cyrilzakka/clinical-trials huggingface dataset:
Nutritional Status of Critically Ill Diabetic Patients

1. To investigate the nutritional status of patients with type 2 diabetes mellitus in the intensive care unit.
2. To detect the impact of nutritional status on outcome (mortality, length of hospital stay,duration of mechanical ventilation, and need for renal replacement therapy)

Nutrition support in the Intensive Care Unit is very important since it has a significant impact on recovery from illness and overall outcome. Patients in the intensive care unit have a higher risk of malnutrition than patients undergoing general admission to hospitals . In critically ill patients, malnutrition may result in impaired immunological function, impaired ventilatory drive, and weakened respiratory muscles, leading to prolonged ventilatory dependence and increased infectious morbidity and mortality.

An appropriate nutritional support is indispensable to critically ill patients, who are almost at the hyper-metabolic state of their clinical condition such as trauma, sepsis, and major surgery. These critical conditions result in a disproportional release of cytokine and stress hormones that alter energy and protein metabolism and eventually lead to malnourishment.

A recent systematic review revealed the strikingly high prevalence of malnutrition in intensive care unit patients (ranged from 38% to 78%), which is associated with the patients' increased morbidity, mortality, and hospital-related cost.The increased dependency on mechanical ventilation, length of hospital stay, intensive care unit readmission, persistence of infection, and risk of hospital mortality associated with undernutrition, make it an important dilemma in the care of Intensive Care unit patients.

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose.( and associated with serious complications, demand for multimodal treatment, and significant economic burden With the development of complications and hospital lengths of stay, life expectancy is worsened with diabetes, and nutritional status is generally correlated with these total outcomes.

In this research,investigators will evaluate the nutritional state in critically ill diabetic patients with type 2 diabetes mellitus, and detect the impact of poor nutritional status on out comes regarding mortality, length of hospital stay , length of mechanical ventilation, and need for renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

Age above 18 years. Diabetic type ll. Admitted for more than 48 hours.

Exclusion Criteria:

Type 1 Diabetes Mellitus. Age under 18 years Readmission in intensive care unit. Adimssion for less than 48 hours
Clinical Investigation of the Bi Flex M Multifocal IOL

During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles for viewing near objects. This study has been designed to look at how well a multifocal IOL corrects distance and near vision in comparison with a conventional monofocal IOL. Both types of IOLs are commercially available and are commonly implanted. Using new non-invasive methods we hope to be able to better judge the visual performance of these IOLs. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Age related cataract patients requiring cataract surgery with phacoemulsification.
* Patients requiring primary IOL implantation
* Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
* Patients with normal anterior segments apart from cataracts
* Subjects with clear intraocular media other than cataract

Exclusion Criteria:

* Preexisting pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:
* Microphthalmia
* Corneal decompensation or Endothelial Insufficiency
* Pseudo exfoliation
* High myopia
* Pars planitis
* Patient with greater than 1 dioptre of preoperative corneal astigmatism
* Subjects who are expected to require retinal laser treatment
* Previous intraocular and/or corneal surgery
* History of uveitis, glaucoma, proliferative diabetic retinopathy, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
* Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location
* Subjects using a systemic medication that is known to cause ocular side effects
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
* Subjects who have only one eye with potentially good vision
* Patients who are not willing to cooperate for the follow up period
* Visual eccentricity of greater than 0.7mm
* Pregnant women
* Patients where it is not possible to take informed consent
Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.

In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Admitted to a study hospital
* Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
* Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
* Written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion Criteria:

* No matching plasma donor (Exact matching in both the ABO system is required)
* Unavailability of plasma
* Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
* Estimated glomerular filtration rate \<60 (kidney failure stage III or more)
* Pregnancy (urinary-hcg)
* Breast feeding
* History of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy)
* Inability to give informed consent
rTMS and Body Shape Perception

Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.

This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS.

Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described).

Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age above 18
* Restrictive anorexia nervosa with a disease duration more than one year and less than three years.
* Body Mass Index below 16
* Patient receiving or having received optimal treatment for anorexia nervosa
* Right-handed
* Normal blood ionogramme
* Previous stable antidepressor treatment for one month and no expected modification in the three following months
* Patients arriving by car with someone else or by public transportation

Exclusion Criteria:

* Pregnancy
* Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc.
* History of epileptic seizure
* Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.)
* History of previous rTMS
Arithmetic Abilities in Children With 22q11.2DS

The study ARITH22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome.

Children with 22q11.2 deletion syndrome often have arithmetic learning disability because of magnitude representation impairment. Previous works suggested that magnitude representation impairment could be a result of endogenous visuo-spatial attention dysfunction in 22q11.2DS. Nevertheless this relationship is still poor explored. The influence of visuo-spatial abilities on arithmetic achievement could also be modulated by developmental age. The study ARITH22 will test these hypotheses thanks to magnitude comparisons tasks, in children with 22q11.2 deletion syndrome and matched children without developmental disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of 22q11.2 deletion syndrome or no developmental disease
* Aged from 4 to 11 years old
* French language

Exclusion Criteria:

* Diagnosis of intellectual deficiency according to DSM 5 criteria
* Drug prescribed for somatic condition that could influence cerebral functioning
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Eligibility Criteria:
Inclusion Criteria:

* Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
* CD4 count equal to or greater than 100 cells/mm3 at Screening.
* Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

* Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
* Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
* CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.
Physical Parameters in Osteoarthritis Stages

To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.


