cyrilzakka/clinical-trials huggingface dataset:
Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery

The objective is to investigate a goal-oriented postoperative circulation management strategy centered on "oxygen metabolism balance". This strategy is independent of the absolute metrics of oxygen supply and consumption, and aims to enhance oxygen consumption and uptake within the critical "golden 8 hours" following pediatric cardiopulmonary bypass, thereby preventing severe hypotension, cardiopulmonary arrest, and other adverse events.

This study firstly offered a specialized treatment strategy for children, particularly those who have undergone cardiopulmonary bypass surgery, that uses tailored parallel control and is independent of absolute oxygen supply and consumption characteristics.In addition, this study seeks to investigate the correlation between oxygen supply and consumption following pediatric cardiopulmonary bypass surgery and to assess the clinical utility of a goal-directed strategy concerning cardiac function recovery (ICON, echocardiography, myocardial markers) and outcomes (incidence of low cardiac output, duration of endotracheal intubation, length of CCU stay, and mortality). This strategy is of great significance to improve the surgical outcomes and prognoses for children.

Eligibility Criteria:
Inclusion Criteria:

* 1.Body weight \> 2.5kg;
* 2.Preoperative oxygen saturation \>80%;
* 3.Biventricular radical surgery with cardiopulmonary bypass.

Exclusion Criteria:

* 1. Complicated with functional single ventricle and atrial isomerism;
* 2.Complicated with liver, kidney, lung, brain and other vital organ diseases;
* 3.History of rescue before operation;
* 4.Palliative surgery;
* 5.Residual deformities that significantly affected hemodynamics after operation;
* 6.Guardians did not provide the bundle of informed consent.
The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange During Laryngeal Microsurgery

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.

However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.

Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.

Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.

On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.

The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laryngeal microsurgery
* ASA class I-III

Exclusion Criteria:

* patients scheduled for laryngeal microsurgery using CO2 laser
* patients with increased intracranial pressure
* patients with skull base defect
* patients with chronic obstructive pulmonary disease
* patients with pulmonary hypertension
* patients requiring rapid sequence induction
Extended Access of Momelotinib in Adults With Myelofibrosis

The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

* Known hypersensitivity to MMB, its metabolites, or formulation excipients

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Ondansetron for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥ 37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.


Eligibility Criteria:
Inclusion Criteria:

* first episode of symptomatic typical atrial flutter
* \> 18 years old

Exclusion Criteria:

* Prior antiarrhythmic drug treatment for atrial flutter
* History of cavotricuspid isthmus ablation
* Pregnancy
* Hyperthyroidism
* contraindication for anticoagulant therapy
* Life expectancy \< 1 year
* contraindication to catheter ablation or to electrical cardioversion
Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. The project aim to improve the quality of the treatment with MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims to examine the most effective MIE settings when used in stable state and when respiratory tract infections are present.

On the basis of a prevalence study and a bench study different settings will be studied in children with NMD and weak cough to examine if settings derived from the lung model, are optimal to increase the peak cough flow (PCF) and comfort measured by visual analogue scale (VAS) in children with NMD and weak cough.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed neuromuscular disease \< 18 years
* Established use (\> 3mnd) of MI-E.
* Reduced PCF

  * PCF \< 270 l/min (when \> 12 years)
  * \< 5th percentiles for PCF 16 (when 4 - 12 years)
* Clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections).

Exclusion Criteria:

* age \< 6 mnd
* obstructive lung disease (hyperinflation or emphysema on x-ray.
RCT of the Effectiveness of the WfWI Intervention in Afghanistan

This is an individually randomised control trial to assess the effectiveness of a livelihoods and social empowerment intervention, delivered by Women for Women International, on married women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Women should be in the lowest economic level (earning less than US$1.25/day)
* Unemployed
* No in education/school
* Not involved in a similar programme
* Able to provide informed consent

Exclusion Criteria:

* Not mentally incapacitated, so as unable to provide informed consent
* Already been part of the WfWI intervention previously
Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear

Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.

Methods:

The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.

Follow-up:

Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.


Eligibility Criteria:
Inclusion Criteria:

* receiving unilateral ACL reconstruction in our hospital
* postoperative follow-up over 3 month

Exclusion Criteria:

* postoperative follow-up less than 3 month
* possible pregnency
* with coagulation disease
* NSAIDs intake during study period
Appropriateness of Methodist Health System(MHS) Inter-facility Transfers of Traumatic Intracranial Subarachnoid Hemorrhage and Spontaneous Bleeds for Level-1 Advanced Surgical Intervention

Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment.

Brain injuries are common and challenging problems faced by emergency physicians. These diagnoses may include traumatic intracerebral hemorrhage, subarachnoid hemorrhage, ruptured cerebral aneurysms, unruptured cerebral aneurysms, and arteriovenous malformations, which require neurological, neurosurgical, and/or endovascular treatment. Depending on the indication and its severity, transfer to a comprehensive stroke center for access to advanced neuro-critical care may be necessary. Comprehensive stroke centers are widely supported and have the resources and infrastructure to have in-house expert stroke providers, teams, operating rooms, and interventional radiology suites that are always available.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Diagnosed with traumatic intracranial subarachnoid hemorrhage or a spontaneous bleed
* Patients originating at Methodist Mansfield medical center (MMMC) or Methodist Charlton medical center(MCMC)and subsequently transferred to Methodist Dallas medical center (MDMC)

Exclusion Criteria:

* Does not meet inclusion criteria defined in section 3.1
Validation of Receptor Occupancy Simulation

* To estimate dopamine receptor occupancy by aripiprazole using computer simulation
* To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics
* To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of schizophrenia
* treated with aripiprazole or risperidone
* no change in dose of antipsychotics for at least 6 weeks
* total PANSS score should be below 80

Exclusion Criteria:

* Other psychiatric disorders rather than schizophrenia
* history of head trauma
* positive in urine hCG
* on antidepressant, anticholinergics or mood stabilizer
Project CADENCE (CAncer Detected Early caN be CurEd)

With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be dysregulated during disease progression. Combining the power of multi-omic cancer biomarkers, the investigators hypothesize that the sensitivity and specificity of MiRXES MCST can be significantly improved compared to existing multi-cancer diagnostic tests.

