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

Trial Title: Pilot Study of the Modified Atkins Diet for Tourette Syndrome

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

Eligibility Criteria:
Inclusion Criteria:~* Ages 12-65 years~* Tourette syndrome (vocal and motor tics for over a year)~* \> 20 score on the Yale Global Tic Severity Scale~* Ability to follow instructions and comply with the dietary changes~Exclusion Criteria:~* Secondary tics~* Underweight (BMI \< 5%)~* Prior use of the Atkins diet for over 2 days~* High cholesterol or triglycerides~* Major depression or anxiety disorder~* Pregnancy~* Substance abuse

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Modified Atkins Diet (Type: EXPERIMENTAL): Patients are started on the modified Atkins diet at 15 grams per 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: Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Age 18 or over~* Histological diagnosis of recurrent or metastatic gastric cancer~* Immunohistochemistry (IHC 0 or 1+) or FISH negative (if IHQ 2+) for HER2 on tissue biopsy, according to institutional routine~* Candidates to initiate first-line palliative treatment; Previous adjuvant treatment is allowed since its termination occurred at least 12 months ago~* ECOG performance range 0 to 2~* Informed consent form signed by patient or legal representative~Exclusion Criteria:~* Patients already on or previously using anti-HER2 therapy~* Left ventricular ejection fraction (LVEF) \<55% baseline, as already evaluated in the gastric cancer routine~* Pregnant or lactating women~* Patients participating in other experimental drug protocols~* Patients who received previous palliative chemotherapy~* Another synchronic neoplasia requiring systemic treatment

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

Study Arms:
- Interventional (Type: EXPERIMENTAL): Use of trastuzumab combination chemotherapy in patients with relapsed or metastatic gastric cancer with expression HER2 negative in the tumor tissue but positive in CTC.

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: Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder

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

Eligibility Criteria:
Inclusion Criteria:~* DSM-V criteria for borderline personality disorder (Structured Clinical Interview for Disorders)~Exclusion Criteria:~* Criteria of DSM-V substance use disorder from moderate to severe (except for tobacco and caffeine) in the last six months~* schizophrenic disorder~* Bipolar disorder

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

Study Arms:
- Social exclusion (Type: EXPERIMENTAL): Participating at the cyberball game in exclusion condition in wich they will receive 2 time the ball in the 10 first throw then none of them in the last 20 throw.
- Social inclusion (Type: ACTIVE_COMPARATOR): Participating at the cyberball game in inclusion condition in wich they will receive 33% of the throw : 10 in a total of 30

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

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

Trial Title: Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

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

Eligibility Criteria:
Inclusion Criteria:~* patient acceptance of regional anaesthesia~Exclusion Criteria:~* peripheral arteriosclerosis~* diabetes mellitus~* bleeding disorder~* infection at the puncture site~* allergy to mepivacaine~* pregnancy

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

Study Arms:
- Plain mepivacaine (Type: ACTIVE_COMPARATOR): None
- Mepivacaine with epinephrine (Type: ACTIVE_COMPARATOR): 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: A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~* Male or female ≥18 years old.~* Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.~* Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.~* Measurable disease per RECIST v. 1.1 criteria.~* ECOG performance status 0 or 1.~Exclusion Criteria:~* Radiation therapy within 14 days of C1D1.~* Investigational drug use within 28 days of C1D1.~* Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.

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

Study Arms:
- Dose extension cohort (Type: EXPERIMENTAL): Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts.
- Cohort 3 (Type: EXPERIMENTAL): Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
- Cohort 2 (Type: EXPERIMENTAL): Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
- Cohort 1 (Type: EXPERIMENTAL): Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib

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 Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

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

Eligibility Criteria:
Inclusion Criteria:~* Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.~* Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.~Exclusion Criteria:~* Patient is less than 18 years of age~* Patient is not being treated in the U.S.

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

Study Arms:
- Group A (Type: None): Symptomatic with adnexal mass
- Group B (Type: None): Asymptomatic with adnexal mass
- Group C (Type: None): Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant

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

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

Trial Title: Intracutaneous Sterile Water Injections

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

Eligibility Criteria:
Inclusion Criteria:~* multiparous women~* spontaneous labor~* at least 18 years of age~* presenting for vaginal delivery with cervical dilation of 4 centimeters or less~Exclusion Criteria:~* nulliparous~* less than 18 years old~* contraindication to placement of neuraxial anesthetic~* skin infection in area to be injected~* medical therapies considered to result in tolerance to opioids~* history of chronic pain (requiring regular medical follow-up with pain specialists)~* recent use of opioid analgesics (within the year preceding pregnancy)

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

Study Arms:
- Sterile Water Injection (Type: ACTIVE_COMPARATOR): In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.
- Normal Saline Injection (Type: PLACEBO_COMPARATOR): In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.

