cyrilzakka/clinical-trials huggingface dataset:
New Postoperative Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling Due to Epiretinal Membranes

Epiretinal membranes (ERM) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. Peeling of ERM during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. Occurrence of new intraretinal cystoid changes was described to be associated with a lower level of visual acuity after surgery, compared to patients, that never had intraretinal cystoid changes Aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

Epiretinal membranes (ERM) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. While ERM are rare among young people, they have prevalence rates of up to 30% in the age groups of 70 years or older. Peeling of ERM during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. Nevertheless, there is a risk for development of new intraretinal cystoid changes after peeling of ERM in about 10% of patients. Preoperative presence of intraretinal cystoid changes was already described as a risk factor for postsurgical presence of intraretinal cystoid changes and and occurrence of new intraretinal cystoid changes was described to be associated with a lower level of visual acuity after surgery, compared to patients, that never had intraretinal cystoid changes. Biomarker in presurgical optical coherence tomography (OCT) have been described to be associated with postsurgical results. Using a multivariable approach of analysis, presurgical DRIL and higher central macular thickness (CMT) were significant negative predictors on postsurgical visual acuity three months after surgery. However, influence of preoperative OCT biomarkers on development of new postsurgical intraretinal cystoid changes was not examined in theses studies. Aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* presence of an idiopathic ERM with decrease in visual acuity affecting activities of the daily life
* undergone pars plana vitrectomy with membrane peeling with application of periocular triamcinolone acetonide and a prolonged application of steroidal eye drops for three months after surgery, performed by a single surgeon in the time period from 01/08/2020 to 31/05/2023.
* presence of a follow-up examination at our department three months after surgery (+-1 month), including OCT with accurate image quality for analyzing the presence or absence of intraretinal cystoid changes and visual acuity testing.
* age of 18 years of older.

Exclusion Criteria:

* age below 18 years
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC

For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.

Eligibility Criteria:
Inclusion Criteria:

* UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
* Whole body FDG-PET-scan before start of therapy available: No distant metastases
* CT or MRI of the brain before the start of radical therapy available: No brain metastases
* Platinum-based chemotherapy is mandatory
* Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
* Radiotherapy dose without surgery at least a biological equivalent of 60Gy
* No prior cranial irradiation
* Patients must sign a study-specific informed consent at the time of registration

Exclusion Criteria:

* The opposite of the above
Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment

In heart failure patients, neuropsychological disorders have been prospectively linked to frequent hospitalizations, recurrent cardiac events, and mortality. Cognitive dysfunction is also a frequent comorbidity in heart failure (HF) patients. The benefit of cardiac rehabilitation between patients with cognitive dysfunction and patients without cognitive dysfunction is unknown. Investigators hypothesize that patients with cognitive dysfunction benefit more from cardiac rehabilitation programs than patients without cognitive dysfunction.

Investigators retrospectively reviewed HF patients discharged from acute HF hospitalizations between March 2015 and May 2021 at the heart failure center, Kaohsiung Chang Gung Memorial Hospital. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. Participants may have cognitive impairment when their LNNB-S \>=10. A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II cardiac rehabilitation (CR) after the cardiopulmonary exercise test (CPET) within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result. Participants who received at least one exercise session of phase II CR were considered as receiving CR. Other participants were considered non-receiving CR. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality in four groups (Group a: Candidates without cognitive impairment and receiving CR. Group b: Candidates without cognitive impairment and not-receiving CR. Group c: Candidates with cognitive impairment and receiving CR. Group d: Candidates with cognitive impairment and not-receiving CR.)

Eligibility Criteria:
Inclusion Criteria:

* acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF \<=40%) and discharged alive from the hospital.
* Completed cognitive and psychological functional assessment.
* Aged \>= 20 years of age, male or female.
* Received heart failure disease management coordinated by an HF specialist nurse as described before.

Exclusion Criteria:

* Estimated survival time \< 6 months.
* Long-term bedridden for more than 3 months.
* Terminal heart status. 4. Cannot cooperate with all functional studies.
Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt

The study is a small-scale, short-term unblinded feasibility study to explore the acceptability and feasibility of implementing a reduced-sodium iodised salt intervention in Nigeria. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age.

Reduced-sodium salts are a proven method for reducing sodium intake and lowering blood pressure. No studies to date have tested the effects of sodium reduction on the rise in blood pressure with age during adulthood or the critical periods of childhood and adolescence. The investigators want to explore whether reducing dietary sodium intake using reduced-sodium salt in comparison to regular salt, will attenuate the rise in blood pressure with age. This feasibility study aims to determine the feasibility of implementing a reduced-sodium iodised salt (66% potassium chloride, 34% sodium chloride) intervention in Nigeria. Specifically, the investigators will explore the feasibility of recruiting households with at least one child or adolescent 6-17 years of age and one adult ≥18 years, the acceptability of the reduced-sodium salt intervention, adherence to study procedures and data collection methods, and the effect of the reduced-sodium salt intervention on blood pressure. Secondary outcomes include household eligibility, household composition, willingness to engage in monthly follow-up visits in a longer-term trial, blood pressure, urinary sodium and potassium concentrations, height and weight. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age. The study will be conducted in two rural communities in Nigeria and will recruit 30 households (approximately 150 participants). All participants will be provided with the reduced-sodium salt intervention to replace all regular salt used for cooking, seasoning and food preservation over a 2-month period; there will be no control. Follow-up visits will be at 1 month and 2 months after the baseline visit, conducted either at the home or a local community healthcare centre.

