cyrilzakka/clinical-trials huggingface dataset:
Spectral CT With Advanced CT Technology

The purpose of the study is to collect data to evaluate feasibility of the using photon-counting CT in a clinical setting.

Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50 years
* Male
* Normal renal function per standardized guidelines (GFR \> 60 mL/min)
* Previous CT examination at KS no more than 12 months prior to the study examination
* Signed informed consent

Exclusion Criteria:

* Iodine contrast is contraindicated.
Chicken-Diet vs. Enalapril to Reduce Albuminuria

Diabetic nephropathy (DN) is a chronic diabetic complication and affects up to 40% of patients. The first line treatment for DN is angiotensin blockers drugs that are used to reduce the protein concentration in urine.Previous data showed that this protein, namely albuminuria, could also be reduced in a short term-period by the replacement of red meat in the diet with chicken. The aim of this study is to compare the effects of this chicken diet with enalapril on albuminuria in a long-term period( 12 months)in type 2 diabetic patients.

Replacement of red meat in the diet with chicken reduces urinary albumin excretion rate (UAER) and improves lipid profile in type 2 diabetic patients with micro- and macroalbuminuria in short term studies. The aim of this study was to compare the long-term effect of a chicken-based diet (CD) versus enalapril treatment on renal function and lipid profile in microalbuminuric type 2 diabetic patients. In this 12-month controlled clinical trial 28 patients were randomized to an experimental diet (CD plus active placebo) or enalapril treatment (enalapril 10 mg/day plus patient's usual diet). UAER (immunoturbidimetry), blood pressure levels, anthropometric indices, and compliance with the diet were evaluated monthly. Glomerular filtration rate (51Cr-EDTA), lipid, glycemic, and nutritional indices were measured at baseline, and quarterly. UAER was reduced after CD \[n=13; 62.8 (38.4-125.1) to 49.1 (6.2-146.5) mcg/min; P\<0.001\] and after enalapril treatment \[n=15; 55.8 (22.6-194.3) to 23.1 (4.0-104.9) mcg/min; P\<0.001\]. The reduction of UAER was already significant at 4th month, and there was no difference between the UAER reduction after CD \[32% (95% CI: 6.7-57.6) and after enalapril treatment \[44.7% (95% CI: 28.3-61.1); P=0.366\]. In conclusion, CD and the ACE inhibitor enalapril promoted similar UAER reduction in patients with type 2 diabetes and microalbuminuria. A chicken-based diet might represent an additional therapeutic approach to management of diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus (according to World Health Organization criteria) attending the Endocrine Division's outpatient clinic at Hospital de Clínicas de Porto Alegre, Brazil. Patients were selected according to the following criteria: age \<75 years, A1c \<10%, 24-hour UAER 20 mcg/min and 199 mcg/min confirmed at least twice in a 6-month period, serum triglycerides \<400 mg/dl and normal liver and thyroid function tests.

Exclusion Criteria:

* Patients were excluded from the study if they had BMI \>34 kg/m2, serum creatinine \>1.5 mg/dl, repeated episodes of urinary tract infection, other renal diseases, symptomatic autonomic neuropathy, heart failure, and acute myocardial infarction, coronary artery revascularization procedures or stroke within the last 6 months.
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.
* Target tumors outside prior radiation field(s).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
* Adequate renal function
* Adequate liver function
* No history of hemorrhagic cystitis or evidence of microscopic hematuria
* Capable of understanding the protocol requirements and risks and providing written informed consent.
* Either 0 or 1 prior chemotherapy regimens

Exclusion Criteria:

* Subject has a diagnosis of gastrointestinal stromal tumors.
* Concurrent serious medical illness unrelated to tumor within the past 6 months.
* Known chronic infectious disease, such as AIDS or hepatitis.
* Positive screening pregnancy test or is breast-feeding.
* A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.
* Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.
* History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.
* Known or clinically suspected brain metastases.
* Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.
* Received any investigational drug within the last 30 days.
* Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.
* Received a prior camptothecin analog (e.g., topotecan, irinotecan).
Instrument for Glaucoma Early Detection and Monitoring

To introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma.

The clinical study will evaluate a novel instrument designed to record visual evoked potentials elicited by stimuli determined in prior research (Greenstein et al., 1998; Badr et al., 2003) to drive select visual pathways that exhibit glaucomatous damage in an efficient and automated manner. The results obtained with this novel device will be compared with results obtained using an existing commercial device. Statistical results, sensitivity and specificity, will be generated for the assessment of the accuracy of the test to discriminate glaucoma patients from controls. Repeatability of the test will also be analyzed based on the test-retest results.

