cyrilzakka/clinical-trials huggingface dataset:
Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy

Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this treatment showed substantial patient benefits and decrease of local recurrence and deaths from breast cancer, it also results in some severe late side-effects, such as skin fibrosis and cardiac failure. It's possible to offer breast irradiation (RT) and minimizing toxicities radiation dose to skin, lung and heart. This will be achieved with highly conformal RT delivery using Tomotherapy. We plan to evaluate this approach in clinical study. We plan also to evaluate the value of genomic, cellular and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to prospectively validate that Tomotherapy for breast RT can decrease skin, lung and heart toxicities and maintaining excellent cancer control after lumpectomy.

Radiotherapy is standard treatment after conservative surgery for early-stage breast cancer. Although this approach substantially improves local control and reduces deaths from breast cancer, it also results in some severe late side-effects, including skin fibrosis, deaths from radiation-induced cardiac disease and lung cancer. We will undertake a novel approach to the evaluation of radiation-induced toxicity during and after whole breast irradiation (RT) following breast-conserving surgery, with the long-term strategic goal of minimizing RT toxicity in early breast cancer. Theoretically, it is possible to achieve this goal through very highly conformal RT delivery and avoidance of RT in toxicity-prone individuals where possible. We plan to evaluate the utility of genomic analysis, cellular DNA repair competence, and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to (a) prospectively validate that HT for breast RT can decrease acute toxicity whilst maintaining excellent cancer control after BCS; (b) demonstrate that novel surrogate markers will aid in the prediction of acute and/or late normal tissue toxicity with a view to identify toxicity-prone (or conversely, robust) individuals from amongst the breast cancer population.

Eligibility Criteria:
Inclusion Criteria:

* early breast cancer treated with lumpectomy
* must have T1-2 N0-1 invasive carcinoma of the breast
* must sign an informed consent
* must be at least 18 years of age

Exclusion Criteria:

* collagen vascular disease
* metastatic disease
* pregnant or lactating
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients

HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia


Eligibility Criteria:
Inclusion Criteria:

* hospitalized for intensive care,
* Over 18 years of age,
* Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
* Mean arterial pressure greater than 65mmHg

Exclusion Criteria:

* Absence of consent to participate in the study
* Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate\> 4mMol / L.
* Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
* Unavailable enteral route.
* Use of hydrochlorothiazide in the last 7 days of ICU admission.
* History of allergy or intolerance to hydrochlorothiazide or other thiazides.
* Nephrogenic Diabetes Insipidus.
* Renal impairment KDIGO 3
* Indication of renal replacement therapy.
* Acute neurological insult.
* Heart failure American Heart Association classification (AHA), class D.
* Liver cirrhosis Child-Pugh C.
* Pregnant women
* Exclusive palliative care
* Dying, with expected survival less than 48 hours
Retrospective Review of Esophageal Cancer at MSKCC

Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy
* Pathologic staged T3 tumors (pT3)

Exclusion Criteria:

* Pathologic staged T0-2 (pT0-2) or T4 tumors (pT4)
* Patients with histologic types other than EAC or ESCC, dysplasia or carcinoma in situ without tumor invasion,
* Patients undergoing salvage esophagectomy
* Evidence of distant metastatic disease
* Patients with a positive proximal or distal margin
Comparison of Sucess of Pulpotomy, Direct Pulp Capping and Indirect Pulp Capping Modalities Using MTA in Primary Teeth

450 healthy children with primary teeth of deep carious lesions without signs or symptomes of irreverisible pulp damage was selected randompy divoded into 3 groups each of 150 children that inder go vital pulp therapy through pulpotomy,direct pulp capping or indirect pulp capping using MTA as capping material for each modality then followed up for 2 years or more


Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Aged from 3 to 10 years old
* Deep cariuos primary tooth

Exclusion Criteria:

* Primary teeth with any signs or syptoms of irreversible pulpitis
* Primary teeth of any signs or symptomes of vitality loss
* Primary teeth near to exfoliation
Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers

this is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. The study evaluates changes in CXCL11 (a chemokine involved in T-cell recruitment) and TEMRA (terminally differentiated effector memory T cells re-expressing CD45RA) levels in serum before and after treatment.

