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

Trial Title: Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates

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

Eligibility Criteria:
Inclusion Criteria:~* Preterm~* Very low birth weight baby: birth weight 1-1.5 kg~* Both inside and outside delivered babies~* Gender: males and females~* Probable severe sepsis (septic score)~Exclusion Criteria:~* Extremely low birth weight babies: \< 1 kg~* Babies \>1.5 kg birth weight~* Babies born with congenital malformations~* Full term babies~* IUGR babies~* Child with no signs of sepsis~* HBsAg Positive~* HIV Positive

- Gender: ALL
- Minimum Age: 1 Day
- Maximum Age: 30 Days
- Healthy Volunteers: f

Study Arms:
- case group (Type: ACTIVE_COMPARATOR): 'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
- control group (Type: PLACEBO_COMPARATOR): antibiotics only

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

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

Trial Title: Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis

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:~1. Confirmed diagnosis of CF established in neonatal period either via CF newborn screening (NBS) or because of symptoms typical for CF (e.g. meconium ileus), positive family history or positive prenatal screening and fulfilling at least one of the following three criteria:~   * sweat chloride ≥ 60mEq/L~  * two CF causing mutations of CFTR gen~  * alterations of transepithelial potential difference of nasal or rectal epithelia typical for CF.~2. Age at enrolment is 0 to 4 months.~3. Patient's and parent's ability to comply with medication use, study visits, and study procedures is judged by the investigator (therefore parents have to understand the character of the study and individual consequences).~4. Participation in this study is voluntary. Only patients, whose parents or legal guardians gave written consent, are included.~Exclusion Criteria:~1. Born \< 30 weeks gestation.~2. Prolonged mechanical ventilation in the first 3 months of life.~3. A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol.~4. Previous major surgery except for meconium ileus.~5. Other major organ dysfunction, excluding pancreatic or hepatic dysfunction or another condition due to cystic fibrosis.~6. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by investigator.~7. History of adverse reaction to sedation.~8. Known hypersensitivity to study treatment.~9. Participation in other interventional studies at the same time.~Criteria, which lead to a displacement of the procedures in sedation until the child has recovered:~* Clinically significant upper airway obstruction as determined by investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnoea).~* Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 2 weeks preceding visit.~* Oxygen saturation \<95% before initial pulmonary function test or initial MRI.~* Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy.

- Gender: ALL
- Minimum Age: None
- Maximum Age: 4 Months
- Healthy Volunteers: f

Study Arms:
- Hypertonic Saline (Type: EXPERIMENTAL): Inhalation with 6% Hypertonic Saline twice daily over 1 year
- Isotonic Saline (Type: ACTIVE_COMPARATOR): Inhalation with 0.9% Isotonic Saline twice daily over 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: Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

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:~* Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH \< 15 mIU/ml~* Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.~Exclusion Criteria:~* Women who have had more than 3 previous IVF/ET cycles

- Gender: FEMALE
- Minimum Age: 21 Years
- Maximum Age: 39 Years
- Healthy Volunteers: f

Study Arms:
- Crinone 8% Vaginal Gel (Type: ACTIVE_COMPARATOR): Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
- Intramuscular Progesterone (Type: ACTIVE_COMPARATOR): Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.~.

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 Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

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~* Patients with essential hypertension~* Patients who are eligible and able to participate in the study~Exclusion Criteria~* Severe hypertension~* History or evidence of a secondary form of hypertension~Other protocol-defined exclusion criteria may apply.

- 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: Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

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

Eligibility Criteria:
Inclusion Criteria:~* positive results of both rapid urease test and histology,~* a positive result of urea breath test,~* or a positive result of culture.~Exclusion Criteria:~* ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,~* patients with allergic history to the medications used,~* patients with previous gastric surgery,~* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),~* pregnant women

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- esomeprazole+amox+levo (Type: ACTIVE_COMPARATOR): esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
- esomeprazole+bismuth+tetra+levo (Type: EXPERIMENTAL): esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

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 Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Male~* Age 18-65~* Morning serum testosterone (T) \<300 ng/dL on two occasions~Exclusion Criteria:~* Significant intercurrent disease~* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.~* Serum transaminases \>2 times upper limit of normal~* Serum bilirubin \>2.0 mg/dL~* Hematocrit \<35% or \>50%~* BMI \>36~* Untreated, obstructive sleep apnea.

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

Study Arms:
- Fasting (Treatment A) (Type: EXPERIMENTAL): Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state
- Very low fat diet (Treatment B) (Type: EXPERIMENTAL): Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat).
- Low fat diet (Treatment C) (Type: EXPERIMENTAL): Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat).
- Normal diet (Treatment D) (Type: EXPERIMENTAL): Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat).
- High fat diet (Treatment E) (Type: EXPERIMENTAL): Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat).

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: The Effects of an Antioxidant Formulation on Ocular Blood Flow

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

Eligibility Criteria:
Inclusion Criteria:~* Age 30 years or older.~* Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities.~* Best corrected visual acuity at 20/60 or better in study eye.~* Willingness to avoid caffeine and smoking for 12 hours before and during the study visits.~Exclusion Criteria:~* History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.~* History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.~* Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease~* History of/or current renal or hepatic impairment.~* History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.~* Recent surgery or surgery planned near study timeline~* History of bleeding disorder~* Use of blood thinning medications~* Use of specified dietary supplements for three weeks prior to study entry and throughout study period.

