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

Trial Title: Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* Menstruating and has cycles between 21 and 35 days~* Meets DSM-IV criteria for PMDD~* Experienced symptoms of PMDD in at least 9 of 12 menstrual cycles within 1 year of study entry~* Willing to use an effective form of birth control throughout the study~Exclusion Criteria:~* Meets MINI DSM-IV criteria for major depressive episode, substance abuse, bulimia nervosa, anorexia, bipolar disorder, or a psychotic disorder, such as schizophrenia or schizoaffective disorder, within 6 months of study entry~* Meets MINI DSM-IV criteria for a substance dependence disorder within 12 months of study entry~* Shows follicular phase symptoms consistent with a diagnosis of major depression~* Shows symptoms consistent with bipolar disorder~* Diagnosed with a severe, clinically significant co-existing condition that may prevent study participation~* Suicidal~* Taking ongoing antidepressant or other psychotropic medication~* History of hypersensitivity or an adverse reaction to sertraline~* Pregnant or breastfeeding~* Currently undergoing treatment with a depot hormonal preparation or any other medication that would lead to a lack of menses or markedly irregular menses~* Using a hormonal contraceptive pill or hormonal device within 6 months of study entry~* Taking a hormonal contraceptive pill that includes 20 micrograms of ethinyl estradiol and 3 micrograms of drospirenone~* Has been in individual psychotherapy or individual counseling for 3 months or less at study entry

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 48 Years
- Healthy Volunteers: f

Study Arms:
- Sertraline (Type: EXPERIMENTAL): Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
- Placebo (Type: PLACEBO_COMPARATOR): Participants will take similar looking placebo during the symptomatic period.

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 Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

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

Eligibility Criteria:
Inclusion Criteria:~* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1 and agrees to an acceptable method of contraception~* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)~* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.~* At Visit 1, FEV1/FVC ratio must be \<0.70~* At Visit 1, post-bronchodilator FEV1/FVC ratio of \<70% and FEV1 must be 30% to 80% before predicted normal value, calculated using NHANES III reference equations.~Exclusion criteria:~* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.~* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.~* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.~* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).~* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).~* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.~* Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.~Please refer to the study protocol for the complete inclusion criteria list.

- Gender: ALL
- Minimum Age: 40 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- GFF MDI, 14.4/9.6μg (Type: EXPERIMENTAL): Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
- Placebo MDI (Type: PLACEBO_COMPARATOR): Placebo Metered Dose Inhaler (MDI)

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 of LY900014 in Participants With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: BASIC_SCIENCE
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year~* Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)~* Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%)~* Have had no episodes of severe hypoglycaemia in the last 6 months~Exclusion Criteria:~* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data~* Have a history of renal impairment~* Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives~* Have proliferative retinopathy or maculopathy and/or severe neuropathy

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

Study Arms:
- LY900014 (Type: EXPERIMENTAL): Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods
- Insulin Lispro (Humalog) (Type: ACTIVE_COMPARATOR): Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods

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: Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI

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

Eligibility Criteria:
Inclusion Criteria:~* Patients presenting with STEMI defined as both of the following: a) Symptoms of myocardial ischemia lasting for ≥ 30 minutes, and b) Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads.~* Referred for primary PCI for presenting symptoms.~* Randomized within 12 hours of symptom onset and prior to diagnostic angiography.~Exclusion Criteria:~* Age ≤18 years.~* Pregnancy or breastfeeding.~* Current or planned treatment with a PCSK9 inhibitor.~* Allergy or contra-indication to a PCSK9 inhibitor.~* Killip class ≥2.~* Known Creatinine clearance \<30mL/min.~* Suspected takotsubo / stress-induced cardiomyopathy or acute pericarditis.~* Any other medical, geographic, or social factor making study participation impractical or precluding follow-up.

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

Study Arms:
- Alirocumab (Type: EXPERIMENTAL): None
- Sham Control (Type: SHAM_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: A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Study Design Characteristics:
- Allocation: NON_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:~* Successful completion of Protocol PB-06-002 or PB-06-005~* The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent~Exclusion Criteria:~* Currently taking another investigational drug for any condition.~* Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.~* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 18 Years
- Healthy Volunteers: f

Study Arms:
- 60 Units/kg (Type: EXPERIMENTAL): None
- 30 Units/kg (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: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Type 2 diabetes~* Treatment with metformin alone for at least three months~* HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)~* Body Mass Index (BMI) less than or equal to 45.0~Exclusion Criteria:~* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors~* Treatment with anti-diabetic drugs other than metformin within the last three months~* Any serious medical condition~* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

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

Study Arms:
- Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg (Type: EXPERIMENTAL): Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
- Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg (Type: EXPERIMENTAL): Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
- Sita -> Sita (Type: ACTIVE_COMPARATOR): Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
- Sita -> Sita -> Lira 1.2 mg (Type: EXPERIMENTAL): Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
- Sita -> Sita -> Lira 1.8 mg (Type: EXPERIMENTAL): Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.

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: Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* to live in a non-fluoridated area~* to have at least 20 natural teeth~* signed a consent form agreeing to carefully follow the research instructions~Exclusion Criteria:~* presence of active caries lesions~* periodontal disease~* use of antibiotics/medication.

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: 30 Years
- Healthy Volunteers: t

Study Arms:
- dentifrice intervention (Type: EXPERIMENTAL): 4 types of dentifrices were used in 4 different periods in a crossover study design.

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: Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma~  * CD5 positive OR~ * Evidence of bcl-1 oncogene overexpression~* Measurable or evaluable disease with at least one of the following:~  * Clear cut radiographic findings~ * Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan~ * Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only~ * Enlarged liver with proof of lymphoma by biopsy~* CNS involvement allowed~* Fully HLA matched donor for allogeneic transplantation~PATIENT CHARACTERISTICS:~Age:~* 18 and over~Performance status:~* ECOG 0-3~Life expectancy:~* Not specified~Hematopoietic:~* Not specified~Hepatic:~* Bilirubin no greater than 3.0 mg/dL~Renal:~* Creatinine no greater than 2.0 mg/dL~Cardiovascular:~* No significant cardiac disease~Other:~* No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix~* No other medical problems that would preclude study~* HIV negative~* Not pregnant or nursing~* Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* See Disease Characteristics~Chemotherapy:~* See Disease Characteristics~* Prior chemotherapy, including doxorubicin, allowed~Endocrine therapy:~* See Disease Characteristics~* Prior steroids allowed~Radiotherapy:~* See Disease Characteristics~* Prior radiotherapy allowed excluding the indicator lesions~Surgery:~* Not specified

- 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: complete
Please assess the completion status of the following clinical trial:

Trial Title: Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate

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

Eligibility Criteria:
Inclusion Criteria:~* Age 18-60 years.~* BMI\> 19kg/m2 and \<29kg/m2.~* Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.~* Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM\> 70%.~* No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.~* Signed informed consent~Exclusion Criteria:~* Smoking~* Drug abuse~* Pregnant or lactating~* Infection with Hepatitis B or C, or HIV~* Known drug allergies~* Family history of blood disorders or coagulation.~* History of disease that alters the absorption, metabolism or excretion of drugs, including jaundice.~* Personal history of bleeding and / or blood dyscrasias (especially hemophilia, hypoprothrombinemia), including vascular malformations reasonable suspicion.~* History of any medically relevant condition~* Background of major surgery in the last 3 months~* Prescription of chronic medication in the 14 days prior to study participation.~* Participation in another study involving the administration of an investigational product in the last 4 months or a product already on the market in the last three months.

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

Study Arms:
- prasugrel and acetylsalicylic (Type: ACTIVE_COMPARATOR): single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally
- lysine acetylsalicylate and prasugrel (Type: EXPERIMENTAL): single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous

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 Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery~* BRAF or NRAS mutation in tumor tissue~* All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol~* Evidence of measurable tumor disease as per RECIST~* WHO performance status of 0-2~* Adequate organ function and laboratory parameters~Exclusion Criteria:~* History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO~* Patients with unstable CNS metastasis~* Prior treatment with a MEK- inhibitor~* Impaired cardiovascular function~* HIV, active Hepatitis B, and/or active Hepatitis C infection~* Pregnant or nursing (lactating) women~* Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements~Other protocol-defined inclusion/exclusion criteria may apply.

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

Study Arms:
- BRAFV600 mutant, 45mg bid MEK162 (Type: EXPERIMENTAL): BRAFV600 mutant, 45mg bid MEK162
- NRAS mutant, 45mg bid MEK162 (Type: EXPERIMENTAL): NRAS mutant, 45mg bid MEK162
- BRAFV600 mutant, 60mg bid MEK162 (Type: EXPERIMENTAL): BRAFV600 mutant, 60mg bid MEK162

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: Study of Pain Control With Hormonal IUS Insertion

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

Eligibility Criteria:
Inclusion Criteria:~* Nulliparous (i.e., no pregnancy \> 24 weeks)~* Not currently pregnant~* Not pregnant in the past 6 weeks~* Willing to be randomized to a paracervical nerve block or sham paracervical block group~* Interested in using an intrauterine system (IUS)~* Able to read and provide written informed consent in English~Exclusion Criteria:~* An allergy, hypersensitivity, or absolute medical contra-indication to using lidocaine, other amino-amide local anesthetics, or to non-steroidal anti-inflammatory agents, such as ibuprofen~* A history of epilepsy or peptic ulcer disease~* Moderate to severe asthma that precludes non-steroidal anti-inflammatory drug (NSAID) use~* Hepatic or renal failure~* Moderate to severe cardiac disease~* Previous use of an IUS or a history of a prior failed IUS insertion~* Use of a narcotic or benzodiazepine in the past 24 hours~* Positive pregnancy test or reasonable risk of pregnancy~* Current cervicitis~* Intrauterine infection in the past 90 days~* Meet Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for IUS use~* Currently breastfeeding

- Gender: FEMALE
- Minimum Age: 14 Years
- Maximum Age: 22 Years
- Healthy Volunteers: t

Study Arms:
- Paracervical Nerve Block (Type: ACTIVE_COMPARATOR): Ten milliliters of 1% lidocaine paracervical anesthetic will be injected at three cervical locations: 1 mL at the tenaculum site (12 o'clock on a clock face) and 4.5 mL each at the 4 o'clock and 8 o'clock positions. A 3 minute waiting period will be used between the administration of the paracervical nerve block and the insertion of IUS to allow the paracervical block to take effect.
- Sham Paracervical Block (Type: SHAM_COMPARATOR): To perform the sham cervical block, the cervix will be touched with the blunt end of a Q-tip at the three locations described above for the paracervical block. The cervical mucosa will not be broken during the sham block. A 3 minute waiting period will again occur between administration of the sham block and IUS insertion to be consistent with the procedure used for the nerve block.

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

Answer: outcome: complete