cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Cytokines and the Severity of Meningococcal Disease

Objectives:

Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate the level of these cytokines to severity of MD.

Design:

Prospective, nonrandomized study.

Setting:

Tertiary referral intensive care unit.

Patients:

Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.

Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD:

IL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival.

Design: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit. Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.

Measurements and Main Results: in process Conclusions: in process

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnostic of meningococcal disease

Exclusion Criteria:

* no meningococcal disease
Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications

This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.

The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome.

The main aim of this study is to evaluate blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome The secondary objective is to correlate the levels of the above markers with the presence/entity of cardiac involvement and its progression over time.

All patients will undergo:

* a baseline assessment including:

  * blood sampling for US-Troponin I, BNP, NT-proBNP, ST2
  * cardiological evaluation including ECG and echocardiogram
* a three-monthly revaluation of these markers
* a six monthly cardiological reassessment with a echocardiogram

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology

Exclusion Criteria:

* age \<18 years
* patients diagnosed with heart disease prior to diagnosis of NET
Effectiveness of Chinese Handwriting Intervention Program for Children With ASD

This research aims to investigate the effectiveness and acceptability of the newly developed Chinese handwriting performance intervention program


Eligibility Criteria:
Inclusion Criteria:

1. first or second grader
2. reported problems with poor handwriting legibility or performed less readable handwriting as claimed by their school teachers or caregivers
3. score at most 33 scores in overall legibility dimension or at-least 45 incorrect strokes in Chinese Handwriting Legibility Assessment for Children (CHLAC)
4. previously diagnosed with ASD
5. and score at least seven scores in Autism Behavior Checklist Taiwan Version (ABC-T) will be included in this study.

Exclusion Criteria:

1. any physical disability affecting the upper limb
2. any hearing or visual impairment
3. intelligence quotient below 70 or previously diagnosed with intellectual disability
4. unable to follow the evaluation instruction.
Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. Although effective in the long term, it causes severe postoperative pain.

Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time.

The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility.

Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.


Eligibility Criteria:
INCLUSION CRITERIA

* Age over 18 years
* Grade III hemorrhoids
* BMI below 30
* Indication for OEH surgery
* Signed written informed consent

EXCLUSION CRITERIA

* Acute hemorrhoidal disease (thrombosis)
* Previous hemorrhoid surgery
* Coexistence of anal fissure
* Coexistence of perianal fistula
* Coexistence of rectal or anal prolapse
* Active inflammatory bowel disease
* Active anal or colorectal cancer
* Language barrier or difficulty in oral and/or written comprehension
Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery

This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke

The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and older
* at least 12 months from stroke
* mild-to-severe upper extremity motor deficit
* single ischemic or hemorrhagic stroke

Exclusion Criteria:

* history of head injury with loss of consciousness
* seizures
* severe alcohol or drug abuse
* psychiatric illness interfering with participation in the study including uncontrolled depression
* cognitive deficits severe enough to preclude informed consent
* ferromagnetic material near the brain
* individuals that could be pregnant
* cardiac or neural pacemakers
* if currently receiving occupational therapy services
Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.

The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
* Patient consent

Randomization Criteria:

* Admission in post-anesthesia care unit after major thoracic or abdominal surgery
* Randomization and device establishment within a time less than one hour after the endotracheal intubation
* Availability of the prototype FreeO2
* Absence of criteria of gravity justifying immediately a different technique of ventilatory support:

  * Disturbance of consciousness with a Glasgow Coma Score ≤ 12
  * Serious ventricular rhythm disorders
  * Hemodynamic instability (SBP \<80mmHg or recourse to vasopressors)
  * Cardiac or respiratory arrest
  * pH \< 7.35 and PaCO2 \> 55 mm Hg
* Necessity of an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
* Absence of necessity of a urgent surgery
* Oxygen saturation measured by Spo2 sensor

Exclusion Criteria:

* BMI ≥ 35 kg/m2
* Obstructive sleep Apnea (with or without Mechanical therapy)
* Emergency Surgery for life-threatening
* Age \<18 years
* Pregnant women, lactating
* perturbed or non-cooperative patient
The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )

Single-blinded, multi-center, multi-national (Finland, Sweden, Denmark, Norway) Primary outcome in this study is QuickDASH (The short form of Disabilities of the arm, shoulder and hand) score measured at two years.

Secondary outcomes are QuickDASH at/after one, two (short term) and five years (medium term), general visual analog scale (VAS) for pain, Oxford shoulder score (OSS), Constant-score (CS), number of re-operations and complications. Quality of life is assessed with 15-D. Cost-effectiveness analysis will be performed after completion of the trial.

In addition to 2 years main outcome (short term) follow-up will continue to 5 years (medium term) and 10 years (long term). The power calculation is based on 2 years.

Eligibility Criteria:
Inclusion Criteria:

Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. Both B and C type includes subgroups: Displaced \[2\], Impacted \[3\] or Non impacted \[4\] from the universal modifiers list.

Exclusion Criteria:

Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment.

Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment.

Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture

General

* Refuse to participate
* Age under 65 years of age, or over 85 years of age
* Serious poly-trauma or additional surgery
* Non-independent, drug/alcohol abuse or institutionalized (low co-operation)
* Contra-indications for surgery
* Does not understand written and spoken guidance in local languages
* Previous fracture with symptomatic sequelae in either shoulder
* Patients living outside the hospital's catchment area
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure

The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during chemotherapy and post-treatment thermal cure


Eligibility Criteria:
Inclusion Criteria:

* Woman,
* Age \> or = 18 years,
* Performance status \> or = 1 (according to WHO criteria),
* Patient with histologically proven breast cancer, not metastasized,
* Patient treated with neoadjuvant or adjuvant chemotherapy,
* Absence of cutaneous lesions related to the pathology,
* Patient fluent in the French language,
* Patient affiliated to a social security scheme,
* Obtaining written, signed and dated informed consent.

