cyrilzakka/clinical-trials huggingface dataset:
PERCEPTION of QUALITY of LIFE in PATIENTS UNDERGOING ENDOSCOPIC VERTICAL GASTROPLASTY: a DESCRIPTIVE EXPLORATORY STUDY

An emerging alternative to bariatric surgery for the treatment of obesity is bariatric endoscopic gastroplasty (gve), which offers a less invasive approach with fewer complications. however, the weight loss achieved through this technique is generally lower than that achieved with traditional bariatric surgery, leaving the impact on patients' quality of life uncertain. the aim of this multicentre exploratory descriptive study is to investigate the perception of the quality of life of patients with obesity undergoing gve, conducted at the complex operative unit of surgical digestive endoscopy of the university policlinico Agostino Gemelli IRCCS foundation as the promoting centre. italian patients over 18 years old, in post-gve follow-up for at least six months, with access to and familiarity with a computer or tablet will be included. data will be collected via a single semi-structured interview on microsoft teams, audio recorded and transcribed in full, and analysed using nvivo v1.6.2.32. participants' statements will be categorised into semantic categories and subsequently refined into sub-themes and themes through an iterative process.


Eligibility Criteria:
Inclusion Criteria:

* Age: Patients older than 18 years.
* Treatment: Patients who have undergone GVE surgery and have been in post- surgery for at least six months.
* Access and technological competence: Patients who have a computer or tablet at home and are familiar with their use.
* Informed consent: Patients who are able to understand and give informed consent informed consent to participate in the study.
* Language comprehension: Patients who have a good understanding of the language Italian language, both written and spoken, to ensure correct completion and understanding of the informed consent and the study instructions.

Exclusion Criteria:

* Patients who have been enrolled in experimental studies involving additional procedures during GVE will be excluded
Efficacy Study of Bowel Preparation Before Colonoscopy

The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
* Are able to communicate with study personnel and comply with study requirements.
* Are able and willing to follow study-specified testing, diet, and hydration regimen.
* Have been informed of the nature and risks of the study and have given written informed consent.

Exclusion Criteria:

* Have known or suspected liver disease or any history of abnormal liver function tests.
* Have clinically active cardiovascular disease within the past 6 months.
* Have blood pressure greater than 150/90 mm Hg.
* Have known or suspected renal insufficiency.
* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
* Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
* Have diabetes or a history of diabetes.
* Have clinical evidence of dehydration.
* Are pregnant or breast-feeding.
* Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
* Use prohibited medications of the study in the defined timeframes.
* Have received any investigational agent within 30 days before dosing.
* Have any known contraindications to the study treatment.
* Have any known or suspected allergies to the components of the study medication.
* Have any other condition which would make the subject unsuitable for inclusion in the study.
Presep and Vascath Interaction Study

This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.

The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the MICU
* PreSep venous oxygen saturation central venous catheter already in place
* VasCath central venous dialysis catheter already in place
* Planned hemodialysis

Exclusion Criteria:

* Patient unable to undergo hemodialysis
* Contraindication for PreSep or VasCath catheters
MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled

Exclusion Criteria:

* Diagnosis of glaucoma other than open angle glaucoma
* Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
* Neovascular glaucoma in the study eye
* Prior glaucoma surgery in the study eye
* Clinically significant corneal disease
* Patients with poor vision
ESGVS: Sclerotherapy With Lauromacrogol

To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

A multicenter randomized double blind study to evaluate the efficacy and the tolerance of echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great Saphenous Vein (GSV) insufficiency.

One hundred fifty eligible patients will be recruited during 6 months from 9 study centers with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2 ,and 3 years.

After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3% Lauromacrogol 400 foam (ratio 1:1).

Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years.

Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional injection of 4 ml of foam can be performed if needed.

Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2, and 3 years.

The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be a criterion of therapeutic failure.

The therapeutic success or failure criteria are evaluated by a non investigator angiologist for 5 patients randomized from each investigational site at 1, 2 and 3 years.

Eligibility Criteria:
Inclusion Criteria:

* 25 - 75 years
* Hawaii CEAP classification : C2-5 Ep, As2-3 Pr
* Clinical Varicose veins C2, Edema C3, Skin changes C4, Healed ulcer C5
* Etiology Ep Primary GSV insufficiency
* As2-3: Ostial and or crural truncular GVS incompetence
* Maximal inferior diameter of the leg GSV (patient in decubitus) between 4 and 8mm
* Pr: reflux by echo doppler in orthostatism \> 1 second
* Information consent form signed by the investigator and the patient.

Exclusion Criteria:

* deep venous reflux (CEAP: Ad)
* Short saphenous vein or non saphenous network insufficiency (CEAP: A4-5)
* Clinical class: C1 or C6
* Recurrent GSV varicose veins after stripping
* Thrombophilia or antecedent of deep vein thrombosis
* Psychiatric disorders
* Known allergy to Lauromacrogol or to one of its component
* Arteriopathy. (IPS \< 0.8)
* Post-thrombotic disease
* Chronic hepatoma
* Renal insufficiency (creatinine \> 150 micromol/l)
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).


