cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease

The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are:

What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease?

The participants will:

Undergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Gender unspecified
* Histologically confirmed Ulcerative Colitis
* Diagnosis confirmed by a specialist physician

Exclusion Criteria:

* Patients with any amputation or prosthesis
* Patients with a pacemaker
* Patients with any neoplasm
* Pregnancy or lactation
* With comorbidities such as diabetes, hypertension, heart failure, thyroid problems
Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)

Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism.

In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL.

The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system.
* Patients submitted to bilateral cataract surgery.
* Transparent ocular media, other than the bilateral cataract.

Exclusion Criteria:

* Preoperatory corneal astigmatism greater than 0.75D
* Corneal surgery or trauma prior to cataract surgery Irregular cornea
* Choroidal hemorrhage
* Microftalmos Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Concomitant ocular disease
* Not age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Proliferative diabetic retinopathy
* Amblyopia
* Extremelly shallow anterior chamber
* Severe chronic uveitis
* Rubella
* Mature/dense cataract difficulting fundas assessment preoperatively
* Prior retinal detachment
* Concurrent participation in another investigation with medication or clinical devices
Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 (SARS-CoV-2) Sarcopenia

Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Age range of 60 - 80 years with
* A positive diagnosis of post-COVID-19 sarcopenia

Exclusion Criteria:

* Under medication
* History of lower limb surgeries, fractures
* Cardiac problems
* Respiratory problems
* Neurological problems
* Systemic problems and any other contraindications for aerobic training
Evaluation of a Weight Management Program

This retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use.


Eligibility Criteria:
Inclusion Criteria:

* Records of the first 40 study center participants who enrolled in the OPTIFAST Program from January 1, 2006 through June 30, 2006
* Records of subjects who completed the active weight loss phase of the program
* Records where data is available through the transitional phase of the program

Exclusion Criteria:

* Concurrent use of appetite suppressants or other weight loss medications
Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell transplantation.

PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radiation therapy.

OBJECTIVES: I. Determine if captopril can block or prevent lung injury in patients undergoing autologous bone marrow or stem cell transplantation following cyclophosphamide and total body radiotherapy or high dose chemotherapy. II. Determine a series of surrogate lung injury prediction markers for monitoring patients undergoing therapy.

OUTLINE: This is a randomized study. Patients are stratified according to preparative regimen (high dose chemotherapy versus cyclophosphamide and total body radiotherapy). Patients are randomized into one of two treatment arms. All patients undergo a conditioning regimen consisting of cyclophosphamide daily on days -6 and -5 and total body radiotherapy on day -4 through -1, or high dose chemotherapy per transplantation protocol. Arm I: Patients receive oral captopril 2 to 3 times daily beginning on the first day of the conditioning regimen and continuing until day 100 post autologous bone marrow or stem cell transplantation. Arm II: Patients receive no captopril while undergoing conditioning therapy. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Eligible for existing autologous bone marrow or stem cell transplantation protocols using either a high dose chemotherapy regimen or a cyclophosphamide and total body radiotherapy regimen

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other concurrent medical illness that would preclude study

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior captopril or other ACE inhibitors
A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra

Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Eligibility Criteria:
Inclusion Criteria:

* Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

Exclusion Criteria:

* Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200
Interrater Reliability of Infant Motor Profile

The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.

It is very hard to assess risky infants because of many problems like lack of cooperation, crying, discomfort ect. But with "Infant Motor Profile (IMP)" it is possible to assess motor behavior of risky infants in their daily environment. The assessment relays on video recordings so after recording the motor behavior many people can score the same children many times to have a certain idea about the infant. With this tool it could be easier to set a therapy program after determining the basic motor problem. In Turkey there are a lot of risky infants which later have diagnosed with Cerebral Palsy, Metabolic Disorders and other diseases. Also there are a lot of infants with Down Syndrome (DS) and Spina Bifida (SB). It has been known motor development is impaired with different childhood conditions but there is less information in literature about motor development of children with SB, DS and other diseases. With this study motor status of risky infants between 3- 24 months old will be explored, interrater and intrarater reliability of Infant Motor Profile will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Cerebral Palsy
* Clinical Diagnosis of Down Syndrome
* Clinical Diagnosis of Spina Bifida

Exclusion Criteria:

* Uncontrolled Epilepsy
* Severe Congenital Disorders
Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count

The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.

The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.

The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.

The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years old
* 1 to 9 or 13 to 20 antral follicles
* Caucasian, occidental Europe
* Presence of both ovaries
* Informed consent

Exclusion Criteria:

* Ovarian anomalies
* Menopause
* Pregnancy
* Other diseases
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy

France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.


Eligibility Criteria:
Inclusion Criteria:

* people aged 50 years or more ;
* at high risk of colorectal cancer ;
* living in Rhône administrative departement or Metropolitan Lyon

Exclusion Criteria:

* person with chronic inflammatory bowel disease
* colorectal cancer in diagnosis or treatment period
Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)

The primary objective of the study is to determine the effect of pozelimab on active CD55-deficient protein-losing enteropathy (PLE; CHAPLE).

