cyrilzakka/clinical-trials huggingface dataset:
Guided Creeping Technique (GCT) in Treating Gingival Recession

A novel minimally invasive guided creeping technique (GCT) is suggested to treat gingival recessions.

Background: Coronally advanced flap with connective tissue grafting in a conventional or minimally invasive approaches includes massive soft tissue reflection that reduce soft tissue support and compromise vascularity around the grafted material. In an attempt to preserve soft tissue support, graft stability and maximizing graft protection in treating recession defects the present novel minimally invasive guided creeping technique (GCT) is suggested.

Methods: Twelve patients, each contributing a single Cairo RT1 GR defect, were treated by guided creeping technique and completed the 6 months follow up. Clinical, evaluations were performed and differences among groups were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Systemically and periodontally healthy
* Presence of isolated buccal Cairo RT1 gingival recessions
* An identifiable CEJ
* Affected teeth with at least 2mm attached gingiva.

Exclusion Criteria:

* Smokers
* Pregnancy
* Using antiepileptic drugs
* Using antibiotics for at least 20 days before surgery
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients

The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or bacterial disease. These patients are different from healthy volunteers because they have received myeloablative treatment, which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections, which typically occur during the week after transplant. It is therefore essential to know that hLF 1-11 is safe and well tolerated when given during neutropenia and mucosal barrier injury before infections ensue.

Human lactoferrin (hLF) is a glycoprotein containing 692 amino acids and found in the saliva, milk, tears, and other body fluids. The peptide representing the first cationic domain, i.e. the peptide comprising the first eleven residues of hLF (further referred to as hLF1-11) was significantly more effective than the full length protein or the peptide representing the second cationic domain. As with other antimicrobial peptides, hLF1-11 shows poor antimicrobial activity under physiological conditions in vitro, but it is highly effective in vivo against infections due to a variety of microorganisms, including Gram negative and Gram positive bacteria and fungi. The objective is to develop hLF1-11 for the treatment of fungal and bacterial infections that develop during neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplant(HSCT) formerly referred to as bone marrow transplant. Rates of infection and related morbidity are high in this population, making it an attractive target for testing clinically the proof-of-principle that hLF1-11 can provide effective treatment. Subsequently, hLF1-11 will be developed further as a systemic antifungal agent

Eligibility Criteria:
Inclusion Criteria:

Recipients will be eligible for inclusions if they satisfy the following conditions:

* Has been admitted for an autologous HSCT after myeloablative therapy with high-dose melphalan;
* Is being managed with a 3 or 4-lumen central venous catheter;
* Is at least 18 years old;
* Has a BMI \<30 kg/M2;
* Has no medical reason for not participating
* Has adequate renal function (creatinine \< 1.5 x ULN)
* Has adequate liver function (ASAT, ALAT \< 2.5 x ULN, bilirubin \< 1.5 x ULN);
* If a woman, is functionally post-menopausal
* Has not participated in a study of a new chemical molecular entity in the previous 3 months
* Is able and willing to participate;
* Has provided written informed consent.
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding.

In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent for study participation obtained before undergoing any study specific procedures
* Diagnosed with congenital FXIII deficiency requiring prophylactic treatment
* Males and females of any age

Exclusion Criteria:

* Diagnosis of acquired FXIII deficiency
* Administration of a FXIII-containing product, including blood transfusions or other blood products, within 3 weeks prior to the Baseline/Day 0 Visit
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Use of any other IMP within 4 weeks prior to Baseline/Day 0 Visit
* Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study
* Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance
* Any laboratory finding or medical condition which, in the opinion of the Investigator, would put the subject or subject's disease management at risk
Prebiotics Change Microflora and Decrease LPS

The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.

The study followed a randomized, parallel placebo-controlled double-blind design.

A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention.

As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet.

The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Stable weight (+/- 3 kg) for the last 3 months
* Body Mass Index (BMI) between 18.5 and 27 kg/m²
* Consuming between 13 and 18 g of dietary fiber a day
* Student on campus at the Institut Polytechnique LaSalle Beauvais
* Informed consent form signed
* Able to follow the requirement of the study
* Have a social security

Exclusion Criteria:

* Has a serious pathology
* Has a gastrointestinal, vesicular or pancreatic disease
* Took an antibiotic or a laxative treatment in the last 6 months
* Surgery of the gastrointestinal tract in the last 12 months
* Orange juice intolerance
* Chronic or recurring diarrhea, constipation or abdominal pain
* Taking drugs known to have an effect on the gastrointestinal, pancreatic and vesicular function
* Recent gastroenteritis or foodborne illness
* Diabetes
* Consuming regularly of probiotics- or prebiotics-enriched products in the last month
* Drinking more than 3 glasses of alcohol a day
* Is deprived of liberty
* Is under judicial protection
Subconjunctival Humira for Boston Keratoprosthesis

This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.

