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

Trial Title: A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Adequate complete blood counts, liver and renal function~* Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization~* Male subjects agree to use appropriate contraception~* Willing to provide written informed consent and willing to comply with study requirements.~* Non-smokers and non-nicotine users for at least 90 days before screening~* On stable statin co-medication \[for designated multiple dose cohorts only\]~Exclusion Criteria:~* Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk~* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study~* History of multiple drug allergies or intolerance to subcutaneous injection~* Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)

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

Study Arms:
- ALN-PCSSC (Type: ACTIVE_COMPARATOR): None
- Sterile Normal Saline (0.9% NaCl) (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: Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: FACTORIAL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* People who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days;~* Sign the informed consent form voluntarily.~Exclusion Criteria:~* Chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.;~* The female is pregnant or in the period of preparing for pregnancy or breast-feeding;~* Have a history of smoking;~* Have a history of thrombosis in the upper limbs;~* Severe damage to local soft tissues of upper limbs, fractures, etc.;~* Allergic to sulfa;~* Are taking one or more drugs;~* Past laboratory tests suggest hypokalemia, hyponatremia, or liver and kidney damage;~* Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 50 Years
- Healthy Volunteers: t

Study Arms:
- Medicine Group (Type: ACTIVE_COMPARATOR): Start orally take Acetazolamide 2 days before entering the hypoxic room.
- RIPC Group (Type: ACTIVE_COMPARATOR): Start RIPC training twice daily, 6 days before entering the hypoxic room.
- Rapid RIPC Group (Type: EXPERIMENTAL): Start RIPC training forth daily, 3 days before entering the hypoxic room.
- Combined Group (Type: EXPERIMENTAL): Medicine + Rapid RIPC
- Control Group (Type: NO_INTERVENTION): Subjects do not receive specific interventions before entering the hypoxic room.

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 Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

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:~Subjects must satisfy the following criteria to be enrolled in the study:~1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.~2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline.~3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.~4. Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.~Exclusion Criteria:~The presence of any of the following will exclude a subject from enrollment:~1. Subject has a diagnosis of plaque-type psoriasis.~2. Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.~3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).~4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.~5. Subject has periodontitis obviously requiring treatment at screening.~6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.~7. Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.~8. Subject is pregnant or breastfeeding.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Placebo then Apremilast 30mg BID (Type: EXPERIMENTAL): Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
- Apremilast 30 mg BID then Apremilast 30 mg BID (Type: EXPERIMENTAL): Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

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: Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women

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

Eligibility Criteria:
Inclusion Criteria:~* age between 18 and 35 years~* Postpartum contraception desire~Exclusion Criteria:~* smoking, alcoholism or drug addiction~* presence of systemic diseases (diabetis melittus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia)~* having a body mass index ≥ 30 kg/m2~* personal history of arterial or venous thrombosis~* using any medication that might interfere with blood coagulation or with the assessment of haemostatic and inflammatory variables~* presenting alterations in hepatic enzymes~* being allergic to local anaesthetics (xylocaine)

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 35 Years
- Healthy Volunteers: t

Study Arms:
- etonogestrel implant (Type: EXPERIMENTAL): Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration.
- depot medroxyprogesterone acetate (Type: ACTIVE_COMPARATOR): At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).

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: Qvar Versus Clenil, a General Practice Research Database Study

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

Eligibility Criteria:
Inclusion Criteria:~* Aged: 4-80 years~* Paediatric cohort (aged 4-11 years), and~* Adult cohort (aged 12-80 years )~* Evidence of asthma and current asthma therapy:~* All cohorts (IPDI, IPDS, IPDA):~  * a diagnostic code for asthma, and / or \*≥2 prescriptions for asthma at different points in time during the prior year and/or IPDI only: ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription in addition to that received at IPD~IPDA and IPDS only:~* 1 ICS prescription in the baseline year, and~* 1 other asthma prescription during the baseline year.~  \*Evidence of current therapy:~* 2 prescription for ICS during the outcome year (i.e. ≥1 prescription in addition to the prescription at index date~  * Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).~Exclusion Criteria:~* Had a COPD read code at any time; and/or~* Had any chronic respiratory disease, except asthma, at any time; and/or~* Patients on maintenance oral steroids during baseline year~* Received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or~* Received ICS therapy during baseline year via DPI (IPDA and IPDS cohorts only).~* If they received multiple ICS prescriptions on the same day at IPD or immediately before

- Gender: ALL
- Minimum Age: 4 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- IPDI EF HFA-BDP (Type: None): Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
- IPDI SP HFA-BDP (Type: None): Patients initiating inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
- IPDA SP HFA-BDP (Type: None): Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
- IPDA EF HFA-BDP (Type: None): Patients increased inhaled corticosteroid therapy as extra fine particle HFA-BDP MDI at the index date
- IPDS SP HFA-BDP (Type: None): Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
- IPDS EF HFA-BDP (Type: None): Patients increased inhaled corticosteroid therapy as extrafine particle HFA-BDP MDI at the index date

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: Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System

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

Eligibility Criteria:
Inclusion Criteria:~1. Patient must be 16 to 25 years old~2. Patient must have at least one unrestored molar identified as sound according to the ICDAS coding system~3. Patient must have at least one unrestored erupting (in which case occlusal surface must be such that, apart from minimal presence of an operculum over the distal marginal ridge, it is clear of the gingivae (gum)) or erupted third molar with a caries lesion identified, coded 1, 2 or 3 (according to the ICDAS coding system)~4. Patient must be willing and able to give written informed consent~5. Patient must be willing and able to adhere to study schedule~Exclusion Criteria:~1. Recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)~2. On-going re-mineralisation treatment including, but not limited to high concentration prescription fluoride toothpaste~3. Any patient with a fixed orthodontic appliance~4. Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months~5. Pregnant and / or nursing mothers

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: 25 Years
- Healthy Volunteers: f

Study Arms:
- Sound and Unsound Molars (Type: OTHER): Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System

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: Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

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

Eligibility Criteria:
Inclusion Criteria:~* Age according to approved label and physician discretion~* Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before~Exclusion Criteria:~* Subjects who previously enrolled in this study~* Subjects who are unlikely to comply with protocol requirements~* Hypersensitivity to biphasic insulin aspart or to any of the excipients~* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

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

Study Arms:
- A (Type: None): biphasic insulin aspart

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 Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic 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: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Cytokine refractory metastatic renal cell carcinoma with clear cell component~* Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy~* Prior nephrectomy~Exclusion Criteria:~* Prior treatment with any systemic therapy other than 1 cytokine therapy~* History of or known brain metastases~* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

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

Study Arms:
- 1 (Type: EXPERIMENTAL): 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: Tiotropium / Respimat One Year Study in COPD.

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

Eligibility Criteria:
Inclusion Criteria:~1. Male or female~2. At least 40 years old~3. Smoker or ex-smoker~4. Smoking history \> 10 pack-years~5. Forced Expiratory Volume in 1 Second (FEV1) \< 60% predicted~Exclusion Criteria:~1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure~2. History of asthma or allergic conditions.~3. Malignancy requiring treatment within past 5 years~4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis~5. Known active tuberculosis~6. Known hypersensitivity to anticholinergic drugs.

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

Study Arms:
- Tiotropium (Type: OTHER): Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
- Placebo (Type: OTHER): Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

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: To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.

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:~* Females of child-bearing potential must be using and are willing to continue using effective birth control methods, or be willing to practice sexual abstinence throughout treatment or be nonheterosexual active~* Confirmed pulmonary MDR-TB infection including those infected with XDR (extensively drug resistant)-TB~* Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (= 1+ smear-positive)~* HIV-positive patients are eligible, provided they meet the requirements as described in the protocol~* Must voluntarily sign the Informed Consent Form (ICF) prior to starting any study activities~* Willing to comply with protocol requirements~* Willing to comply with NTP treatment guidelines~Exclusion Criteria:~* Patients having a known or suspected hypersensitivity or serious adverse reaction to TMC207~* Patients with significant cardiac arrhythmia requiring medication~* Patients with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection~* Patients with certain QT/QTc interval characteristics as described in the protocol~* Patients having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start~* Women who are pregnant or breastfeeding~* Patients who have previously received treatment with TMC207 as part of a clinical trial.

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

Study Arms:
- TMC207 (Type: EXPERIMENTAL): TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks in addition to Background Regimen (BR) for the treatment of multi-drug resistant tuberculosis (MDR-TB).

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: Rasagiline Rescue in Alzheimer's Disease Clinical Trial

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

Eligibility Criteria:
Inclusion Criteria:~* Males or females 50 to 90 of age inclusive.~* Diagnosis of probable AD (NINCDS-ADRDA criteria)~* Positive fluoro-deoxyglucose PET (\[18F\]-FDG PET) scan compatible with AD as determined by the ADM Diagnostics LLC (ADMdx) Criteria at screening~* Mini Mental Status Exam = 12 - 22 (inclusive)~* Must have a study partner who is able and willing to comply with all required study procedures.~* Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.~* If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 3 months prior to screening~Exclusion Criteria:~* Any non-AD neurological disease~* MRI findings indication of a non-AD diagnosis~* Screening laboratory studies that are 1.5 times above or below the highest and lowest range of normal for each test respectively~* History of melanoma; history of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer

- Gender: ALL
- Minimum Age: 50 Years
- Maximum Age: 90 Years
- Healthy Volunteers: f

Study Arms:
- Placebo (Type: PLACEBO_COMPARATOR): Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
- Rasagiline (Type: ACTIVE_COMPARATOR): Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.~Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).

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: Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine

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

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent~* Adults 20-59 years of age~Exclusion Criteria:~* Allergies to eggs, thimerosal, gentamicin sulphate, neomycin~* Life-threatening reaction to previous Flu vaccine~* Bleeding disorder~* Pregnancy~* Receipt of blood or blood products in past 3 months~* Chronic illness~* Compromised immune system~* Previous lab-confirmed H1N12009 infection~* Receipt of H1N12009 vaccine~* Receipt of Seasonal Influenza vaccine since March 2009

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 59 Years
- Healthy Volunteers: t

Study Arms:
- 1 (Type: OTHER): Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently
- 2 (Type: OTHER): Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine

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

Answer: outcome: complete