cyrilzakka/clinical-trials huggingface dataset:
Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered

The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.

The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop systems approaches to integrating health information technology (HIT), stakeholder engagement mechanisms, and process design/engineering methods focused on patient safety, development and enhancement of tools, health care system interventions, and translation into practice. The three technological toolkits to be developed as part of the Patient Safety Learning Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage patients and their family caregivers in the design of HIT tools to prevent patient falls and related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication; and 3) MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and fosters a health system focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and systems engineering researchers, collaborating with patients and family for evolving and applying these approaches to adverse event prevention in hospitalized patients. In addition, a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems engineering approaches to develop and provide a system-wide methodology to aid in the successful implementation and improvement of Health Information Technology (HIT) tools and a model known as the Patient SatisfActive® will be developed, tested, and refined to create a culture of patient- and family-centered care.

Eligibility Criteria:
Inclusion Criteria:

* patients 18-99 years of age

Exclusion Criteria:

* patients under age 18 years
Inflatable Penile Prostheses : Which Patients Can Correctly Use the Scrotal Pump ?

Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Nevertheless, a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options.

Since the first implantation of foreign material intracarvernosally in 1966 by Beheri, multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance. First introduced in 1973 by Scott et al., inflatable prosthesis provides now high general satisfaction rates (69-94%), better than in malleable prostheses, except for few authors.

In addition to changes in materials and construction, the two main manufacturers of IPP, Boston scientific AMS (Marlborough, MA, USA) and Coloplast (Minneapolis, MN, USA), modernized the pump mechanism of their devices. Since the introduction of AMS IPP, three main pump formats have been used : the standard pump has been replaced in 2004 by the " Tactile " pump and then the " Momentary Squeeze " (MS) pump in 2006, smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation. Coloplast also replaced in 2008 their " Genesis " pump by a " One Touch Release " (OTR) pump, and finally in 2014 by the current " Touch " pump, smaller, and presenting a biconcave deflation button, easier to find.

Despite all technological advances, appropriate pre-operative counselling and careful post-operative teachning, a significant part of patients has still difficulties to handle the pump and thus, does not use their IPP, regardless of any material malfunction. That situation obviously leads to patient's dissatisfaction and highlights the operating risks of a useless surgical procedure.

The purposes of this study were:to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation, then to show a correlation between easy handling and post-operative satisfaction. And last but not least, to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling. That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction.


Eligibility Criteria:
All cases included were discussed and approved by a multidisciplinary team. Patients who underwent prosthesis replacement or second implantation were not included. We excluded patients who refused or were not able to answer our questionnaire, patients who provided unreliable answers, and patients that experimented a secondary malfunction of their IP.
Investigation of Effects of Delayed Feedback on Non-motor Symptoms in Individuals With Parkinson's Disease

Learning deficits are frequent in individuals with Parkinson's Disease. Clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). Learning though immediate feedback has been shown to be depended on the brain chemical dopamine that is disrupted in individuals with Parkinson's Disease. During learning, feedback can also be presented after a delay. The investigators propose that learning through delayed feedback will lead to greater learning in individuals with Parkinson's Disease, since learning through delayed feedback does not rely on dopamine. During the proposed paradigm, participants with Parkinson's Disease complete a multiple-choice test. After making their selection on the multiple-choice test, they either see feedback immediately or are given feedback 25 minute later after reviewing their selection on the multiple-choice test. The investigators hypothesize that participants will learn better when they are provided with delayed feedback.


Eligibility Criteria:
Inclusion Criteria:

* Only participants with scores above 24/30 on the Montreal Cognitive Assessment will be recruited for participation to exclude dementia.

Exclusion Criteria:

* Individuals with neurological conditions other than PD such as epilepsy, multiple sclerosis, brain tumors, etc. will be excluded to control for the effects these conditions have on the brain and behavior.
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1.

This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. All infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. If an echocardiogram was done that showed a PDA, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. Infants will be stratified into birthweights \<800 gm and 800-1200 gm.