Visual evoked potential (VEP) is a measure of neural function in the eye and brain. Three skin electrodes are placed on the surface of the scalp to record the electrical activity from the brain while the subject is observing a flickering stimulus with isolated-check/dot pattern. The whole procedure is non-invasive and the risks are negligible.

Isolated-Check/dot Stimuli of about 10 Hz with luminance contrast of 10%, 15%, -10%, and -15% will be used to test each eye. Eight samples for each stimulus will be recorded. Each experimental run takes 2 seconds. The T-circ statistical method is performed to process the data, and the VEP signal to noise ratio (SNR) is calculated in order to obtain an optimized condition (stimulus and threshold) to separate glaucoma patients and normal group.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 - 75 years old
* Visual acuity: 20/30 or better

Exclusion Criteria:

* Eye disease other than glaucoma
Effects of BIS Closed Loop Target Controlled Infusion on Perioperative Inflammatory Response and Prognosis of Elderly Patients Undergoing Laparoscopic Radical Gastrectomy for Gastric Cancer

The purpose of this study is to find the elderly patients with laparoscopic gastric cancer radical is suitable the BIS closed round target control level of anesthesia depth of sedation, can decrease the elderly laparoscopic gastric cancer radical surgery in patients with perioperative inflammatory reaction, and reduce the incidence of perioperative pulmonary complications such as, for elderly patients with gastric cancer radical perioperative inflammation control to provide the reference and provide guidance for clinical anesthesia work.

In this study, elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer were randomly divided into BIS closed circle target controlled infusion (BIS) 55 group and 45 group, and the levels of perioperative inflammatory response indicators IL-6, TNF-α and IL-10 at different depths of anesthesia and sedation were recorded. The duration of stay in anesthesia recovery room, quality of recovery, postoperative pain and postoperative pulmonary complications were observed. Objective To evaluate the feasibility of BIS closed loop target controlled infusion in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer.

Perioperative period is a process of intense stress response, which is mainly manifested by the production and aggregation of inflammatory factors, which adversely affect multiple organs such as brain, heart and lung, and is an important risk factor for increasing postoperative complications and postoperative mortality .

Perioperative inflammatory response status has a clear relationship with postoperative recovery of patients, and perioperative anesthesia and sedation depth management and precision anesthesia is one of the most critical links to control the stress response, and appropriate anesthesia and sedation depth control and stress regulation can significantly improve the prognosis of patients . How to reduce the adverse effects of perioperative stress response on patients has been the focus of research and attention in recent years.

Eligibility Criteria:
Inclusion Criteria:

Age 65 or above ASA-PSTYPE I or II Both male and female Laparoscopic radical gastrectomy for gastric cancer

Exclusion Criteria:

The patient had abnormal liver, kidney and other important organs before surgery The patient has chronic pain Patients with neurological or mental disorders Long-term use of sedation, painkillers and antipsychotic drugs The patient has contraindications for opioid use
Quality Control of Ventral Hernia Surgery by Prospective Registration

Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.


Eligibility Criteria:
Inclusion criteria

* Consecutively all patients with an elective or emergency repair of every ventral/incisional hernia (including parastomal hernia)
* Male and female
* 18 years or older
* Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of one of the 18 participating Belgian hospitals, but by specific surgeons)
* Elective and emergency surgery
* Signed informed consent form

Exclusion criteria

* Younger than 18 years
* Not operated or supervised by participating surgeon
* Pregnant at inclusion in the registry
* No signed informed consent form
Functional Soft Palate Reconstruction

The aim of the study is to show that the innovative, dynamic palatal reconstruction technique (free radial flap plasty in combination with displacement of the digastric muscle) leads to a good functional outcome in terms of speech and swallowing in the context of the current literature.

Tumors in the throat and pharynx are common and often lead to impaired swallowing and phonation after surgical tumor resection. The posterior part of the digastric muscle is responsible for sealing during the pharyngeal swallowing phase, among other things. By relocating the digastric muscle, a defect in the area of the soft palate can now be reconstructed with a muscle whose physiological function is already integrated into the complex process of the swallowing act and thus leads to a better seal. This new, previously undescribed reconstruction option has been used on various patients at the University Hospital with good functional results.

This study is to describe the new dynamic technique for soft palate reconstruction and to analyze the associated functional and surgical outcomes including postoperative complications, speech and swallowing function. The resulting values will be compared with the existing literature. The aim is to investigate whether the functional outcome in terms of phonation and swallowing can be improved by this technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients after tumor resection of the soft palate with reconstruction by a free radial flap and displacement of the digastric muscle.

