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

Trial Title: Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

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:~* Male and female subjects aged more than or equal to (\>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction~* Subjects diagnosed with RMS according to the revised McDonald criteria (2010)~* Treatment naïve or subjects on other DMDs who will switch to Rebif.~* Subjects will receive 1st Rebif 44 mcg dose after signing informed consent~* Subjects willing and able to provide signed informed consent.~Exclusion Criteria:~* Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information~* Subjects participating in other clinical studies/trials~* Any female subject of childbearing potential who is not on contraceptives~* Subjects refusal to participate in the study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- Relapsing Multiple Sclerosis (RMS) group (Type: None): Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)

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

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

Trial Title: Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB

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:~* Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines~* Weight \>3kg ≤15 kg at enrolment~* \> 42 weeks gestational age~* On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs \[ABC+3TC or AZT+3TC or d4T+3TC\]~* Clinical diagnosis of TB requiring RIF-based therapy~* Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.~Exclusion Criteria:~* For neonates, less than 42 weeks gestation and 14 days old~* Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)~* Anticipation at the start that anti-TB treatment duration will be longer than 9 months~* Any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.~* Children with known malignancies and contraindications to taking LPV/r~* Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.

- Gender: ALL
- Minimum Age: 2 Weeks
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- TB/HIV co-infection (Type: EXPERIMENTAL): Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1

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 to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

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

Eligibility Criteria:
Inclusion Criteria:~* Having signed written informed consent~* Healthy female subjects of any racial origin~* 18-39 years at the time of screening~* Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg~* Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months~* Normal uterus and two functioning ovaries~* Agrees to use an adequate method of contraception during the study~* Non-smoking or moderate smokers of \< 10 cigarettes a day~Exclusion Criteria:~* Pregnancy~* Polycystic ovary syndrome, impaired ovarian function, severe endometriosis class III or IV, submucosal myoma uteri~* History of endocrine abnormalities with treatment within the last six months.~* Contraindications for the use of gonadotropins and goserelin~* Breast-feeding or being within a period of 2 months after delivery or abortion.~* Use of an injectable hormonal contraceptive within a period of 6 months prior to screening~* Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 39 Years
- Healthy Volunteers: t

Study Arms:
- XM17 (Type: EXPERIMENTAL): XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL.
- Gonal-f® (Type: EXPERIMENTAL): Gonal-f® will be provided in pens with integrated vials of 0.5 mL
- Zoladex® (Type: ACTIVE_COMPARATOR): Zoladex® 3.6 mg will be administered by subcutaneous injection

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 Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies~2. Willingness to comply with the schedule and procedures of this study.~3. Signed informed consent form (ICF).~Exclusion Criteria:~1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- ATX-101 (Type: EXPERIMENTAL): Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.
- Placebo (Type: PLACEBO_COMPARATOR): Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.

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: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

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:~* Male or female ≥18 years of age~* Treated with eculizumab for PNH for at least 3 months prior to Day 1~* LDH level ≤1.5 × upper limit of normal (ULN) at screening~* PNH diagnosis confirmed by documented high-sensitivity flow cytometry.~* Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.~* Body weight ≥40 to \<100 kilogram (kg)~* Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.~* Willing and able to give written informed consent and comply with study visit schedule.~Exclusion Criteria:~* More than 1 LDH value \> 2 × ULN within the 3 months prior to study entry~* History of bone marrow transplantation.~* History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the Investigator or Sponsor, would preclude participation.~* Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).~* Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.~* Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

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

Study Arms:
- Ravulizumab SC Treatment Group (Type: EXPERIMENTAL): In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by SC maintenance doses of ravulizumab administered via the ravulizumab OBDS on Day 15 and every week (qw) thereafter for a total of 10 weeks of study treatment.~In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274.
- Ravulizumab IV Treatment Group (Type: ACTIVE_COMPARATOR): In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by IV maintenance doses of ravulizumab on Day 15.~In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274.

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: LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy~Exclusion Criteria:~* Cases with evidence of associated endometrial cancer.~* Cases with simple hyperplasia without atypia.~* Patients failed to collect at least 2 endometrial samples during treatment course.

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

Study Arms:
- levonorgestrel intrauterine system (LNG-IUD) (Type: ACTIVE_COMPARATOR): levonorgestrel intrauterine system (LNG-IUD) applied.~* Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.~* Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.~* Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.
- Megestrol acetate (MA) (Type: ACTIVE_COMPARATOR): Megesterol arm will receive 160 mg daily~* Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.~* Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.~* Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.

