cyrilzakka/clinical-trials huggingface dataset:
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut

Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.


Eligibility Criteria:
Inclusion Criteria:

* The patient has histologically confirmed relapsed or recurrent GBM.
* EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay.
* Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate.
* Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day.
* The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
* The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy.
* The patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing.
* Males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut.
* The patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut.

Exclusion Criteria:

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Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.

Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.

The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.

Eligibility Criteria:
Inclusion Criteria:

* multiparous female patients.
* aged between 30 and 60 years
* who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
* complex rectocele was one having any of the following features: size \> 3 cm in diameter, associated enterocoele or internal rectal prolapse

Exclusion Criteria:

* paradoxical contraction of puborectalis muscle (anismus),
* complete external rectal prolapse
* fecal incontinence
* other benign anal conditions
* those who are unfit for surgery due to associated severe co-morbidities
The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings

Study objective: This study is planning to explore factors predicting the use of life-sustaining treatment, develop the screening criteria of proactive clinical ethics consultations, the effect of proactive clinical ethics consultations and interprofessional practice on end-of-life care of the critically ill in the intensive care settings, and develop the competency for trainees by interprofessional education.

Methods: Data will be collected prospectively. Data between January 2013 and April 2014 was collected from hospital electronic record and ethics consultation document. All data will be analyzed for patients dying in the intensive care settings during the first stage of the study. Factors predicting the use of life-sustaining treatment will be determined. The Delphi technique will be applied to secure a consensus among the panel of experts chosen to help develop the screening criteria of proactive ethics consultations. A prospective randomized controlled trial will be conducted during the second stage of the study on a convenience sample of adult critical ill patients in the intensive care settings. Patients will randomize to the intervention group receive proactive ethics consultations. The control group will undergo routine intensive care, receiving clinical ethics consultations as requested by healthcare team, patients or family. All participants will be asked to complete a questionnaire rating their satisfaction with the healthcare process and consultations if conducted. Mean length of stay and the duration of the use of life-sustaining treatment will be compared between two groups. Secondary outcomes will include the proportion of satisfied families and healthcare team members. The interprofessional education with the core curriculum and case scenario for simulation will be developed, implement, and evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Medical staff involved in caring for terminal patients
2. Cases of active clinical ethics consultation in our hospital

Exclusion Criteria:

1. Medical staff who refuse to participate in the study or are unable to understand the way the study is conducted
2. Cases of refusing to participate in the research or unable to understand the way the research is conducted.
A Pilot Study to Explore the Role of Gut Flora in Fatty Liver

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Fatty Liver.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Fatty Liver.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers)
3. Diagnosis of fatty liver

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to \<18 years old in Japan in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan.

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are diagnosed with atopic dermatitis (AD).
* History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD.
* Participants initiating upadacitinib for the treatment of AD in routine clinical practice.
* Body weight \>=30 kg at the start of dosing.

Exclusion Criteria:

* Prior treatment with upadacitinib
* Currently participating in another registrational clinical research study
* Participants for whom upadacitinib is contraindicated
A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema

Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood supply). A particular feature of DR is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. This peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. The investigators wish to study DR and DMO using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with DR and DMO in order to understand how the condition develops and whether there are any unique risk factors that can be identified


Eligibility Criteria:
Inclusion Criteria:

Group 1 (Healthy controls without DM):

* Persons older than 18 years without DM
* Fundus free of any signs of retinal disease
* Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes

Group 2 (Persons with DM with no retinopathy):

* Persons with Type 1 or type 2 diabetes older than 18 years
* Normal fundus, Absence of features of DR or DMO in both eyes
* Best Corrected Visual Acuity 20/40 (73 ETDRS letters) in at least one eye

Group 3:

* Persons with Type 1 or type 2 diabetes 18 years and older
* Fundus signs of mild, moderate or severe DR and or DMO
* Best Corrected Visual Acuity 20/200 (33 ETDRS letters) or better

Exclusion Criteria:

* Recent ocular surgical procedures performed within the previous 3 months
* Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
* Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
* Neurological conditions that can impair vision
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision

Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Wound size \<10X10cm2, the wound base only involves subcutaneous and muscle tissue；
2. Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
3. There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
4. Men or women older than 17 years old and younger than 75 years old;
5. Psychologically stable, able to complete the test process.

Exclusion Criteria:

1. Wound size\>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
2. Surgical incision with purulent infection, local purulent secretions can be seen;
3. Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
4. Patients with diabetes;
5. Glucocorticoid users;
6. Patients with immune dermatosis;
7. Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;
8. Psycho-psychological disorders and poor compliance.
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis (JIA) patients in routine clinical practice in Korea. JIA patients experience persistent joint pain, swelling and stiffness. This is a prospective observational study.

