cyrilzakka/clinical-trials huggingface dataset:
Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)

This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. This is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. This inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. Over the years, many factors that contribute to this reaction have been discussed. One potential explanation is the release of endotoxin into the bloodstream during CPB. Endotoxin is a molecule that is a part of bacteria which are native to the human gut. In healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. During major interventions, and especially during cardiac surgery with CPB, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. While previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. This study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with CPB.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients undergoing cardiac surgery requiring CPB
2. written informed consent

Exclusion Criteria:

1. emergency surgery in the context of acute coronary syndrome
2. patients with chronic inflammatory diseases of the gut
3. patients receiving immunosuppressive drugs
4. patients with infectious endocarditis
5. patients with sepsis
6. patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 ml/min/1,73m²
7. persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
8. persons held in an institution by legal of official order -
Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.

we planned a randomized prospective trial for cancer patients with DIH. The objective of the present study was to determine whether the rotation of corticosteroids affects the incidence and intensity of DIH without compromising the antiemetic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* all solid cancer patients on chemotherapy
* age \>18 years
* received dexamethasone as an antiemetic

Exclusion Criteria:

* brain metastases
* hiccups before dexamethasone administration
* uncontrolled diabetes mellitus
* uncontrolled esophagitis or peptic ulcer
Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma

The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma


Eligibility Criteria:
Inclusion Criteria:

* Children with moderate persistent asthma
* Age range of 8-\< 18 years old
* Both sex

Exclusion Criteria:

* Children with any pulmonary or chronic systemic diseases other than asthma (cystic fibrosis, bronchiectasis, tuberculosis, diabetes mellitus, and liver disease).
* Children with immunodeficiency.
* Children with thyroid disorder.
* Children with recent infection (especially pneumonia), surgery, anesthesia.
* Children having clinical evidence of any heart renal and hepatic diseases.
* Children having cystic fibrosis or congenital respiratory disease.
* Children having chronic diarrhea and mal-absorption.
* Children having clinical evidence of malnutrition.
* Children on medications that could interfere with L-carnitine level including antibiotics use. (particularly ampicillins) and anti- convulsing particularly valoproic acid.
Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients

Clinical studies, with a distinct focus on treatment resistant depression, play a crucial role in evaluating the safety and effectiveness of novel treatments. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption.

The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of treatment resistant depression
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No prior treatment for treatment resistant depression

Exclusion Criteria:

* Enrolled in another research study
* Inability to provide written informed consent
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Retrospective Study of Trabectedin in Soft Tissue Sarcomas

This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting.

A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug.

This is a national, multi-centre observational retrospective and prospective chart review study of treatment patterns and clinical outcomes in a subset of patients with Soft Tissue Sarcoma who received trabectedin as per licensed indication.

In the absence of availability of existing databases, a retrospective chart review design was selected.

It is anticipated that the medical charts will contain the information required to answer study objectives. This chart review study will be conducted in 25 sites in Italy An estimated total of 900 charts will be abstracted. This study requires no intervention or interference with standard medical care, and thus it will not affect patient treatment.

The study is sponsored by Italian Sarcoma Group Charts of patients who initiated trabectedin as part of the approved treatment for a Soft Tissue Sarcoma , will be identified by site staff. Each identified chart will be assigned a unique study identification number. Site staff will review the medical charts for all identified patients to determine patient eligibility. Those patients who meet eligibility criteria will be enrolled into the final study cohort as subject.

Data from subject medical charts will be abstracted by local site study staff and entered at the site into an electronic data capture (EDC) system. The system will also facilitate the monitoring of the completeness and quality of study data as the study data accrue.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received trabectedin according to the approved indication in the period January 2010 December 2015

Exclusion Criteria:

* Trabectedin started before January 2010 and after December 2015
* Participation into clinical trials with trabectedin
* Clinical chart missing, empty, or not retrievable.
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \< 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification.
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None

Exclusion Criteria:

-
Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.

The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
* Age 16 or over

Exclusion Criteria:

-
Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.

The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An near-infrared spectroscopy (NIRS) sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The tissue oxygen saturation (StO2) data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope was defined as the descending slope of StO2 value until it reached the minimum value. The recovery slope was calculated from the deflation of the tourniquet until the recovery of StO2 to the maximum value.

Eligibility Criteria:
Inclusion Criteria:

* The patients who were scheduled for spinal anesthesia
* 18\< age \< 60 years old

Exclusion Criteria:

* American Society of Anesthesiologists physical status class \> III,
* allergy or sensitivity to study medications,
* alcohol or drug abuse history,
* body mass index \> 35 kg/ m2 or \< 15 kg/m2,
* p regnancy or breastfeeding status,
* diabetes and on insulin treatment,
* untreated or uncontrolled arterial hypertension,
* peripheral arterial disease,
* corticosteroid treatment, coagulopathy, and lower limb deformities or burns
* patients who may not tolerate VOT
PWS European Blood Bank for Infants and Controls From 0 to 48 Months

The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary objective is to describe the evolution of circulating hormones involved in feeding and appetite regulation during the 4 first years of life. The secondary objective is to make this blood bank available for other research projects and particularly the investigation of hormones involved in hypogonadism.

