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

Trial Title: Pharmacotoxicology of Trichloroethylene Metabolites

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* healthy~* normal screening labs~Exclusion Criteria:~* no gastrointestinal surgery~* no smoking~* no medication~* not pregnant

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- 1A: Chloral Hydrate and DCA: Env (Type: EXPERIMENTAL): Subjects consume Chloral Hydrate 1.5ug/kg by mouth for 5 nights. On the 6th day they consume DCA 2.5ug/kg by mouth and have blood samples drawn. (Period 1)
- 1B: Chloral Hydrate Env dose (Type: EXPERIMENTAL): Drug Study Subjects are admitted to the clinical research unit and receive 1.5 ug/kg (environmental dose) of Chloral Hydrate for 5 nights. Pharmacokinetics are done on days 1 and day 5. (Period 2)
- 2A: Chloral Hydrate and DCA therapeutic (Type: EXPERIMENTAL): Drug Study Subjects are admitted to the clinical research center and receive a clinical dose of Chloral Hydrate for 5 nights (25mg/kg). On day 6 they are given a clinical dose (25mg/kg)of Dichloroacetate. (Period 3)
- 2B: Chloral Hydrate Therapeutic (Type: EXPERIMENTAL): Subjects are given 25 mg/kg of Chloral Hydrate for five nights. Pharmacokinetics are done on days 1 and 5. (Period 4)

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: GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE3
- Number of Arms: 3.0

Eligibility Criteria:
Key Inclusion Criteria:~* Participant must have been male or female, aged between 2 and 18 years (inclusive).~* Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.~* Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.~* All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.~Key Exclusion Criteria:~* Participant had clinically significant unstable medical conditions other than epilepsy.~* Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.~* Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.~* Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.~* There were plans for the participant to travel outside their country of residence during the study.~* Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- 10 mg/kg/day GWP42003-P (Type: EXPERIMENTAL): GWP42003-P oral solution (100 mg/milliliter \[mL\] cannabidiol in sesame oil with anhydrous ethanol with added sweetener \[sucralose\] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 20 mg/kg/day dose.
- 20 mg/kg/day GWP42003-P (Type: EXPERIMENTAL): GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener \[sucralose\] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
- Placebo Control (Type: PLACEBO_COMPARATOR): Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.

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: Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~- 1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.~4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination~Exclusion Criteria:~* 1.History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose

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

Study Arms:
- Compound lisinopril tablets (Type: EXPERIMENTAL): a single oral of Compound lisinopril tablets test formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)
- Compound lisinopril tablets(Lisonorm®) (Type: ACTIVE_COMPARATOR): a single oral of Compound lisinopril tablets reference formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)

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 Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

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:~* Postmenopausal~* Body mass index between 18 and 38 kg/m2, inclusive~* Subject experiences moderate or severe hot flashes~Key Exclusion Criteria:~* Inability to comply with the use of prohibited and allowed medications as described in the protocol.~* Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.~* Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.~* Any clinically significant abnormal laboratory test result(s) measured at Screening.~* Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.~* Uncontrolled hypertension.~* A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.

- Gender: FEMALE
- Minimum Age: 40 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- 160 mg Elinzanetant (BAY3427080) (Type: EXPERIMENTAL): Participants received 4x40 mg elinzanetant capsules.
- 120 mg Elinzanetant (BAY3427080) (Type: EXPERIMENTAL): Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.
- 80 mg Elinzanetant (BAY3427080) (Type: EXPERIMENTAL): Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.
- 40 mg Elinzanetant (BAY3427080) (Type: EXPERIMENTAL): Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.
- Placebo (Type: PLACEBO_COMPARATOR): Participants received four placebo capsules orally once daily in the evening before bedtime.

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 of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Females of non childbearing potential;~* Patients with T2DM, inadequately controlled with metformin;~* HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c \<6.5% (for non-diabetic obese, if enrolled)~* Total body weight \>50 kg (110 lbs)~* BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI \>30.5 to ≤45.5 kg/m2 (for non-diabetic obese)~Exclusion Criteria~* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;~* Medical history of T2DM (for non-diabetic obese participants, if enrolled);~* Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;~* Evidence or history of clinically significant cardiovascular disease;~* Any malignancy not considered cured;~* Acute pancreatitis or history of chronic pancreatitis;~* Acute gallbladder disease;~* Any condition possibly affecting drug absorption;~* Personal or family history of MTC or MEN2;~* Medical or psychiatric condition that may increase the risk of study participation;~* Any vaccination within the 1 week prior to admission to the CRU;~* Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;~* Known prior participation in a trial involving PF-07081532;~* A positive urine drug screen at screening or admission;~* Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;~* Positive COVID-19 test at screening or admission;~* Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);~* 12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;~* Participants with ANY of the following abnormalities in clinical laboratory tests: \*AST or ALT level ≥1.5x ULN;~  * Total bilirubin level ≥1.5x ULN;~ * TSH\> ULN;~ * Fasting C-peptide \<0.8 ng/mL;~ * Serum calcitonin \> ULN;~ * Amylase \> ULN;~ * Lipase \> ULN;~ * eGFR \<60 mL/min/1.73m2 (per MDRD equation);~ * FPG \>270 mg/dL~* History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;~* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;~* History of sensitivity to heparin or heparin induced thrombocytopenia;~* Known intolerance to any GLP-1R agonist.

