cyrilzakka/clinical-trials huggingface dataset:
BostonGene and Exigent Genomic INsight Study

The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings.

The BEGIN Study, conducted by BostonGene and Exigent, is a prospective investigation aimed at evaluating the efficacy and feasibility of comprehensive molecular testing in advanced cancer patients within the community setting. Recent advancements in cancer treatment have led to the integration of targeted and immune-based therapies into standard practice. Recognizing the significance of genomic and molecular alterations in patient therapy selection, BostonGene has developed a high-throughput sequencing platform, the BostonGene Tumor Portrait test, which provides a comprehensive overview of tumors and their microenvironment.

The primary objectives of the study include determining the frequency of actionable findings identified by the BostonGene Tumor Portrait test, assessing the feasibility and turnaround time of comprehensive sequencing analysis, and evaluating the frequency of patient enrollment in clinical trials based on test results. Secondary objectives involve determining the frequency of patients receiving molecularly matched therapy, evaluating concordance between DNA and RNA targets, and assessing the impact of test findings on treatment decisions.

The study will involve four cohorts of patients with breast cancer, non-small cell lung cancer, melanoma, and sarcoma, each comprising 100 participants. Subjects will be identified through designated pilot sites. The study duration will be up to two years, with data collection including baseline demographics, medical history, treatment decisions, and patient outcomes.

Overall, the study aims to elucidate the clinical utility of the BostonGene Tumor Portrait test in guiding treatment decisions for advanced cancer patients in real-world community settings, with a focus on actionable findings, treatment efficacy, and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a confirmed malignancy of:

Locally recurrent, unresectable, or metastatic breast cancer or; Unresectable stage III or metastatic non-small cell lung cancer or; Unresectable or metastatic melanoma or; Locally advanced or metastatic l sarcoma.

* Life expectancy \> 3 months as per the treating physician
* Willingness to provide informed consent
* Living in the United States at time of enrollment
* Agree to participate in genomic and molecular profiling

Exclusion Criteria:

* not meeting the inclusion criteria
The Study on the Esketamine in the Treatment of Postherpetic Neuralgia

Herpes zoster (HZ) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the sensory ganglia. Postherpetic neuralgia (PHN) often occurs after herpes zoster heals and persists for a long time. At present, clinically anticonvulsants (such as gabapentin, pregabalin) and antidepressants (such as amitriptyline) are clinically first-line drugs for the treatment of PHN, which are not usually effective to treat PHN well, as well as to alleviate patients' bad mental symptoms. Esketamine, as a well-known N-methyl-D-aspartate receptor inhibitor, has both analgesic and antidepressant effects with extremely few incidence of respiratory depression, delirium, hallucinations, nausea and vomiting. Therefore, we hypothesize that esketamine could relieve PHN and Anxiety and depression-like symptoms symptoms in patients with PHN. This study intended to compare the efficacy of pregabalin, amitriptyline combined with esketamine therapy and pregabalin combined with amitriptyline therapy for alleviating PHN, and to further explore the feasibility and safety of esketamine in the treatment of PHN as well as underlying the mechanism of esketamine on the PHN.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old; Patients with post-herpetic neuralgia with anxiety and depression; NRS ≧4 points; A and (or) D ≧8 points in the Hospital Anxiety and Depression Scale (HADS) ; The course of disease ≧3 months; Patients with invalid conventional treatment (pregabalin or gabapentin combined with anti-anxiety depression, anti-epileptic dugs).

Exclusion Criteria:

* Present acute and chronic pain caused by other disease during treatment; Serious systemic disease; Severe infection, history of heart, lung, liver and kidney dysfunction, tumor, immunodeficiency and other serious diseases, or currently receiving or have recently received immunosuppression or cytotoxic drug treatment; A history of mental illness such as epilepsy, depression, Alzheimer's, multiple sclerosis, Parkinson, etc., and a history of head trauma; Participating in another clinical trial.
Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female

The aim of this study is to evaluate the effect of whole-body vibration in the presence or absence of localized radiofrequency on body composition in obese female subjects. Moreover, strength tests will be performed. The study hypothesis is that whole-body vibration induces positive changes in body composition i.e., reduction of fat mass and increase of lean mass with associated increase in performance. The possible additive role of radiofrequency will also be assessed.