Eligibility Criteria:
Inclusion Criteria:

* birth weight less than 1200 gm

Exclusion Criteria:

* none
Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years.

Short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. Inserting a chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. However, this treatment is still suboptimal and prolonged hospitalization is common. Recent data from adults suggests that adding an additional medicine (DNase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children.

This is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone. Other outcomes related to effectiveness, safety and cost will be assessed as well.


Eligibility Criteria:
Inclusion Criteria:

1. age 6 months to 18 years
2. hospitalized with diagnosis of pleural empyema requiring chest tube drainage with fibrinolytics as judged by the attending physician with the following criteria:

   1. pneumonia with pleural effusion as documented on ultrasound of the chest; AND
   2. need for further intervention in addition to antibiotics based on clinical criteria \[persistent fever despite on antibiotics for at least 48 hours OR significant respiratory distress tachypnea, hypoxia) as a result of the pleural fluid collection\]

Exclusion Criteria:

1. empyema as a result of tuberculosis, fungus or non-infectious causes (e.g. malignancy)
2. known coagulation impairment
3. suspected or proven allergy to tPA or DNase
4. chronic lung disease or other chronic illnesses (e.g. immunodeficiency or neurologic impairment)
5. child has already undergone a drainage procedure (e.g. chest drain or VATS).
6. recent administration of an investigational drug (within previous 30 days)
7. pregnancy
8. breastfeeding
Clinical Association Between Celiac Disease and Intussusception in Children

Clinical association Between Celiac Disease and Intussusception in children


Eligibility Criteria:
Inclusion Criteria:

Children aged 6 months to 18 years Diagnosed with celiac disease based on serology and biopsy Diagnosed with intussusception confirmed by imaging Parent or legal guardian provides informed consent

Exclusion Criteria:

Children with known gastrointestinal abnormalities other than celiac disease History of abdominal surgery Incomplete or unavailable medical records Patients on immunosuppressive therapy
Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment

The purpose of this retrospective observational study is to describe the treatment patterns with MENOPUR and to understand the clinical impact for patients that underwent infertility treatment under real-world setting.

The primary objective is to describe the treatment patterns for the general population and for selected patient profiles.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult females who underwent ART treatment with MENOPUR for ovarian stimulation in 2018

Exclusion Criteria:

* None
Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.

Eligibility Criteria:
Inclusion Criteria:

Infants are eligible if they meet all the following inclusion criteria except 4.

1. ≥36 weeks gestation
2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
3. Moderate to severe encephalopathy (Sarnat II to III)
4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
5. Up to 24 hours of age
6. Autologous umbilical cord blood available to infuse within 3 days after birth
7. A person with parental authority must have consented for the study.

Exclusion Criteria:

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe growth restriction, with birth-weight less than 1800 g
4. Severe infectious disease, such as sepsis
5. Hyperkalemia
6. Outborn infants (Infants born at hospitals other than the study sites)
7. Volume of collected cord blood \<40 ml
8. Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Cryotherapy for Breast Cancer Trial

The purpose of this study is to evaluate the clinical feasibility and safety of the ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.


Eligibility Criteria:
Inclusion Criteria:

* Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. Patients with contralateral disease will remain eligible. Note: Results of ER, PR, HER-2/neu must be obtained on pre-registration needle core biopsy material.
* Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and mammogram. The largest dimension measured will be used to determine eligibility.
* Tumor enhancement on MRI
* Tumor with \<25% intraductal components in the aggregate.
* Non-pregnant and non-lactating patients. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for \> 12 months to be considered not of childbearing potential.
* Adequate breast size for safe cryoablation. Patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy.

Exclusion Criteria:

* Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
* History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
* Prior or planned neoadjuvant chemotherapy for breast cancer.
* Patients with thrombocytopenia and or any other coagulation abnormality
Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test

The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle.

The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.

Eligibility Criteria:
Inclusion Criteria:

* - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
* Regular menstruation cycle
* Patient's willingness to participate in the study

Exclusion Criteria:

* - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo
* No frozen embryos after IVF cycle
* Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®
Interval Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization

The goal of this clinical trial is to determine whether inspiratory muscle training aids in the recovery of respiratory muscle strength and helps prevent further muscle weakness in patients with myasthenia gravis.

The primary research questions are:

Does inspiratory muscle training enhance respiratory muscle strength recovery? Does the intervention lead to improved lung volumes? Participants underwent daily inspiratory muscle training and aerobic exercise for six consecutive weeks.

Patients with myasthenia gravis who experience acute exacerbations requiring hospitalization often suffer a significant decline in muscle strength, followed by partial recovery after the acute phase. This randomized controlled trial aims to evaluate the potential of early inspiratory muscle training and aerobic exercise in promoting muscle strength recovery and preventing further weakness. The study will assess differences in lung function, respiratory muscle strength, and dyspnea levels following the intervention after patients are discharged from the hospital post-acute exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized due to a myasthenia gravis crisis
* Cleared for discharge from the hospital
* Capable of completing six weeks of home-based respiratory muscle and exercise training

Exclusion Criteria:

* Myasthenia Gravis Foundation of America (MGFA) classification I or V
* Presence of concurrent heart, kidney, liver, or metabolic diseases, or malignant tumors
* Ability to follow exercise instructions
* New York Heart Association (NYHA) Class III/IV
* Pulmonary disease (FEV1/FVC ratio \&amp;lt; 0.7 and FEV1 \&amp;lt; 50% predicted)
A Study of DTC in Patients With AIDS and AIDS Related Complex

To determine if ditiocarb sodium (sodium diethyldithiocarbamate; DTC) restores immune and host defense function; if DTC ameliorates the AIDS related complex (ARC) symptoms in patients with AIDS and ARC; if DTC prevents progression from ARC to AIDS or progression of AIDS; and if DTC prolongs survival in AIDS.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Active opportunistic infection or progressive Kaposi's sarcoma (KS).
* Dementia.
* Lymphoma.

Concurrent Medication:

Excluded within 3 weeks of study entry:

* Other experimental AIDS therapy.

Patients with the following are excluded:

* Active opportunistic infection or progressive Kaposi's sarcoma (KS).

Patients must be either HIV seropositive or have AIDS or AIDS related complex (ARC) and have life expectancy of at least 6 months.
RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms.

Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

Eligibility Criteria:
Inclusion Criteria:

* See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)

Additional Appendix A (IVIG Sub-study) Level Inclusion Criteria:

1. Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms
2. COMPASS-31 Score \> 40

Exclusion Criteria:

* See NCT06305780 for RECOVER-AUTO: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)

Additional Appendix A (IVIG Sub-study) Level Exclusion Criteria:

1. Current or previous IVIG treatment
2. Contraindication to intravenous immunoglobulin.
3. Known allergic reactions to blood products including IVIG and/or subcutaneous immunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reactions
4. Selective IgA deficiency
5. Current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors
6. Use of immunosuppressants such as Plaquenil, or low-dose steroid (prednisone, no more than 10mg a day) will be excluded unless the participant is on stable (\>4 weeks) dose
7. Significant thrombotic events after the acute phase of COVID-19 and/or within 6 months of enrollment
8. Veins that are not viable for infusions
9. Not willing to adhere to dosing schedule for IVIG infusions for 9 months
Effect of Music in Intraoperative Period

Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.

Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* The patients that had an orthopedic operation
* The patients who took spinal anesthesia
* able to understand, read and speak Turkish, so they may complete the informed consent and questionaires
* Aged 18 or older
* Have a Body Mass Index (BMI) \<40
* ASA (American Society of Anaesthesiologists) I-II-III statuses.

Exclusion Criteria:

* Patients with vision and hearing problems and inability to complete questionnaires,
* The patients not have psychiatric disease history and psychiatric drug use,
* The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)
* The patients not underwent emergency surgeries