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

Trial Title: Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

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:~* Age between 18 and 75 years~* French citizen~* Signed consent for participation~* No dental infection~* No programmed dental surgery during the treatment~* Effective contraception for women of childbearing potential~* Patient with advanced otosclerosis defined by:~* Slowly progressive uni or bilateral hearing loss~* No past medical history of chronic otitis media~* No past medical history of other causes of cochlear damage (significant surgical trauma with a 30 dB deterioration of bone conduction at 4000 Hz in postoperative period, sound trauma, barotrauma, ototoxic drugs)~* Normal tympanic membranes~* A conductive or mixed hearing loss~* A moderate to severe hearing loss on at least one ear (average of thresholds at 500, 1000, 2000 and 4000 Hz) on air conduction between 30 and 90 dB.~* Normal tympanometry or with a decreased peak~* Absent ipsilateral stapedial reflex~* As possible, intraoperative confirmation of stapediovestibular ankylosis~* radiological confirmation if CT-scan before inclusion available~Exclusion Criteria:~* Individuals not covered by the french public health insurance~* Pure-tone average \< 30 dB ou \> 90 dB~* Programmed stapes surgery during the observation period~* Previous treatment by biphosphonate~* Known intolerance to tiludronate~* Other contraindications to tiludronate treatment:~* allergy to biphosphonates~* hypersensitivity to one of the excipients~* severe renal failure (creatinine clearance \< 30 mL/min)~* juvenile Paget's disease~* pregnancy and breastfeeding~* galactose intolerance, lactase insufficiency, glucose-galactose malabsorption~* Ongoing chemotherapy or radiotherapy or patient achieves of a cancer~* Long-term systemic steroid treatment

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

Study Arms:
- Skelid (Type: EXPERIMENTAL): tiludronic acid
- Control (Type: PLACEBO_COMPARATOR): Placebo

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: Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease

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:~1. HIV-1 infection~2. The absence of exclusionary resistance mutations on a genotypic resistance assay~3. Antiretroviral (ARV) drug-naïve~4. Screening HIV-1 RNA \>1000 copies/mL~5. Screening CD4+ T-cell count \< 200 cells/ml~6. Laboratory values obtained within 30 days prior to study entry.~   * Absolute neutrophil count (ANC) \>500/mm3~  * Hemoglobin \>8.0 g/dL~  * Platelet count \>40,000/mm3~  * AST (SGOT), ALT (SGPT), and alkaline phosphatase \<5 x ULN~  * Total bilirubin \<2.5 x ULN~  * Calculated creatinine clearance ≥60 mL/min (by Cockcroft-Gault equation)~7. For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.~8. Contraception requirements~9. Men and women age \>18 years and \< 60 years.~10. Ability and willingness of subject or legal guardian/representative to give written informed consent.~Exclusion Criteria:~1. Currently breast-feeding.~2. Use of immunomodulators, vaccines, growth hormone, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.~3. Known allergy/sensitivity to study drugs, pneumococcal polysaccharide vaccine, tetanus-diphtheria vaccine~4. Receipt of pneumococcal polysaccharide vaccine or tetanus-diphtheria vaccine in the past 5 years.~5. Active drug or alcohol use or dependence~6. Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.~7. Requirement for any current medications that are prohibited with any study treatment.~8. Evidence of any major resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry~9. Current or anticipated imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness~10. History of, or current bipolar disorder, major depression, schizophrenia or other psychotic disorders

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

Study Arms:
- ARM A/Lopinavir/ritonavir (Type: ACTIVE_COMPARATOR): Subjects randomized to Arm A initiated Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
- ARM B/Efavirenz (Type: ACTIVE_COMPARATOR): Subjects randomized to Arm B initiated Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD

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: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Known Sezary Syndrome~* Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale \> 4.~* Age 18 through 80 years of age.~* Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to study participation.~Exclusion Criteria:~* Known hepatic impairment (defined as liver function tests \>3 times the upper limit of normal).~* Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).~* Concurrent use of pimozide, terfenadine, astemizole, or cisapride.

