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

Trial Title: Carvedilol PAH A Pilot Study of Efficacy and Safety

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

Eligibility Criteria:
Inclusion Criteria:~1. Subjects will be eligible to participate in the study if all of the following conditions exist:~2. Age \> 18 years~3. WHO category 1 pulmonary arterial hypertension (Dana Point 2008)~4. WHO functional class II-III~5. RVEF by cardiac MRI \< 40%~6. Mean pulmonary artery pressure \> 40 mm Hg~7. Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and functional class in the past 3 months. Patient can be on either mono or combination PAH-specific therapy~Exclusion Criteria:~* 1. Subjects will be excluded from participation in the study if any of the following conditions exist: 2. Significant persistent bradycardia (resting heart rate \< 60 bpm) without a permanent pacemaker 3. Second or third degree AV block without a permanent pacemaker 4. Significant sinus tachycardia (resting heart rate \> 100 bpm) 5. Use of anti-arrhythmic drugs 6. Hypotension defined as systolic blood pressure \< 100 mmHg at the time of enrollment 7. Significant illness in the past 30 days requiring hospitalization 8. Acute decompensated right heart failure within past 30 days 9. Known allergy or intolerance to carvedilol or other β blockers 10. Cardiac index \< 2 l/min/m2 or right atrial pressure \> 15 mm Hg 11. Asthma

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 99 Years
- Healthy Volunteers: f

Study Arms:
- Carvedilol (Type: EXPERIMENTAL): Carvedilol 0-3.125 mg daily Escalating to 6.25 twice a day

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®

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

Eligibility Criteria:
Inclusion Criteria:~* Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.~* Male and female participants 18 to 65 years of age.~* Participants must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite® app. Participants with a smartphone, that is not compatible with the Abilify MyCite® app will be offered a loaner phone for the trial period.~* Clinical diagnosis of schizophrenia and able to ingest oral medication.~* Positive and Negative Syndrome Scale (PANSS) total score between 60-90.~* Participants currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.~* Participants are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.~* Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems.~Exclusion Criteria:~* Females who are breast-feeding and/or who are pregnant.~* Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®.~* Any participants who participated in another clinical trial within 30 days of enrollment.~* Participants who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.~* Participants with a current DSM-5 diagnosis other than schizophrenia.~* Participants with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor.

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

Study Arms:
- Abilify MyCite® (Type: EXPERIMENTAL): Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease

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

Eligibility Criteria:
Inclusion Criteria:~1. Patients who are at least 18 years old~2. Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or Control patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)~3. Patients requiring coloscopy as part of their medical follow-up~4. Social insured.~Exclusion Criteria:~1. Pregnant women~2. Breastfeeding women~3. People in emergency~4. Persons unable to understand, read and / or sign informed consent~5. Patients who recently had an intercurrent episode (eg recent diarrhea ...)~6. Persons deprived of their liberty~7. Persons protected by a legal protection status

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

Study Arms:
- Control patients (Type: None): None
- Crohn's disease patients (Type: None): None
- Ulcerative colitis patients (Type: None): None

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

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

Eligibility Criteria:
Inclusion Criteria:~* healthy, non-smoking volunteers older than 18 years of age~Exclusion Criteria:~* history of gastrointestinal disease~* known infection~* previous eradication of Helicobacter pylori~* any prescription or over the counter antacid medication~* pregnant and lactating women

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

Study Arms:
- 1 (Type: ACTIVE_COMPARATOR): * esomeprazole 20mg po once per day for 7 days~* 24hr pH study on day 7~* followed by washout for 7 days~* generic omeprazole 20mg po once per day for 7 days~* 24hr pH study on day 7
- 2 (Type: ACTIVE_COMPARATOR): * generic omeprazole 20mg po once per day for 7 days~* 24hr pH study on day 7~* followed by washout for 7 days~* esomeprazole 20mg po once per day for 7 days~* 24hr pH study on day 7

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

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

Eligibility Criteria:
Inclusion Criteria:~* Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU).~* Informed consent.~Exclusion Criteria:~* Age \< 18 years~* Pregnancy~* Do Not Resuscitate (DNR/DNI) with limitations of care~* Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease)~* Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds~* Patients that need immediate surgical treatment~* Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells \< 50 mm2,~* Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.~* Patients with severe sepsis/septic shock transferred from another hospital~* Patients with features of sepsis/septic shock \> 24 hours~* Patients who require treatment with corticosteroids for an indication other than sepsis (chronic corticosteroid use, known Addison's Disease, Ulcerative colitis, Crohn's disease...)

