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

Trial Title: Phase III Confirmatory Study in Erythropoietic Protoporphyria

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:
Inclusion Criteria:~* Male or female subjects with characteristic symptoms of EPP phototoxicity and a biochemically-confirmed diagnosis of EPP.~* Aged 18 years old and above (inclusive).~* Able to understand and sign the written Informed Consent Form.~* Willing to take precautions to prevent pregnancy until completion of the study (Day 180).~Exclusion Criteria:~* Any allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the study medication~* EPP patients with significant hepatic involvement~* Personal history of melanoma or dysplastic nevus syndrome.~* Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.~* Any other photodermatosis such as polymorphic light eruption, actinic prurigo, discoid lupus erythematosus, chronic actinic dermatitis or solar urticaria.~* Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.~* Acute history of drug or alcohol abuse (in the last 6 months).~* Patient assessed as not suitable for the study in the opinion of the Investigator (e.g. noncompliance history, allergic to local anesthetics, faints when given injections or giving blood).~* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.~* Prior and concomitant therapy with medications which may interfere with the objectives of the study, including drugs that cause photosensitivity or skin pigmentation.~* Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.~* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).

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

Study Arms:
- Afamelanotide (Type: EXPERIMENTAL): One 16mg subcutaneous implant every 2 months for 6 months.
- Placebo (Type: PLACEBO_COMPARATOR): One placebo subcutaneous implant every 2 months for 6 months.

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: Stanford Regulating Circuits of the Brain Study- Ketamine

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

Eligibility Criteria:
Inclusion Criteria:~* Ages 18-55 years~* At least 2 prior uses of ketamine when aged 18+~* BMI within healthy range (18-30)~* Ability to speak, read, or understand English~Exclusion Criteria:~* Current active suicide ideation or history of suicide attempts~* Current mood, anxiety, eating, psychotic, or substance use disorder~* Lifetime psychotic or bipolar disorder~* Schizophrenia in a first degree relative~* Current use of psychotropic medication~* Prior adverse ketamine response~* Allergy or hypersensitivity to ketamine~* Use of ketamine in past 7 days~* Cannabis use in the past 7 days, illicit recreational drug use in the 48 hours prior to sessions, and/or alcohol use in the 24 hours prior to sessions~* Concurrent use of any medications that might increase the risk of participation (e.g., drug interactions)~* History of epilepsy, convulsions, seizures, LOC \>10 min~* Renal/hepatic impairment~* Hypertension (Stage 1 defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg on 2 of 3 measurements at least 15 min apart at initial screening; systolic blood pressure \>155 mmHg or diastolic blood pressure \>99 mmHg on 2 of 3 measurements at least 15 min apart during infusion visits)~* Heart rate \<50 bpm or \>150 bpm at initial screening~* Chronic congestive heart failure, tachyarrhythmias, myocardial ischemia assessed via EKG at initial screening~* EKG QTcF intervals \>430 ms for men and \>470 ms for women~* Direct physical access to or routine handling of addicting drugs in the regular course of work duties~* MRI contraindication~* Pregnant or nursing females

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: None

Study Arms:
- Volunteers (Type: None): Participants will receive an IV infusion of ketamine (\~.05mg/kg and 0.5mg/kg) or placebo.~Ketamine is an FDA-approved dissociative anesthetic. The study doses are in the subanesthetic range. During the infusion, an ACLS-certified psychiatrist or anesthesiologist will provide continuous monitoring.~Afterwards, patients will be monitored on-site by an ACLS-certified MD or highly skilled research nursing staff, and an on-call emergency response team for 4 hours (ketamine's half-life is 15 min; 4 hrs= 16 half-lives).

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: Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

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:~* Must sign informed consent.~* Male or female 6-12 years old.~* Negative pregnancy test.~* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.~* No co-morbid illness that could affect safety, tolerability or interfere with participation.~* Blood pressure (BP) within the 95th percentile for age, gender, and height.~* Willing and able to comply with all the requirements defined in protocol.~Exclusion Criteria:~* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).~* At risk for suicidal or violent behavior towards self or others.~* History of a suicide attempt.~* History of a structural cardiac abnormality or other serious cardiac problems.~* Non-responder to psychostimulant treatment.~* Is overweight.~* Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.~* Has Conduct Disorder.~* Known history of alcohol or other substance abuse within the last 6 months.~* Any abnormal thyroid function.~* A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.~* Has had treatment with any known liver altering agents within 30 days prior to Screening.~* Taking any excluded medication.~* Previous use of DAYTRANA.~* Taking other medications that have Central Nervous System (CNS) effects.~* Female subject is pregnant or lactating.~* Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.~* Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.~* Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.~* A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.

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

Study Arms:
- Methylphenidate Transdermal System (Type: EXPERIMENTAL): To characterize the dermal reactions seen with the use of DAYTRANA

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: Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.

