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

Trial Title: Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials

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:~1. Enrollment in STEADY-PD3 or SURE-PD3 studies~2. Prior consent to be contacted by the University of Rochester (UR) or if a participant from STEADY-PD III or SURE-PD3 studies directly contacts UR to request information about study participation~3. Internet-enabled device that will support participation in tele-visits~4. Have created or willing to create a Global Unique Identifier (GUID)~5. Willing and able to provide informed consent~6. English fluency~7. For participants opting to participate in the smartphone component, possession of a suitable smartphone (iPhone or Android) with adequate data plan and cellular network access/signal or wifi access~Exclusion Criteria:~1. Inability to carry out study activities as determined by study staff

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

Study Arms:
- former phase 3 PD trial participants (Type: None): The AT-HOME PD cohort enrolled upon completion of STEADY-PD3 or during completion of SURE-PD3; enrolling 2 to 6 years after diagnosis, and on standard dopaminergic therapy for 0 to 3 years. Former STEADY-PD3 participants had been randomized (1:1) to 3 years of isradipine or placebo treatment; SURE-PD3 participants had been randomized (1:1) to 2 years of inosine or placebo 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: A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

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

Eligibility Criteria:
Inclusion Criteria:~* Patients ≥ 18 years of age of both genders,~* Cervical dystonia~* symptoms with a minimum duration of 18 months,~* Negative pregnancy test in sexually active women,~* Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).~Exclusion Criteria:~* Patient with cervical contractures~* Known significant underlying dysphasia~* Patients who have received botulinum toxin treatment within the past 4 months.~* Contraindication to botulinum toxin treatment~* Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS ...)~* Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,~* Patients who required more than 500 units of Dysport or 200 units of Botox.~* Any concomitant treatment that could interfere with the action of botulinum toxin,~* Subjects having participated within the last 3 months or currently participating in an investigational drug study,~* Pregnancy,~* Lactation.

- Gender: ALL
- Minimum Age: 20 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Dysport® to Botox® (Type: EXPERIMENTAL): Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
- Botox® to Dysport® (Type: EXPERIMENTAL): Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

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 and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

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

Eligibility Criteria:
Inclusion Criteria:~* Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) \<50,000 copies/mL~* Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a \<13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1)~* Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1)~* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last dose of the study vaccine.~Exclusion Criteria:~* History of World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months~* History of invasive pneumococcal disease~* Known hypersensitivity to any vaccine component~* Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease~* Bleeding disorder contraindicating intramuscular vaccinations~* History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer~* Female participant: positive urine or serum pregnancy test~* Expect to receive any pneumococcal vaccine during the study outside of the protocol~* Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease~* Received a blood transfusion or blood products within 6 months of enrollment~* Participated in another clinical study of an investigational product within 2 months of enrollment~* Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- V114 (Type: EXPERIMENTAL): Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
- Prevnar 13™ (Type: ACTIVE_COMPARATOR): Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)

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: Prophylactic Treatment With Oseltamivir

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

Eligibility Criteria:
Inclusion Criteria:~* 18 years or older~* exposure to influenza during hospitalization~* risk factors for influenza complications~* consent for participation obtained~Exclusion Criteria:~* younger than 18 years~* hematological malignancy~* hospitalized in intensive care unit~* refusal to participate

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

Study Arms:
- 5 days (Type: ACTIVE_COMPARATOR): oral oseltamivir 75 mg once daily for 5 days post-exposure
- 10 days (Type: ACTIVE_COMPARATOR): oral oseltamivir 75 mg once daily for 10 days post-exposure

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: Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia

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

Eligibility Criteria:
Inclusion Criteria:~* Aged 29-77 years; have lived in Pasto, Colombia for at least 5 years and plan to remain in Pasto for ≥5 more years;~* Currently have Helicobacter pylori infection;~* Willing to refrain from alcohol consumption for 2 weeks;~* Have never taken a therapy to eradicate Helicobacter pylori;~* Have not taken antibiotics, bismuth compounds, proton-pump inhibitors, H2-receptor antagonists, or antacids within 30 days of the trial;~* Are not pregnant, and have little or no risk of pregnancy.~Exclusion Criteria:~* History of kidney, liver, heart, or mental disease;~* Frequent alcohol consumption;~* Allergic to clarithromycin, amoxicillin, penicillin, omeprazole or metronidazole;~* Currently taking drugs which may interact with any of the trial medications.

- Gender: ALL
- Minimum Age: 29 Years
- Maximum Age: 77 Years
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid for 14 days (with or without omeprazole 20 mg bid)
- 2 (Type: ACTIVE_COMPARATOR): Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days

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: Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~-Participants with Masseter Muscle Hypertrophy~Exclusion Criteria:~* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function~* Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face~* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction~* History of or current temporomandibular joint disorder (TMJD)

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

Study Arms:
- BOTOX® 24U (Type: ACTIVE_COMPARATOR): Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
- BOTOX® 48U (Type: ACTIVE_COMPARATOR): Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
- BOTOX® 72U (Type: ACTIVE_COMPARATOR): Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
- BOTOX® 96U (Type: ACTIVE_COMPARATOR): Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

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 Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

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

Eligibility Criteria:
Inclusion Criteria:~1. 18 years old to less than 65 years old~2. Subjects with malignancy must be receiving chemotherapy~3. Medically stable~4. Able to understand and willingness to sign a written informed consent~5. Able to comply with study procedures~6. Life expectancy of more than 3 months~7. Adequate organ function:~   * ANC \>1000/mm3~  * Platelet \>100,000/uL~  * Creatinine \<2 mg/dL~  * AST and ALT \<3 times the ULN~Exclusion Criteria:~1. Allergy to eggs~2. Prior allergy to Influenza Vaccine~3. History of Guillain-Barre Syndrome~4. Current febrile illness~5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)~6. Autologous or Allogenic Stem Cell Transplant with in a year~7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 64 Years
- Healthy Volunteers: f

Study Arms:
- High-Dose Influenza Vaccine (Type: EXPERIMENTAL): None
- Standard Trivalent Influenza Vaccine (Type: ACTIVE_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 Study of Vemurafenib in Participants With Metastatic Melanoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist~* Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1~* Participants may or may not have received prior systemic therapy for metastatic melanoma~* Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2~* Adequate hematologic, renal and liver function~Exclusion Criteria:~* Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib~* Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix~* Concurrent administration of any anti-cancer therapies other than those administered in the study~* Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug~* Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

- Gender: ALL
- Minimum Age: 16 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Vemurafenib (Type: EXPERIMENTAL): Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

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: Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

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:~* 10 years of age or older~* Executed informed consent~* Documented diagnosis of HAE (Type I or II)~* Presentation at the site within 8 hours of patient recognition of an moderate to severe HAE acute attack~Exclusion Criteria:~* Receipt of an investigational drug or device, within 30 days prior to study treatment~* Receipt of non-investigational C1-INH within 7 days of treatment~* Receipt of DX-88 (ecallantide) within 3 days prior to study treatment~* Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)~* Pregnancy or breastfeeding

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- DX-88 (ecallantide) (Type: EXPERIMENTAL): DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections.
- Placebo (Type: PLACEBO_COMPARATOR): Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.

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 Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis

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

Eligibility Criteria:
Inclusion Criteria:~* Adult trauma patients admitted to ICU within 24 hours from trauma onset with injury severity score (ISS) ≥ 16 will be recruited after obtaining informed consent~Exclusion Criteria:~* • Patients admitted to ICU after time exceeding 24 hours from trauma onset.~  * Patients whose age is less than 18 years.~ * Pregnant female.~ * Breast feeding women.~ * Arrest within 24 hours of admission.~ * Immune deficiency or administration of immune suppressant drugs.~ * Serum calcium greater than or equal to 10 mg/dl or phosphate greater than or equal 6 mg/dl.~ * History of primary parathyroid disease.~ * Metabolic bone disease.~ * Sarcoidosis.~ * End stage renal disease.~ * receiving intermittent renal replacement therapy (RRT).~ * Failure of enteral feeding or any contraindication to enteral administration.~ * Obesity , body mass index (BMI \> 35 kg/m2)~ * Known contraindication to vitamin C or thiamine (oxalate nephropathy or known glucose-6-phosphate dehydrogenase deficiency)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Low risk group (Type: NO_INTERVENTION): no specific treatment will be given
- High risk control (Type: NO_INTERVENTION): no specific treatment will be given
- High risk DP (Type: ACTIVE_COMPARATOR): patients will receive one intramuscular (IM) injection of 400,000 IU of cholecalciferol on day- 1 Also, starting from day 1 and till day 6 (for consequential 6 days), patients will receive lactobacillus probiotics (10 billion colony forming unit) in a dose of 6 sachets per day
- High risk CB (Type: ACTIVE_COMPARATOR): Patients will receive vitamin C plus thiamine starting from day 1 in a dose of 1 gm vitamin C and 200 mg thiamine intravenous 4 times at 12-hour intervals for 48 hours

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: Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE4
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* ages 18 and older~* complaint of nausea and/or vomiting reported at 3 or above on verbal numerical rating scale at the time of triage~Exclusion Criteria:~* allergy to isopropyl alcohol or ondansetron~* inability to breathe through nose (e.g., recent upper respiratory infection)~* intake of cefoperazone, disulfiram, or metronidazole within the last 24 hours~* mental status precluding informed consent including intoxication~* known QT-prolongation~* clinical suspicion for serotonin syndrome~* intravenous catheter in place prior to study start~* medications administered since patient arrival (e.g., in triage)

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

Study Arms:
- Inhaled ISO + oral ondansetron (Type: ACTIVE_COMPARATOR): Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral elixir comprising ondansetron (4 mg).
- Inhaled ISO + oral placebo (Type: EXPERIMENTAL): Inhaled isopropyl alcohol pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.
- Inhaled placebo + oral ondansetron (Type: ACTIVE_COMPARATOR): Inhaled normal saline pads as needed for nausea (up to q30 minutes) and drink oral placebo elixir.

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: Dose Finding Study to Treat High Phosphate Levels in the Blood.

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE2
- Number of Arms: 7.0

Eligibility Criteria:
Inclusion Criteria:~1. Females and males aged ≥18 years~2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months~3. Prescribed and taking at least 3 doses of phosphate binder per day~4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening~5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening~6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out~Exclusion Criteria:~1. Severe hyperphosphatemia defined as \>10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.~2. Serum parathyroid hormone \>1200 pg/mL~3. Significant metabolic acidosis~4. Clinical signs of hypovolemia at randomization~   -

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

Study Arms:
- 1 mg bid (Type: EXPERIMENTAL): 1 mg AZD1722 bid
- 3 mg bid (Type: EXPERIMENTAL): 3 mg AZD1722 bid
- 10 mg bid (Type: EXPERIMENTAL): 10 mg AZD1722 bid
- 30 mg bid (Type: EXPERIMENTAL): 30 mg AZD1722 bid
- 3 mg od (Type: EXPERIMENTAL): 3 mg AZD1722 od
- 30 mg od (Type: EXPERIMENTAL): 30 mg AZD1722 od
- Placebo (Type: PLACEBO_COMPARATOR): Placebo (double dummy technique)

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

Answer: outcome: complete