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

Trial Title: Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

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: Have a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) for Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric evaluation.~* Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.~* Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).~* Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.~* Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.~* Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.~Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.~* Subjects who have been hospitalized for psychotic symptoms within the last 6 months.~* Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.~* Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.~* Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.~* Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of\>= 3 on Item 8 of the AIMS at screening or baseline.~* Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.~* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 35 Years
- Healthy Volunteers: f

Study Arms:
- Brexpiprazole (Type: EXPERIMENTAL): Up to 4 mg/day, once daily dose, tablets, 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: Safety Study of Gene-modified Autologous Fibroblasts in Recessive Dystrophic Epidermolysis Bullosa

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

Eligibility Criteria:
Inclusion Criteria:~1. Clinical and genetic diagnosis of RDEB with confirmed bi-allelic COL7A1 mutations.~2. A reduced number or morphologically abnormal anchoring fibrils confirmed by TEM.~3. At least 5x8cm of intact skin on the trunk and/or extremities that is suitable for cell injections.~4. Able to undergo local anaesthesia.~5. Subjects aged ≥ 17 years and able to give informed consent prior to the first study intervention.~Exclusion Criteria:~1. Subjects who received other investigational medicinal products within 6 months prior to enrolment into this study.~2. Past medical history of biopsy proven skin malignancy.~3. Subjects who have received immunotherapy including oral corticosteroids (Prednisolone \>1mg/kg) for more than one week (intranasal and topical preparations are permitted) or chemotherapy within 60 days of enrolment into this study.~4. Known allergy to any of the constituents of the investigational medicinal product (IMP).~5. Subjects with BOTH:~   * positive serum antibodies to C7 confirmed by ELISA and~  * positive IIF with binding to the base of salt split skin.~6. Subjects who are pregnant or of child-bearing potential who are neither abstinent nor practising an acceptable means of contraception when this is in line with the usual and preferred lifestyle of the subject, as determined by the Investigator, for 12 months after the cell injections.~7. Subjects with positive results for HIV, Hepatitis B, Hepatitis C, HTLV or Syphilis.

- Gender: ALL
- Minimum Age: 17 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Gene-modified autologous fibroblasts (Type: EXPERIMENTAL): 3 intradermal injections of COL7A1 gene-modified autologous fibroblasts will be administered on day 0 only.

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: Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section~Exclusion Criteria:~* Significant coexisting disease such as hepato-renal and cardiovascular disease~* Any contraindication to regional anesthesia such as local infection or bleeding disorders~* Allergy to ketamine or midazolam~* Long-term opioid use or a history of chronic pain. -

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 45 Years
- Healthy Volunteers: f

Study Arms:
- clonidine (Type: ACTIVE_COMPARATOR): The clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free intrathecally
- Fentanyl (Type: ACTIVE_COMPARATOR): The fentanyl group (groupF) received bupivacaine 10mg combined with 25 microgram clonidine preservative free intrathecally
- distilled water (Type: PLACEBO_COMPARATOR): The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

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: 12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Male and female patients with a diagnosis of type 2 diabetes mellitus~* either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening~* HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%~* HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients~* Age between 18 and 80 years~* BMI less than 40 kg/m2~* Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation~Exclusion Criteria:~1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent~2. Impaired hepatic function~3. Renal insufficiency or impaired renal function~4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation~5. Chronic or clinically relevant acute infections~6. Current or chronic urogenital tract infection determined by medical history~7. History of clinically relevant allergy/hypersensitivity~8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent~9. Treatment with anti obesity drugs~10. Current treatment with systemic steroids~11. Alcohol abuse~12. Treatment with an investigational drug within 2 months prior to informed consent~13. known intolerance to metformin~14. Dehydration~15. Unstable or acute CHF~16. Acute or chronic acidosis~17. Hereditary galactose intolerance~18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- 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: Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

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

Eligibility Criteria:
Inclusion Criteria:~* 0 to 3 day old infants~* Mother seronegative for Human Immunodeficiency Virus (HIV)~* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg~* Apgar score \>7 at 5 or 10 minutes of life~* Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate~* Able to attend all scheduled visits and to comply with all trial procedures.~Exclusion Criteria:~* Current or planned participation in another clinical trial during the entire duration of the present trial~* Suspected congenital or acquired immunodeficiency~* Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history~* Chronic illness at a stage that could interfere with trial conduct or completion~* Blood or blood-derived products received since birth~* Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age~* Oral Poliovirus Vaccine (OPV) administration at birth~* Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity~* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination~* History of seizures~* Febrile or acute illness on the day of inclusion.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 3 Days
- Healthy Volunteers: t

