cyrilzakka/clinical-trials huggingface dataset:
Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.

OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed until death.

PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) Bidimensionally measurable disease The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies Bone metastases CNS lesions CEA, CA19-9, or AFP levels Ascites No CNS disease only No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 OR Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant underlying medical or psychiatric illness No active infections No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to only site of measurable disease At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: Not specified
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential thrombocythemia according to WHO 2008
* Any of the following as high-risk patient

  * Over 60 years old
  * \>100 X 10\^4/ul of platelet count
  * increased more than 300K of platelet count in 3 months
  * Hypertension, diabetes, past history of thromboembolic bleeding

Exclusion Criteria:

* Patients with an adverse drug reaction or intolerability to anagrelide
* Any of the following cardiac abnormalities;

  * Complete left bundle branch block on ECG
  * Patients using a pacemaker
  * Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
  * Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
  * Clinically significant bradycardia (\<less than 50 per minute)
  * History of clinically proven myocardial infarction and unstable angina within 3 months
* Pregnant women, nursing mothers
Changes in Eye Pressure and Anterior Chamber Depth With Oral Endothelin Antagonist Therapy

There is growing evidence that a cause of glaucoma is linked to circulatory problems and poor auto-regulation of blood flow to the optic nerve. Pulmonary hypertension (PH)is a disease characterized by low oxygen levels in the blood and altered blood circulation. The decrease in oxygen delivery to the optic nerve could lead to the loss of nerve fiber layer(NFL)in the retina and the resulting visual field compromise. This situation is characteristic of glaucoma. The ability to identify NFL thinning early could lead to earlier diagnosis of glaucoma and more effective treatment to limit dysfunction from visual field loss.

We hypothesize that the rate of structural damage to the NFL, a feature of glaucoma, is higher in patients with PH than expected in healthy populations lacking this disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with pulmonary hypertension
* between the ages of 18 and 80 years
* ability to undergo the various ocular exams.

Exclusion Criteria:

* patients with other diseases that could affect the nerve fiber layer
* special populations; ie children, pregnancy, lactating females, prisoners
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension
* Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

Exclusion Criteria:

* None
Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans

Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For example, high dose prednisolone treatment has been shown to be an effective therapy for different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis. However, contradictory results exists for the influence of high dose prednisolone therapy per se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of high dose, short time therapy with intravenous prednisolone in patients with optic neuritis and severe Graves´ Ophthalmopathy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 19 and 65 years, nonsmokers
* Group A: Patients with Graves´ Ophthalmopathy (moderate to severe and active ophthalmopathy; i.e. clinical activity score \>3 or =3) suitable for high-dose treatment with prednisolone as assessed by an independent ophthalmologist
* Group B: Patients with acute onset of optic neuritis suitable for high-dose treatment with prednisolone suitable for high-dose treatment with prednisolone as assessed by the ophthalmologist
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant and not to interfere with prednisolone treatment (normal liver blood parameter and hepatitis serology).
* Ametropy of less than 3 dpt.

Exclusion Criteria:

* Regular use of medication which could interfere with the study objectives, especially treatment with vasoactive drugs
* Active peptic ulcer or insulin dependent diabetes mellitus
* Hepatitis or elevated hepatic blood parameters
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy
Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) including Crohn's disease (CD) and Ulcerative colitis (UC) is a chronic idiopathic intestinal disorder involving the interplay of environmental, immunomodulatory and genetic causative factors. Treatment for IBD is multimodal and includes lifestyle modification, chronic pharmacotherapy and surgery. Given the need for chronic pharmacotherapy, medication adherence is a crucial therapeutic goal in the management of IBD. In fact, medication non-adherence has been associated with greater risk of relapse and increased healthcare costs.

In a previous study, the investigators found clinically identifiable risk factors for non-adherence for self-injectable biologic medications in a population with moderate to severe CD. These risk factors included smoking, prior biologic use, psychiatric history, and current narcotic use. The primary objective of this study is to use a multidisciplinary team approach that implements a targeted coaching intervention to promote behavioral change and improve medication adherence in adult patients with IBD who are at high risk of non-adherence.