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: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. El Escorial criteria for definite or probable ALS~2. Either men or non pregnant women between 20-75 years of age.~3. Patient is mentally intact and psychologically stable~4. For early stage ALS- Patients will be with ALS-FRS-R scale of at least 30 and disease duration of less than 2 years.Or, for progressive stage ALS- Patients will be with an ALS-FRS-R scale of 15-30 and disease duration of less than 2 years~5. For early stage ALS- Patient has sufficiently bulky muscles. Or, for progressive stage ALS- Patient with at least 60% FVC~6. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.~Exclusion Criteria:~1. Positive test for HBV, HCV, HIV and Mycoplasma.~2. High protein in the CSF.~3. Lymphocytosis in the CSF.~4. Positive for anti-GM1 antibodies.~5. Patient has significant conduction blocks or slow nerve conduction velocities (a reduction of more than 30%) confirmed by nerve conduction velocity - EMG studies.~6. The patient is a respiratory dependent.~7. Renal failure, impaired hepatic function~8. Patients suffering from significant cardiac disease, malignant diseases or any other disease that may risk the patient or interfere with the ability to interpret the results~9. Active infections.~10. Participation in another clinical trial within 1 month prior to start of this study.~11. Subject unwilling or unable to comply with the requirements of the protocol.~12. Patient has not been treated previously with any cellular therapy.

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

Study Arms:
- MSC-NTF cells IM (Type: EXPERIMENTAL): Intramuscular administration in early stage patients
- MSC-NTF cells IT (Type: EXPERIMENTAL): Intrathecal administration in progressive stage patients

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: Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion criteria:~healthy female and male subjects

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

Study Arms:
- BI 10773 (Type: EXPERIMENTAL): single oral (high and low) dose per subject
- Placebo (Type: PLACEBO_COMPARATOR): 2 single oral doses per subject
- Moxifloxacin (Type: ACTIVE_COMPARATOR): single oral dose per subject

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 and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* be 40 - 70 years of age, inclusive~* be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)~* be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation~* if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection~Exclusion Criteria:~* if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy~* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner~* has a known history of autoimmune disease~* has previously received any hepatitis B vaccine (approved or investigational)

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- HEPLISAV and/or Placebo (Type: EXPERIMENTAL): 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
- Engerix-B(1) (Type: ACTIVE_COMPARATOR): 1.0 mL Engerix-B

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 Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Idiopathic RLS~Exclusion Criteria:~* secondary RLS~* history of sleep disturbances~* symptomatic orthostatic hypotension

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: 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: Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

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:~* Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months~* Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months~* Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months~* Insulin naive~* HbA1c between 7.0% and 10.0%~* FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)~* Body Mass Index (BMI) below 40.0 kg/m\^2~Exclusion Criteria:~* Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial~* Any disease or condition which the Investigator feels would interfere with the trial~* Any contraindication to metformin or glimepiride (according to local labelling)

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

Study Arms:
- BIAsp 30 (Type: EXPERIMENTAL): 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
- Insulin glargine (Type: ACTIVE_COMPARATOR): 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride

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: Effectiveness of Dance on Patients With Fibromyalgia

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

Eligibility Criteria:
Inclusion Criteria:~* classification of fibromyalgia based on the criteria of the American College of Rheumatology~* female gender~* aged between 18 and 65 years~Exclusion Criteria:~* not having altered treatment in previous three years~* having signed a term of informed consent~* patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Dance Group (Type: EXPERIMENTAL): Belly dance
- Control Group (Type: NO_INTERVENTION): Waiting list

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: Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

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:~* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis~* Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period~* Not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.~* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.~Exclusion Criteria:~- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

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

Study Arms:
- TEV-48125 (225 mg/1 month) group (Type: EXPERIMENTAL): TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \[except for a loading dose of 675 mg in subjects with CM\]).
- TEV-48125 (675 mg/3 month) group (Type: EXPERIMENTAL): TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).

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: Physical Activity After a Normal Spontaneous or Cesarean Delivery

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

Eligibility Criteria:
Inclusion Criteria:~* Women 18-45 years old giving birth after receiving a neuraxial analgesia/anesthesia technique. American Society of Anesthesiologists classification 1-2.~Exclusion Criteria:~* History of chronic pain~* Recent use of opioids (other than postpartum)~* Emergency case requiring general anesthesia (GA) or conversion to GA~* BMI \> 45~* Need to perform more extensive surgery (i.e Hysterectomy) Need for the neonate to be admitted to NICU (This will prompt mothers to walk more frequently, and longer distances to visit the baby)

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

Study Arms:
- normal spontaneous vaginal delivery (Type: EXPERIMENTAL): Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
- Cesarean Delivery (Type: EXPERIMENTAL): Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).

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: Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

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:~* Histologically or cytologically proven prostate cancer.~* The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.~* Serum testosterone levels \>5 nmol/L.~* Karnofsky performance index \>40.~* Expected survival \> 18 months.~* Absence of another malignancy, other than local dermatological, for the previous 5 years.~* Signed informed consent before entry into the study.~Exclusion Criteria:~* Prior hormonal treatment for prostate cancer within 6 months prior to study start.~* Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.~* Presence of another neoplastic lesion or brain metastases.~* Prior hypophysectomy or adrenalectomy.~* Known or suspicion of vertebral metastases with risk of spinal compression.~* Severe kidney or liver failure (creatinine \> 2 times the upper normal limit, ASAT and ALAT \>3 times the upper normal limit).~* Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.~* Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).~* Known hypersensitivity to any of the test materials or related compounds.~* Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.~* Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens, and progesterone.~* Use of systemic or inhaled corticosteroids (topical application permitted).~* Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted).~* Inability to give Informed Consent or to comply fully with the protocol.

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

Study Arms:
- Triptorelin (Type: EXPERIMENTAL): None

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

Answer: outcome: complete