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

Trial Title: Effects of Tetrahydrobiopterin on Blood Pressure

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female patients without childbearing potential between the ages of 18 and 75 years~2. History of documented essential hypertension or newly diagnosed hypertension (BP \>140 mmHg systolic and/or 90 mmHg diastolic measured on 2 separate occasions)~3. Patients on conventional anti-hypertensive therapy with poorly controlled hypertension (BP \>135/85 mmHg). Their anti-hypertensive regimen will remain unchanged throughout the study period. Patients will not need to stop taking their prescribed anti-hypertensives.~4. Controls will be recruited for part 2 of the study. These will be patients who meet the age and childbearing criteria above, who have no history of hypertension, arterial BP of \<130 systolic and \<85 diastolic, no evidence of diabetes mellitus, total cholesterol \<240 and be non-smoking for at least six months.~5. Patients can be at any stage of hypertension. They can be at any performance status. The only requirement will be that they be able to come to scheduled follow up visits either by themselves or with assistance. Patients will need to be able to give informed consent.~Exclusion Criteria:~1. Female subjects with childbearing potential.~2. History of symptomatic coronary or peripheral vascular disease.~3. Known secondary causes for hypertension~4. Severe uncontrolled hypertension (BP \>180 mmHg systolic and /or 110 mmHg diastolic).~5. Severe co-morbid conditions which would limit life expectancy to less than 6 months.~6. Patients unable to give informed consent or adhere to the protocol.~7. Patients participating in another study protocol.~8. Patients with organ failure, creatinine \>2.5 mg/dL or hepatic enzymes \>2X normal~9. Recent (within 6 weeks) alteration of any concomitant therapy.~10. Presence of intercurrent illness~11. Bleeding disorders

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Dose-response of oral BH4 (Type: EXPERIMENTAL): Eight subjects received 100 mg of oral BH4 twice a day and 8 received 200 mg twice daily.
- Onset & duration of action of oral BH4 (Type: EXPERIMENTAL): Eight hypertensive subjects were assigned to either 5 mg kg-1 day-1 (n=4) or 10 mg kg-1 day-1 (n=4) of BH4, given in two divided doses orally for 8 weeks.

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: Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

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

Eligibility Criteria:
Inclusion Criteria:~* Females and males age 18 -75.~* An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort.~* Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid \>2000 micromoles/48h~Exclusion Criteria:~* IBS patients with known clinically-relevant inflammation.~* IBS patient with known bleeding diathesis~* History of abdominal surgery~Patients participating will not take any of the following disallowed medications for at least 7 days prior to and during the remainder of the study:~* Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron~* Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors~* All narcotics~* Anti-cholinergic agents~* Tramadol~* Oral anticoagulants~* Antimuscarinics~* Peppermint oil~* Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole~Gastrointestinal preparations:~* Anti-nausea agents~* Osmotic laxative agents~* Prokinetic agents~* 5-HT3 antagonists

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 75 Years
- Healthy Volunteers: f

Study Arms:
- Colesevelam (Type: ACTIVE_COMPARATOR): Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks.~Baseline testing period consists of: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, and medication pick up.~Treatment period will have subject take the study drug 1875 mg of medication orally twice daily with lunch and supper for 4-5 weeks.~The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.
- Placebo (Type: PLACEBO_COMPARATOR): Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks.~The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.

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: Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA

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

Eligibility Criteria:
Inclusion Criteria:~* TKA within 72 hours and VAS\>60 during 45 degrees active flexion of the knee despite conventional pain medication~* informed consent~* ASA 1-3~* BMI 18-40~Exclusion Criteria:~* Unable to communicate in Danish~* Allergic reactions toward ropivacaine~* Alcohol and or drug abuse~* Unable to cooperate~* Known sensory disturbances in the lower limbs

- Gender: ALL
- Minimum Age: 30 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Active FNB, placebo ACB (Type: EXPERIMENTAL): FNB with 30 ml of ropivacaine 0,2% and ACB with 30 ml of placebo (saline). The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.
- Active ACB, placebo FNB (Type: EXPERIMENTAL): ACB with 30 ml of ropivacaine 0,2% and FNB with 30 ml of placebo (saline.The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.

