cyrilzakka/clinical-trials huggingface dataset:
Fluid Management in Patients Undergoing Cardiac Surgery

Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance

Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.


Eligibility Criteria:
Inclusion Criteria:

* Elective single heart valve replacement
* Elective double valve replacement
* Elective single or double valve replacement and coronary artery bypass grafting

Exclusion Criteria:

* Patients unable to give informed consent
* Patients younger than 18 years of age or older than 80 years
* Pregnancy or breastfeeding
* Ejection fraction (EF) of less than 30% preoperatively
* Preexisting renal insufficiency with a glomerular filtration rate below 30ml/min
* Patients transferred form the intensive care unit to the operating theater
* Emergency operation
* Reoperation
* Patients planned for fast-track surgery
* Patients planned for minimal extracorporal circuits
* Preexisting anemia requiring immediate perioperative blood transfusion
* Chronic inflammatory diseases
* Any signs of infection or sepsis
* Limitation of full therapy (e.g. Jehowa's witnesses)
Syncing Screening and Services for Suicide Prevention Across Health and Justice Systems

This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

This study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. There are 3 primary aims of this study: (1) Examine the effectiveness of the intervention on suicide attempt outcomes. (2) Evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) Evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Released from jail between February 2021 and July of 2028
* Had a prior primary care visit or behavioral health visit at a participating health system in the past 3 years

Exclusion Criteria:

* Does not currently reside in the same state as the study site (i.e.- Michigan, Minnesota)
* Would require a translator to participate in the research according to EHR data
* Previously requested to be excluded from research
Problem-Solving Training for Concussion

Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.

This study will be a longitudinal randomized two-arm parallel group clinical trial. Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU). Participants assigned to PST-Concussion will receive six, approximately 30-minute telehealth treatment sessions. Assessments will include standard self-report and cognitive measures that will be administered at baseline, post-treatment, and three-month follow-up. The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. Secondary and tertiary objectives will be to evaluate whether PST-Concussion is associated with appreciable change in subjective neurocognitive functioning, objective neurocognitive functioning, psychosocial functioning, and disability and quality of life. Multi-level modeling will be used to evaluate treatment effects at post-treatment and three-month follow-up. A test of non-inferiority will be conducted to evaluate the potential durability of observed treatment effects from post-test to follow-up. A portion of participants assigned to PST-Concussion will also be interviewed at post-treatment or follow-up to gain insight into the practical impact of intervention on psychosocial functioning and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking Veteran enrolled in VHA care;
* History of concussion (mild traumatic brain injury or mTBI);
* Current psychological distress;
* Subjective neurocognitive symptoms of \>= 3 months.

Exclusion Criteria:

* Moderate to severe TBI or other major neurocognitive disorder;
* Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features);
* Acute suicidal ideation;
* Inpatient psychiatric hospitalization within the past 12 months;
* Other illness/ condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.
EAP_GS010_single Patient

Expanded Access Use for a single patient of Bilateral Intravitreal Injection of GS010 in a Single Subject Affected with G11778A ND4 Leber Hereditary Optic Neuropathy


Eligibility Criteria:
The EAP applies to patients not eligible to ongoing GS010 clinical trials.

Inclusion Criteria:

* Presence of documented G11778A ND4 LHON-causing mutation
* Signature of informed consent and assent from the parent/guardian and the patient.

Exclusion Criteria:

Contraindications to GS010 product or IVT procedures are to be checked prior to consent signature and treatment injection:

* Any known allergy or hypersensitivity to GS010 or its constituents.
* Contraindication to intravitreal injection in any eye.
* Intravitreal drug delivery to any eye within 30 days prior to the injection
* Previous vitrectomy in either eye.
* Narrow angle in any eye contra-indicating pupillary dilation.
* Presence of disorders or diseases of the eye or adnexa, excluding LHON, which may interfere with visual or ocular assessments, including SD-OCT, during the study period.
* Presence of known/documented mutations, other than the G11778A ND4 LHON-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system.
* Presence of systemic or ocular/vision diseases, disorders or pathologies, other than LHON, known to cause or be associated with vision loss, or whose associated treatment(s) or therapy(ies) is/are known to cause or be associated with vision loss.
* Presence of optic neuropathy from any cause except LHON.
* Presence of illness or disease that, in the opinion of the Investigator, include symptoms and/or the associated treatments that can alter visual function, for instance cancers or pathology of the central nervous system, including Multiple Sclerosis (diagnosis of Multiple Sclerosis must be based on the 2010 Revisions to the McDonald Criteria \[Polman 2011\]).
* History of recurrent uveitis (idiopathic or immune-related) or active ocular inflammation.
* Previous treatment with ocular gene therapy in either eye.
* Subjects who have undergone ocular surgery of clinical relevance (per Investigator assessment) within 90 days prior to injection.
* Subjects who are unable to tolerate (e.g. the immune modulating regimen) or unable or unwilling to comply with all the protocol requirements.
Study of D-Methadone in Patients With Chronic Pain

The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.


Eligibility Criteria:
Inclusion Criteria:

Phase I and Phase II portions of the study:

* 18 years of age or older
* Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry.
* Give informed consent to participate in this study.
* Karnofsky Performance Score (KPS) \>= to 80
* Negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). Patients must also use a medically approved contraceptive method during the study period.

Phase I only:

* Responsible companion living with patient during study.

Phase II only:

* Group 1 -- Patients must be taking chronic opioid therapy (long acting morphine, long acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days. The dose of as needed short acting opioid does not need to be stable.
* Group 2 -- Patients must not be receiving opioids and must have cancer related neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic neuralgia.

Exclusion Criteria:

Phase I and Phase II:

* Known hypersensitivity to methadone
* Patient taking methadone or with a history of methadone treatment within one month of study enrollment.
* Patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment:

  * Abacavir,
  * Benzodiazepines,
  * Carbamazepine,
  * Efavirenz,
  * Fluconazole,
  * Fluvoxamine,
  * FOS amprenavir,
  * Fosphenytoin,
  * Naltrexone,
  * Nelfinavir,
  * Nevirapine,
  * Phenytoin,
  * Rifampin,
  * Rifapentine,
  * Risperidone,
  * Ritonavir,
  * St. John's Wort,
  * Zidovudine
* Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry.
* Neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection.
* Women who are pregnant or nursing.
* Women of childbearing potential who do not agree to use a medically recognized method of contraception during the study period.
Topical Cannabidiol Application and Skin Vascular Reactivity

Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age and older
* English speaking
* Non-obese class III, BMI ≤ 39.9
* Normal HbA1C of \<6.5%

Exclusion Criteria:

* Abnormal resting heart rate (\<60 or \>100 bpm) or BP (systolic \<100 or \>129 mmHg, diastolic \<60 or \>100 mmHg) values
* Rash, skin disease, disorders of pigmentation
* Known skin allergies
* Diabetes
* Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
* Illegal drug use
* Recent (within the last 30 days) CBD users either topical or oral
* Allergy or hypersensitivity to investigational agents
* Women who are pregnant or breastfeeding
The Effect of Sexual Minority Awareness Education on the Level of Knowledge and Attitude Towards LGBT Individuals

Purpose:This research was planned to determine the effect of the sexual minority awareness training program given to nursing students on the level of knowledge and attitude towards LGBT individuals.

Design:The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test. LGBT Ally Identity Measure, Attitude Towards Lesbians and Gays Scale, Attitudes Toward Transgendered Individuals Scale will be used as data collection forms.

Hypotheses:

H1: The LGBT Ally Identity Measure scores of students who receive sexual minority awareness training will increase after the training

H2: The LGBT Ally Identity Measure scores of students receiving sexual minority awareness training will increase compared to the control group.

H3: Attitude Towards Lesbians and Gays scale scores of students who receive sexual minority awareness training will increase after the training

H4: Attitude Towards Lesbians and Gays scale scores of students who receive sexual minority awareness training will increase compared to the control group.

H5: Attitudes Toward Transgendered Individuals Scale scores of students who receive sexual minority awareness training will increase after the training

H6: Attitudes Toward Transgendered Individuals Scale scores of students who receive sexual minority awareness training will increase compared to the control group.

This research was planned to determine the effect of the sexual minority awareness training program given to nursing students on the level of knowledge and attitude towards LGBT individuals.

The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test. LGBT Ally Identity Measure, Attitude Towards Lesbians and Gays Scale, Attitudes Toward Transgendered Individuals Scale will be used as data collection forms.

Eligibility Criteria:
Inclusion Criteria:

* Be a student of the faculty of nursing
* No barriers to accessing technology for participation in the online training program
* Absence of a communication barrier related to vision and hearing

Exclusion Criteria:

* leaving the nursing faculty for various reasons
* have received training on sexual minorities
Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies


Eligibility Criteria:
Inclusion Criteria:

* Advanced or High Risk Haematological Malignancies
* Age 18-65 years
* no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
* Informed consent

Exclusion Criteria:

* Active infectious disease at inclusion
* HIV- positivity or active hepatitis infection
* Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit) at inclusion
* Impaired renal function (Creatinine-clearance \<60 ml/min; Serum Creatinine \>1.5 x upper normal limit) at inclusion
* Psychiatric diseases or conditions that might impair the ability to give informed consent
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants

The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 32 weeks at birth
* Current gestational age \> 28+6 weeks
* Nasal CPAP for \> 24 hours
* Nasal CPAP pressure \< 8 cmH2O
* Oxygen requirement \< 30% and not increasing
* Respiratory rate \< 70 per minute
* Less than 3 episodes of oxygen saturation \< 70% or a heart rate \< 70 beat per minute in the preceding 24 hours
* Tolerates time off CPAP during cares (up to 15 minutes)

Exclusion Criteria:

* Congenital malformations of the heart (except patent ductus arteriosus, atrial septal defect and patent foramen ovale), lung, and gastrointestinal tract
* Surgical procedures performed on the gastrointestinal tract
* Known or suspected to have congenital neuromuscular disease
* Known or suspected syndrome
Long-term Use of Romidepsin in Patients With CTCL

Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS), the leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical manifestations and prognosis are highly variable. Improving the management of this incurable disease with limited toxicity is the main point of the current research. Romidepsin is a well-tolerated histone deacetylase inhibitor which has demonstrated activity against advanced stages of CTCL. In November 2009, it was approved by the US Food and Drug Administration (FDA) for the treatment of CTCL in patients who have received at least one prior systemic therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is said that it should be continued as long as the patient receives benefit and tolerates the drug. We experienced in our clinic that a long-term (\>6 months) use of Romidepsin, even with spared doses allows patients to maintain disease in complete remission or under control without severe side effects. We aim to demonstrate how many patients have benefited of this maintenance therapy, and detect the side effects related to the long-term use of Romidepsin, as well as characterize those patients that can get benefit of this therapy.

This project is a retrospective and prospective chart review of patients who present at Northwestern Medical Faculty Foundation clinic with the diagnosis of CTCL. It includes Mycosis Fungoid, Sézary Syndrome and other subtypes of CTCL, like Cytotoxic Cutaneous T-cell lymphomas. Those patients that received or will be prescribed per standard of care with romidepsin for at least 1 month (or at least more than 1 cycle of treatment) will be reviewed. We estimate that 50 patients could fit the criteria above, since the drug started to be prescribed in the Dermatology Clinic. Clinical information regarding diagnosis, stage, prior treatment received, and therapeutic response will be recorded. Blood parameters such as cell blood count, calcium, magnesium, potassium, and albumin at baseline and after treatment with romidepsin will be reviewed, and recorded if abnormalities are detected. Electrocardiogram changes will also be checked and recorded. All the information will be gathered in an excel spreadsheet in order to perform a descriptive analysis. We aim to assess the use of romidepsin as maintenance therapy and assess which schedule of treatment was most frequently used and associated with a better response with fewer side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of Cutaneous T-cell Lymphoma who present to the Northwestern Medical Faculty Foundation Dermatology clinic between January 1, 2009 and December 31, 2014
* Stages with more than 20% of bosy surface area affected or higher for MF and SS, and other CTCL variants
* Patients treated with romidepsin
* Between 18 and 89 years

Exclusion Criteria:

* Patients under 18 and over 89 years
* Patients with the diagnosis of CTCL that did not received romidepsin as a treatment
Diagnostic Biomarkers to Correlate Molecular Changes and Inflammatory Cascade in the Dental Pulp.

This study aimed to evaluate the molecular changes that occur within the pulp tissue during inflammation and its correlation with vital pulp therapy with its different treatment modalities (Direct pulp capping, Partial Pulpotomy and Complete Pulpotomy).

The diagnosis of irreversible pulpitis was based only on the clinical signs and symptoms which does not always match that of the histological changes of the pulp tissues. So, it is more appropriate to diagnose the pulp according to the molecular changes taking place throughout the pulp tissues. Different studies have been conducted to study the molecular changes that take place in the inflamed pulp, Including a study that was conducted by Rechenberg et al in 2014 which states different locations to obtain samples for these molecules. The best of which was the dental pulp blood sample. Many studies stated the way to obtain a blood sample from the pulp and how to prepare and test it to evaluate the levels and concentrations of different inflammatory molecules. Many studies were also conducted to study the different changes and accurateness of measurement of different molecules.

The pulp inflammation occurs in a low compliance environment of dentinal walls. So, During acute inflammatory reaction, Vasodilatation occurs along with increased capillary permeability, Which leads to increase in the pulp interstitial fluid pressure which creates more pressure on blood vessels and this prevents beneficial blood flow, which decreases the ability of the pulp to defend itself from bacterial attacks causing tissue necrosis. This necrotic tissue is colonized by bacterial tissues.

In the literature, one of the novel treatment modalities for irrevesible inflammation of the pulp is partial removal of the inflammed pulp tissue according to clinical sign (bleeding control), The pulp tissue is removed partially until reaching complete coronal pulp removal or complete pulpectomy until hemostasis is obtained after 10 minutes of moist cotton pellet application.So, The normal pulp is preserved.

In 2019, Ricucci et al conducted a systematic review for treatment of deep carious lesions with pulp exposure. With treatment modalities ranging from direct pulp capping, partial pulpotomy, complete pulpotomy and pulpectomy. Based only on clinical signs of normal appearance of the pulp tissue under magnification with dental operating microscope and bleeding control within 10 minutes with a moist cotton pellet.

Eligibility Criteria:
Inclusion Criteria:

* Positive response to cold testing.
* The age range from 15-45 years.
* Patients of both sex.
* Has clinical symptoms of pulpitis with normal apical tissues and supported by radiographic evaluation with no periradicular changes.

Exclusion Criteria:

* Patients over 45 years of age.
* Patients with clinical symptoms of periradicular inflammation or periradicular radiographic changes.
* Negative response to cold testing.