cyrilzakka/clinical-trials huggingface dataset:
The Use of Biochemical Analyzes to Monitor the Development of Wounds

Chronic wounds represent a growing challenge in medical care.

Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display an infection prematurely. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) measured overed 3 days, would indicate a change in the wound bed (infection, Inflammation) earlier than the regularly performed clinical assessment.

Part 2: The aim of this part of the study was to evaluate (I) the possibility of wound fluid acquisition by means of an "additional collector" during ongoing NPWT and to answer if (II) this secretion can be biochemically analyzed for enzyme activities in order to be able to detect a change in the wound situation at an early stage.

The study is composed of two parts, which run independently of each other. However, in both parts the course of the wounds is analyzed.

Part 1: Two wound swabs are taken. One used for routinely performed microbiological analysis and the second will be used for biochemical analysis (enzyme activities). The aim of the wound swabs is to answer the question whether the rapid diagnostic tool used in the examination can display an infection prematurely or not. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) would indicate a change in the wound bed (infection, inflammation) earlier than the regular clinical assessment. These wound swabs are expected to function as an improvement of the biochemical assays or rather of the technology concerning sensitivity and specificity of, for example, the pH number, the MPO, the LYS, the gelatinase and the elastase. In addition to that, the correlation between the Enzyme activities and the course of the infection will be examined. This technology is supposed to be later used as an early infection diagnostic tool in wound fluids. The followup of this testing system is a crucial prerequisite for the application of the technology in VAC therapy (part 2).

Part 2: The findings of this examination will be used to investigate the applicability of the developed in-vitro early infection diagnostic tool in negative-pressure therapy (VAC therapy; vacuum assisted closure).

Patients of the plastic surgery with a NPWT are included in this prospective study. Before the NPWT will be applied, two swabs (biochemical and microbiological analysis) of the wounds will be taken. After installation of the dressing, the connecting tube between the wound and the vacuum-generating device will be cut and an "additional collector" will be inserted. This collector will be changed daily and afterwards the concentrations of enzymes (lysozyme, elastase, myeloperoxidase) will be biochemically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* older than 18 years old
* open wound of varying etiology
* VAC therapy (KCI) (part 2)

Exclusion Criteria:

* under 18 years old
* pregnant women
* less than three measurement data (less than three swabs) = part 1
* VAC-instill therapy = part 2
Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.

The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

BACKGROUND: The benefit of preventive treatment for SMA stenosis remains uncertain. The latest guidelines remain unclear given the lack of data in the literature.

Eligibility Criteria:
Inclusion Criteria:

* the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

Exclusion Criteria:

-
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.

Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
* No more than 2 weeks of prior treatment with a protease inhibitor.
* No active opportunistic infection or other serious AIDS-defining condition.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malabsorption or inadequate oral intake.
* Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
* Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
* Active malignancy or anticipated need for chemotherapy during the study.
* Anticipated need for disallowed medications during the study.

Concurrent Medication:

Excluded:

* Other protease inhibitors.

Prior Medication:

Excluded:

* More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.
* More than 2 weeks of any protease inhibitor.
Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients

vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen

vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.

Eligibility Criteria:
Inclusion Criteria:

* stage III/IV
* fresh frozen tumor-tissue
* age 18-75
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria:

* systemic glucocorticoids
* brain metestasis
* other malignancies
Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke

In fact theWorld Health Organization estimates that 2-3% in general populations of countries across the world tend to be affected by severe mental disorders (1) Thrombolytic therapy seems to be of great importance in achieving better quality of life in ischemic stroke patients who respond to this therapy(rTPA).

There is a substantial body of evidenc suggesting a strong relation between neurotrophic factors and depression and anxiety pathogenesis (2,8) Brain-derived neurotrophic factor (BDNF), a member of the neurotrophic family known to regulate neuronal plasticity and survival , may play an important role in the pathophysiology of depression and anxiety (3,9).

Different studies indicated patients who were exposed to traumatic events have anxiety comorbidity and lower levels of serum BDNF compared to those without a history of traumatic events (4) .

BDNF has an antidepressant and anxiolytic effect which suggest that BDNF is implicated in the regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the proBDNF protein, was associated with lower activity-dependent secretion of BDNF (5)and has been implicated with increased susceptibility to neuropsychiatric disorders including depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest that BDNF is likely to be an important etiological factor in memory, depression and anxiety disorders (6,10).

BDNF arises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNFarises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNF (7).

The purpose of this study is to examine the quality of life after stroke of patients treated with thrombolysis .

Eligibility Criteria:
Inclusion Criteria:

1. age more than 40.
2. None of the pt had history of other psychiatric illness.
3. male and female.

Exclusion Criteria:

* 1-smoker. 2-substance abuser or dependence. 3-History of other psychiatric illness. 4-History of other neurological illness.
Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer

The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial cancer.

