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

Trial Title: Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years~All subjects must satisfy the following criteria at study entry:~* Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)~* For females of reproductive age, they must not be pregnant (as determined by verbal screening)~* Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.~* Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.~Exclusion Criteria:~* Ongoing serious chronic disease~* Immunocompromising condition or therapy~* Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment~* one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months~* one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months~* intake of any anti-diarrhoeal medicine in the past week~* abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours~* acute disease one week prior to enrollment, with or without fever. Temperature \> or = 38 degrees C (oral) or axillary temperature \> or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject~* receipt of antibiotics in past 14 days~* receipt of live or killed enteric vaccine in last month~* receipt of killed oral cholear vaccine

- Gender: ALL
- Minimum Age: 1 Year
- Maximum Age: 40 Years
- Healthy Volunteers: t

Study Arms:
- 1 (Type: EXPERIMENTAL): Cholera Vaccine
- 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: Progesterone for Postpartum Cocaine Relapse

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:~* Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.~* Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.~* Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.~Exclusion Criteria:~Women will be ineligible for the trial if they:~1. have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;~2. have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);~3. speak a language other than English;~4. are planning on moving out of the area in the first six months after delivery;~5. are unable to understand the study or are unable to provide informed consent;~6. are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);~7. have pending incarceration;~8. are currently incarcerated;~9. are using another progestin;~10. are unwilling to accept randomization;~11. are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Matched placebo pills to be taken twice daily
- Progesterone (Type: EXPERIMENTAL): 100 mgs progesterone twice daily

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 VP20621 for Prevention of Recurrent Clostridium Difficile Infection

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

Eligibility Criteria:
Inclusion Criteria:~1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.~2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.~3. Subjects who are medically stable.~4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.~5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.~Exclusion Criteria:~1. Subjects who have had more than 2 episodes of CDI within the last 6 months.~2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.~3. GI surgery within 6 weeks before the day of randomization~4. Have known immunodeficiency disorder, such as HIV Infection~5. Pregnant or breast feeding females.~6. Concurrent acute life-threatening diseases.~7. Inability to tolerate oral liquids.~8. Have an absolute neutrophil count \< 1000/mm3 at screening

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

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): None
- VP20621 Low Dose and Placebo (Type: EXPERIMENTAL): None
- VP20621 High Dose and Placebo (Type: EXPERIMENTAL): None
- VP20621 High Dose (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: S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination~  * APL-RARα-negative by RT-PCR are not eligible~* High-risk disease, defined as WBC \> 100,000/mm\^3~* Bone marrow specimens must be made available for cytogenetic studies~PATIENT CHARACTERISTICS:~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* No prolonged QTc \> 0.47 sec~* No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission~PRIOR CONCURRENT THERAPY:~* No prior systemic chemotherapy for acute leukemia~  * At least 3 days since prior tretinoin (ATRA) allowed~* Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- Treatment (Type: EXPERIMENTAL): Induction:~ATRA 45mg/m2 PO D1-CR Gemtuzumab Ozogamicin 9 mg/m2 IV D1 Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR~Consolidation 1 and 2:~Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest~Consolidation 2 and 3:~ATRA 45 mg/m2 PO D1-7 Daunomycin 50 mg/m2/d IV D1-3~Consolidation 5 and 6:~GO 9mg/m2 IV D1~Maintenance:~ATRA 45 mg/m2/d PO D1-7 every 14 days 6-MP 60 mg/m2/d PO daily for 1 year Methotrexate 20 mg/m2 PO once/wk for 1 year

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 Host Response to Lactobacillus Johnsonii

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* To participate in the study individuals must~  * be 18-50 years old.~ * be willing to complete multiple questionnaires via computer.~ * be willing to take the probiotic or placebo capsule daily for 8 weeks.~ * be willing to provide 1 stool during weeks 0, 2, 4, 8 and 12 of the study.~ * be willing to provide blood samples at weeks -1, 0, 2, 4, 8 and 12 of the study.~ * have daily access to a computer with internet access for the entire 13-wk study.~ * be willing to provide a social security number~Exclusion Criteria:~* To participate in the study individuals must NOT~  * currently take medications for constipation, diarrhea or psychological disorders (depression, anxiety, insomnia etc.).~ * have taken antibiotics within the past four weeks prior to randomization.~ * currently take probiotic supplements and do not want to discontinue a minimum of two weeks prior to the study~ * have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), chronic disease like diabetes or kidney disease, immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, transplant patient etc.)~ * currently receive medical treatment for stress induced symptoms/disorders~ * be a current smoker

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

Study Arms:
- Probiotic (Type: ACTIVE_COMPARATOR): L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks
- Placebo (Type: PLACEBO_COMPARATOR): Encapsulated starch placebo administered for 8 weeks

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: Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

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

Eligibility Criteria:
Inclusion Criteria:~* Documented HIV infection~* Stable antiretroviral regimen for greater than 3 months~* Hypertriglyceridemia (fasting triglycerides greater than 150mg/dl)~* Evidence of fat redistribution (e.g., increased abdominal or cervical fat, and/or decreased subcutaneous fat of the face, arms, or legs) on physical exam~Exclusion Criteria:~* Current therapy with a lipid lowering medication (e.g., fibrates, HMG CoA reductase inhibitors, resins) or treatment with these agents in the 3 months prior to study entry~* Current use of hormone replacement therapy, oral contraceptives for women, or supraphysiologic testosterone therapy in men~* Fasting triglycerides greater than 1000mg/dl~* Active alcohol or substance abuse~* Active peptic ulcer disease~* History of renal failure or serum creatinine greater than 2.0~* Serious opportunistic infection within the 3 months prior to study entry~* Hemoglobin less than 11.0 mg/dl~* Elevated transaminase levels (AST or ALT greater than 2.5x the upper limit of normal)~* Previously diagnosed diabetes mellitus or patients receiving current treatment for diabetes