Over the last ten years, the age at diagnosis in PWS has fallen significantly and the majority of cases is now diagnosed during the 1st trimester of life giving the possibility to collect precise clinical data and serum samples at early stages. The investigators of the project are involved in the care of patients with PWS and have a devoted clinic and an organized network in their country through clinical networks or patient associations.

The investigators propose to perform a prospective multicentric study, both longitudinal (duration 30 months) and cross-sectional with implementation of a blood bank in link with a multicenter database including clinical data on birth, auxology, endocrine functions and feeding behaviour. The cohort will include 200 infants from 3 to 48 months with PWS and 200 controls matched on age recruited in the 6 participating countries. The investigators make the assumption that 3 blood sampling will be necessary during the first year and 6 monthly sampling thereafter. For measuring hormones and neuropeptides (ghrelin, insulin, leptin, pancreatic polypeptide, oxytocin, cortisol, melatonin, orexin A, GLP-1 and PYY) involved in feeding and appetite regulation the investigators will use primarily multiplex microplates technics requiring 50-200µl of sample. Intragroup and intergroup comparisons will be performed in order to describe the evolution of each hormone with time and to compare data obtained in the PWS group with those obtained in the control group.

Eligibility Criteria:
Inclusion Criteria (PWS infants cohort)

* Genetic diagnosis of Prader-Willi syndrome

Exclusion Criteria (PWS infants cohort)

* none

Inclusion Criteria (control group)

* children hospitalized for a planned surgery for malformation, orthopaedic or visceral surgery

Exclusion Criteria (control group)

* children with endocrine disorder
Dietary Quality and Subsequent Cardiovascular Disease

To examine dietary quality and subsequent cardiovascular disease (CVD).

BACKGROUND:

Although considerable evidence exists for associations between diet and subsequent cardiovascular disease (CVD) among younger and middle-aged adults, no comprehensive studies of these relationships have been conducted using a national sample of older Americans. National guidelines have recommended reductions of dietary fat, saturated fat, cholesterol and sodium as dietary practice to reduce CVD. However, it is possible that the focus on eliminating dietary components may obscure the advantages of consuming diets that are nutritionally adequate.

Findings from this study could have important implications for setting research priorities to further study the effects of specific dietary variables on CVD, and for implementing national nutrition policies to assist Americans in selecting healthy diets.

DESIGN NARRATIVE:

Data from NHANES I and the three cycles of NHANES I Epidemiologic Followup Study (NHEFS) were used to 1) to examine the associations between several measures of dietary quality at baseline and subsequent 14-year morbidity and mortality from CVD for a national sample of 6109 United States adults aged 45 to 74 years at baseline; 2) to assess the relative importance of the associations of dietary quality and CVD for older adults compared to middle-aged adults. Dietary variables were based on responses to the 24-hour dietary recall and the food frequency questionnaire administered at baseline and included a composite measure of dietary quality, intakes of specific nutrients, and usual consumption of foods from 19 food groups. Baseline measures used as covariates included body mass index, blood pressure, serum cholesterol, sociodemographic variables (e.g., age, race, income, occupation), behavioral variables (e.g., smoking, alcohol consumption, activity level), and chronic health conditions. CVD outcomes were determined from medical history questionnaires, hospital records and death certificates. Change in blood pressure between baseline and 10-year followup were examined as an outcome variable as well as a covariate in the association between diet and CVD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.


Eligibility Criteria:
Inclusion Criteria:

* Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
* Participants with minimum of 20 natural teeth.
* At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

  1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
  3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion Criteria:

* Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
* Any condition which, in the opinion of the investigator, causes dry mouth.
* Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
* Participant using of a desensitising dentifrice within 6 weeks of screening
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis

The goal of this diagnostic test is to develop an artificial intelligence (AI)-based pan-cancer universal diagnostic model for detecting pathological lymph node metastasis (LNM), and prospectively evaluate its apllication value in the real-world clinical practice.

Investigators will compare the diagnostic performance (sensitivity, specificity, etc.) of the AI model and routine pathological report issued by pathologists, to see if the AI model can improve the clinical workflow of pathological evaluation of cancer LNM in in the real world.

Lymph node metastasis (LNM) is a common mode of cancer metastasis, and accurate postoperative pathological lymph node staging is of great significance for further treatment and prognosis assessment. However, the current pathological evaluation of lymph nodes relies on manual examination by pathologists, which has a relatively low diagnostic efficiency and is prone to missed-diagnosis for micro metastatic lesions.

Therefore, investigators are to develope an artificial intelligence (AI)-based diagnostic model for detecting pathological cancer lymph node metastasis based on deep learning algorithms, and evaluate its apllication value in the real-world clinical settings.

This study is a diagnostic test with no intervention measures, planning to collect pathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images (WSIs). The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results (with or without LNM). The routine pathological examination will be performed as usual. These two processes will not interfere with each other. And if there are inconsistency in slide-level classification between AI and routine pathological examination, investigators would convene senior pathologists for discussion to make the final decision (immunohistochemistry would be performed if necessary). The final result will be presented to the patient in the form of a pathological report.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer, undergoing radical tumor resection and lymph node dissection.
* Patients with complete clinical and pathological information.

Exclusion Criteria:

* The patient refused to participate in this diagnostic test.