* recruitment of female obese subjects
* baseline assessment (body composition with dual energy x-ray absorptiometry (DXA) and strength tests)
* 2-mo whole body vibration training (2 sessions a week, 30 min per session) with or without local delivery of radiofrequency (two randomly selected groups)
* final assessment (body composition with DXA and strength tests)
* data collation and analysis

Eligibility Criteria:
Inclusion Criteria:

* BMI: \>25
* normal locomotion
* informed consent form signed

Exclusion Criteria:

* acute illness
* endocrine pathologies or diabetes mellitus
* vascular pathology
* pacemaker
* pregnancy
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* Women, still with uterus, planning total hysterectomy as part of surgical repair for pelvic organ prolapse
* Symptomatic anterior and/or apical vaginal prolapse greater than or equal to Stage 2 (i.e., bulge extends to at least 1 cm of the hymen or beyond)
* Women between 1 and 10 years after menopause. Menopause is defined as one year of amenorrhea or surgical ovariectomy.
* Age 40-70 years old
* No estrogen replacement therapy in the last 1 month
* Physically capable of daily application of vaginal cream

Exclusion Criteria:

* BMI \>35
* Prior surgical repair of prolapse involving the vaginal cuff.
* Prior total hysterectomy
* Premenopausal or postmenopausal \>10 years
* Prior steroid hormone replacement therapy of duration \>1 month (oral or vaginal estrogen, testosterone or corticosteroids)
* History of connective tissue disease (Ehlers-Danlos, Marfan, etc)
* History of vaginal radiation
* Contraindications for estrogen replacement therapy (current, or history of, spontaneous deep vein thrombosis, stroke, coronary artery disease, breast or endometrial cancer)
* Concurrent use of steroid cream for treatment of Lichen sclerosis
* Recent history (within last month) of vaginal infection or vaginitis
* Current tobacco use
Personalizing MPK Prescription

In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.


Eligibility Criteria:
Inclusion Criteria:

* A unilateral transfemoral amputation of the lower limb at least six months post fitting of definitive lower extremity prosthesis
* Habitual use of a lower extremity prosthesis in daily living activities (based on assessment of a physiatrist and/or prosthetist and patient self-report)
* Aged between 18 to 75 years
* K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of a physiatrist and/or prosthetist)

Exclusion Criteria:

* Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
* Individuals who have open wounds on their residual limb
* Individuals with known visual impairments that would prevent them from safely operating a prosthesis during over ground walking or ascending stairs (based on assessment of the physiatrist and/or prosthetist and patient self-report)
* Individuals with known hearing impairments or who use hearing aids that would prevent them from responding to an auditory instruction (based on assessment of the physiatrist and/or prosthetist and patient self-report)
* Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
Pharmacokinetic Study of Marine Active in Health Men

Hyperuricemia is often associated with metabolic syndrome, which is a known precursor of atherosclerosis. The Yaizu Suisankagaku Industry Company have developed industrial production, named Marine Active. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

Hyperuricemia is a common metabolic disorder. It can result from a decreased renal uric acid excretion, increased urate production, or both. The classical association with clinical gout is well-known. The principal indications for uric acid-lowering therapy, including allopurinol, probenecid and sulfinpyrazone, are the patients with gout history, macroscopic subcutaneous tophi, frequent attacks of gouty arthritis, or a documented state of uric acid overproduction. Hyperuricemia is often associated with metabolic syndrome,which is known a percursor of atherosclerosis. For the gout attack only 5% per year of the hyperuricemic population, medical management is not indicated for patients without gouty arthritis. Diet control is the leading way to control serum uric acid level, but usually it is not enough. So how to management hyperuricemia is important and is a potential management.Histidine-containing dipeptides such as Anserine and Carnosine have been studied extensively in recent years. These dipeptides were shown to be effective in acting as buffering agents against protons developed during anaerobic exercise. Anserine and Carnosine also have strong anti-oxidant activity, anti-cancer activity, immuno-response modulation, fat reduction and enhanced wound healing functions. The Yaizu Suisankagaku Industry Company have developed industrial production process to extract and purify the dipeptides from Bonito and Tuna. The extract, named Marine Active, was able to offer anti-fatigue activity by animal trial data. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

Eligibility Criteria:
Inclusion Criteria:

-Male volunteers, age between 20 to 35 years

Exclusion Criteria:

* Chronic medical history
* Significant liver or renal dysfunction,
* Have been administrated by any drug within 2 weeks before the initiation of study.
Bioequivalence Study of AG2202

The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.

