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

Trial Title: To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women

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

Eligibility Criteria:
Inclusion Criteria:~Women must meet all the following criteria to be eligible to enrol in the trial:~1. Previously enrolled in the IPM 027 trial~2. Available for all visits and consent to follow all procedures scheduled for the trial~3. Using an effective method of contraception at the Enrolment Visit, and intending to use an effective contraceptive method for the duration of trial participation, unless post-menopausal with no history of menses for one year prior to screening~4. HIV-negative as determined by the HIV algorithm applied at Screening/Pre- Enrolment~5. Willing to refrain from participation in another research trial using drugs, vaccines, medical devices and microbicides for the duration of the IPM 032 trial~6. Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts); confidentiality to be maintained.~Exclusion Criteria:~Women who meet any of the following criteria are NOT eligible to enrol in the trial:~1. Investigational product use permanently discontinued in response to an AE (where the AE was considered related to investigational product) or safety-related concern while taking part in the IPM 027 trial~2. Participant self-report of taking post-exposure prophylaxis (PEP) within ≤ 2 months at Screening Visit Note: Participants may be enrolled after completing the PEP regimen and a negative HIV test was documented at least 2 months prior to screening for IPM 032~3. Currently pregnant, intends to become pregnant or currently breast-feeding~4. Known drug abuse or alcohol dependence in the 12 months prior to screening~5. Participated in another research trial (other than IPM 027) using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 30 days prior to screening~6. Any new illness or condition(s), chronic condition(s) or abnormal laboratory finding(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives or the participant's adherence to trial requirements

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- Dapivirine Vaginal Ring-004 (Type: EXPERIMENTAL): Dapivirine Vaginal Ring, 25 mg.Each participant will engage in the screening process for up to 45 days prior to enrolment and will use the monthly Dapivirine Vaginal Ring for a period of up to 12 months. IPM will have the option to extend this trial period.

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 Efficacy of Turoctocog Alfa in Haemophilia A Subjects

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- 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:~* Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg~* Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)~* No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A~* No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)~Exclusion Criteria:~* Congenital or acquired coagulation disorders other than haemophilia A~* Creatinine levels 50% above normal level (as defined by central laboratory range)~* Known or suspected allergy to trial product (N8) or related products

- Gender: MALE
- Minimum Age: 12 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- rFVIII (Type: EXPERIMENTAL): 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: Synera Venipuncture Pain

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.~* Is 18 years of age or older.~* Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.~* Male or female patients~* Has signed the most recent Patient Informed Consent Form~* Has signed a Patient Authorization Form (HIPPA)~Exclusion Criteria:~* Patients with sensitivity to lidocaine, tetracaine, or any other component of the product~* Known sensitivity to any components of test materials (sulphites and adhesives)~* Patients with damaged or broken skin at the designated patch site~* Pregnant or breastfeeding women patients~* Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit~* Previous irradiation to the site of the patch

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

Study Arms:
- Arm 1 (Type: EXPERIMENTAL): First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch
- Arm 2 (Type: EXPERIMENTAL): First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch

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 Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone (RISPERDAL® CONSTA™)

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)~* patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit~* patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request.~Exclusion Criteria:~* Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation~* known hypersensitivity, intolerance, or unresponsiveness to risperidone~* history of drug allergy or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness~* tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles~* pregnant or nursing females, or those lacking adequate contraception

- Gender: ALL
- Minimum Age: 18 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: Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

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

Eligibility Criteria:
Inclusion Criteria~1. Be ≥12 years of age.~2. Weigh ≥ 40 kg.~3. Be a recipient of stem cell or solid organ transplantation.~4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.~5. Have a current CMV infection that is resistant (known CMV genetic mutations) or refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir and/or foscarnet.~6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.~7. Be able to swallow tablets.~8. If adult, provide written informed consent. If child (age \<18 years), have a parent/legal guardian who is willing and able to provide written informed consent (with assent from the child when appropriate).~9. Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus \[HSV type 1 and type 2\] and varicella zoster virus \[VZV\]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.~Exclusion Criteria~1. Be receiving any other anti-CMV agent(s).~2. Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.~3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.~4. Have severe hepatic impairment.~5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.~6. Have expected survival less than 6 weeks.~7. Be pregnant or breastfeeding.~8. Other clinically significant medical or surgical condition.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Maribavir 400 mg twice daily (Type: EXPERIMENTAL): None
- Maribavir 800 mg twice daily (Type: EXPERIMENTAL): None
- Maribavir 1200 mg twice daily (Type: EXPERIMENTAL): 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: Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

