cyrilzakka/clinical-trials huggingface dataset:
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis

This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

PRIMARY OBJECTIVES:

I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis (LEF).

II. To explore the correlation between elasticity of skin/soft tissues and the following: 1) symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head and Neck LEF Grading Criteria.

OUTLINE:

Participants will be evaluated for LEF status using the Head and Neck External Lymphedema - Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H\&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer involving the head and neck
* Completed all therapy
* No evidence of cancer (NED)
* Ability to understand English in order to complete questionnaires
* Able to provide informed consent

Exclusion Criteria:

* Have medical record documentation of significant cognitive impairment that would preclude the ability to provide informed consent
* Are unwilling to undergo the study assessment
* Have recurrent and/or metastatic cancer
Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment

The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.

Gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (T2DM). Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with T2DM and to detect the potential mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities；
* Male or female between 18 and 70 years of age
* 19≤Body mass index(BMI)≤30kg/m2
* No participate in any clinical trial at least 3 months
* Newly diagnosed T2DM (OGTT) or not received previous pharmacological treatment
* 7%≤HbA1c≤9%
* Females in child-bearing period should be given birth control
* No severe disease about heart, lung and kidney
* Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol
* Subject is likely to comply with the Investigators instruction

Exclusion Criteria:

* Type 2 or 1 diabetes mellitus received previous pharmacological treatment
* Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
* Impaired liver function, defined as Aspartate aminotransferase（AST） or Alanine transaminase (ALT)\> 2 times upper limit of normal (central laboratory)
* Impaired renal function, defined as serum-creatinine≥133μmol/L
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
* Chronic gastrointestinal diseases
* Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
* Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial
* Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write
* Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* Known or suspected abuse of alcohol, narcotics or illicit drugs
Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry

Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide written informed consent to participate in the study.
* Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA.
* Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10.
* Subjects must satisfy the study investigator about their fitness to participate in the study.
* Subjects must be available to complete the study.

Exclusion Criteria:

* Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures.
* Subjects who have participated in a clinical trial in the previous month.
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.

Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of enrolment
* Lesional epilepsy (incl. mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent stereoelectroencephalography (SEEG) preceding resective surgery)
* Provided informed consent for study participation by the subject

Exclusion Criteria:

* Prior brain surgery (excl. SEEG)
* Occipital lesion
* Multiple epileptic foci or suspected dual pathology
* Surgeries involving a disconnection, or hemispherectomy.
* Planned awake surgery and/or functional recordings
* Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
* Active participation in another investigational device study
* Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
* Insufficient understanding of Dutch language.
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3

A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.

A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of chronic hepatitis C on the basis of detectable serum HCV RNA during the screening period and at least a 6-month history of exposure to risk factors for HCV.
* Have never received treatment with an interferon alfa product or an interferon alfa combination product.
* Have HCV genotype 2 or 3.
* Have compensated liver disease with the following minimum criteria: white blood cell count (WBC) \>3,000/mm3, absolute neutrophil count (ANC) \> 1,800/mm3, platelets \>100,000/mm3, hemoglobin (Hb) \> 13 g/dL for males and \> 12 g/dL for females.

Exclusion Criteria:

* Evidence of decompensated liver disease.
* Pregnant or lactating female.
* History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
* A current drug or alcohol addiction.
Obturator Nerve Block With Femoral and Sciatic Block

The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.


Eligibility Criteria:
Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* Hisory of neurologica disease, diabetes, pregnancy, neuropathy
Outcomes of Isolated LCx Occlusion

To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute occlusion.

ST-segment elevation myocardial infarction (STEMI) involving acute occlusion of the left circumflex (LCx) coronary artery represent only 14-21% of STEMIs

LCx acute occlusion may be difficult to be diagnosed . Only 50% of patients with LCx occlusion exhibited ST segment elevation during the acute phase, 38% showed no ST segment changes, while 15% presented with isolated ST segment depression This may lead to delay in transfer to cath lab, delay in reperfusion therapy and consequently loss of more myocytes and more major adverse cardiovascular events (MACE) .