The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed if sentinel lymph node is positive.

Eligibility Criteria:
Inclusion Criteria:

* • 1.Age \>18 and \<80 years old

  * 2. The pathological diagnosis was epithelial ovarian cancer
  * 3.Survival time is expected to exceed 3 months
  * 4.Signed consent form

Exclusion Criteria:

* 1. Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function
* 2.Patients with a history of exhaustion or deep vein thrombosis;
* 3. Liver insufficiency (transaminase \>2.5 times the upper limit of the standard);
* 4. Renal insufficiency (serum muscle liver \>2 times the standard upper limit);
* 5. Pregnancy and perinatal patients;
* 6. History of major organ transplantation and immune disease;
* 7. Psychiatric condition or language barriers
* 8. Alcohol or drug abuser (current or previous)
* 9. Unable or unwilling to sign informed consent or comply with study requirements;
* 10. Patients with other malignant tumors.
Absorption and Metabolism of Dietary Phenolics From Raspberries

Red raspberries are a rich source of (poly)phenolic compounds, the main components being anthocyanins and ellagitannins. There is growing evidence linking consumption of these compounds with beneficial effects on human health. However, the mechanisms involved remain poorly understood principally because of a limited understanding of the bioavailability of ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins. All urine excreted over 48 h after the ingestion of raspberries was collected and blood samples were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites were identified and quantified by ultra high performance liquid chromatography-mass spectrometry (UHPLC-MS).


Eligibility Criteria:
Inclusion Criteria:

* in general good health

Exclusion Criteria:

* smoking
* pregnancy
* vegetarian
* sustained use of nutritional supplements
Depression and Body Image Distress Following Mastectomy With Reconstruction

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.


Eligibility Criteria:
Inclusion Criteria:

1. Female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the Massachusetts General Hospital (MGH) Plastic and Reconstructive Surgery Program
2. English language proficiency
3. Ability to provide informed consent.

Exclusion Criteria:

1. Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
2. Current active suicidal ideation
3. Current treatment plan includes radiation and/or ongoing chemotherapy
4. Does not have access to Internet at home, required to complete study questionnaires
Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice

Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers

This is a cross sectional Clinical Investigation in order to quantify the reliability and agreement of estimated core body temperature using emitted surface body heat measured by the InstaTemp MD™ Non-Touch thermometer when compared to other widely marketed reference Thermometers

Eligibility Criteria:
Inclusion Criteria:

1. Any age
2. Either gender
3. Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
4. Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).

Exclusion Criteria:

1. Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
2. Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
4. Subjects currently using cooling blankets or fans.
5. Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
6. Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement)
7. Those participating in a clinical trial of an investigational medicinal product
Evolution and Treatments of Chronic Inflammatory Systemic Diseases

Patients with chronic inflammatory diseases (CID) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease \[MC\] and ulcerative colitis \[RCH\]), chronic inflammatory skin diseases (psoriasis or Verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis \[RA\] and spondyloarthritis \[SpA\] including psoriatic arthritis \[PsA\]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for IBD (MC, UC or indeterminate colitis) in the gastroenterology department of Besançon University Hospital
* Subject meeting the clinical, morphological and histological diagnostic criteria for MC, UC or indeterminate colitis or
* Patients treated for chronic inflammatory rheumatism (RA, SpA, PsA) in the rheumatology department of the University Hospital of Besançon Subject meeting the ACR 2010 classification criteria of RA or modified New York criteria of Ankylosing spondylitis or ASAS criteria of axial or peripheral SpA or CASPAR criteria of PsA or
* Patients treated for chronic inflammatory skin disease (Psoriasis, Verneuil's disease) in the dermatology department of the University Hospital of Besançon

Exclusion Criteria:

* Opposition of the patient
* Patients in emergency situation, persons deprived of their liberty, protected minors or adults.
Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section

The primary aim of this study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative hemodynamics in cesarean section operations.Investigators think that low-dose bupivacaine and fentanyl mixture applied in cesarean section cause fewer hemodynamic changes,provide adequate anesthesia and analgesia quality,cause fewer side effects,and postoperatively,patients may return to their daily activities more quickly.This study was conducted on 80 pregnant women undergo an elective cesarean section.Patients were randomly allocated in GrupA and GroupB. Combined spinal-epidural anesthesia was performed in the sitting position using the needle-inside-needle technique.After cerebrospinal fluid flow was observed, GroupA patients were given a solution containing 5 mg isobaric bupivacaine+15 µg fentanyl (1.3 ml),and Group B was administered a solution containing 7 mg isobaric bupivacaine+15 µg fentanyl (1.7ml).Hypotension,bradycardia,duration of analgesia,postoperative nausea and vomiting were recorded.


