cyrilzakka/clinical-trials huggingface dataset:
Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study

The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.


Eligibility Criteria:
Inclusion Criteria:

* Patients are females with histologically proven carcinoma of the breast
* The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised.
* Age ≥ 18 years
* Written informed consent has been obtained
* Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Non palpable breast tumor or prior surgery of this breast
* Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW
* History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment
* Inadequately controlled hypertension with or without current antihypertensive medication
* Significant renal or hepatic impairment (grade II or higher deviations by CTCAE)
* History of allergy or infusion reactions bevacizumab or other monoclonal antibodies
* Pregnant or lactating women
* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Life expectancy \< 12 weeks
* Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue
Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide Informed Consent
* Age \> 40
* Surveillance Colonoscopy (History of Adenomas)

Exclusion Criteria:

* Poor or Fair Bowel Prep
* Difficult First Insertion
* Familial Polyposis
* Inflammatory Bowel Disease
* Pregnancy
* Active GI Bleeding
* Prior colonic or rectal resection
* Conserved Sattus
* Colonoscopy less than 3 years ago
* Screening Colonoscopy
* Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.

Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.

Eligibility Criteria:
Inclusion:

Patients enrolled in TBTC Study 25 Informed consent

Exclusion:

Severe anemia (Hct \<25%) Any severe adverse event related to study drugs in TBTC Study 25
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.

Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.

Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

Eligibility Criteria:
Inclusion Criteria:

* Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
* Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
* Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
* A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion Criteria:

* Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
* Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
* Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.
HVA vs IA/DA or VA in the Treatment of ND HR-AML

The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.

The HVA regimen exerts a synergistic pro-apoptotic effect and has demonstrated significant clinical efficacy against R/R AML and also overcomes adaptive resistance observed in the VA regimen. Exploratory work with small sample sizes in first-line settings suggests that combination of HHT and Ven+AZA exhibits potent anti-AML effects with good safety profiles, particularly in overcoming the impact of high-risk factors associated with AML relative to standard treatments. This indicates its potential as a more ideal option for the treatment of newly diagnosed AML with high risk factors. Therefore a prospective, multi-center, randomized controlled clinical study is planned to evaluate the efficacy and safety of the HVA regimen compared to intensive chemotherapy (IA/DA) or Venetoclax plus azacitidine (VA) regimens in newly diagnosed high-risk fit-AML or unfit AML patients.

Eligibility Criteria:
Inclusion Criteria:

* According to the world health organization (WHO) classification of newly diagnosed with AML patients;
* Age ≥18 years old;
* High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
* Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of AML;
* Expected survival ≥12 weeks;
* The eastern tumor cooperation group (ECOG) score 3 points or less;
* Kidney function: creatinine clearance acuity 30 ml/min;
* Liver function: ALT \< 5 times normal value, bilirubin \< 3 times normal value;
* Sign the informed consent form and understand and abide by the plan calls for process.

Exclusion Criteria:

* Acute promyelocytic leukemia;
* With central nervous system leukemia (CNSL) ;
* The cardiac function \> level 2;
* The AIDS virus (HIV) infection;
* Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
* Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
* Being allergy to the experimental drugs;
* Pregnant and lactating women;
* Patients who could not understand or adhere to the study protocol;
* Patients deemed by the investigator to be ineligible for enrollment.
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound

This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject has systolic blood pressure of 160 mmHg in average or greater.
* Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
* Subject has two functioning kidneys, defined as eGFR ≥ 45 ml/min.
* Subject has at least one renal artery on each side which is greater than 4mm.

Exclusion Criteria:

* Subject has hydronephrosis as seen on MRA or ultrasound.
* Subject has renal stenosis greater than 50% based on baseline MRA.
* Subject has a renal stent or other implant in the region.
* Subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
* Subject has a history of abdominal surgery within the past six months.
* Subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
* Subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
* Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
* Subject has hemodynamically significant valvular heart disease.
* Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
* Subject has a body weight \> 150 kilograms.
* Subject has a target treatment depth \> 14 cm.
* Subject is pregnant, nursing or intends to become pregnant during the trial period.
* Subject is currently enrolled in other potentially confounding research.
* Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients

This study aims to find out:

1. The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.
2. To find out how study drug is broken down in the body
3. To know the effects of the study drug on the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Life expectancy \> 3 months.
* Measurable disease as defined by RECIST 1.1 criteria
* Blood coagulation parameters:

  * PT INR ≤ 1.5X ULN
  * PTT INR ≤1.2X ULN
* Patients must have adequate venous peripheral access for apheresis.
* Satisfactory organ and bone marrow function as defined by:

  * absolute neutrophil count \> 1,000/μL
  * platelets \>100,000/μL
  * hemoglobin ≥9 g/dL
  * serum ALT and AST ≤ 3X ULN or AST and ALT ≤5X ULN, if liver function abnormalities are thought to be from underlying malignancy
  * total serum bilirubin ≤ 2X ULN
  * Creatinine \<1.5X ULN
  * Stable amylase for 2 weeks

Exclusion Criteria:

* Prior gene therapy or therapy with any murine monoclonal antibodies or any murine containing product.
* Concurrent treatment with any anticancer agent including chemotherapy, hormonal therapy or radiation therapy. Must be 5 X half-life or 6 weeks (whichever is shorter) post dosing of previous cancer therapies.
* History of allergy or hypersensitivity to murine proteins or study product excipients
* Females who are pregnant, trying to become pregnant, or breastfeeding.
* Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV).
* Active infection requiring systemic treatment.
* Active brain, leptomeningeal, or paraspinal metastases, except for asymptomatic metastases and are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent for at least 14 days prior to the start of study interventions.
* Impaired cardiac function (AHA NY Heart Association Grade II-IV) or clinically significant cardiac disease.
* Lack of recovery of prior CTCAE Grade 3 or above adverse events due to earlier therapies.
* Chronic use of corticosteroids in excess of \>10mg daily of prednisone or equivalent within 4 weeks prior to alopecia.
* Concomitant use of complementary or alternative medication or therapy such as Chinese herbal medicine.
* History of Crohn's disease, inflammatory bowel disease, or ulcerative colitis within the past 5 years
* Abnormal bowel function which would make assessment of bowel permeability difficult to access
* Major trauma or major surgery within 4 weeks prior to first dose of study drug
Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia

Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life.

The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia.

The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients diagnosed with chronic lung disease (≥ 18years).
2. Only patients who are willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

1. Patients with other major comorbidities that could significantly impact muscle mass and function, such as severe heart failure, advanced liver or kidney disease, uncontrolled diabetes, or malignancies.
2. Patients with acute exacerbations of their chronic lung disease or any other acute illness at the time of the study. 3. Patients with a history of neuromuscular disorders or disability that could significantly affect muscle mass and function.

4. Patients who have undergone recent surgery in the past 6 months or have received specific treatments that could influence muscle mass and function, such as long-term corticosteroid use, chemotherapy, or radiation therapy.

5. Patients with life expectancy of less than 6 months 6. Patients who are unable or unwilling to comply with the study protocol or procedures.

7. Patients that are unable to give informed consent.
Reducing Cost of Azythromycin by Transferring From IV to Oral Therapy

Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The investigators believe that intravenous therapy is prolonged more that necessary and that oral therapy can be used much earlier in the course of the disease. The investigators plan to check if that statement is true and intervene in order to shorten the intravenous therapy.

The study will be performed in two stages. First a retrospective review of medical files of 50 patients hospitalized in the Haemek Medical Center with severe community acquired pneumonia, treated with azythromycin. The files will be reviewed for the criteria clinical improvement, and for azythromycin therapy, oral or intravenous.

The results of this review will help us define the appropriate behavioral intervention in order to cause doctors to transfer from IV to PO therapy at the earliest appropriate time. An intervention such as posters, pharmacy overseeing etc will be introduced. 3 months after the intervention, an additional 50 files of pneumonia patients treated with azythromycin will be reviewed in order to check the efficacy of the intervention.

The Review board and the NIH will be updated about the intervention, as soon as the investigators have decided what intervention is appropriate

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized with community acquired pneumonia treated by azythromycin

Exclusion Criteria:

* Age under 18
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip


Eligibility Criteria:
Inclusion criteria:

* Postmenopausal (PMO) women between 45 and 89 years of age.
* Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar spine OR
* Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar spine with at least one documented osteoporotic vertebral fracture or a previously documented history of an osteoporotic clinical non-vertebral fracture not due to excessive trauma

Exclusion criteria:

* Any prior use of strontium
* Any past or active kidney disease or problems with kidney function
* Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not limited to alendronate, risedronate and pamidronate) longer than 3 months consecutively. If bisphosphonate exposure is less than or equal to 3 months , a washout period of 1 year to randomization is required
* Calcium levels in blood within the normal range
* Normal liver function
* Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma
* Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry (DXA) measurement
* Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone Replacement Therapy within 3 months of randomization
* Allergy or previous exposure to teriparatide

Other protocol-defined inclusion/exclusion criteria may apply
Diabetic Peripheral Neuropathic Pain (DPNP)

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
* Score of ≥3 on Michigan Neuropathy Screening Instrument
* The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
* Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
* Male or female, 18-85 years of age.

Exclusion Criteria:

* History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).
* Other severe pain that may potentially confound pain assessment.
* Hemoglobin A1c \> 9%
* Hemoglobin ≤ 9 g/dL
* Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
* Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for \<4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
* Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.