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

Study Arms:
- Active substances (Type: EXPERIMENTAL): Vitamin C: Vitamin C will be mixed as 1500 mg vitamin C in 50ml container, which will then be infused over 30 minutes to 1 hour. The bag will be labeled by the pharmacy as Vitamin C. The dosing schedule is 1500mg every 6 hours for 4 days or until discharge from the ICU.~Hydrocortisone: Hydrocortisone will be mixed as 50 mg of Hydrocortisone in 50 ml of 0.9 % Sodium Chloride. Patients will be treated with hydrocortisone 50mg IV q 6 hourly for 4 days or until ICU discharge.~Thiamine: Intravenous thiamine will be given in a dose of 200mg q 12 hourly for 4 days or until ICU discharge.
- Control (Type: PLACEBO_COMPARATOR): Vitamin C placebo will consist of an identical container of 50cc normal saline (0.9% Sodium Chloride Injection) (but with no vitamin C) and will be labelled vitamin C. Placebo will be infused over 30-60 minutes as per the infusion instructions of the active vitamin. Hydrocortisone placebo will be provided in an identical 50 ml bag of 0.9% Sodium Chloride Injection. Placebo patients will receive a matching vial of 0.9% Sodium Chloride Injection.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)

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:~1. Males or females aged ≥ 18 and ≤ 70 years~2. Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum~3. HCV genotype 1 infection~4. Child-Pugh-Turcotte (CPT) score \< 7 and Model for End-Stage Liver Disease (MELD) score \< 18~5. PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)~6. Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:~   1. Single lesion up to 6 cm, or~  2. Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm~7. Listed for liver transplantation~8. Willingness to give written consent and agree to double contraception~Exclusion Criteria:~1. Decompensated cirrhosis~2. Baseline platelet count less than 35,000/µL~3. Baseline hemoglobin level less than 10 g/dL~4. Baseline absolute neutrophil count less than 750/mm3~5. Baseline creatinine clearance \< 50 mL per min.~6. Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy~7. Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 69 Years
- Healthy Volunteers: f

Study Arms:
- Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir (Type: EXPERIMENTAL): Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (\< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

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

Eligibility Criteria:
Inclusion Criteria:~* Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia~* Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug~* Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg~* Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.~Exclusion Criteria:~* History of psychiatric or personality disorders that may affect the patient's ability to participate~* History of stroke, chronic seizures, or major neurological disorder~* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)~* Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus~* History of neoplastic disease within previous 5 years~* Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)~* Has had major surgery, donated and/or received blood within previous 8 weeks~* Participated in another investigational study within previous 4 weeks~* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food~* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)~* Cannot swallow large tablets~* Pregnant or breastfeeding

- Gender: ALL
- Minimum Age: 10 Years
- Maximum Age: 16 Years
- Healthy Volunteers: f

Study Arms:
- MK-0524A 1 g/20 mg (Panel A) (Type: EXPERIMENTAL): Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
- MK-0524A 2 g/40 mg (Panel B) (Type: EXPERIMENTAL): Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Normal Pressure Hydrocephalus Treatment by Acetazolamide

Study Design Characteristics:
- Allocation: NON_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:~Included will be subjects with a probable diagnosis of iNPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both.~1. Are 60 years old or older~2. Patients who understand the study protocol~3. Patients who meet the criteria for NPH~   1. A typical personal history~  2. A typical brain imaging on head CT or MRI~  3. Normal LP findings excluding other conditions~  4. Exclusion of other conditions causing the symptomatology~  5. Patients who underwent Continuous lumbar drainage or spinal tap which improved symptomatology.~Exclusion Criteria:~1. Patients below the age of 60 years.~2. Patients who underwent shunt surgery~3. Patients with a concurrent diagnosis of a neurodegenerative or neurovascular disease that causes a significant impairment of gait and cognitive functions~4. Patients with symptom duration of more than 6 month~5. Patients with contraindications for acetazolamide treatment:~   * Cirrhosis or marked liver disease or dysfunction~  * hyperchloremic acidosis~  * hypersensitivity to acetazolamide or any component of the product~  * hypersensitivity to sulfonamides or other sulfonamide derivatives, as cross-sensitivity may occur~  * hypokalemia~  * hyponatremia~  * renal dysfunction or disease~  * suprarenal gland failure

- Gender: ALL
- Minimum Age: 60 Years
- Maximum Age: 80 Years
- Healthy Volunteers: f

Study Arms:
- Acetazolamide (Type: ACTIVE_COMPARATOR): active comparator group will receives 500 mg azetazolamide daily
- sugar pill (Type: PLACEBO_COMPARATOR): placebo comparator group will receives placebo daily.

