cyrilzakka/clinical-trials huggingface dataset:
SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents

This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents.

This is an investigator-initiated protocol examining the effectiveness of intracoronary brachytherapy using the Novoste beta-emitting catheter for recurrent stenosis after treatment with multiple drug-eluting stents. While intracoronary brachytherapy has been used for this purpose by clinicians for some time, data supporting this clinical decision-making is lacking.

Currently, when cardiologists find restenosis after implanting a drug-eluting stent, they often place a stent that elutes a different drug within that stent. If a patient presents with restenosis in the segment that has already been treated with both sirolimus and paclitaxel-eluting stents, further options are limited. Intracoronary brachytherapy is often used in this scenario, but the efficacy of this approach has not been well studied. The investigators recently reviewed the clinical outcomes of five patients who underwent intracoronary radiation after drug-eluting stents. They discovered only one episode of target vessel revascularization and no episodes of stent thrombosis. While this sample is small, investigators believe that a prospective study will provide important information regarding this approach.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Eligible for percutaneous coronary intervention.
3. Target lesion with recurrent restenosis (\>50% by visual estimate) previously treated with any 2 or more combination of DES stents.
4. Signs or symptoms of ischemia attributable to the target lesion, or stenosis \> 50% by visual estimation of the lesion during angiography.
5. Target lesion is located within a native coronary artery or bypass graft.
6. Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up.
7. Able to understand and sign informed consent.

Exclusion Criteria:

1. Confirmed pregnancy at the time of index PCI.
2. Has known allergies to aspirin, and to both clopidogrel (Plavix ®) and ticlopidine (Ticlid ®).
3. Has known allergies or contraindication to heparin and Bivalirudin (Angiomax ®).
4. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
5. Any serious disease condition with life expectancy of less than 1 year.
6. Unsuccessful coronary revascularization procedure (residual stenosis \> 30%).
7. Angiographic evidence of thrombus.
8. No Previous intracoronary radiation to the target artery.
Exercise in Breast Cancer Survivors

The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age and \< 65 years of age
* Female
* BMI \> 25
* Weight \< 350 pounds
* English as a primary language
* Postmenopausal
* Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy
* Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable)
* 6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization

Exclusion Criteria:

* Recurrent breast cancer
* DCIS only (no invasive component)
* Taking a Beta Blocker or Verapamil
* Pregnant
* Wheelchair bound
* Unable to ambulate independently
* Concurrent uncontrolled medical or psychiatric disorder
* Open wound
* Stage IV breast cancer
* Progression of disease
* Bilateral mastectomies
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study

The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is at least 18 years of age.
2. The subject has been informed of the nature of the trial and agrees to its provisions.
3. The subject has a pre-implantation BMI within the protocol limits.
4. The subject agrees to the follow-up visit schedule.
5. The subject is a candidate for a LAGB procedure.
6. The subject agrees to comply with specified follow-up evaluations.
7. The subject is willing to fast for 2 hours prior to each adjustment visit.

Exclusion Criteria:

1. The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial.
2. The subject has a condition that is contraindicated for LAGB procedures.
3. The subject is currently using weight loss medications or supplements.
4. The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months.
5. The subject is currently participating in an investigational drug or another medical device trial.
6. The subject had a previous LAGB procedure.
7. The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.
Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.

The ability to perform laparoscopic colorectal surgery is an essential attribute of a general surgeon. Data on the participation of residents and the outcomes of colorectal procedures performed by surgeons in training are in demand. The objective of this study is to comprehensively investigate the outcomes of colorectal procedures performed by general surgery residents supervised by experienced colorectal surgeons and assess their previous laparoscopic experience.

The ability to perform laparoscopic colorectal surgery is an essential attribute of a general surgeon. Residents' contribution to colorectal procedures ranges from 33 to 40%. Few papers describe the outcomes of treatment provided by residents. The learning curve in colorectal techniques requires 88 to 152 cases to reach proficiency. Data on the participation of residents and the outcomes of procedures performed by surgeons in training are in demand. The objective of this study is to comprehensively investigate the outcomes of colorectal procedures performed by general surgery residents supervised by experienced colorectal surgeons and assess their previous laparoscopic experience. A retrospective single-center analysis was performed based on a review of database records. It included 498 elective colorectal procedures performed in a high-volume colorectal surgery center, where over 200 procedures are performed each year. The study included all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023. 43 procedures were performed by residents and 455 by experienced colorectal surgeons. The procedures were performed by five experienced colorectal surgeons and three residents in their third to sixth year of surgical training. When performing evaluated procedures, residents were performed under the surveillance of experienced colorectal surgeons, according to Polish law requirements.