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: Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

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:~* Age \>18 years~* Symptomatic gout~* Serum uric acid \>7 mg/dL~* Intolerance of, or inadequate response to, conventional therapy for gout~* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method~Exclusion Criteria:~* End stage renal failure that requires dialysis~* Concurrent use of uric-acid lowering agents~* Glucose-6-phosphate dehydrogenase (G6PD) deficiency~* A history of anaphylactic reaction to a recombinant protein~* Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)~* A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject

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

Study Arms:
- pegloticase (Type: EXPERIMENTAL): All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.

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 Oral Treatments for Hepatitis C

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 6.0

Eligibility Criteria:
Inclusion Criteria:~* HCV Genotype 1a or 1b~* Adult patients (age 18 years or older)~* Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or Zepatier (EBR/GZR))~Exclusion Criteria:~* Inability to provide written informed consent~* HARVONI® is not a covered drug on benefits formulary~* Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)~* Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)~* Pregnant or breastfeeding women

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

Study Arms:
- EBR/GZR (elbasvir/grazoprevir) with RBV (Type: ACTIVE_COMPARATOR): Patients received 1 EBR/GZR (elbasvir/grazoprevir) (Zepatier) tablet (50/100mg) once daily for 12 to 16 weeks (provider discretion) with Ribavirin (RBV) 200 mg/tablet, 1-3/day, taken 1-2 times per day (dosage at discretion of provider).
- EBR/GZR (elbasvir/grazoprevir) (Type: ACTIVE_COMPARATOR): Patients received 1 EBR/GZR (elbasvir/grazoprevir) tablet (50/100 mg) once daily for 12 to 16 weeks (provider discretion) (without Ribavirin)
- SOF/LDV (sofosbuvir/ledipasvir) with RBV (Type: ACTIVE_COMPARATOR): Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) (Harvoni) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (at discretion of provider). RBV taken as 200 mg/tablet(capsule), 1-3 pills/day, 1-2 times/day.
- SOF/LDV (sofosbuvir/ledipasvir) (Type: ACTIVE_COMPARATOR): Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)
- PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) with RBV (Phase 1 only) (Type: ACTIVE_COMPARATOR): Patients received Pr0D (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) orally daily with food for 12 to 24 weeks with RBV (Ribavirin). Ombitasvir/Paritaprevir/Ritonavir (12.5/75/50 mg/tablet) -2 tablets once daily with food for 12 to 24 weeks and 1 dasabuvir tablet (250 mg) twice daily with food for 12 to 24 weeks.~RBV (200 mg/pill) 1-3 pills/day, 1-2 times/day (use and dosage at provider discretion). Total daily RBV dosage ranged from 200 to 1200 mg.
- PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir) (Type: ACTIVE_COMPARATOR): Patients received 2 ombitasvir/paritaprevir/ritonavir tablets (12.5/75/50 mg) once daily and 1 dasabuvir (250 mg) tablet twice daily with food for 12 to 24 weeks without Ribavirin (as per provider instructions)

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: Misoprostol Administration Before Operative Hysteroscopy

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~Symptomatic patients that were suspected as having intrauterine pathology, such as submucosal myoma, endometrial polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.~Inclusion criteria were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -~Exclusion Criteria:~Exclusion criteria included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.

- Gender: FEMALE
- Minimum Age: 18 Years
- Maximum Age: 55 Years
- Healthy Volunteers: f

Study Arms:
- Oral misoprostol (Type: EXPERIMENTAL): The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery.
- Sublingual misoprostol (Type: EXPERIMENTAL): The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery.
- Vaginal misoprostol (Type: EXPERIMENTAL): The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery.
- Control (Type: EXPERIMENTAL): The no-misoprostol group did not administer the medication of misoprostol before the procedure

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: Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