Study Arms:
- Group 1: DTaP-IPV-Hep B-PRP-T (Type: EXPERIMENTAL): None
- Group 2: CombAct-HIB™ + OPV (Type: EXPERIMENTAL): None
- Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth) (Type: ACTIVE_COMPARATOR): None

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: Dual bNAb Treatment in Children

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria for PK Step\*:~* On ART for at least 96 weeks~* Greater than or equal to 96 weeks and less than 5 years of age at enrollment~* HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry~* Ability to remain in close study follow-up for at least 12 weeks~* Willingness to receive IV infusions of bNAbs~* Willingness to provide signed informed consent (by the parent/guardian)~  * \*It is anticipated that all children in PK Step will be from Early Infant Treatment (EIT) Study (NCT02369406); however, up to 4 HIV+ children outside the PK Study (age range 2-5 years) may participate in the PK Step if otherwise eligible and if EIT children are unavailable.~Inclusion Criteria for Entry into Step 1 (followed by participation in Steps 2-3):~* EIT Study participant (NCT02369406)~* On ART for at least 96 weeks~* Greater than or equal to 96 weeks and less than 7 years of age at enrollment~* HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry~* Ability to remain in close study follow-up for at least 56 weeks~* Willingness to receive IV infusions of bNAbs~* Willingness to provide signed informed consent (by the parent/guardian)~Exclusion Criteria:~* Medical condition making survival for at least 32 weeks unlikely~* Active tuberculosis or malignancy~* Actively breastfeeding~* Previous receipt of VRC01/VRC01LS or 10-1074 (except during the PK Step)

- Gender: ALL
- Minimum Age: 96 Weeks
- Maximum Age: 7 Years
- Healthy Volunteers: f

Study Arms:
- Group PK-A: ART + VRC01LS (Type: EXPERIMENTAL): In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
- Group PK-B: ART + 10-1074 (Type: EXPERIMENTAL): In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
- Steps 1-3 Participants (ART + 10-1074 + VRC01LS) (Type: EXPERIMENTAL): In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. Following a recommendation from the study team and Safety Monitoring Committee (SMC) to increase the maintenance dosing based on the PK Step, a VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.

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: Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

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

Eligibility Criteria:
Inclusion Criteria:~* Patients aged 18-70.~* Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).~* Patients who have never received H. pylori eradication treatment.~Exclusion Criteria:~* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.~* Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.~* Patients with active gastrointestinal bleeding.~* Patients with a history of upper gastrointestinal surgery.~* Patients allergic to treatment drugs.~* Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks~* Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse~* Patients who are unwilling or incapable to provide informed consents.

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

Study Arms:
- Tid group (Type: EXPERIMENTAL): Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid
- Qid group (Type: ACTIVE_COMPARATOR): Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

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: Proof of Mechanism in ELT

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

Eligibility Criteria:
Inclusion Criteria:~* Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation~* Baseline Ejaculation Latency time \< 3 minutes~* Subjects must agree to use a contraception methods as per protocol~* Body weight \> or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2~* Subject with normal visual acuity (with appropriate correction if needed)~* Subject able to cooperate in all study procedure including the eye examination with use of mydriatics~Exclusion Criteria:~* Erectile dysfunction~* History of migraine~* Current clinically relevant abnormality~* History of psychiatric illness or suicidal attempts or behaviours~* History of any eye disorder or colour blind, excluding myopia and presbyopia~* Cardiac conduction disorder or other clinically significant cardiac disease~* Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests~* Regular consumption of alcohol~* History of sensitivity or intolerance to drugs~* Consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids\] from 7 days prior to the first dose of study medication~* Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start~* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication~* Participation in another clinical trial in the previous month~* Exposure to more than four new experimental drugs within the previous 12 months~* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.~* Unwillingness or inability to follow the procedures outlined in the protocol.

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: f

Study Arms:
- GSK958108 3 mg (Type: EXPERIMENTAL): Experimental
- Placebo of GSK958108 (Type: PLACEBO_COMPARATOR): Placebo

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: Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia~Exclusion Criteria:~* Patients who are not alert before procedure~* Hemodynamicaly unstable patients before procedure~* Patients with history of adverse reaction of allergic reaction to study drugs~* Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support~* Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h~* Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption~* Severe hepatic or renal dysfunction~* Alcohol or drug dependence~* Organic brain disorder~* Spinal or cerebellar ataxia~* Acute narrow-angle glaucoma~* Patients with shock or coma~* Pregnant or lactating women~* Patients with hypersensitive to beans or peanut~* Patients who refuse to participate

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Remimazolam with flumazenil (Type: EXPERIMENTAL): Patients allocated to remimazolam with flumazenil group receives remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
- Propofol total intravenous anesthesia (Type: ACTIVE_COMPARATOR): Patients allocated to propofol total intravenous anesthesia group receives propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.

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

Answer: outcome: complete