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: Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

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

Eligibility Criteria:
Inclusion Criteria:~* Age between 18 and 35 years (inclusive), in good general health and requesting contraception.~* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).~Exclusion Criteria:~* Known or suspected pregnancy or is lactating.~* History of ectopic pregnancies.~* Any genital infection (until successfully treated).~* Abnormal uterine bleeding of unknown origin.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- LCS12 (Type: EXPERIMENTAL): Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
- LCS16 (Type: EXPERIMENTAL): Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro

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: Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age 18-50 years~* Men or women~* Vision corrected to at least 20-40~* No tobacco use~* Education of ≥12 years (No GED)~Exclusion Criteria:~* History of major psychiatric illness defined as major depressive disorder, bipolar disorder, post traumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia or eating disorders~* History of drug or alcohol abuse or dependence~* History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease~* Taking central nervous system (CNS) acting medications (e.g. antidepressants, hypnotics)~* History of allergic reaction or medical contraindication to phenytoin or hydrocortisone therapy~* Metal implants, claustrophobia or other contraindications to MRI~* Significant medical conditions (e.g. myocardial infarction, diabetes)~* Pregnant or nursing women~* Prisoners~* History of mental retardation, special education classes, dementia or other severe cognitive disorders~* Baseline Hamilton Rating Scale for Depression Score \> 7~* History of a suicide attempt~* History of systemic corticosteroid use or current inhaled corticosteroid use

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Four Treatments Per Participant (Type: EXPERIMENTAL): This study has one arm due to a crossover design. All 17 subjects received 4 treatments: placebo then placebo, phenytoin then placebo, placebo then hydrocortisone, and phenytoin then hydrocortisone. Each treatment was randomly assigned and had a unique sequence out of 24 possible sequences.

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: An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of Crohn's Disease.~* Over the age of 18 years.~* Must have received the first infusion of infliximab on or after 1st January 2003 (when the maintenance therapy license was granted).~* Must have received at least one infusion of infliximab.~* A minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records.~* Must have been under the care of the participating center for the entirety of the study period.~Exclusion Criteria:~* Should not have been involved in any clinical trial during the observational period (ie, a minimum of 12 months before and 24 months after first receiving infliximab).~* Should not have received any biologic therapy prior to infliximab.

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

Study Arms:
- Infliximab (Type: None): Infliximab as prescribed by a physician in normal practice for Crohn's disease

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

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

Trial Title: Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity

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

Eligibility Criteria:
Inclusion Criteria:~* Waist circumference ≥94cm.~* Body Mass Index ≤ 45kg/m2.~* Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \> 3.~Exclusion Criteria:~* Blood Pressure \> 160 / 95 mmHg.~* Diabetes mellitus 1 or 2.~* Historical of bariatric surgery.~* Patient treated with a lipid-decreasing medication.~* A fasting plasma triglycerides concentration \> 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration \> 220mg/dL.

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

Study Arms:
- GFT505 80mg (Type: EXPERIMENTAL): None
- Matching placebo (Type: PLACEBO_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: Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

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

Eligibility Criteria:
Key Inclusion Criteria:~* Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib~* Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age~* Adequate renal, hepatic and pancreatic function~* Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)~* Written informed consent~Key Exclusion Criteria:~* Treatment with strong CYP3A4 inhibitors or inducers~* Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval~* Acute or chronic liver, pancreatic or severe renal disease~* History of pancreatitis or chronic pancreatitis.~* Impaired cardiac function~* No evidence of active graft vs host and \<3mo since Stem Cell Transplant~* Total body irradiation (TBI) or craniospinal radiation therapy \<6months~* Hypersensitivity to the active ingredient or any of the excipients including lactose.~* the criteria regarding pregnancy and contraception~* Active or systemic bacterial, fungal, or viral infection~* known Hepatitis B, Hepatitis C, or HIV infection

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Newly diagnosed and untreated Ph+ CML in first CP (Type: EXPERIMENTAL): Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
- Resistant/intolerant Ph+ CML in CP (Type: EXPERIMENTAL): Resistant or Intolerant to either imatinib or dasatinib
- Resistant/intolerant Ph+ CML in AP (Type: EXPERIMENTAL): Resistant or intolerant to either imatinib or dasatinib - at the end no patients were enrolled in this 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: EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

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:~* Children aged birth to \< 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to \< 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.~* For children younger than 6 months:~  * Gestational age at birth of at least 37 weeks.~ * Oral feeding/nasogastric/gastric feeding for at least 10 days.~ * Body weight ≥2600 g~Exclusion Criteria:~* Active bleeding or bleeding risk contraindicating anticoagulant therapy~* An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)~* Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT\> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total~* Platelet count \< 50 x 109/L~* Sustained uncontrolled hypertension defined as \> 95th age percentile~* Life expectancy \< 3 months~* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically~* Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine~* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding

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

Study Arms:
- BAY59-7939 (Type: EXPERIMENTAL): Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.
- Standard of Care (Type: EXPERIMENTAL): Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care

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

Answer: outcome: complete