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

Study Arms:
- PF-07081532 (Type: EXPERIMENTAL): multiple dosing, once-daily for 42 days
- Placebo (Type: PLACEBO_COMPARATOR): multiple dosing, once-daily for 42 days

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 CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

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:
Key Inclusion Criteria:~1. Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.~2. Age≥ 21 years old.~3. Abnormal distal esophageal pH determined by total % time pH \<4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.~4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).~5. Patient has provided written informed consent for participation in the randomized study.~Key Exclusion Criteria:~1. Currently taking double-dose PPIs (twice daily dosing).~2. Hiatal hernia \>3cm as determined by endoscopy.~3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences.~4. Esophagitis Grade C or D (Los Angeles classification).~5. Body mass index \>35.~6. Diagnosed with an esophageal motility disorder LES.~7. Esophageal stricture or gross esophageal anatomic abnormalities~8. History of/or known Barrett's esophagus.~9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Control Arm (Type: ACTIVE_COMPARATOR): Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\]
- Treatment Arm (Type: ACTIVE_COMPARATOR): LINX Reflux Management System

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 Effects of Dexmedetomidine on Intravenous Anesthetic Requirements for Children Undergoing Dental Procedures

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE4
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* ASA 1-2~* Elective dental surgery~* Planned general anesthesia with TIVA~* Age 2-10 years~Exclusion Criteria:~* General anesthesia with inhalation induction~* Documented seizure disorder~* Cardiac disease~* Cardiac rhythm abnormalities~* Chronic hypertension~* Weight \< 5th centile or \> 95th centile for age~* Pre-operative administration of anxiolytics (such as benzodiazepines or opioid analgesics)~* Hypersensitivity to dexmedetomidine or any other study medication

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 10 Years
- Healthy Volunteers: f

Study Arms:
- Saline bolus (Type: SHAM_COMPARATOR): 10mL normal saline solution administered intravenously over 60 seconds starting after intubation.
- Dexmedetomidine 0.25 mcg/kg (Type: EXPERIMENTAL): 0.25 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.
- Dexmedetomidine 0.50 mcg/kg (Type: EXPERIMENTAL): 0.50 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.
- Dexmedetomidine 1.00 mcg/kg (Type: EXPERIMENTAL): 1.00 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.

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: Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee

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

Eligibility Criteria:
Inclusion Criteria:~* Osteoarthritis of the knee for a minimum of six months~* Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3 using a 5-point Likert scale~* Presenting two out of the three following criteria - Morning stiffness of less than 30 minutes duration, Crepitus on motion, Age \>= 40 years~* Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to screening or the patient was taking an NSAID on a regular basis (\>25 out of 30 days) at a therapeutic level for at least 30 days prior to screening~* Each of the following three criteria (the osteoarthritis flare criteria) must be met - Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of index knee pain at walking by at least 15 mm on VAS at baseline compared to screening, Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from screening~Exclusion Criteria:~* Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence radiographic criteria~* Intraarticular injections or arthroscopy of the index knee within 3 months prior to screening~* Signs of any clinically important inflammation of the index knee including redness, warmth and or a large bulging effusion with the loss of normal contour~* Crystalline-induced synovitis in the index knee~* History, physical examination or radiographic suggestive of acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory arthritis of the index knee

- Gender: ALL
- Minimum Age: 40 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: Preventing Depression in Late Life: A Model for Low and Middle Income Countries

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

Eligibility Criteria:
Inclusion Criteria:~* Patient at the participating primary care centers~* age 60 and older~* GHQ scores 4 or above~* Hindi MMSE scores 24 or higher~* no episodes of major depression or anxiety disorder within the past 12 months~* no current antidepressant pharmacotherapy~Exclusion Criteria:~* episode of major depression or anxiety disorder within the past 12 months~* current antidepressant pharmacotherapy~* younger than age 60~* Hindi MMSE scores less than 24~* GHQ scores less than 4

- Gender: ALL
- Minimum Age: 60 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- problem solving therapy + Behavioral Treatment of Insomnia (Type: EXPERIMENTAL): Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed
- Enhanced Usual Care (Type: NO_INTERVENTION): Care as usual with scheduled assessments of clinical status

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: Pilot Study of Using Copeptin to Predict Response to Tolvaptan

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:~1. Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration~2. Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening~3. Meet baseline copeptin criteria for entry~4. Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)~Exclusion Criteria:~1. Current New York Heart Association Functional Class IV heart failure~2. Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration~3. Presence of clinical contraindications to tolvaptan~4. Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months~5. Cardiovascular surgical procedure within the past 4 weeks~6. CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.~7. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.~8. Chronic uncontrolled diabetes mellitus as determined by the investigator.~9. Supine systolic arterial blood pressure \< 90 mmHg at screening~10. Serum creatinine \> 3.5 mg/dL at screening~11. Serum potassium \> 5.5 mEq/L or \< 3.5 mEq/L at screening~12. Subjects currently treated with hemofiltration or dialysis~j. Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems

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

Study Arms:
- Tolvaptan (Type: OTHER): Single arm study

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

Answer: outcome: complete