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

Trial Title: Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Metastatic Renal Cell Carcinoma.~2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.~Exclusion Criteria:~1. Prior chemotherapy.~2. Prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib.~3. Laboratory values outside normal ranges.~4. Myocardial infarction (MI) within past 12 months.~5. Current congestive heart failure.

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

Study Arms:
- Cohort A (Type: EXPERIMENTAL): Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle
- Cohorts F and G (Type: EXPERIMENTAL): Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle

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: The Mindfulness, Incontinence and Sexual Function Treatment Study

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. Women 19 years and older with both UI and sexual dysfunction, seen at the Centre for Pelvic Floor, and are interested and available to participate in the study.~2. UI is defined as one of the items below:~   * Stress UI: involuntary loss of urine with increased intra-abdominal pressure (effort, coughing, laughing, sneezing, physical exercise, etc.)~     * Symptoms and positive response to question # 17 of Pelvic Floor Distress Inventory (PFDI-20)~    * Or Positive cough stress test on exam~    * Or positive urodynamics stress UI Urgency UI (also referred to as overactive bladder): involuntary loss of urine with urgency~    * Symptoms and positive response to question # 16 of PFDI-20~    * Or positive urodynamics overactive bladder~  * Mixed UI: combination of stress and urgency UI~  * +/- prolapse or other PFDs concomitantly~  * Can chose any treatment for their condition that is offered to them, but for analysis purposes, must agree to using only one line of treatment during the course of study (should not change treatment during study)~3. Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more, for significant distress to be experienced as a result, and for the condition to not be better explained by a mental or medical condition.~4. Sexual distress will be diagnosed as score of 11 or higher on the female sexual dysfunction scale~Exclusion Criteria:~1. Non-English speaking~2. Pregnancy~3. Neurological conditions explaining UI~4. Congenital genitourinary defects~5. Genital fistulas

- Gender: FEMALE
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Mindfulness Intervention (Type: ACTIVE_COMPARATOR): For those randomly selected to receive mindfulness-based sex therapy, they will be asked to participate in four sessions of group therapy, over a period of 2 months. Sessions will occur in a conference room at St. Paul's Hospital. Part of the protocol of the Mindfulness - based sex therapy is that they will have a diary to be filled in. This diary will not be collected at the end of the therapy, as it is for the participant to keep. The group facilitators will be collecting session attendance.
- No Intervention (Type: NO_INTERVENTION): For those who are not in the intervention group they will simply be asked to fill the initial questionnaire and the 3 month post questionnaire. They will not participate in any other questionnaires.

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: Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

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

Eligibility Criteria:
Inclusion Criteria:~* Adult patient's ≥18 years old with moderately to severely active Rheumatoid Arthritis (RA) (ACR/EULAR criteria )~* Previously untreated with Janus Kinase (JAK) inhibitors~* With an indication for tofacitinib will be eligible.~* All patients will have to be treated with tofacitinib either alone or with methotrexate. -Healthy volunteers should be ≥18 years old.~Exclusion Criteria:~* • treatment with more than three anti-Tumor Necrosis Factor alpha (TNFα). Patients who were receiving anti-TNFα will be required a washout period lasting at least five-half-lives before to start tofacitinib,~  * previously exposed to JAK inhibitors,~ * patients who were receiving non-anti-TNFα biologics (abatacept, tocilizumab, sarilumab or rituximab) will be required a washout period lasting at least five-half-lives before to start tofacitinib~ * Concomitant methotrexate (MTX) will be permitted if started ≥3 months prior to study start and at a stable dose (≤25 mg/week) for ≥4 weeks.~ * history or discovery of an osteoporotic fracture AND/OR T-score≤-3 if ≥50 years AND/OR Z-score ≤-3 if \<50 years during the screening phase,~ * current treatment with oral corticosteroids higher than 10 mg prednisone/day,~ * pathologies or treatments that could affect the bone metabolism (breast cancer with aromatase inhibitors, gastrointestinal malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),~ * weight\> 160 kg,~ * patients on restrictive diets or considering such a diet during the study period,~ * patients with an intense exercise program or planning to benefit from it during the study period,