Eligibility Criteria:
Inclusion Criteria:

* adult patients treated at the Inflammatory Bowel Disease (IBD) clinic at Vanderbilt with Crohn's disease or Ulcerative colitis confirmed by endoscopy or radiology assessment
* currently prescribed a biologic agent (self-injectable or infusion) for management of IBD
* medication dispensing is documented in patient medical record

Exclusion Criteria:

* patients less than 18 years of age
* unstable clinical condition (bleeding, infection, intestinal obstruction, etc.)
* patients who are required to get biologic medication at a specialty pharmacy outside of Vanderbilt University that is not documented in medical record(exclusion due to inability to accurately track prescription refills)
* patients with short bowel syndrome, an ostomy, obstructive disease with strictures, history of tuberculosis, hypersensitivity reaction to anti-TNF agent, cancer, renal failure requiring specific treatment such as dialysis
* patients with severe psychological comorbidity, defined as reported intent to self-harm or harm others or psychiatric hospitalization in the past year
* patients with current alcohol abuse or illegal drug use ascertained by medical history
Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers

This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition.

Results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with Parkinson's Disease and their support persons. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.

The expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. The neutral control writing conditions asks participants to write about how they spent their time the day before.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease

Exclusion Criteria:

Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer

Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.

After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.

Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over;
* As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);
* Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;
* As per self-report, can read and understand English;
* As per self-report, residing in New York, New Jersey, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.

Exclusion Criteria:

* Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;
* Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.
Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System

A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.

Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases \> 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome (mRS \> 2) at 3 month.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* AIS patients receiving EVT within 24 hours of stroke onset
* Written informed consent is obtained

Exclusion Criteria:

* Patients refuse to participate in this study
CoverEdge Algorithm Programming Study

This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.


Eligibility Criteria:
Inclusion Criteria:

* Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
* Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
* Subject is 18 years of age or older when written informed consent is obtained.

Exclusion Criteria:

* Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.
Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer

Anastomotic fistula is the most feared complication after surgical resection of colorectal cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate postoperative period, the pain that it induces, the resources required for its management, the need for stomata with a negative impact on patients' quality of life and the prolongation of hospitalization, it also has a now-recognized adverse effect on long-term survival.

The early detection of this complication may limit its impact. C-reactive protein (CRP) has proved to be an early, reliable marker of the onset of infectious complications of colorectal surgery.

However, the diagnostic procedure to implement in these patients is not at all codified, since this population concerned by systematic CRP assay in the postoperative period is very recent.

The procedures to implement in these patients so that they can obtain the maximal benefit of an early diagnosis have not yet been established. An algorithm for the proactive clinical management must be drawn up to be able to confirm or rule out the presence of a fistula as soon as a high level of CRP is detected, and to propose a quick treatment to ensure that patients benefit from this early diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 and older,
* with a CRP level \> 140 mg/L at D3 or CRP \> 125 mg/L at D4 following colon and/or rectal resection with anastomosis (protected or not by an upstream stoma)
* without clinical signs of severe peritonitis (fever, severe sepsis, generalized abdominal contracture)
* who have provided written informed consent.

Exclusion Criteria:

* patients who have undergone intraperitoneal chemotherapy in the context of the surgical treatment for peritoneal carcinomatosis
* patients with a diagnosis of another infection that could explain the high CRP level,
* patients who underwent eventration repair at the time of the colorectal resection
* patients with an obvious indication for revisit surgery
* persons without health insurance cover
* adults under guardianship
* pregnant or beast-feeding women
Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-45 years
* Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
* Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
* Sign the informed consent form voluntarily and cooperate voluntarily to complete the test

Exclusion Criteria:

* Allergens (allergic to 2 or more drugs, food or pollen)
* comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
* have Clinically significant abnormal screening laboratory values.
* Systolic pressure \> 140mmHg or diastolic \> 90 mmHg
* Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
* The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
* Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
* Have donated or lost blood 400 ml within 8 weeks prior to screening
* Participated in other clinical trials within 3 months prior to screening
* Intakes too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
* Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
* Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer halflife
* Using any psychotropic drug or psychoactive substance
* Women were screened for positive blood pregnancy
* The subjects and their partners were not willing to take contraceptives during trial and six months after the study
* Have a donor plan recently
* Have participated in this trial
* The researchers believe that anyone who is unfit to participate in this test will be involved