* Treatment with baclofen prior to the start of the study.~* Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.~* Pregnancy or breast feeding.~* History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed).~* History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

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

Study Arms:
- baclofen (Type: EXPERIMENTAL): Patients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing.
- placebo (Type: PLACEBO_COMPARATOR): Patients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing.

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 Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Key Inclusion Criteria:~* Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D~* On ivacaftor therapy~* FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height~Key Exclusion Criteria:~* History of clinically significant cirrhosis with or without portal hypertension~* History of solid organ or hematological transplantation~* Lung infection with organisms associated with a more rapid decline in pulmonary status~Other protocol defined Inclusion/Exclusion criteria may apply

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

Study Arms:
- Ivacaftor (Type: ACTIVE_COMPARATOR): Participants received IVA 150 milligrams (mg) orally every 12 hours (q12h) in the treatment period for 12 weeks.
- VX-561: 25 mg (Type: EXPERIMENTAL): Participants received VX-561 25 mg orally daily (qd) in the treatment period for 12 weeks.
- VX-561: 50 mg (Type: EXPERIMENTAL): Participants received VX-561 50 mg orally qd in the treatment period for 12 weeks.
- VX-561: 150 mg (Type: EXPERIMENTAL): Participants received VX-561 150 mg orally qd in the treatment period for 12 weeks.
- VX-561: 250 mg (Type: EXPERIMENTAL): Participants received VX-561 250 mg orally qd in the treatment period for 12 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: Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

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

Eligibility Criteria:
Key inclusion criteria~1. Signed informed consent;~2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;~   * Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).~  * If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.~3. Tumors that were ER+ and/or PgR+;~4. Post-menopausal female subjects ≥ 18 years of age.~5. ECOG Performance Status of 0 or 1;~6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.~7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (\>12 months) to the first dose of randomized therapy.~8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.~Key exclusion criteria:~1. Pre-menopausal, pregnant, or lactating;~2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;~3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;~4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);~5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)~6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.

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

Study Arms:
- Placebo + Letrozole 2.5 mg (Type: PLACEBO_COMPARATOR): Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)
- Lapatinib 1500 mg + Letrozole 2.5 mg (Type: EXPERIMENTAL): Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)

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: Cooling Vest May Reduce Heat Stress During Surgery

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Surgeons who perform elective major orthopedic surgery such as total hip and knee arthroplasties scheduled for 90 to 150 minutes at the Cleveland Clinic Main Campus.~* Orthopedic surgeons ages of 25-65 years old, as body temperatures may be lower and less stable in the elderly (Waalen \& Buxbaum, 2011), who operate frequently enough to participate in four cross-over cases.~* Surgical helmet system is consistently worn for each of the surgeon's four cases, if used in the first case.~Exclusion Criteria:~* Surgical cases that require surgeons to sit on stools during the procedure, which may impact temperature and energy expenditure.~* - Surgeons who report having a recent illness within 24 hours prior to the surgery, symptoms producing a febrile condition;~* Surgeons who worked the previous evening.~* Surgeons who wear lead X-ray gowns.

- Gender: ALL
- Minimum Age: 25 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Cooling vest, then without cooling vest, then without cooling vest, then cooling vest (ABBA) (Type: EXPERIMENTAL): Surgeons first performed one surgery with the cooling vest. On another day, they then performed one surgery without the cooling vest. Then on another day, they performed another surgery without the cooling vest. Then they finally performed one surgery with the cooling vest.
- Without cooling vest, then cooling vest, then cooling vest, then without cooling vest (BAAB) (Type: EXPERIMENTAL): Surgeons first performed one surgery without the cooling vest. On another day, they then performed one surgery with the cooling vest. Then on another day, they performed another surgery with the cooling vest. Then they finally performed one surgery without the cooling vest.
- Cooling vest, then cooling vest, then without cooling vest, then without cooling vest (AABB) (Type: EXPERIMENTAL): Surgeons first performed one surgery with the cooling vest. On another day, they then performed another surgery with the cooling vest. Then on another day, they performed one surgery without the cooling vest. Then they finally performed another surgery without the cooling vest.
- Without cooling vest, then without cooling vest, then cooling vest, then cooling vest (BBAA) (Type: EXPERIMENTAL): Surgeons first performed one surgery without the cooling vest. On another day, they then performed another surgery without the cooling vest. Then on another day, they performed one surgery with the cooling vest. Then they finally performed another surgery with the cooling vest.

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: Nutritional and Neurotransmitter Changes in PKU Subjects on BH4

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:~* Diagnosed with PKU~* ability to provide informed consent (or have legal guardian who can provide informed consent)~* at least 4 years of age~* planning on trying BH4 treatment~Exclusion Criteria:~* Pregnant~* unable to provide informed consent~* less than 4 years of age~* currently taking BH4

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- PKU subjects - baseline (Type: None): Male and female subjects with PKU at baseline starting KuvanTM 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: Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial

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

Eligibility Criteria:
Inclusion Criteria:~* United States Army Combat Medics~Exclusion Criteria:~* Injuries precluding performance of bag valve mask ventilation

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

Study Arms:
- NuMask Intraoral Airway Device (Type: EXPERIMENTAL): A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.
- Bag Valve Mask (Type: ACTIVE_COMPARATOR): A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.

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: Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712

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

Eligibility Criteria:
Inclusion Criteria:~* Males and non-child bearing potential females between 18 and 45 years of age, inclusive.~* BMI between 19 and 32 kg/m2, inclusive.~Exclusion Criteria:~* Condition or history which may present a safety concern to the subject or interfere with outcome variables.~* History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.~* Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.~* Use of tobacco products or daily exposue to second hand smoke.~* Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.~* History of serious mental disorder.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: t

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: Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

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:~* Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia \<50 G/L, and mild or no renal failure (Serum creatinine \< 150 µmol/L),~* negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,~* refractory TTP (after 4 days of standard treatment)~* \> 18 year old~* and signed written informed consent.~Exclusion Criteria:~* Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),~* TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),~* previous treatment with vincristine or cyclophosphamide or other immunomodulatory drugs (except steroids), within 2 months before inclusion ;~* ongoing or planned pregnancy, lactation

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia (\<50 G/L)

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

Answer: outcome: complete