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

Trial Title: Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams

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

Eligibility Criteria:
Inclusion Criteria:~* Any preterm infant with a birth weight less than or equal to 1250 grams admitted in the neonatal intensive care unit of Nantes Hospital~* Inborn or outborn~* No signs of gastrointestinal perforation or ECUN~* Absence of severe congenital disease~* Written informed consent of parental authority.~Exclusion Criteria:~* Newborn with birth weight greater than 1250 grams,~* Gestational age \> 30 AG~* Digestive pathology diagnosed prior PND5: perforation, necrotizing enterocolitis, malformations~* Severe congenital pathology inconsistent with clinical assessment.~* Parental Refusal

- Gender: ALL
- Minimum Age: 5 Days
- Maximum Age: 5 Days
- Healthy Volunteers: f

Study Arms:
- Butyrate (Type: EXPERIMENTAL): New born with a birth weight \<1000g: Seven enemas of butyrate will be performed every 2 days from PND5~New born with a birth weight \>1000g: Seven enemas of butyrate will be performed every day from PND5
- Therapeutic Abstention (Type: NO_INTERVENTION): The protocol will pretend enema: instillation in the diaper the product under consideration, to make the two indistinguishable processes (time, odor, wicking diaper ...)

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

Answer: outcome: terminate
termination_type: feasibility
Please assess the completion status of the following clinical trial:

Trial Title: Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency

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

Eligibility Criteria:
Inclusion Criteria:~* Parents or legally authorized representatives must give signed informed consent before any trial related activities are conducted~* Where required, assent of the subject will be appropriately documented prior to any study related activities~* Completion of assessments at Visit 9 (Month 120 of Study MS301 \[NCT00125164\])~Exclusion Criteria:~* Incomplete participation in MS301 (NCT00125164)~* Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1 injection) or its formulation~* Development or presence of a chronic condition except as approved by the Medical Monitor~* Pregnancy~* Any social or medical condition that, in the opinion of the investigator, would be detrimental to either the subject or the study

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 15 Years
- Healthy Volunteers: f

Study Arms:
- All rhIGF-1 Subjects (Type: EXPERIMENTAL): All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) twice a day (BID) treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 micrograms \[μg\]/ kilogram \[kg\] BID).~MS301 untreated control subjects were randomised in MS306 in a 1:1 ratio to a dose of either 80 or 120 μg/kg rhIGF-1 BID.~Following Protocol Amendment 1, all subjects received either 80 or 120 μg/kg rhIGF-1 BID until the implementation of Protocol Amendment 2.~Following Protocol Amendment 2, all subjects were first switched to receive subcutaneous injections of 160 μg/kg rhIGF-1 once a day (QD), followed by individual dose-escalation first to 200 μg/kg rhIGF-1 QD and subsequently to a targeted maximum dose of 240 μg/kg rhIGF-1 QD. Subjects were treated QD until the early termination of the study.

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

Answer: outcome: terminate
termination_type: safety issues
Please assess the completion status of the following clinical trial:

Trial Title: Catalysing the Containment of COVID-19

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

Eligibility Criteria:
Inclusion Criteria:~1. Adults \>18 years of age.~2. Confirmed COVID-19 on antigen testing\* and/or RT-PCR using NP or OP swabs (or sputum or another sample e.g. stool).~   * Only SAHPRA approved antigen tests will be used to identify COVID-19. A positive antigen detection test will be valid provided that at least one serial PCR test is positive.~3. Presenting within 6 days of symptom onset.~4. Not requiring immediate hospitalisation.~5. Patients with non-severe not requiring admission i.e. mild disease (respiratory rate \<25/min), pulse rate \<120 beats/min, oxygen saturation of ≥93% at sea level sites and \>91% at high altitude sites)~6. Enhanced risk and/or HIV-infected~Exclusion Criteria:~1. Refusal or unable to sign informed consent.~2. Patient who declines or will be unable to comply with follow up visits by study staff.~3. Patients with advanced organ dysfunction/co-morbid conditions that in the opinion of the study doctor would compromise the patient's well-being.~4. Patients who have had symptoms for \> 6 days (as at the day of recruitment).~5. Patients who refuse HIV-testing.~6. Patients using warfarin (Appendix A in the protocol)~7. Patients with a body weight of less than 40kg.~8. Women of child-bearing age (18-50 years) with a positive urine pregnancy test at randomisation.~9. Female patients who are currently breastfeeding.~10. Patients without HIV infection or at least one enhanced risk characteristic