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

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically proven stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer~* No symptomatic brain metastasis~PATIENT CHARACTERISTICS:~Age:~* 18 and over~Performance status:~* WHO/ECOG 0-2~Life expectancy:~* Not specified~Hematopoietic:~* WBC at least 3,000/mm\^3~* Neutrophil count at least 1,500/mm\^3~* Platelet count at least 100,000/mm\^3~Hepatic:~* Bilirubin no greater than 2 times upper limit of normal~Renal:~* Glomerular filtration rate at least 50 mL/min~Cardiovascular:~* No ventricular arrhythmia (LOWN class II or worse)~* No myocardial infarction within the past year~* No severe or uncontrolled hypertension~* No history of congestive heart disease (no New York Heart Association class III or IV heart disease) even if medically controlled~* LVEF at least 50%~Other:~* No other primary malignancies except carcinoma in situ of the cervix or basal cell skin cancer~* No worse than grade I preexisting motor or sensory neurologic pathology or symptoms~* No active infection or other serious underlying medical condition that would prevent compliance~* Not pregnant or nursing~* Fertile patients must use effective contraception~PRIOR CONCURRENT THERAPY:~Biologic therapy:~* Not specified~Chemotherapy:~* No prior chemotherapy~* No other concurrent antineoplastic agents~Endocrine therapy:~* Not specified~Radiotherapy:~* No prior radiotherapy~Surgery:~* Not specified

- Gender: FEMALE
- 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: A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

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:~* A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.~* A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.~* If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.~Exclusion Criteria:~* A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.~* A person who has active internal bleeding or has a history of a bleeding disorder.~* Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.~* A person who has liver disease; for example, cirrhosis.~* A person who has a condition such as alcoholism, mental illness, or is drug dependent.~* A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).

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

Study Arms:
- Prasugrel (Type: EXPERIMENTAL): Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
- Clopidogrel (Type: ACTIVE_COMPARATOR): Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

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: Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia

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

Eligibility Criteria:
Inclusion Criteria:~* HIV infected~* Pregnant women~* Ability to provide informed consent.~* Meets eligibility criteria for HAART initiation~Exclusion Criteria:~* Unwillingness to provide informed consent~* Below the age of legal consent

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

Study Arms:
- Routine three-drug antiretroviral prophyalxis (Type: EXPERIMENTAL): Cohort of 160 HIV-infected women, approached at \> 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT.
- Control arm (Type: NO_INTERVENTION): A cohort of 160 women will be enrolled from the control clinics, from 28 weeks gestation onward. At these sites, the antenatal zidovudine will be offered, with provision of single-dose nevirapine for self-administration in labor. This practice is in accordance with the current standard of care recommended by the Zambian National Guidelines for PMTCT.

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-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

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:~* Men or women at least 18 years of age~* RLS, based on the IRLSSG Diagnostic Criteria~* History of RLS symptoms occurring at least 15 nights in the month prior to Screening or, if on RLS treatment, this frequency of symptoms must have been applicable prior to start of treatment~* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights~* Total RLS severity score of 15 or greater on the IRLS Rating Scale~* If taking dopamine agonists, gabapentin, or other treatments for RLS (e.g., opioids, benzodiazepines) medications must have been discontinued at least 2 weeks prior to Screening;~* If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study;~* Body Mass Index (BMI) of 34 or below~* estimated creatinine clearance of at least 60 mL/min~Exclusion Criteria:~* a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS~* history of RLS symptom augmentation or end of dose rebound with previous dopamine agonist treatment~* neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias);~* other clinically significant or unstable medical condition or conditions which could affect RLS treatment efficacy assessments~* serum ferritin level below 20 ng/mL~* currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR)

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

Study Arms:
- GEn (XP13512/GSK1838262) 600 mg (Type: EXPERIMENTAL): GEn (XP13512/GSK1838262) 600 mg
- GEn (XP13512/GSK1838262) 1200 mg (Type: EXPERIMENTAL): GEn (XP13512/GSK1838262) 1200 mg
- GEn (XP13512/GSK1838262) 1800 mg (Type: EXPERIMENTAL): GEn (XP13512/GSK1838262) 1800 mg
- GEn (XP13512/GSK1838262) 2400 mg (Type: EXPERIMENTAL): GEn (XP13512/GSK1838262) 2400 mg
- Placebo (Type: PLACEBO_COMPARATOR): Placebo

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

Answer: outcome: complete