Eligibility Criteria:
Inclusion Criteria

* ASA I-II
* Pregnant women
* 18-50 years of age
* BMI\<40kg/m2
* 150-180 cm in height

Exclusion Criteria:

* Patients with hypertension induced by emergency obstetric surgery
* Significant systemic disease,
* Multiple pregnancies,
* Fetal or placental abnormality,
* Hypersensitivity or allergy history to the drugs to be used in the study
* Contraindicated neuraxial anesthesia,
* Infection at or around the region to be anesthetized,
* Coagulation abnormalities
* Patients unable to decide or unwilling to participate in the study
Comparative Study of Three Collagen Membranes: 1 Non-cross-linked and 2 Cross-linked

This study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth. These membranes are often used in dental and oral surgery to help with healing and tissue growth. The goal is to find out if one membrane lasts longer than the others, which may help doctors choose the best option for different procedures.

In this study, the membranes will be placed in the mouth in a specific area near the gums of the upper back teeth. The study is designed so that neither the patients nor the researchers evaluating the results will know which membrane is which (this is called a double-blind study). Over time, researchers will measure how much each membrane has broken down. This information may help improve treatment planning and patient outcomes in dental care.

The study was designed as a double-blinded, single-center, randomized clinical trial. Three different types of collagen membranes, ribose cross-linked (RCL) OSSIX Agile, glutaraldehyde cross-linked (GCL) - BioMend Extend, and non-cross-linked (NCL) Jason MB GmbH, were selected for the study.

During the first visit, digital intraoral impressions and clinical pictures will be taken, periodontal charts filled, and oral hygiene sessions conducted by trained hygienists. Two weeks later, during the second visit, patients will be reexamined to exclude any signs of inflammation. Membranes will be cut to a uniform size of 8\*10 mm by an assistant prior to placement. They will be placed in a randomized mesiodistal order on the buccal mucosa, apical to the gingival margins of maxillary premolar and molar teeth (the future position will be evaluated on the intraoral scanned model). To fix the membranes, a vestibular sling suture without any perforation (PTFE 3/0) will be used. A light-cured periodontal dressing (Barricaid, Dentsply Caulk, Dentsply Int. Inc., York, PA, USA) will be placed on the buccal site to fix a knot and two other points on the membrane to fix it to the suture. Standard intraoral pictures will be taken. Patients will be instructed to avoid hard foods, brushing in the area of the membrane, and excessive movements to prevent dislocation of the structure. The same oral hygiene products will be provided to all patients.

Follow-up visits will be scheduled at 3, 7 and 10 days. At the 10-day follow-up clinical evaluation will be performed to assess any perforation. A set of pictures will be taken. Membranes integrity will be analyzed by two blinded examiners using a Scale.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Good overall health (ASA I or ASA II)
* Good oral health

Exclusion Criteria:

* Patients with gingival pathologies
* Individuals with uncontrolled chronic diseases or immunocompromised.
* Pregnant Patients
* Patients who are currently breastfeeding
Influence of Chemotherapy on Postural Control in Women With Cancer

The aim of this study is to understand the strategies for adapting postural control in patients who have received chemotherapy treatment for gynaecological cancer.

Chemotherapy can cause many side effects, including peripheral neuropathies. Chemotherapy induced peripheral neuropathies (CIPN) are primarily sensory impairments that can alter the signals for somatosensory feedback and thus affect the postural control in the standing position. The objective of this study is to evaluate the impact of chemotherapy and peripheral neuropathies on postural control in the standing position. As balance maintenance is a complex construct involving different systems, this study will evaluate maintenance strategies during sensory disturbances in order to better understand post-chemotherapy coping strategies. These sensory disturbances concern vision (eyes closed) and the alteration of the somatosensory system (foam under the feet and vibration system). In addition, this study will evaluate balance in double task situations and dynamic stability. Given the consequent impact of chemotherapy and peripheral neuropathies on quality of life, a quality of life questionnaire will also be administered.

Eligibility Criteria:
Inclusion Criteria:

Women

* between 18 and 65 years;
* with a gynaecological cancer about to start chemotherapy known to be neurotoxic (paclitaxel, docetaxel, nab-paclitaxel, or paclitaxel-carboplatin);
* able to stand upright for 30 s on a flat surface without assistance;
* able to provide written consent

Exclusion Criteria:

Women

* with pre-existing vestibular, uncorrectable visual, or somatosensory disorders or other pathologies altering postural control that would influence testing;
* with exposure to known neurotoxic chemotherapy (paclitaxel, docetaxel, nab-paclitaxel, vinorelbine, trastuzumab-emtansine, eribulin, or paclitaxel-carboplatin) that may have caused previous CIPN;
* with an inability to perform the test due to poor comprehension of instructions or psychological problems.