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

Study Arms:
- Patients with rheumatoid arthritis (Type: None): Patients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day
- Healthy subjects (Type: None): Healthy subjects matched to cases (1:1) on age (±5 years), sex, and menopausal status for women and body mass index (BMI, ±3 kg/m²)

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: Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy

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

Eligibility Criteria:
Inclusion Criteria:~1. Age \>1 year.~2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.~3. Meets institutional criteria for admission to hospital for COVID-19.~4. Admitted to ICU or non-ICU floor within 5 days of enrollment.~5. PaO2/FiO2 \>200 mmHg if intubated.~6. Patient or LAR able to provide informed consent.~Exclusion Criteria:~1. Previous treatment with convalescent plasma for COVID-19.~2. Current use of investigational antiviral therapy targeting SARS-CoV-2.~3. History of anaphylactic transfusion reaction.~4. Clinical diagnosis of acute decompensated heart failure.~5. Objection to blood transfusion.

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

Study Arms:
- Arm A (Type: EXPERIMENTAL): Two units of apheresis HT-CCP, collected from the same donor whenever possible, will be administered sequentially over no greater than a 24-hour period to participants randomized to Arm A. Each unit of HT-CCP will be approximately 250 mL, for a total transfused volume of approximately 500 mL.
- Arm B (Type: PLACEBO_COMPARATOR): Two units of FFP or FP24 (each 200-275 mL, approximately 500 mL total) will be administered sequentially to participants randomized to Arm B. (FFP/FP24 unit volumes vary more than apheresis plasma units. Two FFP/FP24 units that are approximately 250 mL apiece will be provided.)

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: Study of BIIB092 in Participants With Progressive Supranuclear Palsy

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:
Key Inclusion Criteria:~* Participants with probable or possible PSP~* Able to ambulate independently or with assistance~* Able to tolerate MRI~* Have reliable caregiver to accompany participant to all study visits~* Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening~* Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned~Key Exclusion Criteria:~* Presence of other significant neurological or psychiatric disorders~* Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease~* History of early, prominent rapid eye movement (REM) sleep behavior disorder~* History of or screening brain MRI scan indicative of significant abnormality~* Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay~NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

- Gender: ALL
- Minimum Age: 41 Years
- Maximum Age: 86 Years
- Healthy Volunteers: f

Study Arms:
- BIIB092 (Type: EXPERIMENTAL): Participants will receive BIIB092 50 mg/ml intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.
- Placebo (Type: PLACEBO_COMPARATOR): Participants will receive BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.

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: Mitochondrial Function in Patients With Severe Liver Disease

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

Eligibility Criteria:
Inclusion Criteria:~* Severe liver disease defined as known liver disease plus at least one of the following: serum albumin less than 3.0 g/dL or INR more than 2.0.~Exclusion Criteria:~* Portal systemic encephalopathy~* Pregnancy or breastfeeding.~* Anemia (hematocrit \< 32%)~* Significant weight loss or use of diet pills within previous 6 months.~* Cannot give informed consent, understand the protocol, or tolerate any aspect of the protocol.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 70 Years
- Healthy Volunteers: t

Study Arms:
- Orally administered Labeled Glycerol (Type: EXPERIMENTAL): Patients will receive an oral mixture of \[U-13C3\]glycerol (25 mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100 milliliters of water.

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 Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass

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

Eligibility Criteria:
Inclusion Criteria:~* Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery~* Males and non-pregnant, non-lactating females~Exclusion Criteria:~* Subjects will be required to undergo a full medical review in order to exclude serious medical or psychological illness prior to inclusion~* History of a hypersensitivity reaction to more than three drugs or to mannitol~* Participation in any other investigational study within 30 days of the screening phase~* Known alcohol or drug abuse within the last year~* Treatment with certain restricted medications within a specified time prior to participation in the study

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

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: Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~1. Subject has signed consent~2. Age \> 18 years~3. Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant~Exclusion Criteria:~1. Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial issues that might impair compliance with the study.~2. Patients already taking fish oil.

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

Study Arms:
- Primary Prevention Intervention (Type: EXPERIMENTAL): In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.
- Primary Prevention Non-Intervention (Type: PLACEBO_COMPARATOR): In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.
- Secondary Prevention Intervention (Type: EXPERIMENTAL): In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.
- Secondary Prevention Non-Intervention (Type: PLACEBO_COMPARATOR): In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.

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: IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population

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

Eligibility Criteria:
Inclusion Criteria:~* Children of either sex of Caucasian parents~* Age: newborns up to and including 18 years of age~* Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)~* Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years~Exclusion Criteria:~* Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)~* Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes~* An acute disease during the last two weeks prior to recruitment~* Any clinically significant out-of-range lab value~* Healthy paediatric volunteers who are under medical treatment (contraception permitted)~* A family history of short stature (either parent \< P3)~* Children born small for gestational age (birth weight, length, or head circumference \< P10)~* Adopted children or conceived through in vitro fertilization ( IVF )~* Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures

- Gender: ALL
- Minimum Age: None
- Maximum Age: 18 Years
- 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: An fMRI Study of Attention and Effort After Concussion

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

Eligibility Criteria:
Inclusion Criteria:~* Mild TBI (based on criteria of the American Congress of Rehabilitation Medicine)~* Aged 18 to 60~* History of non-penetrating head injury~* Obtaining medical assistance (e.g., personal physician, Emergency Room) within 24 hours post-injury~Exclusion Criteria:~* No prior history of prior post-concussion syndrome (i.e, uncomplicated mild TBI)~* Moderate to severe TBI~* Substance dependence~* Learning disorder~* Attention-deficit disorder~* Mental retardation~* Severe psychiatric disorder requiring hospitalization~* Previous central nervous system disease~* Absence of neurosurgery~* No evidence of alcohol/drug use related to the injury

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 60 Years
- 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: ExploR® Modular Radial Head Data Collection

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

Eligibility Criteria:
Inclusion Criteria:~The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.~1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:~   1. Joint destruction and/or subluxation visible on x-ray~  2. Resistance to conservative treatment~2. Primary replacement after fracture of the radial head~3. Symptomatic sequelae after radial head resection~4. Revision following failed radial head arthroplasty~The device is intended for single use with or without bone cement.~Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.~Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.~Exclusion Criteria:~The exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:~Absolute contraindications:~1. Infection~2. Sepsis~3. Osteomyelitis~Relative contraindications:~1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions~2. Osteoporosis~3. Metabolic disorders which may impair bone function~4. Osteomalacia~5. Distant foci of infections which may spread to the implant site~6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

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

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: Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

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

Eligibility Criteria:
Inclusion Criteria:~* Adults aged 18 and older~* Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.~Exclusion Criteria:~* None

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

Study Arms:
- Medication management & NADA Protocol (Type: EXPERIMENTAL): Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens, and NADA protocol administered biweekly
- Medication management (Type: ACTIVE_COMPARATOR): Standard of care medication management defined by opioid weaning protocol with specific, symptomatic medication regimens.

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 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

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

Eligibility Criteria:
Inclusion Criteria:~* CD4 cell count greater than 50 cells/mm\^3~* HIV-1 RNA viral load greater than or equal to 5000 copies/mL~* Patients must be HIV treatment experienced~* Patients diagnosed with HIV-1 infection~Exclusion Criteria:~* Female patients must not be able to have children or must be under effective contraceptives~* Female patients who are pregnant~* Have taken enfuvirtide and/or T-1249 before~* Have serious kidney problems~* Alcohol and/or drug abuse~* Have had an organ transplant

- 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: terminate
termination_type: enrollment issues