This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection.

The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria
* Patients with poor prognosis for corneal transplantation, severe corneal opacity and/or vascularization
* Patients with vision worse than 20/200 in the eligible eye, and contralateral eye with vision less than 20/40
* Patients with intact nasal light projection
* Willing and able to comply with study plan for the full duration of the study
* Willing and able to sign a written informed consent

Exclusion Criteria:

* Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay \[IGRA\] test, such as Quantiferon-gold)
* Untreated active hepatitis B or C infection.
* Ocular or periocular malignancy and/or infection
* Inability to wear contact lens
* Pregnancy (positive pregnancy test) or lactating
* Participation in another interventional study at the time of screening
* Any of the following baseline lab values

  1. White blood count \<3500 cells per microliter
  2. Platelets \<100,000 per microliter
  3. Hematocrit \<30%
  4. AST or ALT \>1.5X upper limit normal value
* Multiple sclerosis or other demyelinating disease
* Severe uncontrolled infection
* Moderate to severe heart failure (NYHA class III/IV)
* Active malignancy
* History of adalimumab intolerance
* Pregnancy or lactation
* Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
* As judged by the investigator any patients that are questionable for their suitability in the study
Individualized Infiximab Dosing-Proof of Concept Study

The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.

Our aims are:

1. to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients.
2. to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab.

Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females on IFX
2. Patients with IBD
3. Age 6-23
4. Able to obtain consent

Exclusion Criteria:

1. Not receiving infliximab
2. On 10 mg/kg of IFX
3. Not able to obtain consent
Nationwide Implementation of Standardized Structured Reporting

The first objective is to explore factors that impede or facilitate implementation of SSR in pathology (and other disciplines) among the MDT members receiving SSRs. The second objective is to select, develop and evaluate (process and effect outcomes) implementation tools supporting optimal implementation of SSR in pathology. The third objective is to offer implementation tools to all pathology laboratories in the Netherlands and to share the SSR-kit for successful implementation with other medical disciplines

By implementing SSR in various disciplines, we contribute to improving communication, efficiency and quality of multidisciplinary team (MDT) meetings and facilitate optimal treatment decision making. Optimal discussion of each patient at MDT meetings can be achieved by a clear communication of all diagnostic results among MDT members. However, the adoption of innovations, such as SSR, is laborious, especially when the innovation requires changing daily habits. Offering implementation tools supports the adoption of innovations among medical professionals. Implementation tools are most effective when they are developed on the basis of factors that impede or facilitate the innovation. Besides the importance of investigating these factors for SSR among pathologists, we will also involve MDT members receiving pathology SSRs in our study. After all, because MDT members will greatly benefit from SSR, they could play a key role in stimulating the use of SSR among pathologists. Therefore, we will also explore which tools MDT members need to stimulate the diagnostic disciplines in using SSR. Subsequently, we will develop and evaluate implementation tools to support the use of SSR by pathologists. The kit for successful implementation of SSR will be offered to other medical disciplines like radiology, endoscopy, and surgery who face similar challenges with implementation of SSR. The SSR-kit consists of our multidisciplinary approach for the whole process of developing implementation tools for SSR, examples of tools for SSR, and other results of this project.

Eligibility Criteria:
Inclusion Criteria:

* Pathologists of urological, gynecological or gastro-intestinal cancers
* Other MDT-members of urological, gynecological or gastro-intestinal cancers (medical oncologists, radiologists, radiotherapists, urologists, gynecologists, intestinal surgeons, nuclear medicine physicians, nurse practitioners).
* Dutch
* Residents

Exclusion Criteria:

* Retirees
Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy

Primary Objective:

To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

* To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG)
* To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus

The study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks open-label treatment + 1 week follow-up).

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD)
* Signed written informed consent

Exclusion criteria:

* HbA1c \<7% or HbA1c \>10% at screening
* No self-monitoring of blood glucose within 3 months prior to screening visit
* Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit
* In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.


Eligibility Criteria:
Inclusion Criteria :

* Aged over 18 years on the day of inclusion
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative urine pregnancy test
* For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.