Exclusion Criteria:

* Patients with resected oropharyngeal carcinoma but without reconstruction using the dynamic technique described are excluded from the study.
Ultrasound in Undifferentiated Hypotension

Background

* Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality.
* Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions.

Aim

- The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency.

Methods

* Hypotensive (\<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.
* On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed).
* The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician).
* The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).


Eligibility Criteria:
Inclusion Criteria:

* Arterial pressure \<100 mm/Hg at presentation
* At least one of the following symptoms:
* Unresponsive
* Syncope
* Impaired mental status
* Respiratory distress
* Severe malaise and fatigue

Exclusion Criteria:

* Patients undergoing cardiopulmonary resuscitation
* Trauma patients
* Electrocardiographic and clinical diagnosis of STEMI or NSTEMI
* Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose)
* Late evolution of shock state in a patient already treated with known diagnostic tests
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

A total of 124 patients will be considered.

Patients will be randomized 1:1 to one of the following interventions:

A. electronic diary B. paper diary The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

The secondary objectives of the study are:

1. describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription),
2. describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire
3. description of the costs related to therapeutic non-adherence. A total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached.

Eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): A. electronic diary B. paper diary The electronic diary consist of an Android app (for Android version 2.2 and later) for mobile devices, which acts as a diary for the patient.

Adherence will be assessed at each treatment cycle by counting the remaining tablets. For patients with disease progression within six treatment cycles, the assessment of adherence and therefore the count of the remaining tablets will end on the date of progression.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old (both genders)
* Eastern Cooperative Oncology Group (ECOG) ≤2
* Patients with solid and haematological neoplasia (adjuvant or advanced setting) candidates to treatment with oral therapy.

Exclusion Criteria:

* Patients who also receive anticancer treatment intravenously, as such patients access the hospital regularly and are in closer contact with healthcare personnel.
* Patients receiving experimental cancer treatment
* Patients who are unable to cooperate with study procedures (in the researcher's opinion)
* Patients who are candidates for oral drug treatment lasting less than 3 months.
* Patients with a life expectancy \<12 weeks.
* All patients being treated with drugs not listed in the Protocol Appendix C.
Effects of Ketamine on Human Bladders and Its Possible Mechanisms

This study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female
* Cystitis (the clinicians ruled out the causes of bacterial infection)
* Frequent micturition
* The clinicians are willing to sign the ICF

Exclusion Criteria:

* Suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling
* Suffers from other diseases, doctor recognized that is not suitable to carry on the sampling
* The clinicians are not willing to sign the ICF
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)

This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.

Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling. Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care. Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
* Localized prostate cancer with Gleason score ≥8
* Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months
* Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart
* Prostate cancer diagnosed at age ≤ 55 years
* Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.
* Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)

Exclusion Criteria:

* Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.
* Localized prostate cancer previously treated and in remission for \> 2 years unless family history potentially indicates a germline mutation.
* Active hematologic malignancy (e.g. CLL)
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide.

The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.

From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Incisional hernia

Exclusion Criteria:

* Younger than 18 years
* Peritonitis
* Intestinal fistula
Pediatric Vascular Trauma

pediatric vascular trauma

outcomes of treatment and also observation

Eligibility Criteria:
Inclusion Criteria:

* less than 18 years and more 3yrs

Exclusion Criteria:

* iatrogenic injury in non trauma setting
Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema

Device Efficacy:

The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device.

Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time.

The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation.

The edema volume will be measured by a calf circumference measurement.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between 18 to 80 years old
2. Venous edema patients diagnosed by an indent in the skin following finger pressure.
3. Venous edema in both calves
4. Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
5. Subjects able to provide a written informed consent
6. No existence of DVT according to leg deep vein Duplex test

Exclusion Criteria as reported by patients: :

1. Positive pregnancy test
2. Breastfeeding woman
3. moderate or severe Congestive heart failure
4. Cellulitis of tissues of the lower limb.
5. Infectious Dermatitis of the lower limb
6. Acute or within 6 weeks of a deep vein thrombosis (DVT).
7. Postphlebetic patients
8. Known hypersensitivity to any component of the device
9. Subjects unable to provide informed consent
10. Active cancer at the root of the limb or in the adjacent quadrant
11. Any limitation of renal function- according to the investigator's discretion
12. Any limitation of liver function - according to the investigator's discretion
13. Subject who cannot commit to a month of intensive standard therapy
14. Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
15. Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
16. Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments
17. Cardiac or cerebral pacemaker or stimulator
18. Patients after orthopedic / vascular injury in the lower extremities