cyrilzakka/clinical-trials huggingface dataset:
Role of Toxins in Lung Infections Caused by Pseudomonas Aeruginosa

Some bacteria that cause disease can produce toxic substances that may worsen the disease. Pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special interest for patients with cystic fibrosis and repeated long term lung infections.

The goal of this study is to determine whether specific toxins produced by Pseudomonas aeruginosa may be important in the disease process of chronic lung infections of patients with cystic fibrosis.

This study will attempt to measure bacterial production of toxins in blood and sputum and immune system response to toxins in the blood....

The goal of this study is to determine whether virulence determinants that use the type III-secretory pathway may be important in the pathogenesis of chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis (CF). The studies will quantify bacterial effector proteins in serum and sputum and the immune response to specific products as reflected by antibodies in serum. Candidate effector proteins include: (1) exotoxin A, a non-type III-dependent ADP-ribosyltransferase and cytotoxin that does not use the Type III secretory pathway, (2) ExoS, a type III pathway-dependent extracellular ADP-ribosyltransferase with cytotoxic activity, (3) ExoU, another type III-dependent cytotoxin, that is responsible for epithelial injury in acute lung infections, and (4) PcrV, a homolog to the V antigen of Yersinia.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients with cystic fibrosis with a defined mutation in the cystic fibrosis transmembrane regulator (CFTR) (e.g., any of the known variants of the CFTR gene, such as the delta F508 allele).

Patients will have been tested or will be tested for the CFTR gene under another protocol.

Research volunteers that are age-and race-matched as control subjects.

EXCLUSION CRITERIA:

Patients who are less than 9 years of age. Research volunteers less than 18 years of age.

Patients or research volunteers who test positive for human immunodeficiency virus (HIV) or a positive serum test for hepatitis B and/or C virus.

Patients or research volunteers who test positive for tuberculosis.

Research volunteers with pulmonary disease or infection.
Additional Benefits of Virtual Reality Therapy for Individuals With Neck Pain

This study aimed to investigate the effect of adding virtual reality therapy to conventional treatment in patients with chronic neck pain on pain, neck disability index, kinesiophobia, insomnia severity questionnaire, hospital anxiety depression scale, cervical range of motion and pressure pain threshold.

Neck pain is a disease that affects individuals and society worldwide. Between 50% and 85% of the general population experiences neck pain at some point in their lives, and every person who experiences neck pain is likely to experience pain again after 1-5 years. Neck pain is considered chronic if it lasts more than 3 months. Passive and active physical therapy approaches play a very important role in the treatment of neck pain. With the rapid development of technology, new developments such as virtual reality have begun to be used in the treatment of chronic neck pain.

Virtual reality (VR) is a term describing innovative, real-time, computer-based technologies that play an increasing role for many patient groups in the field of physical medicine and rehabilitation. Virtual reality has been shown to be effective in reducing pain and discomfort in patients with different types of chronic pain. Motivation and interaction are the main practical benefits of virtual reality training, especially in video game-based therapy approaches, unlike traditional rehabilitation. Patients play the therapeutic game over and over again to achieve a better score without getting bored. Feedback, an important component of motor learning, is a prominent feature in virtual environments.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 who signed the informed consent form
* Those with existing neck pain
* Those whose neck pain continues for at least 12 weeks

Exclusion Criteria:

* Previous cervical surgery
* Having received FTR from the cervical region in the last 6 months
* Having had a spinal fracture
* History of malignancy
* Those with pacemakers
* Those with rheumatological, vestibular and neurological diseases
* Pregnant women
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel


Eligibility Criteria:
Inclusion Criteria:

* History of motion sickness
* Age 18-75

Exclusion Criteria:

* Nausea-inducing disorder other than motion sickness
* BMI\>40
* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
MyCompass in a Swedish Context - an Automated Self-help Intervention Targeting Mental Health Problems

The study present findings from the implementation of myCompass, a fully automated self-help intervention of Australian origin for mild to moderate anxiety and depression, in a Swedish context. The study also investigates the usage of a specially designed research platform aimed at handling informed consent and online surveys.


Eligibility Criteria:
Inclusion Criteria:

* Swedish resident
* Valid e-mail address
* 18 years old or older
* PHQ-9 score of 5-20
* GAD-7 score of 5-15

Exclusion Criteria:

* suicidal thoughts
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug

We aim to recruit 40 patients suffering from anovulatory obesity with a BMI of 30 or more. Patients will be included from all ethnic groups.

Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity, PI, RI, SD ratio and power Doppler) Participants will then be randomised to receive either metformin or orlistat. Patients receiving orlistat will receive the standard dose of the drug as recommended in the BNF. Metformin will be given in an incremental dose starting at 1000mg per day and increased at 4 weekly intervals to 2000mg/d, depending on the occurrence of any gastrointestinal intolerance. The endocrinological and ultrasound investigations will be repeated at 4 weekly intervals. Both groups will be given a standard exercise and diet program in conjunction with medical treatment.

The clinical endpoint will be the achievement of conception, a Body Mass Index of less than 30, or completion of a 3-month course of treatment.

Study design:

A randomised controlled open label clinical trial. Participants be randomised using a computer generated randomisation program available at the pharmacy of the Jessop Wing, into either one of two arms: metformin or orlistat. The randomisation will be stratified in order to achieve a homogenous distribution of PCOS and non-PCOS patients in both arms of the study.

Eligibility Criteria:
Inclusion Criteria:

1. In the childbearing period 2. Obese with a body mass index of 30 or more. 3. Are anovulatory as shown by day 21-serum progesterone. 4. Polycystic ovarian syndrome will be diagnosed according if at least two of the following three features are present, after exclusion of other aetiologies (Azziz, 2004): (i) Oligo- or anovulation, (ii) Clinical and/or biochemical hyperandrogenism (iii) Polycystic ovaries.

Exclusion Criteria:

1. BMI of less than 30
2. Patients not requesting treatment for their symptoms
3. Patients with contraindications for any of the medications: renal or hepatic impairment, malabsorption syndrome, cholestasis
4. Diabetic patients
5. Pregnancy
6. Breast feeding
Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin

The project topic consists on re-conciliating the fine tuners of the gene expression "microRNAs" and the immunopathogenic occasions responsible for skin disorders in context of skin infection and inflammation such as psoriasis. The skin is a network of effector cells and molecular mediators that constitute a highly sophisticated "Skin Immune System (SIS) described by Jan D Bos in 1986. The cutaneous homeostasis maintenance is dependent on the cross talk between several immune sentinels present in the different compartments of the skin as well as the interplay between innate and adaptive immune responses. The whole is under the control of gene regulation. However, cutaneous homeostasis disruption occurs when the SIS safe framework erroneously sends aggravation signals due to gene regulation disbalance via inflammatory cellular and molecular mediators into the site of infection causing chronic inflammation characterized by thick red irritated skin lesions. The latter was showed to have a characteristic microRNA (regulators of gene expression) signature.


Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 75
* Clinical diagnosis of chronic active psoriasis in non-pustular plaque
* Treated locally with topical corticosteroids

Exclusion Criteria:

* Patient who did not give express consent to participate
* No affiliation to a social security scheme
* Patient treated systemically
* Thrombocytopenic patient
* Patient known to be HIV-positive
* Septic patient
* Patient with only facial lesions
* Patient with psoriasis with joint involvement
* Patient participating in another study
* Patient protected under the law (under guardianship or trusteeship)
* Pregnant or lactating woman
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study

The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.

Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.

Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.

The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
* Completed primary treatment at least 6 months ago
* Not terminally ill
* Attend school
* Living with one or more parents who speak Danish and are willing to co-participate
* Screened as having parent-reported cognitive and/or neurobehavioral impairment

Exclusion Criteria:

• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

This study will evaluate if receiving a kidney transplant from an HIV-infected deceased kidney donor is safe with regards to survival and major transplant-related and HIV-related complications compared to receiving a kidney from an HIV-uninfected deceased kidney donor (HIVD-). Those participants who have accepted an HIVD- organ will be randomized to be followed in the full study or followed in the nested observational group.

Eligibility Criteria:
Inclusion Criteria:

* Participant meets the standard criteria for kidney transplant at the local center.
* Participant is able to understand and provide informed consent.
* Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards.
* Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).
* Participant is ≥18 years old.
* Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease.
* Cluster of Differentiation 4 (CD4)+ T-cell: ≥200/µL within 16 weeks of transplant.
* HIV-1 is below 50 copies RNA/mL. Viral blips between 50-400 copies allowed as long as there are not consecutive measurements \>200 copies/mL.
* Participant is willing to comply with all medication related to their transplant and HIV management.
* For participant with a history of aspergillus colonization or disease, no evidence of active disease.
* The participant must have, or be willing to start seeing, a primary medical care provider with expertise in HIV management.
* All participants participating in sexual activity that could lead to pregnancy must use an FDA approved method of birth control.
* Participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to HIV disease.

Exclusion Criteria:

* Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.
* Participant is pregnant or breastfeeding.
* Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks or may impact the quality or interpretation of the data obtained from the study.
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents

Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* requiring PCI and treated with Xience Sierra
* capable of providing informed consent

Exclusion Criteria:

* known intolerance to components of the study DES or antithrombotic/anticoagulant therapy
* planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) \< 3 months
* patient is known to be pregnant, unlikely to adhere to follow-up or expected live \< 1 year
EFFECTIVENESS AND SAFETY OF CREAM CONTAINING SPENT GRAIN WAX EXTRACT, ARGAN OIL, AND SHEA BUTTER POST-TRICHOLOROACETIC ACID 15% PEEL: RANDOMIZED, CONTROLLED, DOUBLE-BLIND, SPLIT-FACE CLINICAL TRIAL

Chemical peels are resurfacing procedures where chemical agent causes controlled exfoliation of the skin, followed by regeneration and remodelling of the epidermis and dermis layers. Chemical peels can be used to treat various skin condition, such as skin aging, pigmentary disorders, and skin texture disorders. The use of moisturizer after chemical surgery can help speed up the wound healing process and repair the skin barrier. TCA chemical peel has more side effects than other chemical peel solutions. The risk of complications after TCA chemical surgery on Fitzpatrick IV-VI skin types is also higher, especially post-inflammatory hyperpigmentation. There is no specific recommendations regarding the type of moisturizer that can be used after TCA chemical peels. This study aims to assess the effectiveness of a cream containing spent grain wax, argan oil, and shea butter in reducing TCA peel side effects.


Eligibility Criteria:
Inclusion Criteria:

women, 30 - 60 years old with facial skin aging underwent chemical peeling with TCA 15%, have received priming with topical retinoic acid 0.05%, for at least 2 weeks and its use has been discontinued three days before chemical peel.

Exclusion Criteria:

Pregnant or lactating women, patients who received hormonal therapy, immunosuppressants, allergic to any of treatment ingredients, had active skin diseases on the face (acne vulgaris, seborrheic dermatitis, dll), history of keloid/hypertrophic scar, open wound, active infection, or history of recurrent herpes simplex
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.

This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed as IPMN;
* without other malignant tumor;
* agree to sign informed consent.

Exclusion Criteria:

* with mental disorders which can affect cognition and cooperation;
* with serious blood diseases or taking drugs that can affect peripheral blood
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.

The purpose of this study is to assess the effectiveness of ULTRACETÂ® (a combination analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. AdvilÂ®, MotrinÂ® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g. CelebrexÂ®).

This is a randomized, multicenter, placebo-controlled, double-blind study to evaluate the efficacy and safety of ULTRACET® (tramadol 37.5 mg and acetaminophen 325 mg) as add-on therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor. The patients will be randomized into 2 treatment groups: The first group will receive one ULTRACET® tablet 3 times per day for 7 days. The second group will receive one placebo tablet 3 times per day for 7 days. The primary efficacy measurement will be the patients' average daily pain score. Safety will be monitored throughout the study. The study hypothesis is that ULTRACET® will be well tolerated and the average daily pain relief score for the ULTRACET® treatment group will be better than that of placebo group. Patients will take one ULTRACET® tablet or placebo by mouth 3 times per day, for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis at least 6 months before the participation in the clinical trial, (defined by having more than 4 of the diagnosis criteria suggested by American College of Rheumatology (ACR
* 1987))
* have been on a stable daily dose of an NSAID or a COX-2 inhibitor for at least 30 days prior to the start of the study
* have arthralgia (arthritis pain in the joints) for at least 2 days before the entering clinical trial, with a pain score on the Visual Analogue Scale (VAS) of 40 mm or greater.

Exclusion Criteria:

* Have had an inadequate response to Tramadol HCl therapy, or have discontinued Tramadol HCl therapy due to adverse events
* have taken Tramadol HCl within 30 days prior to study entry
* have recently taken other medications for pain relief, (other than their daily NSAID or COX-2 inhibitor
* daily use of aspirin at a dose greater than 100 mg per day.
Use of the Sentinel Node Biopsy for Early Endometrial Cancer.

This is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. The collaborating centres with the OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc will also particpate to the trial.

Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading team in the world published very good result and that the first prospectives trials are already published with also excellents results. The investigators decided then to include this practice in their institutional guideslines and also to registred the procedure.

All the sentinel node biopsy procedures for endometrial cancer will be record online via the REDCap tools, securized on a servor in Saint-Luc. Automatic email for the following of the patients and the post operative event will be send regularly for every patient to the physicians who include the patient. Efficacy of the technique, False negative and postive rate, modifications of the adjuvant treatement, long terme evolution and complication wil be evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer early stage on the pre operative examinations
* Performance status that allow a surgery
* Surgery by laparoscopy or laparotomy

Exclusion Criteria:

* Patient already operated of the hysterectomy who need lymphatic restadification
* Stage IV disease