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

Study Arms:
- Aprepitant (Type: ACTIVE_COMPARATOR): Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
- Placebo (Type: PLACEBO_COMPARATOR): Matching placebo will be given in place of aprepitant

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: A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* No allergic history of Anlotinib~* 18-75 years~* No history of severe arrhythmia or heart failure~* No history of severe ventilation dysfunction or severe pulmonary infection~* No acute or chronic renal failure, creatinine clearance \> 40 mL/min~* Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value~* Blood test: the absolute neutrophil count ≥ 1.5×10\^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10\^9 /L (without blood transfusions and drug therapy 14 days before the screening)~* Blood coagulation function: INR≤2.3~* ECOG: 0-2~* Pathology: hepatocellular carcinoma~* Satisfy any of the following:~A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (\> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs~* Patients participate in the study voluntarily and sign informed consent~Exclusion Criteria:~* Pregnant or lactating women~* Patients who have had or are currently complicated with other malignant tumors~* Recurrent hepatocellular carcinoma~* Patients who participated in other clinical trials within 1 month~* Patients with mental illness~* Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery~* Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed

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

Study Arms:
- Anlotinib (Type: EXPERIMENTAL): Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

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: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

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

Eligibility Criteria:
Inclusion Criteria:~* Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS. Patients will be separately stratified and randomized by disease.~* Patients with history of seizures are eligible but will be stratified separately.~Exclusion Criteria:~* Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.~* Pregnant or lactating women.

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

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: Correlation of Cerebral State Index With the Richmond Agitation-Sedation Scale in Mechanically Ventilated ICU Patients

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

Eligibility Criteria:
Inclusion Criteria:~* Admission the surgical-trauma intensive care unit at the Charleston Area Medical Center General Hospital~* Adult (18-85 years of age)~* Anticipated duration of mechanical ventilation of at least 72 hours~Exclusion Criteria:~* Patients admitted with paralysis or a brain injury~* Patients who are deaf, blind, or have pre-existing dementia/delirium

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Cerebral State Monitor (Type: None): A cerebral state monitor will provide a cerebral state index for mechanically ventilated intensive care patients. Recorded cerebral state indexes will be correlated with clinical assessments of sedation using the Richmond Agitation-Sedation Scale.

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: Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)

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

Eligibility Criteria:
Inclusion Criteria:~* Patients with chronic hepatitis C (serum HCV-RNA-positive)~* Age 3 to 17 years~* Treatment-naïve~* Platelets \>= 100,000/mm\^3~* Neutrophil counts \>= 1,500/ mm\^3~* TSH must be within normal limits~* Hemoglobin \>=12 g/dL (females); \>=13 g/dL (males)~* Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.~* Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.~Exclusion Criteria:~* Contraindications according to the SPC and European approval~* Pretreatment of chronic hepatitis C~* Liver decompensation~* Hypersensitivity to the active substance or to any interferons or to any of the excipients~* Pregnant woman~* Woman who are breast feeding~* Existence of or history of psychiatric condition, in particular depression, suicidal ideation or suicide attempt~* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months~* Severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance \< 50 mlLmin~* Autoimmune hepatitis or history of autoimmune disease~* Severe hepatic dysfunction or decompensated cirrhosis of the liver~* Pre- existing thyroid disease unless it can be controlled with conventional therapy~* Epilepsy and/or compromised central nervous system function~* Individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)

- Gender: ALL
- Minimum Age: 3 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- IntronA/Rebetol (Type: None): Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites

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: Efficacy and Tolerability of the Combination of Valproic Acid and Lenalidomide in the Treatment of Patients With Myelodysplastic Syndrome

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:~* Cytologically/histologically confirmed primary myelodysplastic syndrome (pMDS) with a favorable risk profile, i.e., low or intermediate I risk group according to IPSS (\<10% blasts, no unfavorable karyotype)~* platelet count ≥50.000/µl~* absolute neutrophil count ≥1.000/µl~* age ≥18 years at the time of signing the informed consent form~* Karnofsky performance status \> 50%~* written informed consent to participate~* erythropoietin level \> 200 mU/ml or failure of previous therapy with erythropoietin~* patients in whom allogeneic bone marrow transplantation, treatment with growth factors or immune therapy is not possible due to medical or biologic reasons or patients in whom such a therapy would be possible but who do not agree to such a therapy for personal reasons~* females of childbearing potential (FCBP, see page 23) must agree to one reliable form of contraception or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 4 weeks before starting study drug; 2) while participating in the study, even during treatment interruptions; and 3) for at least 4 weeks after discontinuation from the study.~Exclusion Criteria:~* patients with 5q deletion~* MDS treated with experimental therapy or chemotherapy within 4 weeks prior to start of treatment with study drugs~* previous treatment of MDS with valproic acid or lenalidomide as monotherapy patients suitable for chemotherapy, therapy with growth factors or allogeneic bone marrow transplantation and who are willing to start such a therapy~* hypersensitivity to thalidomide~* insufficient liver function (bilirubin, AST or ALT \> 2 x ULN)~* hepatic disease \[details see full protocol\]~* markedly impaired renal function (serum creatinine \> 2mg/dl)~* pregnancy, breast feeding, lactation, refusal to use safe contraceptive methods during the study~* psychiatric disease or addiction with impaired ability to act and make decisions according to one's free will~* participation in another interventional study 4 weeks prior to or during this study~* known hypersensitivity or allergies to one of the study drugs or their ingredients~* plasmatic coagulation disorder

