cyrilzakka/clinical-trials huggingface dataset:
Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions

68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer under a compassionate IND in patients who have presented with biochemical failure. In this study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for experimental ex-vivo beta probe testing of resected tissue. Immediately following resection of the prostate, the intact tissue will be scanned using a PET camera designed for animal research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher resolution than can be attained using whole-body PET imaging. The experimental beta probe will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.

Primary Objective To assess beta ray detection of prostate cancer ex-vivo using experimental beta probe immediately after prostate cancer removal as determined by pathologist.

Secondary Objectives

* Compare preoperative standard of care staging via CT or MRI to 68Ga-PSMA-11 PET (CT or MRI) findings.
* Compare preoperative 68Ga-PSMA-11 PET (CT or MRI) lesion measurements with postoperative high-resolution PET of ex-vivo tissue.
* To compare the findings of each of the 68Ga-PSMA-11 detection methods to the surgical observations and the clinical tissue histopathology findings.

Exploratory Objective Correlation of beta probe measurements with preoperative 68Ga-PSMA-11 PET (CT or MRI) lesion measurements, postoperative PET/CT ex-vivo images, surgical observations, and pathology findings.

Eligibility Criteria:
Inclusion Criteria

To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:

1. ≥ 18 years of age
2. Must provide written informed consent
3. Presence of high grade prostate cancer (Gleason grade group 1-5) on prostate biopsy or prostate cancer recurrence.
4. Scheduled for prostate cancer removal
5. Willing and able to lie still for approximately 30 minutes in an enclosed space for the 68Ga-PSMA-11 PET CT or MRI

Exclusion Criteria

1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?

Needle Electromyography (EMG) is an important test used to assess muscle and nerve function, but the test can be uncomfortable. It is currently not standard practice to provide any pain-relieving intervention for this procedure. The purpose of this research study is to determine whether auricular (ear) acupuncture will make EMG testing less painful.


Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* Of any racial or ethnic group
* Adult between the ages 18 to 65 years
* Healthy
* Normal sensation and strength
* Pain approximately the same on each side of body with no major difference between right and left sides
* Can understand and are able to complete the outcomes questionnaires which will be explained before the study protocol begins

Exclusion Criteria:

* Pregnant or actively trying to become pregnant
* Diabetes mellitus or other systemic disease which may affect nerve function
* History of a neurologic disorder or other cause for abnormal sensation or weakness
* Have had recent trauma to an upper arm, hand or ear
* Have scars or burns on an upper arm, hand or ear that causes abnormal or decreased sensation
* Taking pain medications on a regular basis
* Have a bleeding or clotting disorder
* Taking blood thinners, such as aspirin, heparin, enoxaparin (Lovenox), clopidogrel (Plavix) or coumadin (Warfarin)
* Have received chemotherapy or radiation
* Have a permanent pacemaker
* Have a serious psychiatric disorder (such as schizophrenia)
* More sensitive to pain on one side of my body more than the other
Psychometric Validation of the ESAS12-F

Assessing symptoms of patients with cancer should be a priority for the physicians to improve their quality of life. The Edmonton Symptom Assessment Scale (ESAS) is a common tool, easy to complete and to analyse. Originally, it has been validated in English with 9 common symptoms. But a new version with 12 commons symptoms and some explanations has been created. This modified version has been translated in French, and the transcultural validation has been done. But the psychometreic validation has not been validated yet.

The primary objective is to validate the psychometric properties of this new version in French.

To validate the tool, we will compare the ESAS12-F to the European Organization for research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) which assesses common symptoms for patients with cancer, which is validated in French, but which is longer and more difficult to complete and to analyse. the patient will complete the ESAS 12-F and the EORTC QLQ-C30 at day 1, then the ESAS12-F at day 2, and the ESAS12-F and the EORTC QLQ-C30 at day 7.


Eligibility Criteria:
Inclusion Criteria:

* more than 18YO
* with advanced cancer
* followed but the palliative care team of the Centre Hospitalier Lyon Sud
* without any cognitive impairment
* can read and speak French

Exclusion Criteria:

* cognitive impairment
* bad performance status
* cannot read or speak French
* no advanced cancer
Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery

The patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic requirements are recorded. It's supposed that both are significantly reduced in patients undergoing TAP block.


Eligibility Criteria:
Inclusion Criteria:

1. Elective cesarean delivery
2. Term pregnancies
3. General anesthesia
4. Pfannenstiel incision

Exclusion Criteria:

1. No history of sensitivity to prescribed analgesic (Bupivacaine or related substances)
2. No preeclampsia
3. No history of psychologic disorders
Improving Symptom Self-management in Adolescents & Young Adults With Cancer

This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates an image of the symptoms the participant is experiencing, for improving symptom self-management in adolescents and young adults with cancer. In this one-group trial, participants will complete the C-SCAT and use it during two clinic visits with their oncology providers.

Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs) with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs create a picture of their symptoms using images and text on an iPad app. The resulting image shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has potential to support AYA's symptom self-management. Facilitating the self-management process, including self-efficacy, self-regulation behaviors, and patient-provider communication, is essential for improving symptom outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 15 to 29 years of age with a diagnosis of cancer (primary, relapsed/recurrent, refractory, progressive, or secondary malignancy) receiving myelosuppressive chemotherapy.
* Completion of at least one cycle of therapy for cancer and anticipated to have at least two additional cycles of myelosuppressive chemotherapy as part of the treatment plan.
* Ability to speak and understand English as required to complete the C-SCAT and study measures.
* Ability to use a tablet computer.

Exclusion Criteria:

* Cognitive and/or physical inabilities to complete the proposed study measures as determined by self--report, parent report of minor, or medical chart.
Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:

  * TIA/Stroke;
  * Euroscore greater than or equal to 5;
  * abnormal clock draw.

Exclusion Criteria:

* Parkinsonism,
* on any antipsychotic medications pre-op,
* active delirium,
* emergent surgery,
* Haloperidol allergy,
* schizophrenia,
* prolonged QTc.
Home Visitation Enhancing Linkages Project

A small pilot randomized controlled trial (RCT) will be conducted to test the impact of an electronic screening and brief intervention (e-SBI) on reduction in substance use (measured via self-report), associated symptoms (depression and parenting stress), and improvement in home visiting retention and substance use treatment engagement. While a pilot RCT was originally planned, the study experienced significant delays and recruitment challenges due to the COVID-19 pandemic. Therefore, after review by the DSMB and study sponsor, the decision was made to eliminate the randomization and assign all participants to the intervention condition to evaluate feasibility and acceptability of the intervention.

The purpose of this clinical trial is to pilot test an electronic screening and brief intervention (e-SBI) that will be adapted for use with pregnant and postpartum women in home visiting (HV) programs. The e-SBI will be tested in a small randomized trial in two home visiting sites, with 20 home visitors and 40 clients. Home visitors will be randomized to the control intervention or the e-SBI. Clients will be surveyed at baseline, and 3- and 6- month follow-up to track e-SBI impacts on reduction in substance use (measured via self-report), associated symptoms (depression and parenting stress), and improvement in home visiting retention and substance use treatment engagement.

While a pilot RCT was originally planned, the study experienced significant delays and recruitment challenges due to the COVID-19 pandemic. Therefore, after review by the DSMB and study sponsor, the decision was made to eliminate the randomization and assign all participants to the intervention condition to evaluate feasibility and acceptability of the intervention. Total enrollment was N = 14. Four participants were assigned to the control condition prior to elimination of randomization. The remaining 10 participants were assigned to the intervention condition. Primary study outcomes were feasibility and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking,
* 18 years or older,
* pregnant or up to 3 months postpartum,
* newly enrolling in home visiting with a participating home visitor,
* not currently attending substance use treatment

Exclusion Criteria:
A Study in Healthy Men to Test How BI 685509 is Processed in the Body

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.

The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP)), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Male subjects with women of child-bearing potential (WOCBP) partner who are vasectomised or willing to use male contraception (condom or sexual abstinence) from time point of study drug administration until 15 weeks thereafter

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* further exclusion criteria apply
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels

To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.

It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group.

For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.

Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured.

Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.

Eligibility Criteria:
Inclusion Criteria:

* LDL-cholesterol levels between 100 and 190 mg/dL.
* Freely agree to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Be pregnant.
* Have planned to change lifestyle and / or dietary habits.
* Having diabetes.
* Having a cerebrovascular disease.
* Having a serious illness.
* Taking products or drugs to control cholesterol levels or with antioxidant activity.
Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion.

The main questions it aims to answer are:

* Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation?
* Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it?
* What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?


Eligibility Criteria:
Inclusion Criteria:

* Absence of a prior history of atrial fibrillation or flutter.
* Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.

Exclusion criteria:

* Presence of thrombus in the left atrial appendage.
* Complications related to the index procedure.
* Insufficient quality of the left atrial electroanatomical map.
Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm

Gallstone ileus is a rare complication of gallstone disease. There is no systematic review on CGI. We analyze published literature on the subject and plan to propose a diagnostic-therapeutic algorithm for CGI. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and AMSTAR (Assessing the methodological quality of systematic reviews) guidelines, we will performe a systematic review of English-, German-, Spanish-, Japanese-, and Italian-language articles using PubMed (1946-2021), PubMed Central (1900-2021), and Google Scholar.