Eligibility Criteria:
Inclusion Criteria:

* all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.

Exclusion Criteria:

* stoma creation
* a history of inflammatory bowel disease
* a history of bowel resection
Functional Roles of Dorsolateral Prefrontal Cortex

Dorsolateral prefrontal cortex (DLPFC) has been found to be involved in cognitive functions such as executive function, response selection, and working memory. By applying transcranial magnetic stimulation (TMS) or transcranial focused ultrasound (FUS), which is a technology to temporally alter brain state in the stimulation site, the investigators aim to find supporting evidence for the causal relationship between the targeted stimulation site and motor learning improvement or response selection.

The purpose of this study is to test the functions of dorsolateral prefrontal cortex in human motor learning. Dorsolateral prefrontal cortex (DLPFC) has been found to be involved in cognitive functions such as executive function, response selection, and working memory. Recent Findings hint potential involvement of dorsolateral prefrontal cortex in motor learning. Rare studies provided supporting evidence on its involvement and functions. This study aims to examine the functional roles of dorsolateral prefrontal cortex in human motor learning. By applying transcranial magnetic stimulation (TMS) or transcranial focused ultrasound (FUS), which is a technology to temporally alter brain state in the stimulation site, the investigators aim to find supporting evidence for the causal relationship between the targeted stimulation site and motor learning improvement or response selection.

Young healthy adults will be recruited and randomly assigned to one of four experimental groups. If randomized into one of the TMS groups, participants will learn to adapt to two visual rotations (20 and 60 degrees) when reaching for a virtual target, subjects will receive repetitive TMS (rTMS) stimulation over the targeted location, left DLPFC, or right DLPFC depending on the study group. How rTMS stimulation influencing the acquisition and retention of motor memory will be assessed based on group comparison of behavioral measures such as reaching accuracy. If randomized into the FUS group, participants will complete a flanker task to focuses on the assessment of response selection and inhibitory control.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult subjects
* 18 to 35 years of age
* Right-handed
* Have no any type of metal in the body
* Provide written informed consent

Exclusion Criteria:

* Presence of a significant medical, psychiatric, or neurologic illness
* History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
* Personal or family history of seizure
* Any history of stroke/transient ischemic attack (TIA) or severe traumatic brain injury
* Taking any medications that may decrease the threshold for seizure
* Pregnancy (self-reported)
* Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
* Failure to follow laboratory or study procedures
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.

This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo.

The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with gMG (age 18-75 years)
* Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator
* Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening
* Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
* Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol
* Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline

Exclusion Criteria:

* Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment

Other protocol-defined inclusion/exclusion criteria may apply.
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE

This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥ 18 years of age
* Has been breastfeeding or actively pumping for at least 4 weeks
* Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
* Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
* Weaning must not be underway

Exclusion Criteria:

* Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
* Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
* Has participated in an investigational drug study within the 90 days prior to CRU admission
3D Translabial Ultrasound for Pessary Size Estimation

This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.

Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.

Eligibility Criteria:
Inclusion Criteria:

* are current pessary users (\> 6 months) who have no pessary related complication, including discomfort, vaginal bleeding, and pessary extrusion
* are able to provide informed consent
* can perform self-care, i.e. removing and inserting the pessary themselves
* are willing to remove their pessary two days before the ultrasound examination date

Exclusion Criteria:

* inability to give informed consent
* inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
* history of pelvic radiation or surgery (excluding hysterectomy)
* using pessaries other than ring, incontinence dish, donut, Shaatz
* inability to perform the Valsalva maneuver or pelvic floor contraction
* restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit
* lack of sensation at the pelvic floor
* being pregnant at the time of the examination
European Study of Cerebral Aspergillosis Treated With Isavuconazole

Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile.

