cyrilzakka/clinical-trials huggingface dataset:
Microbiome and Association With Implant Infections

The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.

PRIMARY OBJECTIVE:

I. To determine the feasibility of breast microbiome sampling using the study techniques

SECONDARY OBJECTIVES:

I. To define the differences in the gut and breast microbiomes between participants undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not.

II. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction.

OUTLINE: Participants are randomized to 1 of 2 cohorts.

COHORT A: Participants receive postoperative antibiotics to take for at least 7 days post-operatively.

COHORT B: Participants receive no antibiotics post-operatively in the absence of clinical evidence of infection.

Participants are followed up for 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
2. Age \>= 18 years
3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
4. Ability to understand a written informed consent document, and the willingness to sign it
5. At least 4 weeks post-completion of chemotherapy or radiation therapy.

Exclusion Criteria:

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
2. Pregnant or breastfeeding
3. Patients who have taken antibiotics within 90 days of the consent date
4. Patients who have taken probiotics within 90 days of the consent date
5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
6. Male patients
Study of 124I-NM404 in Advanced Solid Malignancies

The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.

124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced solid malignancy.
* Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer
* Disease must be at least 1cm in diameter
* Brain metastasis must be stable for at least one month.
* ECOG performance status 0-2
* Anticipated survival less than 5 years, as per the treating physician

Exclusion Criteria:

* Skin lesions only
* Chemotherapy or radiotherapy within 1 week
* Residual toxicities of grade 2 or greater from prior therapy
* Adequate organ function as per specified laboratory parameter
* Platelet count \> or = to 75,000/uL
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read or understand English or Spanish
5. Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:

   1. R-CHOP or R-CHOP-like regimen
   2. BR
   3. BV-AVD or ABVD or checkpoint inhibitor+AVD
6. ECOG Performance Status grade of \<2

   a. PI approval needed if ECOG = 2
7. Approval from treating oncologist, confirmed via email or in writing
8. Delivery of chemotherapy treatments at one of the following institutions:

   1. Sylvester Comprehensive Cancer Center (including satellite/network sites)
   2. University of Miami Hospital/UHealth Tower
9. Internet access on a smart phone, tablet, or computer
10. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria:

1. Individuals younger than 18 years of age
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
6. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. History of dementia or major psychiatric disease
8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis

Exclusion Criteria:

* end stage renal disease (serum creatinine concentration \> 300 μmol/L)
* on dialysis
* chronic moderate to high dose corticosteroid therapy (\> 10 mg/day prednisolon or equivalent)
* preoperative severe hypernatremia (Na+ \> 150 mmol/L), alkalemia (PH \> 7.50), or pulmonary edema
* neurocognitive dysfunction
FLEX FIRST Registry Research Protocol

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age.
2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:

   * Elevated venous pressure during hemodialysis,
   * Abnormal physical findings, and
   * Unexplained decrease in delivered dialysis dose.
3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
5. Subject understands the study and is willing and able to comply with the follow-up requirements.

Exclusion Criteria:

1. Subject has a known or suspected systemic infection.
2. Subject has a known or suspected infection of the hemodialysis graft.
3. Subject has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
Leadless Electrocardiogram (ECG) Evaluation Study

The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.

The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine. The LECG signals are measured from three electrodes mounted on the outside of the pacemaker housing and provides an electrical far field signal of the electrical activity of the heart. The LECG provides three ECG channels as different projections of the electrical activity of the heart, similar to the surface ECG. Clinical interest of LECG is threefold. First, ECG recordings are routinely used to perform pacemaker and cardiac resynchronization systems in-office follow-up mainly to determine pacing thresholds. Connection of ECG electrodes to the patient as well as the time needed to acquire an acceptable ECG signal during routine follow-up could be saved using LECG which would make follow-up easier and less time consuming. Secondly, connecting ECG electrodes requires the patient to be present at the clinic for the follow-up. Use of LECG in conjunction with a transmitting system will allow remote patient follow-up. In that case, correct ventricular capture confirmation by the LECG is of key importance. Finally, LECG stored in device memory at the time of an arrhythmia episode occurrence, can help better classify it.