Exclusion Criteria :

* Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
* Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
* Breast-feeding
* Previous vaccination with an avian flu vaccine
* Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
* Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
* Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products within the past 3 months
* Any vaccination within 4 weeks prior to the first trial vaccination
* Vaccination planned within 4 weeks after any trial vaccination
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Intubation Conditions With Atracurium After Three Minutes

The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

The recommended dose of a non-depolarizing curare to facilitate tracheal intubation is twice the active dose 95 (the dose that reduces muscle force by 95%). At this dosage, curarization of the laryngeal adductors allowing relaxation and abduction (opening) of the vocal cords is considered certain. With atracurium, the dose for intubation is 0.5 mg.kg-1 and the time to full effect is approximately 3 minutes. With the use of newer hypnotics, there are no data evaluating the conditions for intubation after a fixed time of 3 minutes as with current anesthetic practices.

Eligibility Criteria:
Inclusion Criteria:

* Adult female
* Patient to undergo general anesthesia with intubation for scheduled gynecological surgery
* Patient informed about the study and not opposed to it

Exclusion Criteria:

* Patients with severe and morbid obesity (BMI\>35kg/m2)
* Pregnancy
* Patients with difficult intubation
* Allergy to atracurium and to any other drug used.
* Patient under tutorship / curatorship
* Not affiliated with social insurance
* Patient with AME
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2

Lymphedema is a chronic, debilitating disorder characterized by abnormal tissue swelling, adipose deposition and tissue fibrosis, resulting from disruption, blockage, or genetic abnormalities of the lymphatic system. Secondary lymphedema is an acquired lymphedema due to trauma, surgery, radiotherapy or infection among others resulting in a decreased transport capacity of the lymphatic system. This can be combined with an additional load on the lymphatic system due to obesity, venous hypertension or a wound, among others. Advances in oncologic treatment have led to an ever-increasing number of cancer survivors over time. As a result, morbidities related to this treatment (such as secondary lymphedema) are likely to increase too.

Risk factors for the development of LLL after treatment for (gynaecological) cancer are: pelvic and para-aortic lymphadenectomy, the number of pelvic lymph nodes removed, adjuvant radiotherapy, adjuvant chemotherapy, increasing BMI/ BMI ≥25 kg/m², lymphocyst formation, increasing age, increasing time since surgery and insufficient physical activity level.

To the investigators knowledge, no evidence exists regarding which (combination of) measuring methods are most sensitive to detect early lymphedema at the lower limbs after the treatment of cancer. Thresholds for identifying subclinical edema on one or both lower limbs are lacking.

Therefore the investigators want to develop a screening set for patients at risk for developing LLL. Which measurement method (and which criterion) shows the best diagnostic accuracy in screening patients at risk for LLL after cancer treatment? And: What is the added value of combining different measurement methods in terms of diagnostic accuracy?


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of skin melanoma (at the level of the lower limb, at least cancer stage 3), gynecological cancer, uro-genital cancer that will receive surgery (sentinel lymph node biopsy and/or (para-aortic/inguinal/pelvic) lymph node dissection)

Exclusion Criteria:

* Pregnant participants
* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Reduction of Pain in Colonoscopy - Loop First Versus Last

Colonoscopy is an endoscopic examination of the colon. Colonoscopy is used to investigate medical gastroenterological diseases, as well as to investigate suspected cancer and to prevent it by identifying and removing premalignant changes - polyps (e.g., as part of the national screening program for colorectal cancer).

As part of a normal endoscopic examination, the tip of the endoscope is bent (retroflexed) to look "backward" into the rectum. This is done to better see the inside of the rectal opening. Performing such a retroflexion of the scope is often associated with discomfort/pain for the patient. It takes 5-10 seconds. There are no guidelines on when such a retroflexion should be done - at the beginning or at the end of the procedure. The aim is to investigate whether the timing of retroflexion makes a difference in the recollection of pain following the procedure. In this way, the pain of colonoscopy might be reduced in the future simply by changing the timing of the retroflexion.

The study is solely about performing this retroflexion either at the beginning or at the end of the examination. Nothing is changed in the diagnostic part of the examination.

The background of the study is a study from 2003 that shows that taking about a one-minute pause in the rectum at the end of the colonoscopy can reduce the overall pain perception of the examination. This was shown without changing the pain during the procedure and despite the fact that the examination itself was prolonged due to the intervention. This relationship is explained by studies showing that the pain experience at the end of a procedure has a greater influence than the pain experience at the beginning of a procedure on the overall pain experience.

Hypothesis: By retroflexing in the rectum first during a colonoscopy versus at the end, patients will perceive the overall procedure as less painful.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective diagnostic colonoscopy at the surgical department

Exclusion Criteria:

* age \<18
* pregnancy
* colonoscopy under general anæsthesia
* patients not fluent in danish
* patients uanable to understand the study (e.g. people with diagnosed or suspected dementia)