Eligibility Criteria:
Inclusion Criteria:

* having the same OA grade in both knees
* volunteering to participate in the study
* not having undergone previous lower extremity surgery

Exclusion Criteria:

* neurological disorders;
* those with a history of surgery related to the lower extremities;
* those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis;
* those who had neurological, orthopedic, or cognitive disorders that would prevent walking;
* those with a diagnosis of diabetes, obesity, or rheumatological disorders;
* those who had received intra-articular injection therapy within the last three months;
* and those with malignancy or perception problems.
A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia

The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.

Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited.

Recently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings.

A novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.

Eligibility Criteria:
Inclusion Criteria:

1. They have received colonoscopy for screening, surveillance or symptom investigation;
2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;
3. They have histologically proven colorectal neoplasia.
4. Written consent obtained

Exclusion Criteria:

1. Poor quality endoscopic images and videos defined as:

   1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);
   2. Artifacts due to mucus, air bubbles, stool, or blood.
2. Active gastrointestinal bleeding;
3. Fulminant colitis;
4. Obscured view due to poor bowel preparation;
5. Artificial staining of lesion due to chromoendoscopy.
6. Unable to obtain informed consent
Different Resectoscopes Effects to Optic Nerve Sheath Diameter

In this study, in patients with benign prostatic hypertrophy, monopolar and transurethral prostate using bipolar techniques in resection; serum electrolytes in the perioperative period, osmolarity can occur in hemodynamic parameters the effect of changes on optic nerve diameter by ultrasonography.

This study is for TURP operation for Benign Prostate Hypertrophy patients. When patient comes to the operating room, routine preparations will be made. Haemodynamic parameters and over-the-eye with Optic nerve diameter will be checked with ultrasound before and 10 minutes after spinal anesthesia. Monopolar for patients according to the preference of the surgical team resectoscope technique or bipolar resectoscope technique will be applied. During the operation Blood pressure, pulse minute the number of irrigation solutions used and the amount of intravenously administered serum, operation time will be saved. Optic nerve sheath diameter after the operation would be checked again. intraoperative and postoperative complications in the waking room (respiratory distress, hypotension, hypertension, bradycardia, tachycardia, vomiting, headache, restlessness, seizure, arrhythmia, vision disorder) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Ages 50-80
* ASA I-II
* Planned TUR-P operation

Exclusion Criteria:

* Heart or respiratory failure
* Koagülation diathesis
* Eyedisease related patients
Navigating the Clinical Research Process for Glioma

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of glioma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future glioma patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of glioma
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
A Study for Post op Inflammation After Cataract Surgery

This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.

There will be approximately 40 eyes with two groups:

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for study participation if they:

1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
2. Are willing and able to comply with clinic visits and study related procedures
3. Are willing and able to sign the informed consent form
4. Patients age 18yo+

Exclusion Criteria:

Subjects are not eligible for study participation if they:

1. Have active infectious systemic disease
2. Have active infectious ocular or extraocular disease
3. Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
4. Have known hypersensitivity to dexamethasone or are a known steroid responder
5. Have a history of ocular inflammation or macular edema
6. Are currently being treated with immunomodulating agents in the study eye(s)
7. Are currently being treated with immunosuppressants and/or oral steroids
8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)
9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
10. Have a history of complete punctal occlusion in one or both punctum
11. Currently use topical ophthalmic steroid medications
12. Are currently pregnant or nursing.
13. Are unwilling or unable to comply with the study protocol
14. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash

With the present study the investigators wish to examine if reconceptualisation of pain, by educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of pain, in combination with psychologic innoculation is able to influence maladaptive (pain) cognitions, pain (inhibition) and movement performance, and reduce symptoms.

Results from a previous pilot study conducted by the same investigators suggest that intensive pain neurophysiology education (PNE) is able to increase pain thresholds and improve pain behavior and pain-free movement performance in patients with CWAD. However these results have not been confirmed in a randomized controlled trial.

In addition, it has been emphasized that PNE is not a standalone treatment and that future research should examine PNE in combination with other treatment modalities. Another treatment modality that challenges people's beliefs and barriers is psychological inoculation (PI). However, it has not yet been examined if PI could be a useful component in the rehabilitation of chronic pain patients.

Eligibility Criteria:
Inclusion Criteria:

* WAD grades I to II according to the Quebec Task Force criteria
* with chronic pain as result of a whiplash injury
* 18-65 years of age and with Dutch as their native language will be able to participate

Exclusion Criteria:

* other comorbidities or health issues that could explain the pain complaints
* \< 18years \> 65 years
* pregnant