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- supplement w/ antioxidants then placebo (Type: EXPERIMENTAL): dietary supplement with antioxidants, followed by placebo supplement
- placebo then supplement w/ antioxidants (Type: EXPERIMENTAL): placebo supplement, followed by dietary supplement with antioxidants

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: Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment~* Measurable disease or evaluable disease~PATIENT CHARACTERISTICS:~Age:~* 18 to physiological 60~Performance status:~* ECOG 0-2~Life expectancy:~* Greater than 2 months~Hematopoietic:~* WBC greater than 3000/mm3~* Platelet count greater than 100,000/mm3~Hepatic:~* Bilirubin less than 1.5 times normal~* SGOT/SGPT less than 1.5 times normal~Renal:~* BUN less than 1.5 times normal~* Creatinine less than 1.5 times normal~* Creatinine clearance greater than 50 mL/min~Other:~* Ineligible for other high priority national or institutional study~* Not pregnant or nursing~* HIV negative~* No prior malignancy except nonmelanoma skin cancer~* No serious medical or psychiatric illness preventing treatment or informed consent~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* Not specified~Chemotherapy:~* Greater than 4 weeks since prior chemotherapy~* No greater than 2 prior chemotherapy regimens~* No prior taxane or camptothecin~Endocrine therapy:~* No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes)~Radiotherapy:~* Greater than 4 weeks since prior radiation therapy~* No concurrent radiation therapy~Surgery:~* Greater than 4 weeks since prior surgery

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 60 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: Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. OCD diagnosis~2. YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)~3. Previously signed informed consent to participate in this clinical trial~Exclusion Criteria:~1. Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol~2. Current substance dependence or abuse~3. Current psychotic symptoms~4. Current suicide risk~5. Current pregnancy or intention to get pregnant before the end of the treatment protocol

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

Study Arms:
- Quetiapine (fluoxetine plus quetiapine) (Type: EXPERIMENTAL): fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
- Clomipramine (fluoxetine plus clomipramine) (Type: ACTIVE_COMPARATOR): Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
- Placebo (fluoxetine plus placebo) (Type: PLACEBO_COMPARATOR): Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 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: Vertos Mild - Post Market Patient Outcomes

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

Eligibility Criteria:
Inclusion Criteria:~* Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy~* Prior failure of conservative therapy and Oswestry Disability Index (ODI) \>20%~* Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically \>2.5mm),confirmed by pre-op MRI/CT report~* Central canal cross sectional area clearly reduced per MRI/CT report~* If present, anterior listhesis \< or = to 5.0mm (preferred) and deemed stable by the Investigator~* Able to walk at least 10 feet unaided before being limited by pain~* Available to complete 26 weeks of follow up~* A signed Consent Form is obtained from the patient~* Adults 18 years of age or older~Exclusion Criteria:~* Prior surgery at the intended treatment level~* Compound fracture with intraspinal retropulsion contributing to spinal stenosis~* Disabling back or leg pain from causes other than lumbar spinal stenosis~* Disc protrusion or osteophyte formation severe enough to confound study outcome~* Facet hypertrophy severe enough to confound study outcome~* Bleeding disorders and/or current use of anti-coagulants~* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment~* Epidural steroids with 3 weeks prior to procedure~* Inability of patient to lie prone for any reason with anesthesia support~* Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes~* Dementia and/or inability to give informed consent~* Pregnant and/or breastfeeding~* On workman's Compensation or considering litigation associated with back pain

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

Study Arms:
- Minimally invasive lumbar decompression (Type: OTHER): 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: CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)

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

Eligibility Criteria:
Inclusion Criteria:~* Adults \>/=18 years~* Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)~* Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria~* Total Cumulative Illness Rating Scale (CIRS) \> 6 and/or creatinine clearance \< 70 ml/min.~Exclusion Criteria:~* Prior CLL therapy~* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)~* History of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone~* Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing~* Patients with active infection requiring systemic treatment.

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

Study Arms:
- obinutuzumab + chlorambucil (GClb) (Type: EXPERIMENTAL): Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
- rituximab + chlorambucil (RClb) (Type: ACTIVE_COMPARATOR): Participants received 375 mg/m\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
- Chlorambucil (Clb) (Type: ACTIVE_COMPARATOR): Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.

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: Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

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

Eligibility Criteria:
Inclusion Criteria:~* Informed written consent given for three immunizations with MenBVac and five blood tests~* Between the ages of 18 and 55 years inclusive at recruitment~Exclusion Criteria:~* Previous history of bacteriologically confirmed meningococcal disease~* History of clinically significant allergic sensitivity to any vaccine received in the past~* Immunodeficiency~* Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol~* Language difficulties sufficient to preclude adequate comprehension of the study information~* Possibility of pregnancy~* Receipt of any other vaccine in the previous 4 weeks~* Receipt of any group B vaccine in the past~* Current participation in any other clinical trial~* Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral

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

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

Answer: outcome: complete