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

Eligibility Criteria:
Inclusion Criteria:~* BMI: 19\</=BMI\</=25 kg/m2;~* Proper estrogen priming; absence of progesterone exposure prior to exogenous progesterone administration;~* normal pelvic ultrasound;~* absence of active follicular growth following initiation of E2 treatment;~* Complete suppression of ovarian function;~* Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm;~* Full comprehension of the nature and purpose of the study and possible risks and side effects;~* signed written informed consent prior to inclusion in the study~Exclusion Criteria:~* pregnant or lactating women;~* ECG: clinically relevant abnormalities;~* clinical relevant abnormal physical findings which could interfere with the objectives of the study;~* clinical relevant abnormal laboratory values indicative of physical illness, ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;~* history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;~* history of uterine pathologies (fibroids, polyps, adenomyosis, etc), history of dysfunctional bleeding, relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, history of neoplasias (genital apparatus, breast, liver or hormone-dependent cancer) severe liver failure, acute or chronic liver dysfunction, cholestatic jaundice, hypertension, thrombo-phlebitis, thrombo-embolism, cerebro-vascular insult or severe depression; medication, including OTC, during 2 weeks before the start of the study;~* participation in the evaluation of any drug within 1 month prior to the start of the study;~* blood donations during the 1 month prior to this study;~* history of drug, alcohol \[\>1 drink/day defined according to USDA Dietary Guidelines 2005 (18)\] caffeine (\>5 cups/ day of coffee or tea) or tobacco abuse (≥10 cigarettes/day);~* Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.

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

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

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

Trial Title: Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

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

Eligibility Criteria:
Key Inclusion Criteria:~* Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)~* For the phase 2b cohort only: Has a chronological age \>2 weeks of age up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.~* For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.~* For participants in South Korea only: Weighs ≥2 kg~Key Exclusion Criteria:~* Is recommended to receive palivizumab per local guidelines or professional society recommendations.~* Has known hypersensitivity to any component of clesrovimab~* Has a bleeding disorder contraindicating IM administration~* Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose~* Has received any vaccine or monoclonal antibody for the prevention of RSV~* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

- Gender: ALL
- Minimum Age: None
- Maximum Age: 1 Year
- Healthy Volunteers: t

Study Arms:
- Clesrovimab (Type: EXPERIMENTAL): Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
- Placebo (Type: PLACEBO_COMPARATOR): Participants receive a single IM administration of placebo on Day 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: Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

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

Eligibility Criteria:
Inclusion Criteria:~* Age greater than or equal to 18 years~* Onset of severe sepsis within the previous 24 hours~* Must be receiving antibiotic therapy~* Informed consent form signed by patient, legal next-of-kin or legal guardian~* Able to take medication by mouth or feeding tube~Exclusion Criteria:~* Receipt of investigational medication within 4 weeks prior to participation in the study~* Pregnant or breast-feeding~* Severe congestive heart failure~* Known severe HIV infection~* Presence of severe burns~* Patients on high dose immunosuppressants~* Patients whose death is considered imminent~* Patients whose life expectancy for concurrent illness is less than 6 months~* Severe hypoxic encephalopathy or persistent vegetative state~* Severe liver disease~* Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

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

Study Arms:
- 1 (Type: EXPERIMENTAL): Talactoferrin alfa
- 2 (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: A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology~* Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan~* At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (\>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan~* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2~* Adequate hematologic, hepatic, and renal function~* Agrees to protocol-defined use of effective contraception~Exclusion Criteria:~* Active infection or other medical condition that would make prednisone use contraindicated~* Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day~* Pathological finding consistent with small cell carcinoma of the prostate~* Known brain metastasis~* Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

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

Study Arms:
- Abiraterone acetate + Prednisone + ADT (Type: EXPERIMENTAL): Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.
- Placebo + Androgen Deprivation Therapy (ADT) (Type: PLACEBO_COMPARATOR): Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.

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, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

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

Eligibility Criteria:
Inclusion Criteria:~* healthy 6-8 months old infants~Exclusion Criteria:~* previous receipt of any meningococcal B vaccine;~* previous ascertained or suspected disease caused by N meningitidis;~* history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;~* any present or suspected serious acute or chronic disease~* known or suspected autoimmune disease or impairment /alteration of immune function

- Gender: ALL
- Minimum Age: 6 Months
- Maximum Age: 8 Months
- Healthy Volunteers: t

Study Arms:
- rMenB (Type: EXPERIMENTAL): 6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.
- rMenB+OMV (Type: EXPERIMENTAL): 6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.

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 Medication With or Without Psychotherapy for Complicated Grief

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Diagnosed with Complicated Grief and this is the patient's most important (primary) problem~* Ability to give informed consent~* Fluent in English~* Willingness to have sessions audiotaped~* Willingness to undergo random assignment~Exclusion Criteria:~* Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia~* Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception~* Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis~* Prior intolerance of citalopram~* Pending or active disability claim or lawsuit related to the death

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 95 Years
- Healthy Volunteers: f

Study Arms:
- CGT with Citalopram (Type: ACTIVE_COMPARATOR): Targeted psychotherapy for complicated grief will be combined with SSRI medication.
- Citalopram (Type: ACTIVE_COMPARATOR): Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.
- Placebo (Sugar pill) (Type: PLACEBO_COMPARATOR): Inactive medication. It will be combined with grief-focused clinical management.
- CGT with Placebo (Type: ACTIVE_COMPARATOR): The targeted psychotherapy for complicated grief will be combined with inactive medication.

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

Answer: outcome: complete