In this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.

This study consists of four (4) objectives:

* Characterize intra-cellular multi-omic profiles of cancer and adjacent normal tissues to aid the selection of circulating cancer biomarkers.
* Select and verify circulating multi-omic cancer biomarkers by characterizing the circulating multi-omic profiles of the peripheral blood of cancer patients, high-risk, increased-risk, and healthy controls, guided by tissue-based cancer omics profiles.
* Develop multi-cancer screening in vitro diagnostic assay(s) based on the selected blood-borne circulating multi-omic cancer biomarker panel(s) and build algorithm(s) to distinguish cancer cases from control groups.
* Clinically validate the performance (AUC, sensitivity, specificity) of the multi-cancer screening assay(s) and algorithm(s)

Eligibility Criteria:
Inclusion Criteria:

Healthy average-risk cohort Individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. Subjects will be recruited from a state-of-the-art population study.

Increased-risk (genetic/familial) cohort Individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. Subjects will be recruited from Cancer Genetics Service (CGS).

High-risk cohort Individuals diagnosed with diseases that have a high risk of progressing to cancer.

Malignant cohort Individuals diagnosed with cancer. Wherever possible, samples for the 'Malignant group' should have a representation of each cancer stage.

Exclusion Criteria:

Pregnant or lactating (self-declaration), unwilling or unable to provide signed informed consent and has or had received chemotherapy or radiotherapy for cancer treatment and/or any other cancer-related treatment.
Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.

The interoception capacity may be changed with mind-body intervention. This study case investigated the interoceptive capacity, measured by MAIA scale of a pacient with mood disorders and if it can be influenced through of a 7 weeks intervention of interoceptive exercises and the impaction in the patient´s daily life. The aim was analyse the effects of mind-body exercise program with interoceptive approach in the anxiety and depression symptoms, interoceptive capacity, as well your impact in paitient's daily activities. M.S is 47 years old, was forwarded from University Hospital Clementino Fraga Filho to extension project named as "corpo\&mente" (body-mind), an anamnesis was performed including patient's life story, interoceptive scale, anxiety and depression scale from Hamilton and a risk stratification to realize physical activities (it was also performed post-intervention). The exercise program lasted 1h 15 min and it was performed once a week.


Eligibility Criteria:
Inclusion Criteria:

* Participants with anxiety or/and depression clinical diagnosis
* Participants who do not do formal meditation practices

Exclusion Criteria:

* Participants with other diagnosis
* Patients with cognitive conditions
EluPro Antibiotic-Eluting BioEnvelope Registry

A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation

This prospective, multi-center registry study will enroll up to 100 participants who will receive an EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure.

Participant data will be captured at several time points: Screening/Enrollment, day of Surgical Procedure, and at Wound Check (2-4 Weeks) 3, 6, and 12 months post-surgery, as well as any unscheduled visits up to 12 months post-surgery. Any follow-up visit can be completed via telephone/video if the participant is not scheduled to be seen in the office. Patient-reported outcomes such as implant site pain and satisfaction questionnaires shall be administered to participants at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing implantation of EluPro with either a de novo CIED implantation or has an existing CIED and is undergoing CIED replacement or upgrade.
* Patient is willing to comply with scheduled follow-up and study-related visits.
* Patient is 18 years of age or older at the time of enrollment.
* Patient agrees to provide written informed consent and use of PHI.

Exclusion Criteria:

* Patient has a prior history of CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
* Patient is exhibiting signs or symptoms consistent with any type of active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia).
* Patient has Stage 4 or 5 kidney disease (eGFR \<30 ml/min).
* Patient requires long-term vascular access for any reason.
* Patient is undergoing implantation of a CIED that does not fit completely into EluPro, preventing closure of the bioenvelope to secure the CIED.
* Patient is currently on chronic immunosuppressive agents or ≥20mg/day of Prednisone or equivalent.
* Patient has known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to the implantation of EluPro.
* Patient is participating in another clinical study that could impact the outcome and documented pre-approval from the study sponsor has not been obtained.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure.
SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary

Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/LAR and the treating physician based on local label before and independently from the decision to include the patient in this study.
* Male or female, adults above or equal to 18 years of age at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus.
* Patient on metformin (Met) with or without modern oral antidiabetic (MOAD, that is Dipeptidyl Peptidase-4 Inhibitor \[DPP4i\] or/and Sodium-glucose cotransporter-2 Inhibitor \[SGLT2i\]) with or without insulin therapy.
* Available HbA1c value \> 7.0% within 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.

Exclusion Criteria:

* Previous participation in this study (defined as having given informed consent in this study earlier).
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Glucagon like peptide -1 receptor agonist (GLP1-RA) treatment within 90 days prior to the Treatment Initiation visit (V1).
* Patients diagnosed with type 1 diabetes mellitus.
* Female who is known to be pregnant, undergoing fertility treatment, breastfeeding or intends to become pregnant during the study duration.