cyrilzakka/clinical-trials huggingface dataset:
Normal Paranasal Sinuses Microflora Study

The purpose of this study is to check if bacterial and fungal flora exists in healthy paranasal sinuses, and whether it is identical to the flora of nasal cavity.

We plan to harvest tiny examples of maxillary sinus and nasal mucosa for tissue cultures during the orthognathic procedures involving maxillary remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Necessity of maxillary sinus opening during orthognathic surgery
* Negative history of chronic rhinitis or chronic sinusitis
* Informed concent

Exclusion Criteria:

* Recent(1 month or less before the operation) event of acute sinusitis or other disease leading to nasal discharge
* Recent(1 month or less before the operation) antibacterial or antifungal parenteral treatment
Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty

In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the hip
* Willingness and ability to follow study-protocol

Exclusion Criteria:

* Inflammatory arthritis or secondary osteoarthritis.
* Type C (stove pipe) femur
* Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
* Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
* Ongoing oestrogen treatment
* Not suited for the study for other reason (surgeons preference)
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.


Eligibility Criteria:
Inclusion Criteria:

* First-line mCRC
* EGFR positive
* Bi-dimensional measurable index lesion

Exclusion Criteria:

* Previous exposure to EGFR-targeting therapy
* Previous oxaliplatin-based therapy
* Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment
* Radiotherapy
* Surgery
* Any other investigational drug in the 30 days before randomization
* Brain metastasis and/or leptomeningeal disease
* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori


Eligibility Criteria:
Inclusion Criteria:

* ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Previous history of tuberculosis
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models

This study will assess the ability of the Known Medicine platform to predict the efficacy of certain cancer drug treatments and to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.

This is a non-interventional clinical study in which (1) cancer tissue that has been resected, biopsied, or drained due to malignant pleural effusion and that is left remaining after (or is not being used during) a pathology investigation and, where possible, (2) a vial of the same patient's blood is sent to Known Medicine Inc. for placement into organoids and subsequent tumor drug sensitivity measurement.

Patients will be consented prior to performance of a medically indicated and pre-planned surgical procedure during which at least a 1cm3 piece of tumor tissue or \>100 mL pleural effusion fluid and blood in a separate vial are obtained. These samples will be sent after removal to Known Medicine Inc. from the hospital using a kit provided by Known Medicine. Within the Known Medicine provided kit a data form, freezer pack and containers for the specimens will be provided.

If a solid tissue sample, the tissue will be washed and subsequently digested into a single cell solution using enzymatic digestion methods. Cells will be sorted into cancer and stromal cell populations, stained fluorescently with intramembrane stain, and placed into a 3D cell culture matrix within a multi-well plate. Cells may also be genetically sequenced.

If an aspirated fluid sample, cells will be separated from the fluid and further sorted into cancer cell populations.

Cultures will be allowed to sustain themselves for 48 hours, at which point standard of care chemotherapeutic or other FDA approved drug treatments will be administered. After 72 hours, control and treated wells will be imaged using fluorescence and cell phenotype will be evaluated. Media from cultures may also be evaluated. After imaging, media will be removed and a metabolic assay will be performed to determine culture viability. Using the described quantitative outcomes, tumor sensitivity to each of the administered treatments will be determined.

Patients will be followed and their response to treatment and outcome information from the hospital will be obtained which will allow retrospective validation of tumor organoid sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* A demonstrated primary solid cancer for which it is medically indicated and planned to be surgically resected, biopsied, or drained (via malignant pleural effusion).
* The ability to ship the tissue sample within 24 hours of removal from the patient.
* Signed and dated consent to giving tissue as well as allowing for de-identified medical history information regarding administered treatments and treatment outcomes to be shared.
* over 18 years of age

Exclusion Criteria:

* Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.
Future Patient - Telerehabilitation of Patients With Atrial Fibrillation

This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.