Due to relative rare occurrence of isolated LCx coronary artery occlusion, little is known in literature about the clinical outcomes of isolated LCx occlusion , so we will conduct a retrospective observational study in our tertiary primary percutaneous coronary intervention (PCI) center to detect the incidence , procedural and clinical outcomes after 6 months of patients who had isolated LCx acute occlusion and underwent primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented to Assiut University heart hospital with STEMI who underwent primary PCI that revealed isolated LCx acute occlusion (single culprit artery) between January 2018 to January 2025 will be included.

Exclusion Criteria:

-Patients with cardiogenic shock, NYHA class III-IV and multivessel coronary artery disease will be excluded.
Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarcation in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty

Comparison of the effect of two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty

we enrolled 50 patients of both sex of American society of Anesthesiologists (ASA) physical status II where the presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ECG finding. Risk for CAD included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dL), and diabetes. who met the selection criteria were randomly allocated to 1 of the 2 groups (25 patients) each:

* Group (G): received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).
* Group (F): received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved. We aimed to compare the effect of the two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty. The primary outcome included perioperative levels of brain natriuretic peptide \& cardiac troponins. Secondary outcomes included postoperative operative pain assessment using visual analogue scale, total amount of analgesic consumption, patient satisfaction \& cardiovascular complications (myocardial infarction, arrhythmias , heart failure, hypotension, hypertension \& the need for inotropic agents).

Eligibility Criteria:
Inclusion Criteria:

* presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ECG finding. Risk for CAD included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dL), and diabetes.

Exclusion Criteria:

* 1) severe impairment of left ventricular function (ejection fraction \< 40 %). 2) renal failure requiring hemodialysis. 3) known allergies to the drugs used in the present study. 4) contraindications to regional blocks (localized infection, and use of an antiplatelet drug within 3 days before the surgery). 5) unusual blood coagulation tests.
Acute Lung Injury After Aortic Valve Surgery

The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery.

Study questions:

* Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree?
* Is there any correlation between oxyhaemodynamic parameters and lung injury degree?
* Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers?
* Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?


Eligibility Criteria:
Inclusion Criteria:

* elective aortic valve surgery patient
* written consent

Exclusion Criteria:

* none
Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis

The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.

In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients aged ≥18 years
* Signed informed consent form
* Clinically diagnosed acute pharyngitis (TPA ≥5)
* Recent onset of symptoms (≤24 hours)
* Pain intensity of ≥8 on an 11-point NRS
* Difficulty in swallowing (100-mm VAS ≥50 mm)

Exclusion Criteria:

* Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)
* Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
* Purulent tonsillitis
* The use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study
* The use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, \[acetylsalicylic acid \>100 mg\], paracetamol) within 36 hours prior to screening and during the study
* The use of local anaesthetics for treatment of sore throat within 2 days prior to screening and during the study
* The use of any systemic anti-inflammatory drug/local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within 4 weeks prior to screening and during the study
* The use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7 days prior to screening and during the study
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture

Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery.

After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated.

This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older,
* Palpable Dupuytren strand with passive extension deficit according to stadium 1 and 2 of the classification of Tubiana in one or two fingers excluding the thumb, defined as at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint and a maximum of 75 degrees in the MCP or PIP joint

Exclusion Criteria:

* Multiple, invasive or wide strands in the palm,
* Skin irritation,
* Strand localization in the digit only,
* Digital nerve injury,
* Any former treatment for Dupuytren's contracture in the same digit,
* Thumb contracture,
* Stadium 3 and 4 according to the classification of Tubiana
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) \> 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.

Eligibility Criteria:
Inclusion Criteria for group A and B:

* Weight loss \< 10% in the last three months.
* WHO-performance status ≤ 2
* Medical inoperable patients or patients refusing surgery.
* Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
* Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.

Risk group A specification:

* NSCLC (Cytological or histological proven) patients with peripheral tumors \>5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is \> 5 cm).
* Single peripheral lung metastasis in inoperable patients with a diameter of \> 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
* In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV \>5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present.

Risk group B specification:

* Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung.
* In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
* Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.

Exclusion Criteria:

* Patients with central tumors
* Pancoast tumors
* Prior radiotherapy treatment to the thorax
* Patients receiving any systemic treatment during SBRT
* Pregnant patients
* Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.
Different Treatments With the TRV Reposition Chair

To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.

Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years of age
* Medical history compatible with BPPV
* Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

Exclusion Criteria:

* Former treatment with a repositional Chair
* Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair