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

Trial Title: Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

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

Eligibility Criteria:
Inclusion Criteria:~* Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)~* FEV1 \> 40% and \< 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)~* Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:~  750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)~* Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms \> 3 times in the week prior to inclusion~* A documented positive response to the reversibility test.~Exclusion Criteria:~* Pregnant or lactating females or women of childbearing potential without any efficient contraception.~* Heavy smokers defined as smoking for \> 10 pack years.~* Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).~* Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.~* Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.~* Patients with an abnormal QTc interval value in the ECG test, defined as \> 450 msec in males or \> 470 msec in females.~* Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability \> 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

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

Study Arms:
- beclometasone /formoterol (Type: EXPERIMENTAL): beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI
- Beclomethasone (Type: ACTIVE_COMPARATOR): Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.
- Formoterol powder 12 µg/unit dose (Type: ACTIVE_COMPARATOR): Formoterol powder 12 µg/unit dose (Foradil™)

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: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

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

Eligibility Criteria:
Inclusion Criteria:~* Male, age 65 years and older~* Total serum testosterone level \< 350 ng/dl~* Total Modified Physical Performance Test Score \<28~Exclusion Criteria:~* Inability to walk 50 feet independently~* Current use of estrogen, progestin, or androgen containing compound~* Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration~* Visual or hearing impairments that interfere with following directions~* Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training~* History of prostate cancer or hormone dependent neoplasia~* PSA level \> 4 ng/ml~* Serum liver transaminase levels of greater than 2 standard deviations above normal~* Use of drugs for osteoporosis for less than 1 year~* Current participation in a vigorous exercise or weight-training program more than once per week~* History of sleep apnea requiring use of CPAP~* Uncontrolled thyroid disease~* Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)~* hematocrit \> 50%~* AUA symptom score \> 16.~* History of alcohol or substance abuse~* Presence of severe facial acne~* Active symptoms of depression with GDS score \> 5 and symptoms severe enough to cause \>5% weight loss in previous 3 months or interfere with research assessments

- Gender: MALE
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Transdermal Testosterone gel (1%) (Type: ACTIVE_COMPARATOR): Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.
- Placebo gel (Type: PLACEBO_COMPARATOR): Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.

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: Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

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

Eligibility Criteria:
Inclusion Criteria:~* signed an Informed Consent Form~* stable COPD according to current guidelines (GOLD 2013)~* airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \<0.70 and a post-bronchodilator FEV1 of ≥30% and \<80% of predicted normal values at Visit 2.~* current or ex-smokers who have a smoking history of at least 10 pack years~* Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1~* Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).~Exclusion Criteria:~* Pregnant or breast feeding mothers~* Patients with conditions contraindicated for treatment~* Patients with a history of clinically significant diseases~* Patients who have a clinically significant renal disease~* Patients with myocardial infarctions less than 6 months prior to study entry~* Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.~* Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention~* Patients with a history of malignancy of any organ system~* Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening~* Patients who have had a respiratory tract infection within 6 weeks prior to Screening~* Patients with any history of asthma.

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Treatment sequence 1 (Type: EXPERIMENTAL): QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
- Treatment sequence 2 (Type: EXPERIMENTAL): Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

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 Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

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

Eligibility Criteria:
Inclusion Criteria:~* confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment~* willing to use effective contraception for the duration of the study~* able to comply with the requirement to complete a diary card~Exclusion Criteria:~* Pregnant or lactating females~* Major surgery within the 14 days preceding the screening visit~* Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis~* Treatment with another investigational medicinal product within the last 30 days prior to the screening visit~* Previous treatment with M. vaccae~* Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months~* Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system~* Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit~* Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit

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

Study Arms:
- IMM-101 (Type: EXPERIMENTAL): Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:~'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'

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: Pain in Patients With Dementia and Behavioural Disturbances

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: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Aged 65 and older~* Residing in the NHs for at least 4 weeks~* Dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association 1994), FAST score \> 4 (Hughes 1982).~* Clinically relevant BPSD, operationally defined as CMAI score ≥ 39 or higher or/and at least one week history of agitation or aggression (Koss 1997).~* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.~Exclusion Criteria:~* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering~* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation~* Psychosis or other severe mental disorder prior to dementia diagnosis;~* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom~* Schizophrenia, schizoaffective disorder and bipolar disorder~* Uncontrolled epilepsy~* Severe liver impairment~* Renal failure, as measured by or equivalent to an estimated creatinine clearance of \< 50mL/min/1.73m,~* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol.~* Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plaster or pregabalin