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

Study Arms:
- Lenalidomide (Type: EXPERIMENTAL): Lenalidomid in combination valproic acid

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: PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

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

Eligibility Criteria:
Inclusion Criteria:~* Either sex, age ≥ 18 years~* Diagnosis of mesothelioma by multi-disciplinary team (MDT). All histological subtypes are eligible for the trial~* ECOG performance status 0-2 (Appendix C)~* Inoperable disease or operable disease in patients unsuitable for surgery as decided by a MDT~* Chest wall intervention with video-assisted thoracoscopy (VATS), open surgical biopsy (mini-thoracotomy), local anaesthetic thoracoscopy or chest drain~* Able to start radiotherapy within 42 days (6 weeks) of the most recent chest wall procedure~* Chest wall intervention scar visible at time of randomisation~* Radiotherapy target volume acceptable by the local radiotherapist~* Patients enrolled on other clinical trials could be considered after discussion with the chief investigators~Exclusion Criteria:~* Patients who underwent a thoracotomy (as large thoracotomy scars may not be adequately covered by this radiotherapy technique)~* Previous radiotherapy to the region of the chest wall intervention site~* Indwelling pleural catheter in-situ at the intervention site~* Patients currently receiving chemotherapy

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

Study Arms:
- PIT Arm (Type: EXPERIMENTAL): None
- No PIT Arm (Type: NO_INTERVENTION): 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 Pharmacist Initiated Recommendations On Prescribing For Participants In the Senior MEDS Personalized Medication Review

Study Design Characteristics:
- Allocation: N/A
- Intervention Model: N/A
- Observational Model: N/A
- Primary Purpose: N/A
- Time Perspective: N/A
- Masking: N/A
- Phase: None
- Number of Arms: None

Eligibility Criteria:
Inclusion Criteria:~* 55 or older~Exclusion Criteria:~* 54 or younger

- Gender: ALL
- Minimum Age: 55 Years
- Maximum Age: None
- Healthy Volunteers: t

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: Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction

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 addicted to cocaine (according to the DSM V classification)~* Patients admitted for three weeks in the unit 73 of the CHU Brugmann Hospital~* French speaking~Exclusion Criteria:~* Anti-craving or anti-psychotic medication~* Addiction to other drugs (except nicotine or cannabis)~* Neurological medical history~* Psychiatric medical history~* Heavy medical history~* Asthma~* Pregnancy~* Lactose intolerance

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

Study Arms:
- N-acetylcysteine (Type: EXPERIMENTAL): None
- Lactose powder (Type: PLACEBO_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: Genetic and Other Aspects of Podoconiosis

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

Eligibility Criteria:
* INCLUSION CRITERIA:~* All individuals included in our study will be adults (greater than or equal to 18 years) because the average age of onset of the disease is during the third decade of life. In addition, in Ethiopia the legal age to give independent consent for research is 18 years or older. Previous studies have shown that diagnosis of podoconiosis using physical diagnostic criteria in endemic highland areas is highly accurate. To rule out filarial elephantiasis, a rapid ICT card test will be done. Advanced stage podoconiosis cases will be included in the study based on prior assessment of an experienced surgeon (Dr Wendemagegn Enbiale Yeshanehe) who assures eligibility for nodulectomy if a patient with clinical stage III, IV or V podoconiosis has fibrotic nodules. Early clinical stage podoconiosis patients will be individuals with negative filarial test and at clinical stages I or II. Controls will be individuals with no past or current history, signs and symptoms of podoconiosis and no family history of podoconiosis.~EXCLUSION CRITERIA:~-In addition to clinical criteria that make patients and controls non-eligible to undergo surgery, we will also exclude individuals with skin infection, skin lesion at the prospective biopsy site, medical contradictions to biopsy, history of adenolymphangitis during the previous 2 weeks, topical steroid treatment during the previous 2 weeks, with biologically related family members that are included in the study, recent infection, use of systemic antibiotics and use of systemic steroids. Attempts will be made to enroll an equal number of men and women. No prisoners, pregnant women or fetuses will be included in this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Advanced (Type: None): advanced stage podoconiosis
- Control (Type: None): non-podoconiosis controls
- Early (Type: None): early stage podoconiosis

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

Answer: outcome: terminate
termination_type: enrollment issues