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 Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE2/PHASE3
- Number of Arms: 4.0

Eligibility Criteria:
Key Inclusion Criteria~* PAH belonging to one of the subgroups:~  1. I/HPAH, PAH-CTD,~ 2. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse),~ 3. HIV associated or~ 4. PAH due to repaired congenital heart disease (at least 1 year since repair)~* World Health Organization (WHO) Functional Class II, III or IV symptoms~* Stable concomitant background therapy of at least one PAH approved medications~* Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.~Key Exclusion Criteria~* Pulmonary hypertension (PH) belonging to Groups 2 to 5~* A history of left-sided heart disease~* Pregnant or breast-feeding females~Additional criteria may apply, per protocol

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

Study Arms:
- AV-101 10 mg (Type: EXPERIMENTAL): None
- AV-101 35 mg (Type: EXPERIMENTAL): None
- AV-101 70 mg (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None

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: Bone Marrow Transplant From Related Donor for Patients With High Risk Hemoglobinopathies

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: None

Eligibility Criteria:
Inclusion:~* Patients with homozygous B0/+ thalassemia or severe variants of B0/+ thalassemia with an HLA genotypically identical donor.~* Patients with an HLA genotype identical donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb 0/+ and at least one of the following:~Previous central nervous system vaso-occlusive episode with or without residual neurologic findings; Frequent painful vaso-occlusive episodes which significantly interfere with normal life activities and which necessitate chronic transfusion therapy; Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.~* Severe anemia which prevents acceptable quality of life and necessitates chronic transfusion therapy.~* The patient must have an HLA genotype identical donor.~* Between the ages of birth and 65 years.~* Women of childbearing potential must have a negative pregnancy test.~Exclusion:~* Biopsy proven chronic active hepatitis or fibrosis with portal bridging.~* SCD chronic lung disease \>/= stage 3.~* Severe renal dysfunction defined as creatinine clearance \<40 ml/min/1.73 M2~* Severe cardiac dysfunction defined as shortening fraction \<25%.~* HIV infection.~* Severe but unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate bone marrow transplant (BMT).~* Inadequate intellectual capacity to understand the nature and risk inherent in the BMT process and give informed consent (in the case of minors, this criteria must be fulfilled by the legal guardian).~* Pregnant, lactating or unwilling to use appropriate birth control.

- Gender: ALL
- Minimum Age: 1 Day
- Maximum Age: 64 Years
- 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: A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

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

Eligibility Criteria:
Inclusion Criteria:~1. Has provided written informed consent~2. Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan~3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)~4. Has progressed or had recurrence within 30 days prior to randomization~5. Has at least one measurable lesion, as defined by RECIST criteria version 1.1~6. ECOG performance status of 0, 1, or 2~7. Is able to take medications orally~8. Has adequate organ function (bone marrow, kidney and liver)~9. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.~Exclusion Criteria:~1. Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment)~2. Certain serious illnesses or medical condition(s)~3. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration~4. Has received TAS-102~5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies~6. Is a pregnant or lactating female

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

Study Arms:
- TAS-102 (Type: EXPERIMENTAL): None
- Investigator Choice of Amrubicin or Topotecan (Type: ACTIVE_COMPARATOR): Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)

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

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

Trial Title: Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: CROSSOVER
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Generally healthy, male and female adults, 18-30 yrs of age at Screening~* Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;~* Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive~* Sitting blood pressure less than or equal to 135/90 mmHg;~* Demonstrating negative alcohol/drug screen tests;~* Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;~* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;~* Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.~Exclusion Criteria:~* A smoking history of more than or equal to 10 pack-years, or having smoked within 6 months prior to Screening;~* Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening~* Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including but not limited to: asthma, COPD, cystic fibrosis, bronchiectasis, tuberculosis, emphysema, etc.~* Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study~* Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid)~* Use of prohibited drugs or failure to observe the drug washout restrictions~* Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 30 Years
- Healthy Volunteers: t

Study Arms:
- Arm T-Epinephrine Inhalation Aerosol HFA (Type: EXPERIMENTAL): Experimental arm utilizing Epinephrine HFA-MDI (E004)
- Arm C-Epinephrine Inhalation Aerosol CFC (Type: ACTIVE_COMPARATOR): Active comparator arm utilizing Epinephrine CFC-MDI

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: Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

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:~* High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)~* Surgical wound type III or IV..~Exclusion Criteria:~* Patients not giving informed consent.~* Patients requiring open abdominal wound care.~* Patients with abdominal wall malignancy,~* Patients with peritoneal carcinomatosis,~* Patients who are planned for second look laparotomy within 5 days,~* Patients with less thank 3 month life expectancy.~* Patients who are operated with existing wound infection

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

Study Arms:
- ciNPWT (Type: EXPERIMENTAL): Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation.~Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed.
- Traditional wound dressing (Type: NO_INTERVENTION): Control group with traditional, dry laparotomy wound dressing.

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: Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

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

Eligibility Criteria:
Inclusion Criteria:~* 40-85 year old males~* Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.~* Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.~* Patient will read, understand and sign the informed consent agreement~* Patients must have a life expectancy of at least one year.~* Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4~* Percentage positive core rate \< 50% based on sextant or extended biopsy technique.~* Prostate Volume (PV) \>15 grams.~* Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA\> 10 ng.dl before initiation of the study drug~Exclusion Criteria:~* Any 5α-reductase inhibitors medications within the past 12 months before enrollment.~* Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.~* Anticipated blood donation within the next 90 days.~* Serum PSA levels of \>20ng/dl.~* Clinical evidence of metastatic prostate cancer.~* Two documented urinary tract infections in the past year~* CHF, MI (within 6 months) or other symptomatic CVS disease~* Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)~* Enrollment in other studies for any disease in the past 30 days~* Significant urinary incontinence~* Diagnosis of cancer that in not considered cured, except BCC of skin~* Prior transurethral resection of the prostate with a large tissue defect.~* History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology~* Previous or concurrent radiotherapy, hormonal therapy or chemotherapy

- Gender: MALE
- Minimum Age: 40 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Dutasteride (Type: EXPERIMENTAL): The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
- Placebo (Type: PLACEBO_COMPARATOR): The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

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

Answer: outcome: terminate
termination_type: enrollment issues