Eligibility Criteria:
Key Inclusion Criteria include:

1. Participants who completed participation in study AMAG-FER-IDA-301 \[NCT01114139\]
2. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
Pulmonary Complications in Elderly Patients

The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* ASA\<III、 general anesthesia, 60-80 years, BMI\<30kg/m2, pneumoperitoneum time\>0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder)

Exclusion Criteria:

* Severe anemia (Hb\<60g/L), OSA, severe COPD (FEV1\<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to ICU, heart function grade III-IV, severe liver and kidney dysfunction (Child B or C, dialysis), intraoperative bleeding greater than 30% of blood volume.
Foveal Sparing ILM Peeling With ILM Flap Transposition

Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

Idiopathic full thickness macular holes lead to central defects in the visual field and to deterioration of the visual acuity. Introduction of internal limiting membrane (ILM) Peeling techniques lead to significant increase in closure rates of the macular holes.

Foveal sparing ILM peeling represents a surgical technique for macular hole repair with less surgical trauma with high closure rates of the macular hole, compared to classic ILM Peeling \[Ho et al. 2014, Murphy et al 2019\]. The combination of foveal sparing ILM Peeling with the established ILM flap techniques \[Michalewska et al 2010 und 2015\] offers the potential of better improvement in postsurgical visual acuity with the high closure rates, due to ILM flaps.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

Eligibility Criteria:
Inclusion Criteria:

* Vitrectomy with foveal sparing ILM peeling with ILM flap transposition in the time period from 1.10.2020 to 8.7.2022
* Age 18 and older
* Idiopathic full thickness macular hole as indication for surgery
* Full follow-up, including visual acuity testing and OCT preoperative, and 3 months after surgery.

Exclusion Criteria:

* Age \<18 years
Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering

The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP).

In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study.

Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test:

* Method "B1": invitation with test sent to home without prior information letter
* Method "B2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time.

Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).


Eligibility Criteria:
Inclusion Criteria:

* 50 to 74 years old
* Resident of Centre Val de Loire French area
* Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period
* Affiliated to the health insurance scheme

Exclusion Criteria:

* CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease)
* Colonoscopy in the previous 5 years)

Subjects refusing data transmission to research team will be excluded from statistical analyses.
T2MR PCR Detection of ESKAPE Pathogens in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis

Our prospective observational study focuses on the rapid detection of etiologic agents of pyogenic spondylodiscitis and infective endocarditis using the T2 Bacteria Panel (T2Biosystems). This diagnostic method combines polymerase chain reaction (PCR) and T2 magnetic resonance for detection of bacterial DNA from whole blood samples. It detects six pathogens known by the acronym ESKAPE (E. coli, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. faecium). In recent years, similar studies using the Bacteria Panel and Candida Panel have been performed in patients with bloodstream infections, leaving us with optimistic results.The aim of this study is to verify whether T2B can identify the etiologic agents of localized infections, specifically spondylodiscitis and endocarditis, with better sensitivity and specificity and shorter time to result compared to conventional diagnostics from blood culture. Rapid detection of pathogen may reduce time to targeted pathogen-specific antibiotic therapy and subsequently improve outcomes, shorten the treatment and contribute to slowing the development of antibiotic resistance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spondylodiscitis or/and facet joint infection or/and sacroileitis
* Diagnosis of infective endocarditis
* Antibiotic treatment not received or not longer than 24 hours
* Ability to give informed consent

Exclusion Criteria:

* Spine infection or/and endocarditis not confirmed
* Antibiotic treatment longer than 24 hours
* Inability to give informed consent
Study of ANX007 in Participants With Primary Open-angle Glaucoma

This is a double-masked, randomized, sham-controlled study evaluating two dose levels of ANX007 vs sham, administered as repeat Intravitreal (IVT) injections in patients with Primary Open-angle Glaucoma.

This is a phase 1b, double-masked, sham-controlled study evaluating 2 dose levels of ANX007 administered as 2 IVT injections separated by 4 weeks. Approximately 15-29 subjects will be enrolled. An interim analysis of the initial set of 15 participants may be conducted. Based on this analysis, an additional 10-14 participants may be enrolled at a 1:1 ratio to receive one of the two dose levels.

The primary objective is to evaluate the safety and tolerability of repeat IVT injections of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the anterior chamber fluid pharmacokinetics (PK) of ANX007, PD effect of ANX007 on anterior chamber fluid C1q activity, and immunogenicity. An exploratory objective will evaluate ocular PD effect of ANX007.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 years, and above.
2. Diagnosis of primary open-angle glaucoma.
3. Ability to perform a reliable visual field test in the study eye with a cutoff of 33% for fixation losses and 33% for false-positive response rates.
4. Intraocular pressure (IOP) \<21 mm Hg at screening and Day 1.
5. The IOP treatment regimen in the study eye should be stable for at least 4 weeks prior to injection, with no change in the IOP treatment regimen anticipated throughout study participation.
6. Ability to comply with the requirements of the study and complete the full sequence of protocol specified injections, procedures, and evaluations.