Exclusion Criteria:

* Metastatic breast cancer,
* Local relapse of breast cancer
* History of cancer in the 5 years preceding the entry into the trial,
* Patient already treated with chemotherapy,
* Medical contraindications to the use of cosmetic products and the prescription of a spa treatment,
* Patient deprived of liberty or under guardianship.
Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors

This study is a single-center, single-arm phase I clinical trial. A total of 24\~26 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period


Eligibility Criteria:
Inclusion Criteria:

* 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

  2.Patients with advanced cervical cancer, ovarian cancer, endometrial cancer and other gynecological tumors who have progressed or are intolerant to at least first-line therapy, or who are not suitable for existing first-line therapy.

  3.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.

  4.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion Criteria:

* 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.

  2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.

  5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .

  6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses

Having previously demonstrated that supplemental parenteral nutrition to complete an insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical illness, by reducing infectious complications, the present trial aims at investigating the underlying carbohydrate and protein metabolism changes, as well as the immune and inflammatory modulations associated with this improvement.

Enrollment on day 3 of critically ill patients, without contraindication to EN, not achieving 60% of the ICU per protocol energy target.

Intervention: Randomization to either continued pure EN, or from day 4 to supplemental PN to complete EN at target validated by indirect calorimetry.

Measurements: Indirect calorimetry on Days 3, 4, 9 (twice). Primary endpoints = glucose and leucine metabolism On days 4 and 9-10: isotopic investigation of glucose metabolism, and immune and inflammatory responses// Day 9-10: isotopic investigation of protein (leucine) metabolism Secondary endpoints: Insulin requirements, area under the curve (AUC) of blood Glucose, infections after day 9, overall complications, length of mechanical ventilation, of ICU and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* estimated duration of ICU stay \> 5 days,
* estimated survival \> 7 days,
* absence of contraindication to EN
* need for mechanical ventilation
* informed consent obtained from patients, close relative, or referring physician

Exclusion Criteria:

* refusal of the patient or of the next of kin
* age \< 18 years
* non-functional digestive tract (short bowel, persistent ileus, proximal intestinal fistula high rate \> 1.5 litres/day)
* already receiving PN before Day 3
* absence of a central venous catheter
* women who are pregnant (pregnancy test).
* Admission after cardiac arrest, or severe brain injury
Role of Biomarkers in Disease Progression in Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies the role of biomarkers in disease progression in samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To determine the subcellular localization of the MLL-AF1q fusion protein in leukemia cells.

OUTLINE: Cryopreserved specimens are analyzed for MLL-AF1q fusion protein and AF1 gene expression by mass spectrometry, western blot analysis, semi-quantitative PCR, and qPCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cryopreserved acute myeloid leukemia specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Pre-operative Intra-nasal Dexmedetomidine or Insulin for Prevention of Early Post-operative Cognitive Dysfunction in Patients Undergoing Elective Coronary Artery Bypass Graft.

On pump coronary revascularization is a very common leading cause for post-operative cognitive dysfunction regarding patient age grouping and diffuse systemic inflammatory response induced by bypass machine . Many factors are incriminated as pre-operative sleep disturbance, previous history of neurocognitive dysfunction. The accumulating evidence refers to an incidence between 20-40% with majority among geriatric population. The primary pathology is still elusive and many trials are under evaluation. Neuro-inflammation, hypo perfusion, fat emboli and reperfusion injury are among the most postulative aetiologias. The corner stone in the pathology of postoperative cognitive dysfunction is abnormal sleep rhythm. Intra-nasal insulin can provide neuroprotection via providing insulin growth factor and obtund neuronal apoptosis , while dexmedetomidine can antagonize neural-degeneration via regulation of systematic inflammatory cytokines including interleukin 1β, tumor necrosis factor-α, and NF-κB, inhibiting the expressions of Toll-like receptor , and through α2 adrenoceptor-mediated anti-inflammatory pathways


Eligibility Criteria:
Inclusion Criteria:

* Adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization

Exclusion Criteria:

* Combined reperfusion and valve replacement operations.
* Emergency or redo CABG surgery.
* Preoperative MMSE less than 20
* Diabetic or chronic alcoholic population.
* Pre-operative cardiomyopathy (Ejection fraction less than 40%).
* Previous cerebro-vascular stroke or carotid endarterectomy.
* Previous history of carotid endarterectomy.
* History of heparin resistance.
* Preoperative history of dementia, language impairment, severe visual and hearing impairment, any psychiatric disorder.
* Chronic use of hynotics, mode stabilizing drugs or melatonin.
* Reoperation for emergency surgical issues during hospital stay.
* Patient refusal
* Loss to follow up ( patient dyscompliance, mortality)
* population with failed weaning from CPB and the use ventricular assisted device ( intraaortic ballon- impella)
* Pre or post operative pacing.
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma
* Original clinical stage must be IIB （FIGO 2009）
* Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
* Age between 18-65
* Patients must give signed informed consent

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Investigator consider the patients can't finish the whole study
* With normal liver function test (ALT、AST\>2.5×ULN)
* With normal renal function test (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm3