cyrilzakka/clinical-trials huggingface dataset:
SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS

Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis.

New strategies to anticipate the diagnosis of recurrence have been investigated in the last years. In this context, standard serum biomarkers, such as CA-125, and radiological evaluation are commonly used for disease surveillance, However, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of OC, could help clinicians to address this important challenge.

Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. CtDNA has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. Wehave designed a study to assess the ability of ctDNA to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced OC. If proven effective and reliable, ctDNA could be introduced into routine surveillance programme for OC.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed suspicious International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer
2. Age between 18 and 80 years
3. Estimated life expectancy of at least 4 weeks 4. Signed informed consent

Exclusion Criteria:

1. Any previous cancer in the last 5 years
2. Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors
3. Pregnancy or breastfeeding
4. Missed informed consent
Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. The current study will examine whether a brief behavioral intervention of slow breathing paced at a resonance frequency of the cardiovascular system can interrupt automatic alcohol cue reactivity and enhance cognitive control in binge drinkers. Results from the proposed study may provide new prevention and intervention targets to interrupt unhealthy drinking behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Must report at least 2 binge drinking episodes in the past month
* Have normal or corrected-to-normal vision

Exclusion Criteria:

* History or presence of serious psychiatric disorders, neurological disorders, or head injury resulting in a loss of consciousness
* Presence of any serious medical condition
* Report of more than a few occasions (3-4) of illicit drug use, except for cannabis, in the preceding year
Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects

Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.

Ten healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were assessed by using a blinded crossover trial. The subjects were examined regarding blood glucose levels and GER after ingestion of 150g WWB or RWMB on two different occasions after an overnight fast. GER was measured using a standardized real time ultrasonography. GER was calculated as a percentage change in antral cross sectional area 15 and 90 minutes after the finished meal with WWB and RWMB. Finger-prick capillary samples were collected before and 40, 60, and 90 min after the start of the meal to measure blood glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus

Exclusion Criteria:

* with symptoms or prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Daily Checklists and Outcome in the Intensive Care Unit

Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.

The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.


Eligibility Criteria:
Inclusion Criteria:

* Admission to a medical intensive care unit (MICU) team during the study timeframe

Exclusion Criteria:

* Transfer from MICU team to a separate ICU team within 12 hours of admission
* Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
* Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

Exclusion Criteria:

* Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
* Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
* Evidence or history of diabetes mellitus Type 1 or Type 2.
* History or symptoms of autoimmune disorders.
Vietnam Cryptococcal Retention in Care Study Version 1.0

It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.

This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Confirmed HIV infection using National Testing Algorithm
* CD4 ≤100 cells/μL
* Able to provide written informed consent

Exclusion Criteria:

* History of prior CM
* Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
* Currently taking ART or history of ART for more than 4 weeks within the past year
* Known to be currently pregnant or planning to become pregnant during the study period
A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.

The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.

Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patients. However, between 50% and 70% of patients who achieve remission will relapse. Current therapy for patients refractory to initial therapy or who relapse within 6 months of remission is unsatisfactory because complete remission rates are low and remission duration is brief. New drugs with novel mechanisms of action may be more beneficial than the currently available ones. Tipifarnib represents a new class of oncology drugs which have a specific cellular target (inhibition of the farnesyl transferase protein), one of the components of the Ras oncogene, as its specific mechanism of acton. It is believed that inhibition of this protein will lead to a decrease of cellular proliferation or cell death. This is an open-label, multicenter, non-comparative phase 2 study investigating the efficacy and safety of farnesyl transferase inhibition with tipifarnib administered orally as a single agent, twice daily, for the first 21 days of every 28 day cycle. Patients are enrolled by disease status into two cohorts; Cohort 1 includes patients with relapsed AML and Cohort 2, patients with refractory AML. All patients will be treated for a sufficient length of time to determine response to study medication (effectiveness) by evaluating the rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp), duration of complete remission, time to disease progression and progression-free survival, overall survival, and to characterize clinical benefit and quality of life (QOL). The safety profile of tipifarnib will also be determined in patients with refractory of relapsed AML.. The patients will receive six tablets (100 mg each) of tipifarnib twice daily for 21 of 28 day cycles (7 day rest period between cycles). Patients may receive tipifarnib until disease progression or unacceptable toxicity occurs.

Eligibility Criteria:
Inclusion Criteria:

* Refractory or relapsed Acute myeloid leukemia (AML)
* Eastern Cooperative Oncology Group (ECOG) performance of 0-2
* any value of WBC
* able to eat food and medication orally
* females must use contraception and not be pregnant

Exclusion Criteria:

* .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
* must not have active CNS leukemia
* must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
* must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.
The Impact of Opioids in Coronary Heart Disease

In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP).

In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).


Eligibility Criteria:
Inclusion Criteria:

* 40 years or older
* written informed consent

Exclusion Criteria:

* currently cancer
* cognitive limitations
Healthy Minds Program App Dosage

The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.

Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Access to a smartphone or device capable of downloading HMP app
* Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
* Able to speak, read, and write in English
* PROMIS Depression or PROMIS Anxiety \>55

Exclusion Criteria:

* Meditation retreat experience
* Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
* PROMIS Depression \>70
* AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)
The Effect of Bilateral Infraorbital+ Infratrochlear Nerve Block for Rhinoplasty Operations

The aim of our study is to examine the effect of bilateral infraorbital and infratrochlear nerve blocks for rhinoplasty operations on perioperative remifentanil need and postoperative pain scores.

Rhinoplasty operations are one of the most applied cosmetic surgeries in the world.

Depending on the procedure type and hemodynamic lability, the quality of the surgical field, perioperative and postoperative complications as well as the success of surgery are affected.To provide improved surgical field quality, controlled hypotension and high concentrations of inhalation anesthetics, magnesium sulfate, remifentanil, clonidine, calcium channel blockers, tranexamic acid, intravenous nitroglycerin have been used.

The American Society of Anesthesiology recommends using regional anesthesia methods and administering multimodal analgesia in every possible surgery. In our study we have performed bilaterral infraorbital an infratrochlear nerve blocks which are main nerves of the nose, for the patients of rhinoplasty. With blocking the infratrochlear and infraorbital nerves we will examine the need for remifentanil during surgery, postoperative pain scores.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing rhinoplasty surgery

Exclusion Criteria:

* Bleeding disorder
* Patient refusal
* Age under 18
Long-Term Effect of Combined Citrulline and Nitrate-Rich Beetroot Extract Supplementation

Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been investigated to date. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone, cortisol and Testosterone cortisol ratio (T/C)) in male trained triathletes. This study was a double-blind, placebo-controlled trial where participants (n = 32) were randomized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8). Blood samples were collected from all participants at baseline (T1) and after 9 weeks of supplementation (T2).

Triathlon is an endurance sport in which athletes compete sequentially in swimming, cycling and running. Prolonged and strenuous training combined with insufficient recovery can produce muscular and metabolic stress, resulting in structural and functional damage to the musculoskeletal system leading to a fatigue status, which results in decreased athletic performance. As a consequence of this type of combined exercise, there are also alterations in biochemical markers of exercise-induced muscle damage (EIMD) as well as anabolic/catabolic hormones. Therefore, their analysis is useful in determining the balance between training loads and recovery. In this sense, it is essential to include different strategies to reduce or prevent EIMD, which delay or reduce muscle fatigue and improve sports performance. One of these strategies is the use of different ergogenic aids such as L-citrulline (CIT) and nitrates (NIT) which have been proposed as both substances produce an increase in nitric oxide (NO).

Eligibility Criteria:
Inclusion Criteria:

* Males between 25 and 35 years old
* Triathletes
* With at least 5 years of experience
* Without any disease
* Non smokers
* Non drinkers of alcohol
* Not to take any other medications or stimulant substances during the study
* 2 weeks without taking other nutritional supplements

Exclusion Criteria:

* Exclusion criteria:
* Men under 25 and over 35 years of age.
* Non triathletes
* Less than 5 years of experience
* With any disease
* Smokers
* Alcohol drinkers
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous,
* English speaking
* 18-45 years
* single gestation ≥ 37 weeks
* vertex presentation
* American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
* requesting an epidural for labour analgesia
* cervical dilation ≤ 7 cm at the time of initiation of epidural analgesia.

Exclusion Criteria:

* Preeclampsia or HELLP syndrome
* maternal cardiac disease
* severe or uncontrolled maternal systemic disease
* contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
* abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
* chronic analgesic use
* a physical or psychiatric condition which may impair cooperation
* known fetal anomalies/intrauterine fetal demise
* height \< 5'0"
* Body Mass Index \> 45 kg/m2
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer

This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ketogenic diet and chemotherapy may be better in patients with breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of implementing a diet that induces nutritional ketosis in women who are initiating palliative chemotherapy to treat advanced stage breast cancer (BC).

II. To determine the effects of a ketogenic diet on tumor progression. III. To determine the effects of nutritional ketosis on biologic and behavioral health markers.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive standard of care therapy with paclitaxel.

ARM II: Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>= 22 kg/m\^2
* Confirmed diagnosis of metastatic or stage IV BC
* Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory)
* Life expectancy \> 6 months
* Able and willing to follow prescribed diet intervention

Exclusion Criteria:

* Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as \> 12 months \[mo\])
* BMI \< 25 kg/m\^2
* Weight change \> 5% within 3 months of enrollment
* Type 1 diabetes
* History of diabetes with retinopathy requiring treatment
* Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
* Intestinal obstruction
* Bilirubin \> 2
* Albumin \< 3.5
* Glomerular filtration rate (GFR) \< 55 mL/min
* Creatinine \> 2.0
* Urinary albumin \> 1 g/day
* Congestive heart failure
* Pregnant or nursing women
* Unable to provide informed consent
* Uncontrolled concurrent medical conditions that would limit compliance with study requirements