Design:

Randomized controlled trial (RCT) with two parallel arms.

Duration: Six months (including baseline and follow-up assessments).

Setting: Outpatient dermatology clinic at Assiut University Hospital, Egypt.

Objectives:

Compare the immunomodulatory effects of NB-UVB alone vs. NB-UVB + OMP steroids in vitiligo patients.

Assess CXCL11 and TEMRA levels as potential biomarkers for disease activity and treatment response.

Evaluate clinical repigmentation using Vitiligo Extent Score (VES/VESplus).

Methodology:

40 patients with stable non-segmental vitiligo will be enrolled.

20 patients will undergo serum analysis for CXCL11 and TEMRA via ELISA.

Treatment arms:

NB-UVB monotherapy (twice weekly).

NB-UVB + OMP steroids (dexamethasone 2.5-3 mg/week).

Follow-up: Clinical and immunological assessments at baseline and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Clinically diagnosed non-segmental vitiligo (stable for ≥3 months).

Fitzpatrick skin types III-V (common in the Egyptian population).

No recent systemic therapy for vitiligo (within the last 3 months).

Exclusion Criteria:

Photosensitivity disorders (e.g., lupus, porphyria).

Pregnancy or breastfeeding.

Active infections, malignancies, or immunosuppressive conditions.

History of hypertrophic scarring or melanoma.
Intra-articular Pulsed Radiofrequency in Chronic Knee Pain

The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.

This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),
* Kellgren-Lawrence Classification grades II and III OA,
* Giving written and verbal informed consents.

Exclusion Criteria:

* Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months,
* Having a local or systemic infection or a coagulation disorder,
* Patients who refused to participate in the study.
Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury

Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. The purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe TBI.

All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.

The logistic regression found the following variables influencing the mortality: respiratory failure (p\<0.0005; OR: 9.369), pupillary response (p\<0.0212, OR: 3.393) and ISS score (p\<0.0001, OR:1.179). A significant (p\<0.0001) increased risk of death was also found for patients with a midline shift \>15 mm.

The present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe TBI.


Eligibility Criteria:
The inclusion criteria for this study were:

1. patients aged 65 years and older and
2. acute severe TBI defined by an Abbreviated Injury Scale (AIS-head) score of ≥ 3 for the head region.

Exclusion criteria for this study were as followed:

1. oral intubation prior to ED-admission;
2. no details of the time of injury (e.g. chronic subdural hematomas) and
3. any concomitant injuries.
4. Patients who received oral intubation prior to ED-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to TBI induced secondary respiratory failure.
Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. To correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess the effect of theophylline on previous molecular, functional and clinical data. Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and oxidative stress will be determined with specific assays. These determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function


Eligibility Criteria:
Inclusion Criteria:

* Severe COPD according to GOLD guidelines
* Age between 40 and 75
* Admission to hospital due to COPD exacerbation

Exclusion Criteria:

* History of asthma
* Pulmonary embolism
* Pneumonia
* Other chronic inflammatory disease
* Patient on theophylline at the time of admission
* Patient on oral steroids at the time of admission
Improvement of Hemostasis Techniques After Median Sternotomy

The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.


Eligibility Criteria:
Inclusion Criteria:

* men undergoing elective cardiac surgery at the Cardiac surgery department of Aarhus University Hospital, Skejby
* no clopidogrel-treatment
* no osteoporoses
* less than 2 co-morbidities in the form of obesity (BMI\>30), COPD, chronic steroid use, renal failure, immunosuppression and diabetes

Exclusion Criteria:

* profuse sternal bleeding
* serious complications to the surgery fx cerebral infarction
* re-operation due to bleeding
Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI

For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.

To investigate the Optimal Attained LDL-C Levels in Patients Who Achieved ≥50% LDL-C Reduction After PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving PCI with health check up before and after PCI within 3 years

Exclusion Criteria:

* Patients receiving statin before PCI
* Patients with liver cirrhosis
* Patients with cancer
* Patients without prescription of statin
* Patients with LDL-C \<55 mg/dL before PCI
Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

The goal of this prospective cohort observational study is to compare incidence of cholangitis cause by multi-drug resistant pathogens in patient who underwent ERCP.