The overall aim of the FP-AF program is to increase quality of life by giving the patients and relatives more knowledge about atrial fibrillation, its symptoms, and the issues of living with atrial fibrillation in everyday life. The specific aims are to individualize the rehabilitation process and help the patients and relatives develop their own self-management strategies using their own clinical data and their enhanced knowledge about AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with atrial fibrillation
* Adults over 18 years
* Living in Skive, Viborg or Silkeborg Municipalities
* Living at home and capable of caring for themselves
* Have basic computer skills or having a relative/friend with basic computer skills

Exclusion Criteria:

* Pregnancy
* Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
* Life expectancy less than a year
Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.

The prospective study part is an observational, prospective multi-centre study which aims to enrol 2500 patients with ischemic or dilated cardiomyopathy and primary prophylactic ICD indication for reduced left ventricular ejection fraction (LVEF) according to current guidelines. According to the treating physician's decision and preference which is independent from study participation, patients are recruited into one of two groups: patients directly prior to first ICD implantation (ICD Group), or patients who are not considered for prophylactic ICD treatment by the physician or are considered but refuse ICD treatment (Control Group). Patients will undergo simple 12-lead electrocardiogram (ECG) and Holter ECG diagnostics at baseline as well as genetic biobanking at entry to the study. All patients will be subsequently followed for at least 1 year and up to 4 years. Co-primary endpoints are all-cause mortality and appropriate ICD shocks.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or dilated cardiomyopathy and recommendation for primary prophylactic ICD treatment following current international treatment guidelines
* Written informed consent
* If ICD implantation is planned, enrollment and study baseline testing needs to be completed before de-novo ICD implantation

Exclusion Criteria:

* Permanent atrial fibrillation or atrial fibrillation at baseline in case more than 15% of such patients at a given time have been enrolled
* Indication for secondary prophylactic ICD treatment
* Indication or candidate for cardiac resynchronization therapy
* AV block II°-III° at resting heart rates
* Implanted pacemaker
* Unstable cardiac disease such as decompensated heart failure (NYHA functional class IV) or acute coronary syndrome
* Participation in other clinical trials which exclude enrolment in other trials
Zinc Supplementation and Cardiovascular Risk in HIV

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Age ≥18 years
* Zinc level ≤0.75 mg/L
* Receiving a stable antiretroviral regimen with no plans to change during study
* Documentation of an HIV-1 RNA level of ≤400 copies/mL
* No diarrhea or nausea/vomiting for the last month

Exclusion Criteria:

* Pregnancy/lactation
* Presence of inflammatory condition
* Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
* Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
* Known cardiovascular disease
* Uncontrolled diabetes
* Allergy or intolerance to zinc sulfate.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 x Upper limit of normal (ULN)
* Hemoglobin \< 9.0 g/dL
* glomerular filtration rate (GFR) \< 50 mL/min
Selective Neurectomy and Mesh Removal for Chronic Postherniotomy Pain

Chronic postherniotomy pain affects every day activities in 5-8% of patients. However, no established treatment for this pain syndrome exists and previous reports on the effect of surgical intervention suffer from methodological problems. The neurophysiological characteristics suggest that pain arises from deeper neuronal structures injured during surgery or by ongoing inflammation from the mesh. This study investigates the effect of removing inserted mesh and compressed nerves on pain related daily impairment of activities assessed by the validated AAS questionnaire before and 6 months after surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery, and pain related impairment of everyday function. The pain should have occurred after previous open surgery.
* The patient should be able to locate to a specific area with maximum pain. Patients should be able to understand and use pain scales, and the AAS-scale.

Exclusion Criteria:

* All that contradicts the above
Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

Rhinoscleroma is a chronic specific granulomatous inflammation affecting nose in 95-100% but can affect any part of respiratory tract.(1)

It is an endemic disease in Egypt. It is endemic as well in sporadic areas worldwide including Central America, Chili, Central Africa, India, Indonesia and Middle East countries.(2) It is completely eradicated from the developed communities.

