cyrilzakka/clinical-trials huggingface dataset:
The Grief Navigation Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

Parents of children who die traumatically or unexpectedly from things like suicide or an overdose suffer from mental and physical health problems and can experience massive disruptions in their family life. For about half of these parents, the first, and sometimes only, interactions they have with the healthcare system when their child dies are with a medical examiner or coroner (hereafter 'ME'). But MEs have little to no training in helping grieving families, and there are no standards guiding medical examiners or coroners on how or even if they should help grieving families. This gap leaves parents to find the help they need on their own. This research will test two different strategies for addressing this gap in the healthcare system.

Of approximately 60,000 annual deaths of people \< 25 years old, \~45% occur unexpectedly or traumatically (e.g., from homicide, suicide, or unintentional injury) and become a medical examiner or coroner (hereafter 'ME') case. Parents and caregivers (hereafter 'parents') of these children suffer debilitating mental health issues like complicated grief and depression, physical problems and family dysfunction, and struggle to find support. Often, the ME is parents' sole point of contact with the healthcare system. Yet MEs have limited education, guidance, and tools to support bereaved parents. Scalable systems-level interventions are needed, at the point of ME care, to connect bereaved parents to critical supports.

This study will compare two interventions to facilitate care across healthcare settings for bereaved parents:

1. CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and
2. General bereavement support information (GBSI), a standardized treatment regimen developed from extant literature and current recommended standards for supporting parents after a child's death.

This is a pragmatic, multi-site 1:1 randomized controlled comparative effectiveness study using a type I hybrid design. CRx-B and GBSI will be carried out by Missing Pieces, a community-based organization. To learn about which strategy works better, the study team will ask parents to complete surveys \~6.5 months after their child dies.

Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers of ME cases involving a person \< 25 years old from one of the following offices: Cook County Medical Examiners, Lake County Coroners, DuPage County Coroner, Will County Coroner, McHenry County Coroner, Kane County Coroner, Peoria County Coroner
* Parents or caregivers who provide permission to the ME to be referred to Missing Pieces
* Parent or caregivers who are referred to Missing Pieces by a ME
* Parents or caregivers able to read and communicate in English or Spanish

Exclusion Criteria:

* Parents or caregivers unable to read or communicate in English or Spanish
* Parents or caregivers under the age of 18 years old
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery

Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative residual pneumoperitoneum, lung complication, GI discomfort, administered additional analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure 30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in Rajavithi hospital.

Research design is Randomized control trial. The women who go to laparoscopic gynecologic surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40 cmH2O and control

After laparoscopic surgery has finished in operator room (before moving off trocar), woman all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.

The patients in group of using Pulmonary Recruitment Maneuver will be received positive pressure from balloon bag from anesthesiologist 5 times of setting pressure \[30 cmH2O, 40 cmH2O\], 5 seconds per time to increase indirect abdominal pressure to release residual gas

After surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung complication. GI discomfort, administered additional analgesics and time to hospital staying will be evaluated and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Anesthesiologists physical status (ASAPS) classification I-II
* Absence of Pregnancy
* With inform-consent

Exclusion Criteria:

* Inability to accurately express pain
* Past history of shoulder or lung surgery
* Chronic shoulder problem
* Epigastric pain
* Lung disease such as emphysema or pneumothorax
* Severe kidney or liver disease
* Drug allergy (NSAIDs, Paracetamol)
* On current medication: corticosteroid
* Psychiatric disorder
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* At least 18 years of age
* Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
* Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
* Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
* Able to give informed consent

Exclusion Criteria:

* Male gender
* Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
* Acute urinary tract infection
* Treatment with Botox® toxin for other conditions
* Allergy to Botox® toxin
* Hematuria that has not been worked up
* Known bladder malignancy
* Previous history of bladder augmentation
* Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
* Currently taking aminoglycoside antibiotics
* Post-void residual (PVR) \>150 cc (measured by bladder scan or by catheterization) prior to enrollment
* History of chronic pain or pain syndromes
Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)

The purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.

Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of bridge to transplant or destination therapy
* a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events and pump malfunction
* evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see Appendix III); Clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination

Exclusion Criteria:

* absence of an informed consent
* presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch)
* presence of any other ancillary circulatory assist device system
* known history of major thrombotic event e.g. deep vein thrombosis (DVT)
* known history of stroke
* left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant
* evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography
* any other clinical indication for a use of long-term anticoagulation using a vitamin K antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)
INCIDENCE OF Delirium After Cardiac SURGERY Surgery

Delirium is a common problem that occurs after cardiac surgery. The incidence of delirium after cardiac surgery is estimated to be 26-52%, with a significant percentage being hypoactive delirium1-4.Postoperative delirium has been associated with higher hospital costs, longer lengths of hospital stay, increased likelihood of institutionalization, increased risk for dementia, and increased morbidity and mortality.5-7 .

The overall purpose of this study was to determine the incidence and perioperative factors that predispose to cause delirium in postoperative cardiac surgery patients in our ICU


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older of both sexes
* Patients who signed an informed consent
* Patients scheduled for cardiac surgery with extracorporeal circulation (coronary-artery bypass grafting (CABG), cardiac valve replacement (CVR), combined CABG + CVR, excision of cardiac myxoma)

Exclusion Criteria:

* Patients who refused to participate before or after operation;
* Patients in poor general condition;
* Patients with preoperative dementia, delirium or illiterate, psychiatric or mental disorder (epilepsy, schizophrenia, depression);
* Patients who died intraoperatively or within the first 6 hours after the procedure.
A Pilot Study on Neuroimaging in SCD: Part of The Boston Consortium to Cure Sickle Cell Disease

Sickle Cell Disease (SCD) impairs oxygen transport to tissue and causes endothelial injury. Thus, therapeutic interventions aim to improve both, but there is an unmet need for biomarkers to determine when intervention is necessary and evaluate the effectiveness of the chosen intervention in individual patients. This study proposes to monitor SCD and its treatment through their impact on cerebral hemodynamics, as the brain is one of the most vulnerable and consequential targets of the disease. Specifically, this study will optimize quantitative magnetic resonance imaging (MRI) and advanced optical spectroscopy techniques such as frequency-domain near-infrared and diffuse correlation spectroscopies (FDNIRS-DCS) to monitor 1) cerebral oxygen transport with measures of cerebral blood flow (CBF), cerebral oxygen extraction fraction (OEF) and cerebral metabolic rate of oxygen consumption (CMRO2) and 2) endothelial function with cerebrovascular reactivity (CVR).

Additionally, this study aims to monitor baseline cerebral oxygen transport and CVR, as well as changes that occur with treatment (transfusion or genetic therapy to induce fetal hemoglobin) and assess hemoglobinopathy patients with known genotypes and phenotypes. The ultimate goal is to demonstrate the potential of this monitoring approach to select individual SCD subjects for interventions and evaluate individual responses to treatment. Success will help justify inclusion of these modalities in ongoing and future clinical trials of novel SCD therapies.


Eligibility Criteria:
Inclusion Criteria:

Group 1 (healthy controls):

* Children ages 8-18 without SCD

Group 2 (SCD patients without treatment):

* SCD patients ages 8-18 who:

  * have not undergone gene therapy or a bone marrow transplant
  * are not receiving chronic transfusions
  * have not received a blood transfusion in the past 3 months

Group 3 (SCD patients who have undergone gene therapy):

* SCD patients ages 8-18 who have had gene therapy at least one month prior to enrollment

Group 4 (SCD patients who have chronic transfusions):

* SCD patients ages 8-18 who receive chronic transfusions

Exclusion Criteria:

* Electrical implants such as cardiac pacemakers or perfusion pumps;
* Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants;
* Ferromagnetic objects such as jewelry or metal clips;
* Women of childbearing age who are seeking to become pregnant, who are breastfeeding, or who suspect they may be pregnant;
* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions;
* Any greater than normal potential for cardiac arrest;
* Subjects requiring sedation for MRI
Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

The Epidemiological Strategy and Medical Economic (ESME) Breast cancer Database is a multicenter real life database using a retrospective data collection process across 18 French comprehensive cancer centers (FCCC) spread over 20 sites. This database compiles data from patient's electronic medical records (EMR).

This database compiles existing data retrieved fromp patient's electronic medical records (EMR) across the 18 French comprehensive cancer centers spread over 20 sites. .

The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

Cases selected to enter the ESME MBC data platform fulfill specific criteria: (1) Male or female ≥18 years old (2) metastatic breast cancer (3) with first metastasis treated (either completely or partially) at a participating site from January 2008 onwards.Treatment strategies considered include radiotherapy, chemotherapy, targeted therapy and endocrine therapy.

Eligibility Criteria:
Inclusion criteria :

* 18 years old patient
* Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.

Exclusion criteria : None
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease

The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease.

Women are more likely to have nonobstructive coronary artery disease (CAD) . The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease. Endothelium-dependent and -independent dilation, arterial stiffness and wave reflection will be measured at baseline and after walking on a treadmill at a slow pace for 47 minutes. Endothelium-dependent dilation will be measured using brachial artery flow-mediated dilation via high resolution ultrasonography. Endothelium-independent dilation will be measured using brachial artery dilation to sublingual nitroglycerin. Arterial stiffness and wave reflection will measured using applanation tonometry.

Eligibility Criteria:
Inclusion Criteria:

* women with non-obstructive coronary artery disease documented within the past 5 years by coronary angiogram as no coronary arteries with stenosis greater than 50% lesions
* age 18 to 89 years
* able to complete maximal graded exercise test

Exclusion Criteria:

* use of tobacco products within the previous six months
* use of oral contraceptives or hormone replacement therapy within the prior year
* pregnancy (positive urine pregnancy test) or lactation
* history of hepatic disease or infection with hepatitis B, C or HIV
Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to attend all study visits.
* Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).
* At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.
* Use provided artificial tear at least once a week during run-in phase.
* Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Use of artificial tears, as specified in the protocol.
* Use of topical ocular medications, as specified in the protocol.
* Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
* Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.
* Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.
* Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.
* Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study.
* Other protocol-specified exclusion criteria may apply.
Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women

Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.

Multicenter observational study on a cross-week comparative basis with men

In France, as in other industrialized countries, ischemic heart disease is a major cause of morbidity and mortality in women. Work to improve epidemiological knowledge, prevention, screening, risk stratification and treatment of ischemic heart disease in women has a potential impact on all the issues listed.

There is therefore a double challenge:

* A public health issue to alert the female population on cardiovascular risk and its consequences, while the female population does not feel concerned by the potential danger.
* A challenge for health professionals so that they have the same thing vis-à-vis the cardiovascular prevention among women and whatever their field of practice.

Eligibility Criteria:
Inclusion Criteria:

* Women all patients and / or men regardless of age
* Admitted to a cardiology department (in the intensive care unit or cardiology traditional) week of the survey,
* Having presented an acute coronary syndrome, regardless of the type with or without ST segment above, with or without elevated troponin, complicated or not, regardless of its support invasive or conservative,
* Patients who agreed to participate in the study.
Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* With the history of Nasopharyngeal Carcinoma and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.