The main question it aims to answer are:

* Is the single use disposable elevator cap duodenoscope more effective in preventing cholangitis caused by MDR than fixed cap duodeoscope?
* Is the single use disposable elevator cap duodenoscope more effective in preventing severe cholangitis than fixed cap duodenoscope?

Participants will undergo and ERCP procedure. Among the patients who received the procedure, those who developed cholangitis after procedure will treated with antibiotics after blood culture test. The result of the post procedure cholangitis group's blood culture test and lab data including LFT will be collected. Researches will compare single use disposable elevator cap duodenoscope group and fixed distal cap duodenoscope group to see if there is difference in the incidence of cholangitis caused by MDR pathogens.

Insufficient disinfection of duodenoscopes, particularly the elevator site, can cause ERCP-related infections and serve as a significant source of multidrug-resistant (MDR) infection. To address this issue, a disposable elevator cap (DEC) was developed, and a recent randomized clinical trial demonstrated its effectiveness in reducing contamination following high-level disinfection. However, there is limited evidence in actual clinical practice to reduce cholangitis caused by MDR pathogens. This study aimed to compare the efficacy of the novel DEC duodenoscope with the standard duodenoscope in preventing infection transmission.

We conducted a prospective non-randomized cohort study in a single institution comparing baseline characteristics, technical performance, and incidence of acute cholangitis, including MDR pathogen, in 95 patients using a standard duodenoscope and 101 patients using a DEC duodenoscope.

Age, sex, comorbidities, and indication for ERCP were similar between the two groups. However, the standard duodenoscope group had a higher proportion of naïve papilla (51% vs. 34%, p = 0.04), while the technical success rate was slightly higher in the DEC duodenoscope group (95% vs. 85%, p = 0.15). The rates of procedure-related adverse events were similar between the two groups (16% for DEC vs. 15% for standard). The incidence of post-ERCP cholangitis was also similar (10% for DEC vs. 11% for standard, p = 0.90). The proportion of post-ERCP cholangitis caused by MDR pathogens was similar in the two groups (1% for DEC vs. 2% for standard, p = 0.39).

This study suggests that the technical performance of the DEC duodenoscope is similar to that of the standard duodenoscope. However, more clinical data are needed to confirm the efficacy of the DEC duodenoscope in preventing ERCP-related infection transmission.

Eligibility Criteria:
Inclusion Criteria:

* Patient who undergone ERCP
* 19 years age or older

Exclusion Criteria:

* Patients who already undergone biliary drainage
* Patient who already confirmed of multidrug resistant bacterial infection
* Pregnant women
Evaluation of Portal Venous System Thrombosis After Blunt Splenic Trauma Utilizing Doppler Ultrasound

The true incidence of thrombosis in the portal venous system after blunt splenic trauma is unknown and has not been elucidated in the medical literature. The investigators hypothesize that this entity is more common than previously suspected. Consequences of missing this diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment with anticoagulation and avoidance of these complications. In a prospective fashion, doppler ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up who have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in patients initially diagnosed with thrombosis in the portal venous system on their 3 month ultrasound. The investigators will attempt to identify risk factors in this trauma population that would facilitate an early screening protocol.


Eligibility Criteria:
Inclusion Criteria:

* All trauma patients 18 and up admitted to Rambam Medical Center with diagnosis of blunt splenic trauma.

Exclusion Criteria:

* Trauma patients younger than 18.
IPICK Blocking for TKA With Moderate Flexion Contracture

Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °

From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis was knee osteoarthritis
2. The flexion contracture was between 5 and 10 degrees
3. ASA grade I-III

Exclusion Criteria:

1. Lower extremity neuropathy.
2. Contraindications of nerve anesthesia or regional anesthesia.
3. unable to cooperate, allergic to the drugs used in this study.
4. Non steroidal anti-inflammatory drugs are not tolerated.
5. chronic opioid consumption (daily or almost daily use)
Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.


Eligibility Criteria:
Inclusion Criteria:

* malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas
* ECOG Performance Status ≤ 2

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention trials
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis
A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects

This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
* Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
* Weight ≥ 50 kg at Screening

Exclusion Criteria:

* Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
* Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
* Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
* Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.