The following factors might influence the quality of the LECG and/or the axis of the LECG:

* temporal changes of the electrode tissue interface due to device pocket healing process
* changes in device position and orientation over time
* body motion
* poor LECG contact due to oversized device pocket with replacement procedure. The purpose of this study is to obtain more data on leadless ECG (LECG) to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

* patient with a CRT-P indication and
* patient who has signed an informed consent form.

Exclusion Criteria:

* patient younger than 18 years and/or
* unable to complete the 1-Month Follow-up visit and/or
* legally incompetent or illiterate and therefore unable to provide an informed consent
The LADIES Acute Coronary Syndromes Study

The Ladies ACS study will investigate the relation between age at menopause and severity of coronary artery disease in menopausal women with acute coronary syndromes and clinical indication to coronary angiography.

Multicenter prospective study in consecutive patients hospitalized with a wide spectrum of ACS and clinical indication to coronary angiography.

Consecutive patients older than 55 years with an ACS undergoing coronary angiography are eligible for the study, irrespective of subsequent revascularization. Eligible are women and men with a 2:1 enrolment ratio.

Patients will be stratified according to gender and age, including four age categories: 55-64, 65-74, 75-85 and \>85 years. Each age category will include 200 patients, and enrolment in each category will be stopped once this number has been reached.

A specific electronic web-based CRF will collect clinical and procedural data. Clinical data input will take place at the participating Centers. Angiographic data input will be performed at rthe angiographic corelab, blinded of clinical data.

The e-CRF will collect data on

* the characteristics of the ACS
* the relevant risk factors for CAD and known prognostically relevant variables
* prior clinical history (prior MI, PCI, CABG, heart failure, stroke)
* in women fertility history will be captured by specific items, including age at first and last menstrual period, past use of oral contraceptives, ongoing and past hormone replacement therapy (HRT) and whether they had undergone a hysterectomy and/or oophorectomy, as well as information on the number of full-term pregnancies (the sum of live births and stillbirths). Age at menarche is defined as the age at the first menstrual period. Reproductive life span is automatically calculated calculated by subtracting the age at menarche from the age at menopause. The presence of hot flushes, their severity and duration in years will be also captured.

The extent of coronary artery disease will be evaluated at a central corelab using the Gensini score and the SYNTAX score

Eligibility Criteria:
Inclusion Criteria:

Patients \>55 years of age with all of the following characteristics:

* symptoms suggestive of acute myocardial ischemia within the previous 48 hours.
* The diagnosis of an ACS must be confirmed by a typical rise and fall in serum troponin levels as defined by the Third Universal Definition of Myocardial Infarction.
* ECG signs of myocardial ischemia defined as either transient or persistent ST segment elevation or depression \>0.5 mm (but \>1 mm in the case of ST-segment elevation), or persistent and definite T-wave inversion \>1 mm, including the pseudonormalization of a previously negative T-wave, in ≥2 contiguous leads.

Exclusion Criteria:

* none
Gestational Diabetes Mellitus, Obesity and Periodontal Disease

This study evaluated the periodontal condition of gestational diabetes mellitus (GDM) patients and a healthy non-pregnant control group. For the GDM group all medical data were recorded, including obesity/insulin resistance indicators.

Gestational diabetes mellitus is associated to a worse periodontal condition. Many patients with these two diseases are also obese. After delivery, some patients maintain the pre-pregnancy obesity status and this condition is also associated to periodontal disease. The mechanisms involved in the relationship of all these medical and periodontal conditions are not clear.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for GDM group was pregnant women with diagnosis of GDM based on glucose determination described in a previous study (19) and under medical treatment of an endocrinologist and the presence of at least one tooth per sextant.
* Inclusion criteria for control group were absence of periodontal disease, mean age similar to test group and presence of at least one tooth per sextant.

Exclusion Criteria:

* The exclusion criteria for GDM group were pregnant women without diagnosis of diabetes, age below 18 years or higher than 42 years, and the presence of other systemic diseases.
* In control group, women were excluded if they were pregnant, had diabetes or other systemic disease and age below 18 years or higher than 42 years.
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.


Eligibility Criteria:
Inclusion Criteria:

* Medical history for at least 6 months prior to screening of mild cognitive impairment with a Mini Mental State Exam (MMSE) score between 20 and 26 or diagnosis of mild Alzheimer's disease;
* Must be able to swallow dose of study medication;
* Body Mass Index (BMI) between 18.0 and 35.0; and
* Subject and Project Partner are willing to participate and agree to comply with all study requirements.

Exclusion Criteria:

* Blood pressure \> 160 mmHg (systolic) and \> 90 mmHg (diastolic);
* Received HPP854 in a previous trial;
* Participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit.
* Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse;
* Clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder;
* History or presence of cancer except for non melanoma skin cancer. Subjects with a history of prostate cancer stable for \> 3 yrs with no active treatment for \> 3 years prior to Screening may be considered for eligibility;
* Use of the following medications/therapy from 14 days before dosing until after the Final Visit: anti-cholinergic, tricyclic antidepressants, lithium, typical or atypical antipsychotic medications, anticonvulsant medications, immunosuppressive agents, oral corticosteroids, and radiotherapy;
* HbA1C \> 6.5 % at the Screening Visit;
* Vitamin B12 level \< 211 pg/mL at the Screening Visit;
* Any suicidal risk determined by C-SSRS administered by a study staff member appropriately certified for administration of the scale (Baseline/Screening, Phase 1 Study Version) at Screening Visit, Day -6 or Day -1;
* A score of 15 or more on the modified Geriatric Depression Scale (GDS); and
* A score of 5 or more on the Hashinski Ischemic Scale (Rosen modification.
* Contraindications of MRI including: Metallic fragments, clips or devices in the brain, eye, spinal canal, etc; Cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants, etc.
* Contraindications for blood or CSF sampling, including: Bleeding disorder or taking anticoagulants/antiplatelet, chronic active infection.
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency

The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age.
* Healthy volunteers must be in good general health.
* Subjects with hepatic impairment must be judged to be in stable condition.
* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
* Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.
* Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive).

Exclusion Criteria:

* Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
* Have a known history of neuroleptic malignant syndrome.
* Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result.
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start.
* Have had previous exposure with NBI-98854.
Neurotensin - an Important Regulator of Appetite in Humans?

Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.

This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.


Eligibility Criteria:
Inclusion Criteria:

* age = or above 18 years
* normal haemoglobin levels
* male
* informed consent

Exclusion Criteria:

* Diabetes mellitus (fasting plasma glucose or HbA1c)
* Familiy history of diabetes mellitus
* Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
* Family history of inflammatory bowel disease
* Previous intestinal resection
* Body mass index (BMI) over 25 kg/m2
* Smoker
* Nephropathy (S-creatinine\> 130 μM)
* Liver disease (ALAT and/or ASAT \> 2 × upper normal limit)
ARQ 501 in Combination With Docetaxel in Patients With Cancer

The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.

ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no histological cancer type studied appears inherently resistant to treatment with ARQ 501. In animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy, ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon.

This study is designed to explore whether the addition of ARQ 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.

Eligibility Criteria:
Inclusion Criteria:

* Have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.)
* Be ≥18 years old.
* Must not be eligible for therapy of higher curative potential.
* Have a Karnofsky Performance Status (KPS) of ≥70%.
* Have an estimated life expectancy of ≥12 weeks.
* Be male or non-pregnant, non-lactating female patients. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
* Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
* Sign a written informed consent document.
* Have adequate organ function as determined per protocol defined laboratory value

Exclusion Criteria:

* Have received previous treatment with ARQ 501.
* Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
* Are pregnant or lactating.
* Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
* Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
* Have not recovered from acute toxicity of all previous therapy prior to enrollment.
* Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Have symptomatic or untreated central nervous system (CNS) metastases.
* Have a known severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.