The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Proven or probable cerebral aspergillosis according to the EORTC criteria modified by adding diabetes in the host criteria
* In child or adult
* Treated by isavuconazole at least 7 days
* Diagnosed between March 2017 and June 2020

Exclusion Criteria:

* Possible cerebral aspergillosis
* isavuconazole treatment for less than 7 days
Effects of Perioperative Operating Room Environment on Postoperative Delirium

Thi investigators aims to observe the impact of perioperative body temperature and the noise of operating room on postoperative delirium for elderly patients undergoing abdominal surgery. And based on this study the investigators aimed to explore the potential risk factors of postoperative delirium for elderly patients undergoing abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 65-90 years old;
* ASA I-III;
* Patients who plan to undergo elective abdominal surgery under general anesthesia;
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* Patients with known mental illness or lack of communication or cognitive impairment before operation;
* Severe vision, hearing, language impairment or other reasons unable to communicate with visitors;
* Severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;
* Long-term use of sedatives, antidepressants or alcoholism;
* Patients with severe postoperative complications and admitted to intensive care unit;
* Patients who refused or failed to complete the cognitive function test.
* Patients who could not cooperate with the study for any other reason.
Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients

The objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in HIV infected patients comparing patients with and without HAART. Recent studies have demonstrated a specific HIV infected patients neurocognitive disorders profile. These cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed. This cognitive profile is similar to another highly documented one, described for another central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest and most severe disorder is the one related to the information processing speed. For the multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening. A digital version of this test (CSCT), has recently been developed in order to make this early evaluation easier. We hypothesize that CSCT alteration would also predict HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and personal consuming. This short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with HIV-1
* Patients followed in outpatient service, over 18 years of age

Exclusion Criteria:

* Patients infected with HIV-2
* Patients with difficulty understanding the French language
* Patients present with progressive opportunistic infection
* Patients for whom a change of psychotropic treatment was performed in the last 3 weeks
* Patients with drug and / or alcohol addiction
* Patients with a history of psychiatric disorder
* Patients with stroke, endocarditis or meningoencephalitis with severe neurological sequelae
Doula Home Visiting Randomized Trial

The purpose of this randomized controlled trial is to examine whether evidence-based home visiting programs enhanced by doula services have effects on positive parenting practices, breastfeeding, and child and maternal health outcomes.

The goal of this study is to evaluate the impact of doula enhanced evidence-based home visiting programs for young mothers in Illinois. Mothers in the intervention group receive home visits from doulas during pregnancy and in the first few weeks postpartum, and doulas provide mothers with support at the hospital during labor, delivery, and with early breastfeeding. Additionally, mothers in the intervention group receive prenatal and long-term postpartum home visitation services through an evidence-based home visiting program, such as Parents as Teachers and Healthy Families Illinois. Mothers in the comparison group receive a less intensive case management service.

Four existing doula home visiting programs located in economically distressed communities in Illinois were selected for participation in the study. At each site, young pregnant women are recruited for participation in the study, provide informed consent, and complete a baseline interview in their homes during mid-pregnancy. At completion of the baseline interview, mothers are randomly assigned to either the doula home visiting intervention group or the case management comparison group.

At 37 weeks of pregnancy, and at 3 weeks-, 3 months-, 13 months-, and 30 months, and 4 years postpartum, mothers are interviewed in their homes on topics including pregnancy, parenting, health, mental health, feeding practices, employment/education, and relationships. Additionally, at all postpartum visits, mothers are videorecorded interacting with their infants. At the 13 month, 30 month, and 4 year followup sessions, children of the study participants are administered developmental and behavioral assessments.

Based on prior studies of doula services and the goals of doula enhanced home visiting programs, a variety of outcomes are assessed at followup time points. These outcomes include prenatal medical care, prenatal bonding with infant, feelings of efficacy during labor, anesthesia use during labor, breastfeeding, positive parenting behaviors, parenting attitudes and stress, infant health, maternal health, maternal depressive symptoms, and child behavior and development.

Eligibility Criteria:
Inclusion Criteria:

* pregnant and between 12 and 34 weeks gestation
* live within the catchment area of a program site
* between ages of 14-24
* English or Spanish speaking

Exclusion Criteria:

* ward of the Department of Children and Family Services (DCFS)
* under supervision of juvenile justice system
* planning to give up custody of infant
* pregnancy result of sexual assault