If not treated early, the disease progresses to the final sclerotic phase where permanent complications including nasal deformities, anosmia, dysphonia, dysphagia and stridor could happen.(3-5)

Of the wide treatments range (antibiotic combinations, cytostatic drugs, radiation, and laser), none is ideal. The causative organism is resistant to most antibiotics and, being intracellular, is not always exposed to sufficient concentrations of drug. A clinical cure is hard to identify because the end-stage is mucosal fibrosis which, even without active infection, interferes with normal function of the upper respiratory tract. The fibrosed mucosa, especially in crusts, can become secondarily infected with bacteria, which may include klebsiella.(6)

Rifampin (7), streptomycin (8), ciprofloxacin (5) and levofloxacin (9) have been used in treatment of rhinoscleroma.

Most patients are from a low socioeconomic group and cannot afford the price of antibiotics to which klebsiella is susceptible. (6)

The usual regimen given for free by the Ministry of Health in Egypt in histologically positive cases is Rifampicin 300 mg twice daily for six months (based on a nasal biopsy and documented as a Tuberculosis, not rhinoscleroma, to allow free delivery of the medication) then another biopsy is taken to identify if cure or not. If not, Rifampicin is given for another six months and so on.

Unfortunately, due to the high level of antimicrobial resistance, poor patients' compliance, and drugs side effects, the treatment failure rate is increasing. So there is a real need for an alternative drug that is effective, safe and has a short treatment course.

Gemifloxacin is a new fluoroquinolone that has bactericidal activity. It has good intracellular penetration and low toxicity.(10) It is more potent than ciprofloxacin, ofloxacin and levofloxacin.(11)

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Active rhinoscleroma proved both clinically and histopathologically

Exclusion Criteria:

1. Patients younger than 18 years old.
2. inactive Rhinoscleroma
3. Contraindication to treatment severe renal or hepatic impairment
4. Refusal of enrollment in the research by the patient
Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability

The purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.

Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests ankle joint mobilization can improve contributions of spinal influences on ankle muscle activation in individuals with ankle joint pathology, but there is a considerable gap in understanding cortical contributions to muscle activation following joint injury. It is unknown how joint mobilization concurrently affects cortical and spinal neural motor pathways, as well as clinical measures of patient function. The overall aim of this grant is to determine the immediate effects of talocrural joint mobilization on cortical and spinal muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with chronic ankle instability (CAI). The secondary aims of this study will examine changes in ankle dorsiflexion range of motion (ROM) and dynamic balance. This innovate approach will provide the necessary scientific knowledge regarding the potential mechanism and efficacy of joint mobilization.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-45 years
* History of one or more ankle sprains
* Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
* At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

Exclusion Criteria:

* Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
* Diagnosed ankle osteoarthritis
* History of ankle surgery that involves intra-articular fixation
* Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures
Role of Adiposomes in Endothelial Dysfunction

The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2
* Between ages 18-50 years
* Not pregnant
* Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg/dL)
* Medical clearance to participate in a moderate-intensity exercise program

Exclusion Criteria:

* Pregnant women
* Current smokers
* Currently abusing alcohol or drugs
* Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer
* Non-English speakers
* History of allergic reactions to lidocaine
The Effects of a Botanical Moisturizer and an Unscented Soap on Eczema and Itch

The purpose of this study is to examine the effects of a botanical moisturizer and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.


Eligibility Criteria:
Inclusion Criteria:

* Sex: female and male;
* Age : 18 years old and above;
* Phototype: I to IV;
* Type: Caucasian;
* Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);
* Subjects with a SCORAD of 25 - 50;
* Subjects with dry skin on the study areas;
* Subject barely wearing makeup;
* Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;
* No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;
* Subjects agreeing not to change lifestyle habits during the study duration.
* Healthy subject;
* Subject having given her free informed, written consent;
* Subject willing to adhere to the protocol and study procedures;
* Subject with Polish citizenship.

Exclusion Criteria:

* For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (other than eczema);
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
* Subject having undergone a surgery under general anesthesia within the previous month;
* Excessive exposure to sunlight or UV-rays within the previous month;
* Subject enrolled in another clinical trial during the study period (concerns the studied zones).