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Imaging Tumor Hypoxia With 18F-EF5 PET in Recurrent or Metastatic Clear Cell Ovarian Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* Histologically confirmed, advanced metastatic or recurrent clear cell cancer of the ovary~* At least one index lesion measuring 2 cm in diameter~* Must be able to provide written informed consent, and willing to comply with protocol procedures of the study~* Off all active therapy for at least 4 weeks (cytotoxic chemotherapy, radiation, immune therapy, hormone therapy, clinical trials or new agents)~Exclusion Criteria:~* Renal failure (eGFR \< 50mls/min)~* Patients with unknown primaries~* Previous history of cancer, except treated non-melanoma skin cancer, non-invasive breast cancer, non-invasive cervical cancer; or curatively treated solid cancer with no evidence of recurrence for more than 5 years.~* Receiving or had received active therapy in the form or chemotherapy or radiation within 4 weeks of the PET scan~* ECOG status ≥ 3~* Unable to tolerate a PET scan which involves an injection of radiopharmaceutical and lying flat and still for 30 minutes.~* Weight more than 204.5 kg (Physical Limitation of Imaging and Radiotherapy Couches) or cannot fit through the PET/CT machine (diameter 70cm).~* Patient is pregnant or breastfeeding

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

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

Answer: outcome: terminate
termination_type: enrollment issues
Please assess the completion status of the following clinical trial:

Trial Title: Endometrial Injury for Assisted Reproduction

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:~* Women who will start assisted reproductive techniques with planned fresh embryo transfer.~* Age between 18 and 38 years.~* Written informed consent.~Exclusion Criteria:~* None

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 38 Years
- Healthy Volunteers: f

Study Arms:
- Endometrial injury group (Type: EXPERIMENTAL): Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
- Control group (Type: SHAM_COMPARATOR): Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.

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

Answer: outcome: terminate
termination_type: lack of efficacy
Please assess the completion status of the following clinical trial:

Trial Title: Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: SUPPORTIVE_CARE
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Males and females aged 18-65 years.~2. Patients will be initiating antibiotic therapy.~3. The antibiotic therapy consists of one of the following: broad spectrum penicillins, cephalosporins, doxycycline, clarithromycin, ciprofloxacin or isoxazolyl penicillin.~4. The antibiotic therapy is expected to be 3 to 14 days in duration.~5. Obtained his/her informed consent after verbal and written information.~6. Have a high probability for compliance with and completion of the study.~7. Patients having a telephone available.~8. Body Mass Index between 19 and 30.~Exclusion Criteria:~1. Participation in a clinical trial with an investigational product or drug within the 60 days prior to screening.~2. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.~3. Pregnant or breastfeeding women; women planning to become pregnant during the study months.~4. Presence of active diarrhea (3 or more loose or watery stools per 24 hour period).~5. Daily consumption of probiotics, fermented milk and/or yogurt with probiotics.~6. Known to have a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. on-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetable source), ascorbic acid, Colloidal silicon dioxide).~7. Presence of an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis.~8. Regular use of proton pump inhibitors.~9. Bowel surgery, artificial heart valve, history of rheumatic heart disease or infective endocarditis.~10. A previous documented C. difficile infection \< 3 months prior to study initiation.~11. Immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, AIDS).~12. Ongoing or recent use of antibiotic therapy in the 3 months prior to the study product first administration.~13. Planned administration of antibiotics other than broad spectrum penicillins, cephalosporins, doxycycline, ciprofloxacin or isoxazolyl penicillin for the treatment of an infection.~14. History of drug or alcohol abuse.

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

Study Arms:
- Probiotic (Type: ACTIVE_COMPARATOR): Probiotic consumption during and after course of antibiotic
- Placebo (Type: PLACEBO_COMPARATOR): Placebo consumed during and after course of antibiotic

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

Answer: outcome: terminate
termination_type: enrollment issues