The secondary objectives of the study are:

* To evaluate the safety and tolerability of pozelimab in patients with CD55-deficient PLE disease
* To evaluate the effect of pozelimab on CD55-deficient PLE (both patients with active disease at baseline and those with inactive disease on eculizumab, switching to pozelimab)
* To determine the effects of pozelimab on albumin and other serum proteins (total protein, immunoglobulins)
* To determine the effects of pozelimab on ascites
* To determine the effects of pozelimab on stool consistency
* To determine the effect of pozelimab on health-related quality of life
* To determine the effect of pozelimab on lab abnormalities observed in CD55-deficient PLE such as hypertriglyceridemia, thrombocytosis, and hypovitaminosis B12
* To describe the effects of pozelimab on the sparing of concomitant medications and reduction in hospitalization days
* To determine the effects of pozelimab on growth
* To characterize the concentration of pozelimab in patients with CD55-deficient PLE
* To assess the incidence of treatment-emergent ADA for pozelimab in patients with CD55-deficient PLE disease


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis
* Active disease as defined by the protocol or inactive disease on eculizumab therapy (and whose treating physician has the expectation of future access to renewed eculizumab treatment should this be required), and is willing to discontinue eculizumab during screening and start pozelimab at baseline with no eculizumab wash-out

Key Exclusion Criteria:

* History of meningococcal infection
* No documented meningococcal vaccination within 3 years prior to screening and patient unwilling to undergo vaccination during the study
* No documented vaccination for Haemophilus influenzae and Streptococcus pneumoniae if applicable based on local practice or guidelines prior to screening and patient unwilling to undergo vaccination during the study if required per local practice or guidelines
* Presence of a concomitant disease that leads to hypoproteinemia at the time of starting pozelimab
* A concomitant disease that leads to secondary intestinal lymphangiectasia such as a fontan procedure for congenital heart disease

Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population

To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or above 18 years
* Written consent
* Heart Team recommends M-TEER

Exclusion Criteria:

* Mitral Stenosis (MV mean PG \> 5 mmHg)
* Cardiogenic shock or hemodynamic instability at the time of intervention
* Active endocarditis
* Participant in another interventional cardiology study
Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic

Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms.

The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.


Eligibility Criteria:
Inclusion Criteria:

* Adult diabetic patient (type 1,2, MODY, secondary, post transplantation) followed by diabetology consultation at the hospital or by a liberal diabetologist
* Subject affiliated to a social health insurance
* Subject able to understand the objectives of the research
* Subject who expressed his non opposition to the research

Exclusion Criteria:

* Pregnant woman
* Patients with acute complications (foot ulcer, post stroke, post IDM)
* Cancer or life expectancy of less than 6 months
* Inability to provide informed information to the subject (subject in an emergency, difficulty of understanding for the subject, etc.)
* Subject under judicial protection
* Subject under guardianship or curatorship
Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system


Eligibility Criteria:
Inclusion Criteria:

* Physically healthy with no relevant allergies or medical problems
* Male or female between the age of 18 and 30.
* Full permanent dentition except for the third molars
* Class I crowded dentition primarily for the lower anterior teeth (moderate crowding - 4-6 mm - according to Little's Irregularity Index)
* Good oral hygiene and absence of periodontal disease
* Malocclusion to be treated with Invisalign aligners (SmartTrack)
* Any ethnic group

Exclusion Criteria:

* Orthognathic surgical cases
* An extraction treatment plan
* Poor oral hygiene
* Patients with syndromes or craniofacial anomalies.
* The use of any other orthodontic appliance than clear aligners' (Invisalign)
Effect of Hip-focused Neuromuscular Activation Exercise on Foot Posture and Neuromuscular Control

This study planned to investigate the effect of hip-focused neuromuscular activation exercise on foot posture and neuromuscular control in symptomatic and asymptomatic participants. We will follow a cross-over study design to compare the effect of hip focused neuromuscular activation exercise or a sham exercise on foot posture and lower extremity biomechanics. Foot posture will be assessed by Navicular Drop Test (NDT), and lower extremity neuromuscular control will be assessed with Star Excursion Y-Balance Test (SEBT-Y) and Frontal Plane Projection Angle (FPPA) during single leg squat before and after the experiments. The results of this study may provide scientific knowledge for a kinetic chain approach during functional foot rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* To be included, participants should be between the ages of 18 and 45 years.

Exclusion Criteria:

* Participants will be excluded from this study if they have a history of lower body trauma or surgery, or positive trendelenburg sign and slump test.
STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18years
* Small hiatus hernia (\< 2-3 cm)
* Los Angeles Grade 'A' or 'B' Reflux Esophagitis
* LES pressure : 5 - 15 mm Hg
* PPI dependent / refractory GERD
* 24 hr acid exposure study showing abnormal esophageal acid exposure \> 4%
* DeMeester Score \>14.7
* Esophageal manometry showing normal peristalsis

Exclusion Criteria

* Age \< 18 years
* Large hiatus hernia (\> 3 cm)
* Los Angeles Grade 'C' or 'D' Reflux Esophagitis
* LES pressure : \< 5 or \> 15 mm Hg
* Underlying coagulation disorder
* Previous Esophageal or Gastric surgery
* H/o coronary artery disease (CAD)
* Esophageal manometry showing ineffective peristalsis