- Gender: ALL
- Minimum Age: 65 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Treatment as usual (Type: NO_INTERVENTION): Control group
- Paracetamol (Type: ACTIVE_COMPARATOR): Intervention group
- Morphine (Type: ACTIVE_COMPARATOR): Intervention group, individual pain treatment
- Buprenorphine plaster (Type: ACTIVE_COMPARATOR): Intervention group, individual pain treatment
- Pregabalin (Type: ACTIVE_COMPARATOR): Intervention group, individual pain treatment

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: Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Newly diagnosed Salmon-Durie stage II or III multiple myeloma~  * Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks~* Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)~* No evidence of cord compression requiring concurrent steroids~PATIENT CHARACTERISTICS:~* Creatinine clearance ≥ 30 mL/min~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment~* No known HIV positivity~* No peripheral neuropathy ≥ grade 2~* No hypersensitivity to bortezomib, boron, or mannitol~PRIOR CONCURRENT THERAPY:~* No prior bortezomib~* More than 28 days since prior regimens with a duration of \> 1 week but ≤ 2 weeks~* No steroids within 14 days prior to study entry~* No concurrent corticosteroids except for the treatment of a nonmalignant condition~  * May not exceed the equivalent dose of prednisone 10 mg/day~* No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery~* No other concurrent investigational agents

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

Study Arms:
- Bortezomib and Thalidomide (Type: EXPERIMENTAL): The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.

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: Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

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

Eligibility Criteria:
Critical Inclusion Criteria:~1. Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.~2. Subjects must be appropriate candidates for endocrine monotherapy~3. Subjects must have measurable disease or bone only disease~4. Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).~5. Subjects must have ER+ and HER2- tumor status~6. Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.~7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI) for advanced/metastatic breast cancer (mBC).~8. Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.~Critical Exclusion Criteria:~1. Prior treatment with elacestrant or other investigational selective estrogen receptor degrader (SERD) or ER antagonist (D-0502, GDC-0810, GDC- 0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene).~2. Prior anticancer or investigational drug treatment within the following windows:~   1. Fulvestrant treatment \< 42 days before first dose of study drug~  2. Any endocrine therapy \< 14 days before first dose of study drug~  3. Chemotherapy \< 21 days before first dose of study drug~  4. Any investigational anti-cancer drug therapy \< 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor~  5. Bisphosphonates or RANKL inhibitors initiated or dose changed \< 3 months prior to first dose of study drug~3. Presence of symptomatic visceral disease as defined in protocol.

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

Study Arms:
- Elacestrant (Type: EXPERIMENTAL): Subjects in Arm 1 will receive elacestrant
- Standard of Care (SoC) (Type: ACTIVE_COMPARATOR): Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

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: European Study of Dronedarone in Atrial Fibrillation

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:~* Patients with symptomatic permanent AF (\>6 months) for which cardioversion is not considered and resting ventricular rate \> or equal 80 bpm at screening measured on a 6-seconds rhythm strip,~Exclusion Criteria:~* Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes~* Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted~* Clinically overt congestive heart failure at randomization~* Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug~* Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease~* Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control~The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): None
- 2 (Type: PLACEBO_COMPARATOR): 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: Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

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

Eligibility Criteria:
Inclusion Criteria:~1. Healthy male and female subjects ≥ 18 years of age, with external genital warts. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than genital warts following a detailed medical history and a complete physical examination including vital signs and 12-lead ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.~2. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.~3. Willing to give written informed consent and willing and able to comply with the study protocol.~Exclusion Criteria:~Eligible subjects must meet none of the following exclusion criteria at screening:~1. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results including haematology, blood chemistry panel, virology or urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.~2. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).~3. Pregnant, breast feeding or trying to conceive.~4. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.~5. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.~6. Use of active treatment (i.e. cryotherapy, laser therapy, topical medication and/or surgical treatments) for genital warts within 28 days prior to first study drug administration.~7. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients).~8. Males or Females who received a vaccination with Gardasil or Cervarix.~9. Any (medical) condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.

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

Study Arms:
- Omiganan (CLS001) (Type: EXPERIMENTAL): CLS001 Topical Gel, 2.5%
- Vehicle (Type: PLACEBO_COMPARATOR): Vehicle Topical Gel

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

Answer: outcome: complete