Xeljanz is a JAK inhibitor. It was first approved in 2014 for rheumatoid arthritis patients in Korea. The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea.

This study is seeking patients who:

* Are 2 to less than 18 years of age;
* Are given Xeljanz for the treatment of JIA.

The study sponsor will monitor patients' treatment experience for up to 44 weeks. This will help assess the safety and effects of this study medicine.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Pediatric subjects aged from 2 years to less than 18 years
2. Xeljanz administered according to efficacy/effectiveness on the approved labeling
3. Patients who will administer Xeljanz based on the medical judgement of the investigator
4. Evidence of a personally signed and dated informed consent document indicating that the subject (and a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

Subjects meeting any of the following criteria will not be included in the study:

1) Subjects who are contraindicated from taking Xeljanz according to approved labeling\*

\*Refer to most recently approved label
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

The Nexgen TM Augmentation Patella is intended to help compensate for significant bone loss in the patella during revision total knee arthroplasty.

One site will be involved in this study. The aim is to include a total of 25 consecutive series patients who received the NexGen TM Augmentation Patella starting from 2014 at the Inselspital Bern. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
* Rheumatoid arthritis
* Correction of functional deformity
* Revision procedures where other treatments or devices have failed
* Treatment of fractures that are unmanageable using other techniques
* Complication from a failed prosthesis
* For cementless use only
* Supplemental fixation, when required, must be achieved by means of suture attachment.

Exclusion Criteria:

* Off-label use
* Primary arthroplasty
* Overt Infection
* Distant foci of infection (which may spread hematogenously to the implant site)
* Rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram
* Skeletally immature patients
* Cases where there is inadequate bone stock or no bone stock which would make the procedure unjustifiable
* Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
* Patient who is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant, younger than 18 years)
Long-term Ovarian Fertility in Patients Treated for Lymphoma.

This is an observational, single-center, longitudinal cohort study. In order to evaluate the gonadotoxicity of chemotherapy, an AMH monitoring was initiated in 2006 in our fertility observatory in young patients with lymphoma before, during and after chemotherapy. This study is part of the project "She will get better and then want a child" and is supported by the ARS hauts de France (n° DOS/SDES/AR/FIR/2019/282). Our first study published in 2010 shows that AMH decreases sharply during chemotherapy, regardless of the chemotherapy protocol. At the end of chemotherapy, AMH recovery profiles differ according to the protocol received. This follow-up is therefore essential in order to adapt our practices and our preservation strategies, particularly to the type of chemotherapy. Patients are primarily concerned about their chances of subsequent pregnancy, and there is little evidence in the literature about the impact of chemotherapy on ovarian reserve and long-term fertility.

The fisrt objective of our study is to evaluate, at distance from chemotherapy, the evolution of ovarian function in patients treated for lymphoma by evaluating follicular reserve parameters (AMH and antral follicle count) at 5 and 10 years after the end of chemotherapy compared with the initial workup performed before chemotherapy and the workup performed at 12 months after the end of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of lymphoma treated with chemotherapy
* followed in the fertility observatory of the Jeanne de Flandre Hospital at the University Hospital of Lille (project "she will heal and then want a child"), who are at least at 5 years since the end of chemotherapy
* Patients having been informed and having given their written consent to participate in the study.
* Beneficiary of a social security system.

Exclusion Criteria:

* Patient not followed in the fertility observatory.
* Inability of the patient to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
* Patient opposed to her participation in the study.
* Patient under guardianship or curatorship.
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Multicenter Immunotherapy House Dust Mite Allergoid

A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale

Eligibility Criteria:
Inclusion Criteria:

* Positive SPT
* Positive EAST
* Positive specific provocation test

Exclusion Criteria:

* Serious chronic diseases
* other perennial allergies
SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study

Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.

A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.

Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.

Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.

Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.

Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years
2. written informed consent available
3. patient eligible for percutaneous coronary intervention
4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
5. Target reference vessel diameter measured by QCA: 2-4 mm
6. Target lesion length measured by QCA \< 24 mm
7. Target lesion stenosis measured by QCA: \> 70%- \< 100%
8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

Exclusion Criteria:

1. Left ventricular ejection fraction of \< 30%
2. Impaired renal function (serum creatinine \> 2.0 mg/dl)
3. Target lesion located in bifurcation
4. Previous and/or planned brachytherapy of target vessel
5. Lesion of the left main trunk \> 50%, unprotected
6. Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
7. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
8. Patients with a life expectancy of less than one year
9. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
10. Patient currently enrolled in other investigational device or drug trial
11. Patient not able or willing to adhere to follow-up visits
12. Patients who previously participated in this study. -