cyrilzakka/clinical-trials huggingface dataset:
Screening for Fabry Disease in Renal Transplantation

Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

Exploration whether Fabry disease cases can be identified among patients who are followed at the Montpellier University Hospital after renal transplantation, with indeterminate cause of renal failure or diabetic nephropathy (due to its high frequency) or secondary focal segmental hyalinosis (FSH).

At the population level, the identification of cases at the Montpellier centre could then justify to expand this screening to other French centres. The goal is to contribute to adapt current guidelines of renal failure assessment, by systematically including Fabry among the diagnostic tests. Whether all patients with renal failure are concerned, or only those with indeterminate cause, is an important question this study will address.

Eligibility Criteria:
Inclusion Criteria:

* Nephropathy of indeterminate cause, or secondary FSH or diabetic nephropathy
* Patients with kidney transplanted
* Patients still followed at the Montpellier University Hospital
* Obtaining written informed consent
* Age \> 18 years old, no upper age limit

Exclusion Criteria:

* N/A
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Anticipated use of artificial tears during study
* Contraindication to pupil dilatation
Validation of Korean Version of ICIQ-SF

1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women
2. Evaluation the effect of urinary incontinence in pregnant and postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* Being pregnant or postpartum ≤ 3 weeks
* Able to read and understand Korean
* At least 18 years of age

Exclusion Criteria:

* Refuse to participate in the study
* Pelvic inflammatory disease
* Psychiatric disease
* Needed to be treated in the 7 days
Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia

This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.

Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.

Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 75 years of age;
2. Patient with esophageal achalasia;
3. Eckardt score \> 3;
4. Signed informed consent.

Exclusion Criteria:

1. Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk;
2. Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus;
3. Previous endoscopic Botox injection;
4. Previous oesophageal or gastric surgery;
5. Pregnancy or lactation women, or ready to pregnant women;
6. Not capable of filling out questionnaires.
Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients

Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit

Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins \[800 IU (727mg) of a-tocopherol and 500mg of vitamin C\] \[n=48\], or no supplements \[n= 48\] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis.

Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus

Exclusion Criteria:

* severe chronic clinical or psychiatric disease,
* participating in other intervention trials,
* on dietary supplements and
* those unable to give an informed written consent
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone \[r-hFSH\]/recombinant human luteinising hormone \[r-hLH\]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.


Eligibility Criteria:
Inclusion Criteria:

* Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
* Female subjects, less than (\<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
* Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
* Absence of any medical condition in which pregnancy is contraindicated
* Body mass index 18 to 30 kilogram per square meter (kg/m\^2), inclusive
* Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial
* Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
* Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

* Two episodes of POR after maximal stimulation
* History or presence of tumors of the hypothalamus or pituitary gland
* History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
* Presence of endometriosis Grade III - IV, confirmed or suspected
* Presence of uni- or bilateral hydrosalpinx
* Abnormal gynecological bleeding of undetermined origin
* Contraindication to being pregnant and/or carrying a pregnancy to term
* History or presence of ovarian, uterine or mammary cancer
* Use of testicular or epididymal sperm
* Other protocol defined exclusion criteria could apply
Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using FFF With and Without CAD/CAM Customized Cutting Guide

The purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.

Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons causing face disfigurement which require post-ablation reconstruction. One of the most challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor resection causing facial disharmony affecting aesthetics and function.

Free flaps are considered the gold standard for the reconstruction during oncologic surgery combining a high success rate with low donor site morbidity. Various techniques have been practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular graft as an option, offering many Assorted advantages: as it provides a sufficient source for bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor site morbidity may be involved and flap harvesting require no patient reposition.

Mandibular reconstruction using FFF has become the gold standard. However, flap contouring remain an issue and imprecise with inconvenient or suboptimal final results regrading aesthetic and even more consuming time and efforts owing to poor planning when performed traditionally. Recently, with newly introduced technology and virtual planning, the process has become more uniform and reproducible thus enhancing final outcome improving patient life.

Prefabricated cutting guides may be used may be not, however it still in debate regarding its benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to achieve Aesthetic and operation time improvement with more detailed evaluation in patients undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting guide.

Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing mandibular reconstruction using free fibular flap. In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of patients receive FFF but without customized osteotomy guide. only model will be performed as conventional method helping in pre-shaping of reconstruction plate which is another well-established concept of management of mandibular defect.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by tumor involving Mandibular bone.

Exclusion Criteria:

* Patients having poor oncological prognosis
* Patients with poor performance status together with other relative or absolute vascular contraindication.
* Patients require marginal resection or with bilateral fibular fracture
Radiofrequency Denervation for Reducing Chronic Pain: a Meta-analysis

The meta-analysis of data obtained from randomized controlled trial on effectiveness of radiofrequency denervation on reducing chronic neck and low back pain.


Eligibility Criteria:
Inclusion Criteria:

* RCTs with pain VAS as outcome

Exclusion Criteria:

* None
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.