To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 19 years or older at the time of screening
* Subjects with a BMI of 18.0-30.0 kg/m2
* Subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination
* Subjects who are deemed eligible based on the screening tests

Exclusion Criteria:

* Subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose
* Subjects who have taken the investigational drug within 6 months prior to the first dose
* Subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards

CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:

* Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
* Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Hospitalized in surgical or medical wards
* Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis
* Therapy prescribed by the attending ward physician

Exclusion Criteria:

* Patients receiving antimicrobial therapy not prescribed by the attending ward physician
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer

This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
* Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
* Measurable disease by RECIST
* Greater than or equal to 18 years of age
* ECOG PS of 0 or 1

Exclusion Criteria:

* Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
* Evidence of NYHA class III or greater cardiac disease
* History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
* Known HIV infection or AIDS
* Symptomatic CNS metastases
* Pregnant or nursing women
* Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
* History of upper GI bleeding, ulceration, or perforation
* Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
* Previous anti-EGFR kinase therapy
Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-small cell lung cancer
* Non-small cell lung cancer that is not curable with surgery, radiation, or combined modality chemoradiation
* Failed two prior chemotherapy regimens which must have included platinum
* Measurable disease

Exclusion Criteria:

* Treatment with more than two prior chemotherapy regimens
* History of bone marrow transplantation or stem cell support
* Pregnant or lactating women
* Known history of prior gefitinib therapy
* Known history of prior TLK286 therapy
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.


Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 21 years old on day of giving consent for study
* Patients must be able and wiling to give an informed consent
* Patient with chronic HBV infection
* Patient with active hepatocellular carcinoma and chronic hepatitis B
* Healthy subjects

Exclusion Criteria:

* Patients who have co-infection with HIV or chronic hepatitis C
* Subjects with other types of cancer
Trial of Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease

This trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger bioavailable amount of zinc than an FDA approved preparation of inorganic zinc acetate; and 2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better tolerated with significantly less gastrointestinal side effects than the zinc acetate capsules. The trial also tests the hypothesis that, after 6 months of once daily administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper. Additionally, subjects will perform tests of mental function,including the dementia rating scale, the Mini Mental Status Examination and the ADAS-cognitive performance test aimed at Alzheimer's status assessment. Tests will be administered at baseline, 3 and 6 months, and the performance results compared. Care-giver assessments will also be noted.

This multi-center study aims to determine the pharmacokinetics and pharmacodynamics of a novel gastro-retentive, sustained-release zinc cysteine preparation on the blood and urine measures of copper and zinc balance in Alzheimer's disease and mild cognitive impairment. Data expected to be derived include tolerability of the novel preparation in comparison with oral inorganic zinc salt, and long-term effects on primarily blood-measured copper-zinc balance. The study design is that of a prospective, randomized, double blind placebo-controlled clinical trial, with a duration for individual subjects of 6 months. The study will be performed at a total of 3 sites, under the direction of a single principal investigator, with a sub-investigator. The statistical plan calls for a comparison of data from the two long-term parallel groups using ANOVA and other applicable techniques. In addition to blood parameters, mental function assessments obtained at baseline, 3 and 6 months will be evaluated statistically.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease mild to moderate as diagnosed by standard clinical, functional and NINDA-ADRDA criteria
* Mild cognitive impairment diagnosed by standard clinical, functional and NINDA-ADRDA criteria
* All subjects able to swallow Tablets
* Subjects taking copper or zinc containing supplements must have a 30-day wash out before starting study materials
* Screening laboratory values either within normal limits or deemed not clinically significant by investigator

Exclusion Criteria:

* Subjects or their study companions/care givers unable to give adequate informed consent
* Presence of a disease or condition known to affect biometal homeostasis
* Presence of psychosis, substance abuse or other major medical or neurological issues
* Presence of vascular dementia
* Clinically significant anemia at the time of the screening visit
* Current use of a decoppering drug such as trientine or penicillamine
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* angiographic stenosis\>50% or occlusion of one below-knee vessel

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation