cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN)

Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be consistently applied to patients randomized to the intervention, as well as having access to behavioral health trained patient navigators. These key components are often deployed inconsistently as a part of usual care, but per the intervention, will be completed in totality for subjects who are assigned to and participate in the BH-VPN plan.

This study includes a qualitative sub-study to measure perceptions of the impact of the BH-VPN on readmission rates and patient outcomes, experiences with the services provided by the BH-VPN, and provider and clinician ideas for how to improve the services provided by the BH-VPN.


Eligibility Criteria:
Inclusion Criteria:

* Present at a participating ED
* Completed telepsychiatric consult as captured in the EMR
* Completed telepsychiatric consult Monday - Friday during Navigator's potential hours of operation.

Exclusion Criteria:

* None per the protocol
Laparoscopic Surgical Management of Endometriosis on Fertility

The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.

Exclusion Criteria:

* Patients under 18 years
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden

The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are:

* What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?
* What is the impact of tDCS on caregiver burden?

Researchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden.

Participants will:

* Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).
* perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged over 60,
* Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria
* No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,
* Mini Mental State Examination (MMSE) \> 15,
* Composite score called "psychotic factor" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \[12\]) greater than 0,
* Presence of a family caregiver,
* Sufficient written and oral expression in French,
* Written informed consent signed by the patient and his/her family caregiver

Exclusion Criteria:

* History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment,
* Concomitant major psychiatric illness,
* Significant physical illness or comorbidities
* History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,
* Patient under guardianship or curators
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke

The primary objective of this study was to evaluate the efficacy and safety of initiation of edaravone dextivel therapy compared with placebo in patients with acute ischaemic stroke (early and late) and to explore the optimal time window for "brain cell protective therapy" of edaravone dexborneol.

This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of (early and late) initiation treatment of Edaravone Dexborneol versus placebo in patients with acute ischemic stroke, and to explore the optimal time window for "brain cell protective therapy" of Edaravone Dexborneol. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be stratified by time to trial drug: early (\<3 hours) and late (3-6 hours). Then each layer will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15ml edaravone and dexborneol concentrated solution for injection (37.5mg, containing edaravone 30mg and dexborneol 7.5mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, gender is not limited;
* Clinically confirmed acute ischemic stroke;
* Within 6 hours of the onset of this stroke;
* NIHSS score of 4-24 at enrollment;
* mRS score before onset≤ 1 point;
* Subject and subject's agent are able and willing to sign informed consent.

Exclusion Criteria:

* CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
* Previously known severe liver or kidney insufficiency (ALT or AST is greater than 3.0×ULN; serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or dialysis;
* Systolic blood pressure≥220 mmHg or \<90mmHg；
* Recent stroke within prior 1 month；
* Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
* Prior receipt of edaravone or any other neuroprotective drugs;
* History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.;
* Pregnancy, lactation, or planned pregnancy within 90 days;
* Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
* Those with a malignant tumor, severe systemic diseases, or predict survival time \<90 days;
* Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study;
* The investigators consider the patients are not suitable for this trial.
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Despite recent advances in reproductive medicine, poor ovarian response (POR) management is still considered to be very challenging. Commonly, POR patients present with reduced ovarian reserve and poor ovarian stimulation performance. The POR cycles are characterized by a very limited number of retrieved oocytes, subsequently leading to poor embryo formation and thus to high cycle cancelation rate. Despite the fact that POR constitutes a multifactorial condition, it is well demonstrated that advanced maternal age (AMA) is the most significant contributor of POR. As maternal age increases, reduction of neo-angiogenesis in ovaries is observed, leading to accelerated follicular loss. Considering that PRP contains several growth factors such as vascular endothelial growth factor (VEGF) and cytokines, it has been proposed that intraovarian infusion of autologous PRP could restore the ovarian niche microenvironment, increasing ovarian response to external gonadotropin stimulation. However, limited data are available with regards to PRP efficiency in POR patients, which are mainly originating from pilot or small cohort studies. This interventional non-randomised open-label study aims to investigate the effect of autologous PRP intraovarian infusion on improving POR patient performance by studying a large and well-controlled POR population.

Eligibility Criteria:
Inclusion Criteria:

Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following):

1. Age ≥ 40 years
2. AMH \< 1.1 ng/ml OR AFC \< 7
3. ≤ 3 oocytes with a conventional stimulation protocol

   * Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
   * Willing to comply with study requirements

Exclusion Criteria:

* Any pathological disorder related to reproductive system anatomy
* Cycle irregularities
* Amenorrhea
* Endometriosis
* Adenomyosis
* Fibroids and adhesions
* Infections in reproductive system
* Current or previous diagnosis of cancer in reproductive system
* History of familiar cancer in reproductive system
* Severe male factor infertility
* Prior referral for Preimplantation Genetic Testing (PGT) -Ovarian inaccessibility -Endocrinological disorders (Hypothalamus-
* Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
* BMI\>30 kg/m2 or BMI\<18.5 kg/m2
* Systematic autoimmune disorders
Adeno-tonsillectomy in Treatment of Obstructive Sleep Apnea

The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy compared with adenoidectomy with classical unilateral complete tonsillectomy for management of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the technique and reducing postoperative complications.

Tonsillectomy is one of commonly performed pediatric otorhinolaryngology surgeries.

The two main indications of tonsillectomy in children include recurrent tonsillitis and Obstructive Sleep-Disordered Breathing (OSDB); including obstructive sleep apnea and upper airway resistance syndrome.

Total tonsillectomy means total removal of the tonsillar tissue with the tonsillar capsule. The main drawbacks of tonsillectomy are the potential for serious postoperative bleeding, postoperative pain, eating and drinking difficulties, and reduced immune function in the early stages after the operation. Partial tonsillectomy (intracapsular tonsillectomy, subtotal tonsillectomy) means subtotal removal of tonsillar tissue, leaving a margin of tissue on the tonsillar capsule . In contrast to complete tonsil removal, Partial tonsillectomy does not violate the capsule, and leaves lymphoid tissue as a protective tissue on the pharyngeal muscle layer thus preserving of the connective tissue capsule and pharyngeal muscles. This diminishes the direct and indirect trauma during an intraoperative procedure and the inflammation due to secondary infection during the postoperative period. Recently, children with OSDB have benefited from the less invasive partial tonsillectomy with less pain, equivalent or easier recovery, better food intake, and maintain the immunological function of the tonsils, while being as effective as tonsillectomy for resolving upper-airway obstructive symptoms.

Many studies have evaluated the outcomes of the two techniques, but uncertainty remains with regard to the efficacy, complications and long term outcomes. Some studies have reported the recurrence of obstructive symptoms due to regrowth of the remaining tonsillar tissue. Thus, it is important to evaluate Partial tonsillectomy comprehensively, especially paying attention to short-term and long-term results.

Over the last years, unilateral complete tonsillectomy (usually combined with adenoidectomy) was the most commonly utilized procedure for treatment of pediatric obstructive sleep-disordered breathing below the age of four years old in Otorhinolaryngology Department, Assiut University

Eligibility Criteria:
Inclusion Criteria:

* • Age: 1-3 yeas.

  * Diagnosed to have Obstructive Sleep-Disordered Breathing (OSDB) due to adenotonsillar enlargement confirmed by flexible nasoendoscopic assessment.

Exclusion Criteria:

* • Any associated medical comorbidity that contraindicates general anesthesia.

  * Children having other causes for OSDB (e.g. obesity, Down syndrome, craniofacial abnormalities, neuromuscular disorders, sickle cell disease, or mucopolysaccharidoses).
  * Refusal of enrollment in the research by care givers.
Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)

Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.

RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.

Eligibility Criteria:
The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated

Please see the Criteria for each under:

* CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010
* LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049
* SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023
Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients

Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* first-ever ischemic or hemorrhagic stroke at least 1 year earlier
* hand function impairment
* ability to give informed consent and comprehend instructions

Exclusion Criteria:

* previous surgical intervention on vagus nerve
* low hearth rate (\< 60 bpm)
* cognitive impairment or any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* apraxia
* excessive pain in any joint of the paretic extremity
* advanced liver, kidney, cardiac or pulmonary disease
* history of significant alcohol or drug abuse
* depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines
* pregnant women
Ultrasound-Guided Serratus and Transversus Thoracic Muscle Plane Block Vs. Erector Spinae Plane Block for Acute Poststernotomy Pain

Poststernotomy pain represents a complication that can arise following cardiac surgery. Inadequately managed pain has been linked to various adverse outcomes, including myocardial ischemia, cardiac arrhythmias, heightened coagulation tendencies, pulmonary complications, and elevated incidences of delirium and wound infections.

The Erector Spinae Plane (ESP) block, Serratus Anterior Plane (SAP) block, and Transverse Thoracic Muscle Plane (TTMP) block are demonstrated as effective regional anesthesia techniques for sternotomy pain. While these blocks differ in ease of application and efficacy, the optimal analgesic approach for cardiac surgery remains unclear. The aim of this study is to compare the analgesic efficacy of ultrasound-guided SAP and TTMP blocks combination versus ESP block administered alone in patients undergoing open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac Surgery with median sternotomy (valvular and coronary surgeries)

Exclusion Criteria:

* Minimal invasive cardiac surgeries
* Revision surgeries (during postoperative 48 hours)
* Redo cardiac surgeries
* Any contraindications for regional anesthesia technique (any allergies for local anesthetics)
* Preoperative chronic opioid usage
Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus.

The rate of mother-to-child transmission of hepatitis C virus (HCV) is only 5%, even though the level of fetal exposure to the virus during pregnancy is probably much higher. How can the fetus avoid infection in so many cases? We believe the fetal immune system is not immature as has previously been thought, but instead plays an active role in protecting the fetus from infection. In this study, we aim to better understand the immune response of the fetus against maternal HCV infection. In addition, since the fetus has been shown in some cases to make an immune response against vaccines given to the mother during pregnancy, we also aim to study the fetal immune response against maternal influenza virus vaccination. We plan to study 50 HCV-positive pregnant women and their infants (study group) and compare them to 20 HCV-negative pregnant women and their infants (control group). We estimate that approximately 30 women in the study group will have received the influenza virus vaccine. We will analyze 3 important components of mother-to-child transmission: (1) the maternal immune response against HCV and influenza virus vaccine during and after pregnancy; (2) the baby's immune response to these agents at birth, 9-15 months, and 24 months; and (3) the placenta, for the presence of HCV particles or influenza virus vaccine components. The results of this study may have implications for the prevention of mother-to-child transmission of HCV and other infections, as well as for the development of novel vaccination strategies.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women 18 years of age or older
* infants born to these women from this pregnancy
* hepatitis C virus antibody and RNA positive (for study group)
* hepatitis C virus antibody and RNA negative (for control group)

Exclusion Criteria:

* HIV infection
* hepatitis B infection
* plan to use cord blood for another purpose
SENTANTE: Fully Robotic Peripheral Endovascular Interventions

The objective of the study is to evaluate the feasibility, safety and initial efficacy of the clinical and technical performance of the SENTANTE robotic system in the remote delivery and manipulation of commonly used and compatible guidewires and catheter-based devices for use in peripheral endovascular procedures.

The study will be a single-center, prospective investigation, designed to evaluate the safety, feasibility, and initial efficacy of robotic system for remote endovascular interventions in adults with disease which requires peripheral endovascular treatment with compatible devices. Participants meeting the inclusion criteria will undergo endovascular interventions using SENTANTE robotic system. Data will be collected through clinical assessments, imaging and other studies, laboratory tests, and feedback from medical personnel and patients.

The study will adhere to ethical guidelines, obtain informed consent from all participants, and be conducted under the oversight of the Clinical Events Committee.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 19 years and ≤ 90 years of age.
* Subject is willing and able to provide appropriate study-specific informed consent and follow Clinical Investigation Plan (CIP) procedures.
* Life expectancy ≥ 12 months from the date of the index procedure.
* Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
* Subject is diagnosed with a disease which requires peripheral endovascular intervention using compatible with SENTANTE guidewires and catheter-based devices.

Exclusion Criteria:

* Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index procedure.
* Subjects with myocardial infarct or cerebrovascular event within 3 months prior to index procedure.
* Severe vascular anatomy that would preclude safe sheath insertion, or deliverability of stent.
* History of bleeding diathesis or coagulopathy.
* History of thrombophilia.
* Sensitivity to contrast media that cannot be adequately pre-treated.
* Sensitivity to both forms of CIP-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin).
* Sensitivity to an antiplatelet agent AND all CIP acceptable alternative antiplatelet options.
* Major neurologic deficit with NIHSS of ≥ 15.
* Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
* Subject previously enrolled in this clinical trial.
* Possible / probable non-compliance of subject with CIP required follow up or medication.
* Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this Clinical Study.
* Signs of SARS-CoV2 (COVID-19) active infection.
* Patients with intervention-related anxiety, separation anxiety, autophobia and individuals that cannot be left alone without additional sedation or close supervision.