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 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: Impact of Helmet Use in Preschool Children

Study Design Characteristics:
- Allocation: 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:~* Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program~* The child must possess a bicycle or a riding toy to ride~* The child's caregiver speaks English or Spanish~Exclusion Criteria:~* Age less than two or greater than 5-year olds~* 3-5 year old children that do not own a bicycle or a riding toy to ride~* The child's caregiver does not speak English or Spanish.

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 5 Years
- Healthy Volunteers: f

Study Arms:
- Helmet and helmet education (Type: EXPERIMENTAL): Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.
- Helmet education (Type: ACTIVE_COMPARATOR): Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.

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: Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion criteria:~* A histologically confirmed diagnosis of PTCL~* Participants must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.~* Participants must have at least one site of disease measurable in two dimensions by computed tomography (CT).~* Age ≥ 18 years.~* Adequate bone marrow, liver, and renal functions.~* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.~* Negative pregnancy test for women of childbearing potential.~Exclusion criteria:~* Relapse within 100 days of autologous or allogeneic bone marrow transplant.~* Prior histone deacetylase (HDAC) inhibitor therapy.~* Co-existing active infection or any medical condition likely to interfere with trial procedures.~* Severe cardiovascular disease.~* Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.~* Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).~* Symptomatic or untreated central nervous system (CNS) metastases.~* Pregnant or breast-feeding women.~* Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.

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

Study Arms:
- Belinostat (Type: EXPERIMENTAL): Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.

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 of OnabotulinumtoxinA in Migraine

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Subjects fulfilling the diagnostic criteria for migraine without or with aura of the International Headache Classification with a number of migraine days ranging from 9 to 14 days/month in the previous 3 months.~* The frequency needs to be confirmed over the 28 days before the screening visit .~* Subjects have to be in general good health, as confirmed by medical history, baseline physical examination, baseline neurological exam and vital signs.~* Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.~Exclusion Criteria:~* Previous failure of more than two adequate trials of medications from different drug classes used for migraine prophylaxis;~* Onset of migraine after age 50;~* Exclusively migraine aura without headache;~* Diagnosis of other primary or secondary headache disorders. Episodic tension-tyep headache is allowed if the patient can distinguish clearly between attack of migraine and of tension-type headache;~* Another chronic painful condition (e.g. osteoarthritis, low back pain);~* A significant medical history or medical condition of neurological, cardiovascular hepatic or renal disease;~* History of suicide attempt or suicidal ideation or of a major psychiatric disorder;~* History of drug or alcohol abuse within the past two years.~* Known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form 'Botox®'~Withdrawal criteria~• Severe side effects, diary completion insufficient for evaluation.

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

Study Arms:
- BOTOX (Type: EXPERIMENTAL): 155 UI of Botox were injected according to the approved PREEMPT protocol (the only FDA-approved injection pattern for chronic migraine), in 31 sites. From visit 5, the PREEMPT 'follow-the-pain' paradigm was applied in patients falling in the 'non-responder' or 'partial responder' classes after the first BoNT-A injection, with the possibility to increase the doses up to 195 UI in maximum 39 sites. The injections were every 3 months for 4 cycles

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: GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

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:~* Documented HIV infection~* Plasma HIV-RNA \>= 1000 copies/mL~* Must be able to comply with protocol requirements~Exclusion Criteria:~* No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir~* No currently active AIDS defining illness, Category C conditions according to the Center for Disease Control \[CDC\] Classification System for HIV Infection (1993) with the following exceptions, which must be discussed with the Sponsor prior to enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection~* Not currently using an investigational drug~* Not pregnant or breastfeeding~* No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National Institute of Allergy and Infectious Diseases).

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

Study Arms:
- 001 (Type: EXPERIMENTAL): darunavir 600mg bid for 48 wks,ritonavir 100mg bid for 48 wks

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: Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category~Exclusion Criteria:~* A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study~* Patient is likely to be greater than 20% noncompliant in taking study medications~* Patients with chronic medical conditions~* Patients with unstable doses of medications~* Pregnant or lactating women, women intending to become pregnant~* Patient is currently receiving prescription therapy with statins or other lipid-altering medications~* Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 79 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: OTHER): Arm 1: drug + comparator + Placebo
- 2 (Type: OTHER): Arm 2: drug + comparator + Placebo
- 3 (Type: OTHER): Arm 3: drug + comparator + Placebo
- 4 (Type: OTHER): Arm 4: drug + comparator + Placebo
- 5 (Type: OTHER): Arm 5: drug + 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: Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

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:~* Chinese patients~* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints~* Active plaque psoriasis at screening~* Inadequate response to at least one conventional synthetic DMARD~Exclusion Criteria:~* Non-plaque forms of psoriasis (with exception of nail psoriasis)~* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

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

Study Arms:
- Treatment Sequence A (Type: EXPERIMENTAL): Tofacitinib 5 mg BID for 6 months
- Treatment Sequence B (Type: PLACEBO_COMPARATOR): Placebo for 3 months then tofacitinib 5 mg BID for 3 months

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

Answer: outcome: complete