This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years old
* Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus

Exclusion Criteria:

* Has received investigational therapy within 60 days prior to study entry
* Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
* Concurrent use of systemic anti-VEGF agents
* Full thickness or lamellar keratoplasty within 90 days prior to study entry
* Ocular surface reconstruction within 90 days prior to study entry
* Other ocular surgeries within 90 days prior to study entry
* Corneal or ocular surface infection within 90 days prior to study entry
* Ocular or periocular malignancy
* Contact lens (excluding bandage contact lens) within 30 days prior to study entry
* Persistent epithelial defect (\>1mm2 and ≥14 days duration) within 30 days prior to study entry
* Systemic, intravitreal, or periocular steroids within 30 days prior to study entry
* Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to study entry
* Hypertension: systolic BP \> 150 or diastolic BP \> 90
* History of thromboembolic event within 6 months prior to study entry
* Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception (The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch)
* Participation in another simultaneous medical investigation or trial.
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
* Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
* Subjects must be at least 18 years old
* Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
* Subjects must not be pregnant and must meet contraceptive requirements
* Subjects must meet tuberculosis screening criteria
* Subjects must meet laboratory and medical history screening requirements

Exclusion Criteria:

* Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
* Subjects already using certain investigational, biological, or immunosuppressive drugs
* Subjects with certain comorbid conditions
* Subjects who currently have or have a history of certain infections
* Subjects who have recently received live virus or bacterial vaccinations
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
ERAS in Gastrointerstinal Fistulas.

An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of ERAS protocol in surgical patients with ECF.

ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 F, 56 M, mean age 54.1) was evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed.

Eligibility Criteria:
Inclusion Criteria:

* surgery for gastrointestinal fistula

Exclusion Criteria:

* conservative treatment
Nutritional Strategies After Muscle Strain Injuries

Muscle strain injuries are a particularly frequent type of sports injury in soccer, athletics, badminton/ tennis and cross-fit fitness, thereby affecting a broad range of popular leisure time activities. Depending on severity, sports-active individuals may experience long-term functional impairment and pain. Additionally, individuals having sustained one strain injury have a substantially increased risk of injuring the same muscle again. Strain injuries lead to long-term, potentially permanent, loss of muscle mass, thereby weakening the muscle. Muscle atrophy is likely a major factor in the high re-injury risk. Further, strain injuries are associated with a long-term inflammatory response.

In the current study, the investigators seek to study interventions to prevent the loss of muscle mass and elaborate on strategies to address the prolonged inflammation observed at the site of the injured muscle.

The primary aim of this study is to investigate the effect of protein supplementation on the reduction of muscle atrophy following a severe muscle strain injury in comparison to a carbohydrate supplement. As a second purpose, this study aims to elaborate on findings of prolonged inflammation intra-/ intermuscular by large-scale protein analysis and the characterization of cells active at the site of injury.

The study includes the following hypotheses:

1. Protein supplementation administered in combination with a gradually increasing loading regime (rehabilitation with weekly progression in load/ intensity) will be effective in reducing the injury-related loss of muscle mass.
2. The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis.
3. Cells belonging to the group of fibro-adipogenic progenitors will be accumulating intra- and inter-muscularly.


Eligibility Criteria:
Inclusion criteria:

* Sports-active men and women
* Acute muscle strain injury in either the calf muscles or the hamstring muscles
* Visible tear at the muscle-connective tissue interface visible on an US scan as a hypo-/ hyperechoic area

Exclusion criteria:

* Unwillingness to return to sports
* Claustrophobia
* Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within 3 months prior to the strain injury
* Smoking
* Diagnosed or suspected type I or type II diabetes
* Diagnosed or suspected connective tissue and/or rheumatic diseases
* Any observed organ dysfunctions
The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)

This study evaluates the effect of whey protein enriched enteral nutrition in addition to exercise training on the preservation of muscle function in critically ill patients.

One half of patients receive whey protein enriched enteral nutrition with a protein intake of 1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein intake of 1 g/kg/day.

Muscle wasting has an enormous impact on long-term physical performance and quality of life of intensive care survivors. Limitation of muscle wasting might therefore improve physical performance and quality of life. Data on high protein nutritional intake in addition to a standardized exercise training program to prevent skeletal muscle wasting during critical illness are lacking.

Objective: to determine whether early high protein intake, using an enteral whey protein supplement, in addition to a standardized exercise training program and standard enteral nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo muscle function and mass, clinical outcomes and quality of life in critically ill patients. Secondly, to determine whether high protein intake, in addition to standardized exercise and standard enteral nutrition, increases muscle protein synthesis and attenuates activation of the Ubiquitin-Proteasome pathway in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the intensive care
* Mechanically ventilated
* Expected duration of ventilation of 72 hours
* Expected to tolerate and require enteral nutrition for more than 72 hours
* Sequential organ failure assessment (SOFA)-score\>6 on admission day
* Written informed consent of patient or legal representative

Exclusion Criteria:

* Contra-indication to enteral nutrition
* Short bowel syndrome
* Child C liver cirrhosis or acute liver failure
* Dialysis dependency
* Requiring other specific enteral nutrition for medical reason
* Body mass index (BMI) \> 35 kg/m2
* Extensive treatment limitations
* Disseminated malignancy
* Haematological malignancy
* Primary neuromuscular pathology
* Chronic use of corticosteroids for \> 7 days before ICU admission
* Contra-indication for muscle biopsy (need for uninterrupted systemic anticoagulation, prothrombin time \>1.4 , Thrombocytes \<100).