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

Study Arms:
- Nitazoxanide (Type: EXPERIMENTAL): Nitazoxaninde, 1000mg (2pills), oral, twice daily for 7 days. To be taken with food.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo, 2 pills, oral, twice daily for 7 days. To be taken with food.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Insulin Resistance in Non-alcoholic Fatty Liver Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-80 years old Controls:~  * otherwise healthy Case subjects: NAFLD on liver biopsy within the past 3 years or presumed NAFLD with otherwise unexplained elevated ALT and fatty liver by CT or ultrasound~* Able to comply with taking 3 pills a day for 6 months and follow-up safety visits~Exclusion Criteria:~* Controls:~  * history or evidence of hepatic steatosis~* Cases:~  * Cirrhosis on liver biopsy or by clinical exam or fibrosis score~ * Causes of liver dysfunction other than NASH~* Use of medications associated with hepatic steatosis:~  * glucocorticoids~ * estrogens~ * tamoxifen~ * amiodarone~ * accutane~ * sertraline~* Use of medications that cause insulin resistance:~  * niacin~ * glucocorticoids~ * anti-HIV drugs or atypical antipsychotics~* Use of lipid-lowering medications except stable dose statin~* Use of anti-NASH drugs such as:~  * ursodeoxycholic acid~ * betaine milk thistle~* Use of coumadin~* Use of nitrates~* Significant alcohol consumption:~  * Average \>20 grams/day~* In subjects with diabetes~  * a HbA1c \>7.5% or use of insulin~ * metformin~ * rosiglitazone or pioglitazone~* Liver transaminases:~  * Cases: ALT \>5x upper limit of normal~ * Controls: ALT or AST above the normal range~* Iron saturation \>50%~* Creatinine \>1.5 mg/dl for men and \>1.4 mg/dl for women~* Hematocrit \<33%~* Pregnancy or lactation~* Significant weight loss within the past 6 months for controls, or since the liver biopsy for case subjects, history of significant coronary artery disease or congestive heart failure~* Retinopathy

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: t

Study Arms:
- Placebo Arm (Type: PLACEBO_COMPARATOR): matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
- Rosiglitazone Arm (Type: EXPERIMENTAL): rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
- Fenofibrate Arm (Type: EXPERIMENTAL): micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

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:~* Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.~* Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.~* Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study~Exclusion Criteria:~* Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug~* Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being~* Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of yes to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior

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

Study Arms:
- Memantine (Type: EXPERIMENTAL): To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Reduced Intensity AlloSCT in(CML) With Persistent Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Age: Patient must be less than 30 years of age.~* Consent: Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.~* Organ Function: Patient must have adequate organ function as below Adequate renal function defined as:Serum creatinine 1.5 x normal, or Creatinine clearance or radioisotope GFR \> 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range~* Adequate liver function defined as:Total bilirubin \< 2.5 x normal; or SGOT (AST) or SGPT (ALT) \< 5.0 x normal~* Adequate cardiac function defined as:~  * Shortening fraction of \>25% by echocardiogram, or~ * Ejection fraction of \>40% by radionuclide angiogram or echocardiogram~* Adequate pulmonary function defined as:~  -DLCO \>40% by pulmonary function test For children who are uncooperative, no evidence of dyspnea at rest,no exercise intolerance, and a pulse oximetry \>94% in room air.~* Disease Status~  * Patients with CML with either of the following:~ * Patients in 1st or 2nd chronic phase~ * Patients in 1st or 2nd accelerated phase~Exclusion Criteria:~* Patient in blast crisis~* Patient in 3rd or greater chronic phase~* Patient in 3rd or greater accelerated phase~  * women that are pregnant are ineligible

- Gender: ALL
- Minimum Age: None
- Maximum Age: 30 Years
- Healthy Volunteers: f