The search items include 'gallstone ileus', 'colonic gallstone ileus', 'gallstone coleus', 'cholecystocolonic fistula', 'ileo biliar', 'iléus biliaire', 'ileo di calcoli biliary', 'galsteen ileus', 'fístula colecistocolônica', 'fistule cholécystocolique'. Additional studies will be identified by reviewing reference lists of retrieved studies. We will include all cases and case series with a complete description of CGI.

Exclusion criteria: (1) small bowel gallstone ileus; (2) gastric outlet gallstone ileus; (3) non-gallstone intraluminal obstruction; and (4) cholecystocolonic fistula without CGI.

The primary outcome: a relationship of demographic data, gallstone size, symptoms, obstruction level, risk factors, and comorbidities (biliary history, diverticular disease, cardiovascular disease, radiation of pelvis), diagnostics (palpable mass in the abdomen and rectal exam, laboratory tests, sigmoidoscopy/colonoscopy, x-ray, computed tomography (CT), colonic Rigler's triad) with the correct diagnosis.

The secondary outcome: the identification of therapeutic options and related survival.

The third outcome: to develop a comprehensive diagnostic-therapeutic algorithm for CGI.

The study is exempt from ethics approval because we synthesized data from published studies.


Eligibility Criteria:
Inclusion Criteria:

* all published cases and case series with a complete description of colonic gallstone ileus

Exclusion Criteria:

* small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus
Neurophysiological and Acute Pharmacological Studies in FXS Patients

The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 15-55, with fragile X syndrome (FXS) who completed the study entitled "Mechanisms and brain circuits underlying fragile X syndrome (IRB # 2015-8425). FXS is defined as full FMR1 mutations (\>200 CGG repeats) confirmed by genetic testing.
* General good health as determined by physical exam, medical history and laboratory work up.

Exclusion Criteria:

* Subjects with a history of intolerance to acamprosate, lovastatin, or minocycline will be excluded.
* Subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or central nervous system neurological disease unrelated to FXS.
* Uncontrolled seizures impact EEG data as do anticonvulsants, barbiturates, lithium and benzodiazepines and are exclusions (within 5 half-lives). Those taking other psychiatric medications must be on stable doses for 4 weeks before any testing.
* For female subjects of child bearing potential, a positive urine pregnancy test.
* Potential subjects with a creatinine clearance \< 50 mL/min will be excluded.
* Identified medical issues, inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.
The Role of the Microbiome in the Response to Dietary Fibers Intake During Intermediate Fasting

Dietary fibers are generally not degraded by the endogenous digestive enzymes, but rather by the complex ensemble of microorganisms that reside in the human gut \[1\]. This ensemble, collectively known as the human gut microbiome, plays a key role in breaking down, fermenting, and ultimately converting such dietary fibers into a variety of beneficial metabolites, including most notably, short chain fatty acids (SCFA). These end products of fibers' fermentation affect host metabolism, immunity, and physiology, and have been implicated in multiple diseases including obesity, metabolic syndrome, diabetes, and cardiovascular diseases.

Intermediate fasting, and in particular circadian intermediate fasting (i.e. 16 hours of fasting followed by 8 hours of allowed eating), has been shown to have positive associations with multiple health conditions as obesity, diabetes mellitus, cardiovascular disease, cancers, and neurologic disorders In this study, we will try to answer open questions utilizing the long fasting period during the day to investigate the isolated effect of dietary fiber consumption, uncovering the degradation effect, but not the bulking effect, on the microbiome and the host physiology, and in particular its glucose response.

During the 22 days of the study, participants will wear a continuous glucose monitor, fill a daily food diary, and collect stool and oral samples which will be used for microbiota profiling. Participants will be asked to carry out an intermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. Drinking water is allowed throughout the fasting hours.

The groups will consume 4, 12, 20 grams of the dietary fiber per day, according to the group they were assigned to, while not exceeding the total fiber consumption of 50 grams per day, which is considered a high-fiber diet.

Eligibility Criteria:
Inclusion Criteria:

Male and Female BMI\<28 Age - 18-70

Exclusion Criteria:

Consumption of antibiotics 3 months prior to the first day of the experiment. Consumption of probiotic or dietary fibers supplements 1 month prior to the first day of the experiment.

Practiced in intermediate fasting 1 month prior to the first day of the experiment.

Diagnosis with type 1 or type 2 diabetes. Pregnancy, breastfeeding, or fertility treatments in the last 6 months. Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism hepatitis, fibromyalgia, etc.).

Cancer and recent anticancer treatment. Psychiatric disorders. Coagulation disorders. IBD (inflammatory bowel diseases). IBS (Irritable bowel syndrome). Alcohol abuse, more than 2 drinks per day for males, and more than one drink for females.

Substance abuse. BMI\>28. Daily dietary intake higher than 25 grams per day. History of abdominal surgeries (including Bariatric surgery). Mentally incompetent or lack of judgment