Exclusion Criteria:

1. Extensive glaucomatous visual-field damage with a mean deviation worse than -18 dB on Humphrey visual field testing.
2. Any current or prior ocular pathology, other than glaucoma, which could interfere with the conduct of the study including, but not limited to, retinal or optic nerve disease and media opacity in the study eye.
3. History of intraocular inflammatory or infectious eye disease in the study eye.
4. Ocular trauma in the study eye within the preceding 6 months.
5. A history of uncomplicated cataract surgery less than 3 months prior to injection, or trabeculectomy, iridotomy, or other ocular procedures in the study eye that could affect drug distribution and excretion.
6. Any abnormality preventing reliable tonometry in the study eye.
7. Concurrent use of glucocorticoid medications administered by any ocular or systemic route. Nasal, inhaled, and dermatologic (if not administered around the eyes) glucocorticoids are permitted.
8. Receiving monoamine oxidase inhibitor therapy or patient-reported hypersensitivity to any component of apraclonidine, brimonidine, clonidine, phenylephrine, povidone iodine, proparacaine, or ANX007.
9. Active or history of malignancy within the past 5 years with the exception of curatively treated, basal cell carcinoma.
10. Previous treatment with another humanized monoclonal antibody, Fab or Fab'2.
11. History of any autoimmune or neurologic disease.
Hyperglycemia in Surgical Infections

The primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens.

This is a multi-center explanatory trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (NSTI). The primary objective of this study is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed to design and direct a larger multi-center trial if necessary. The multi-center trial (n \>100) will have adequate power to identify a 30% difference in favorable outcome defined as discharge alive from the hospital without an amputation in less than the median number of hospital days. Secondary objectives include evaluation of specific hypotheses relating the intervention to cytokine and neutrophil responses. These preliminary data will provide the basis for future research and grant applications, lend insight into the mechanisms by which hyperglycemia results in adverse effects, and improve outcome through the development of evidence-based therapeutic strategies for patient care.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be enrolled at one of the following centers: the LBJ General Hospital (UT-Houston), the Ben Taub General Hospital (Baylor Houston), The Methodist Hospital (Texas Medical Center), or the University of Texas Health Science Center at San Antonio and the Brooke Army Medical Center.
* We will attempt to enroll all eligible patients with a diagnosis of a necrotizing soft tissue infection (NSTI), including Fournier's gangrene, confirmed in the operating room regardless of age, ethnicity or gender.

Exclusion Criteria:

* Pregnant patients
The Effectiveness of Gamification vs. Traditional Teaching in Undergraduate Medical Education

This study will evaluate the effectiveness of a gamification-based learning method (board game) versus traditional teaching (lecture) in enhancing the knowledge of acute cholecystitis and pancreatitis among medical students in the general surgery ward at Rasoul Akram Hospital. This study will be conducted as an extra-curricular program, using pre- and post-tests to determine the effectiveness of gamification in general surgery learning within undergraduate medical education. The board game will incorporate innovative educational strategies to engage students in learning about acute cholecystitis and pancreatitis


Eligibility Criteria:
Inclusion Criteria:

* Medical students in their clinical externship in the general surgery ward.
* Willingness to participate voluntarily.

Exclusion Criteria:

* Previous knowledge or exposure to acute cholecystitis and pancreatitis.
* Lack of consent or inability to attend the sessions.
* Medical students not currently assigned to general surgery clinical rotations.
Health System Methods to Improve Nursing Retention Amidst Ongoing COVID-19 Pandemic: a Mixed Method Study

This study is a mixed-method exploratory study with the aim to determine an objective compensation or mechanism of support from a healthcare system standpoint to aid in retention of nursing staff amidst the ongoing COVID-19 pandemic. It will include semi-structured qualitative interviews of current and prior nursing staff from the Trauma/Surgical floor, Progressive Care Unit, and ICU, in addition to Trauma/Surgical unit and system administrators; the second portion of the study will include a quantitative survey distributed via email to current nurses on the Trauma/Surgical floor, Progressive Care Unit, and ICU to assess ranked priority of additional mechanisms of support to improve intention of retention.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurses on the Trauma/Surgical floor, Surgical Progressive Care Unit, or Surgical ICU who are currently working or who have worked bedside in the past 24 months
* Adult hospital administrative staff

Exclusion Criteria:

* Non-Registered nurses (ie. CNAs, LPNs)
* RNs without clinical bedside experience in the past 24 months
* RNs working on other units beside the Trauma/Surgical floor, Surgical Progressive Care Unit, or Surgical ICU
Lipofilling as a Treatment for Vestibulodynia

The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome.

Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.


Eligibility Criteria:
Inclusion Criteria:

* Vestibulodynia requesting surgery

Exclusion Criteria:

-