Study Arms:
- Matched Family Donor (Type: EXPERIMENTAL): Matched Family Donor
- Unrelated Donor (Type: EXPERIMENTAL): Unrelated Donor Transplant/ Cord Blood Transplant

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

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:~1. Men and women aged 18-65 years;~2. Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;~3. Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;~4. Absolute T-cell CD4+ subset between 200-500/mm3~5. Individual willing to undergo serial lumbar punctures as outlined in study evaluations;~6. Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);~7. Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.~Exclusion Criteria:~1. Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;~2. Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;~3. Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;~4. Use of prescribed drugs with known substantial interactions with the study drugs;~5. Positive HCV serology;~6. HIV-associated dementia/Global Deterioration Scale ≥4;~7. Pregnancy;~8. Serum creatinine higher than 2.0 mg/dL;~9. Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal

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

Study Arms:
- Raltegravir (Type: EXPERIMENTAL): None
- Efavirenz (Type: ACTIVE_COMPARATOR): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

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

Eligibility Criteria:
Inclusion Criteria:~* Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis~* Regularly menstruating women with normal gynaecological status~* Patient must use a contraception method~* Having given a written informed consent prior to selection~* Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.~Exclusion Criteria:~* Pregnancy or breast feeding.~* Tumors in the genital tract or beast.~* Hypersensitivity to the study product.~* Uterine or vaginal bleeding of unknown origin.~* Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.~* Concomitant medication with antimycotics for other diagnoses.~* Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or 2.~* Immunocompromised individuals.~* Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods~* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.~* Subject under administrative or legal supervision.~* Subject who participate to a previous study within 3 months.

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

Study Arms:
- Saccharomyces cerevisiae CNCM I-3856 (Type: ACTIVE_COMPARATOR): In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
- placebo (Type: PLACEBO_COMPARATOR): In this arm, subjects will be asked to consume one capsule of placebo per day.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

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:~* Patients with symptomatic chronic venous insufficiency.~* Patients in whom endovenous thermal ablation is clinically indicated.~* Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).~* Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow in the saphenous vein \>0.5 seconds after calf compression or while standing.~Exclusion Criteria:~* Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).~* Have a history of Deep Venous Thrombosis (DVT).~* Have a history of hypercoaguability disorder.~* Are pregnant or breastfeeding.~* Are nonambulatory.

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

Study Arms:
- Radiofrequency Ablation (Type: ACTIVE_COMPARATOR): Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.
- Laser Ablation (Type: ACTIVE_COMPARATOR): Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).~Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Use of High Frequency Chest Compression in Pediatric Status Asthmaticus

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:~* 2 to 21 yo (VEST approved for over two yo) Admitted to PICU for status asthmaticus Negative urine pregnancy test prior to initiation of study in those with menses~Exclusion Criteria:~* Absolute contraindication to VEST use:~  1. Unstable head or neck injury~ 2. Active hemorrhage with hemodynamic instability~ 3. Intracranial pressure \> 20 mmHg or those in whom intracranial pressures should be avoided (was a relative contraindication but after discussion moved to absolute)~Presence of anomalies such as:~1. Former premature infant with BPD~2. Congenital bronchogenic or pulmonary anomaly (i.e. CF)~3. Congenital heart disease

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
- 2 (Type: NO_INTERVENTION): This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.

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

Answer: outcome: terminate
termination_type: regulatory/approval
Please assess the completion status of the following clinical trial:

Trial Title: Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia

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

Eligibility Criteria:
Inclusion Criteria:~The criteria for the diagnosis of SCAP included:~* Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg~* RR higher than 30 breaths per minute~* PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)~* Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and~* Use of vasopressor drugs~Exclusion Criteria:~Exclusion criteria included:~* COPD~* Asthma~* Acute cardiogenic pulmonary edema~* Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs~* Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation~* Antecedents of respiratory failure resulting from neuromuscular pathology~* Failure of two or more organs~* Facial deformities; and~* Recent facial, aesophagic and gastric surgeries

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 80 Years
- Healthy Volunteers: None

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

Answer: outcome: terminate
termination_type: lack of efficacy