Eligibility Criteria:
Inclusion Criteria:

* At least one household member is a child or adolescent (6-17 years) and at least one household member is an adult (≥18 years)
* All household members consume greater than half of meals as food prepared in the home (self-report)
* All household members provide signed informed consent/assent (consent obtained from legal guardians for those \<18 years of age; assent also obtained from children/adolescents ≥12 years of age)

Exclusion Criteria:

* Any household member has serious renal impairment.
* Any household member uses a potassium-sparing diuretic.
* Any household member uses a potassium supplement.
* Any household member has other reason for concern about the use of reduced-sodium salt.
Forensic Case and Forensic Evidence Management Training: Paramedic Student Example

This study aimed to provide forensic case and evidence management training to paramedic students and to evaluate the effect of the training on the knowledge level of the students.


Eligibility Criteria:
Inclusion Criteria:

* Paramedic students studying in the 1st and 2nd grades of the First and Emergency Aid Programme who volunteered to participate in the study.

Exclusion Criteria:

* Paramedic students who are not studying in the First and Emergency Aid Programme and who did not volunteer for the research
Ultrasound to Facilitate Stone Passage

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Subjects will be included across three phases:

Phase 1: 20 subjects to demonstrate initial feasibility Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)

This study is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA.

Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.

Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting with at least one kidney stone
* Stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging
* Individuals with SCI - (Phase 2b only)

Exclusion Criteria:

* Individuals under 18 years of age
* Individuals who are pregnant or who are trying to get pregnant
* Prisoners
* with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
* Individuals who are unable to read or understand English
* Individuals who are unable or unwilling to participate in follow up activities
* Individuals who cannot be positioned for ultrasound imaging
* Individuals with uncorrected bleeding disorders or coagulopathies
* Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
* Individuals with a solitary kidney
* Individuals with an uncorrected urinary tract obstruction
* Individuals with an untreated infection
* Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
* Individuals who have received two previous investigational procedures for the same stone target
* Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.
Effectiveness of Cervical Facet Joint Nerve Blocks

1. To demonstrate whether:

   i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

   ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical facet joint pain when used with facet joint nerve blocks.
2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive cervical facet joint nerve block with or without Sarapin and Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
3. To determine the adverse event profile in both groups.


Eligibility Criteria:
Inclusion Criteria:

Positive for facet joint pain with comparative local anesthetic blocks

Candidates are over 18 years of age

Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months.

Exclusion Criteria:

Negative or false-positive response to controlled comparative local anesthetic blocks

Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent

Uncontrolled major Depression or uncontrolled psychiatric disorders

Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.

Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function

Women who are pregnant or lactating

Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints.

Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.

Appropriate adult cochlear implant candidates with sensorineural hearing loss, from English French Canadian centres and Danish centre, received Neuro Zti cochlear implant and fit with Neuro One sound processor.

Speech perception testing, using HINT (Hearing In Noise Test) sentences in quiet (65 dB SPL) (decibel, Sound Pressure Level) and in noise (+10 dB SNR) (decibel, Signal-to-Noise-Ratio), will be administrated pre-operatively in the best listening conditions and 3, 6, and 12 months post-activation in the implanted ear.

Adverse events will be collected during the surgery and over the post-surgical period from activation to12 months post-activation.

Safety will be assessed on the overall English, French and Danish participants. Efficacy will be assessed on English speaking participants.

Eligibility Criteria:
Inclusion criteria

* Adults, eighteen (18) years of age or older.
* Bilateral severe-to-profound sensorineural hearing loss, defined by pure-tone average (PTA) ≥70 dB HL (Hearing Level) at 500, 1000 and 2000 Hz on both ears.
* HINT sentences recognition scores in quiet ≤ 50% correct, in the best-aided listening condition.
* Post-lingual onset of deafness.
* Primary implantation (no re-implantation).
* Up-to-date pneumococcal vaccine.

Exclusion criteria

* Medical conditions that contraindicate undergoing cochlear implant surgery (middle ear diseases i.e. AOM/CSOM (Acute Otitis Media/Chronic Suppurative Otitis Media) , lesions of auditory nerve, pathologies of central auditory pathway, otosclerosis; cochlear malformation i.e. Mondini malformation, cochlear ossification, large vestibular aqueduct).
* Unrealistic expectations regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and medical device.
* Unwillingness or inability of the candidate to comply with all investigational requirements.
Angiotensin II in General Anesthesia

Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.

Hypotension in adult patients undergoing general anesthesia is common. Many of the body's normal mechanisms to maintain adequate blood pressure in the non-anesthetized state are significantly altered by anesthetic agents, which may lead to hypotension. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. In response to this it has become standard of care to attempt to maintain blood pressure levels within 20% of baseline in most patients under anesthesia. Maintaining the baseline blood pressure is important as patients may have pathology such as coronary artery disease, carotid stenosis, and renal artery stenosis, and hypotension may compromise the perfusion of these organs. Vasodilation also plays a key role in hypotension due to general anesthesia. Therefore, the intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.The objective of this study is to determine the infusion rate of Ang II that is necessary to return systolic blood pressure (SBP) to within 5% of baseline or greater in patients with essential hypertension taking ACE inhibitors, ARBs, or different classes of antihypertensive agents and further to determine the plasma levels of different RAAS components

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension and treatment with at least one medication including an ACE inhibitor, ARB, and other agents for greater than 2 months
* Patients undergoing general anesthesia

Exclusion Criteria:

* BMI \> 40
* History of deep venous thrombosis / thromboembolic disease
* History of stroke,
* Baseline SBP of ≥ 160 mmHg,
* History of myocardial infarction or cardiac stents
* Difficult airway
* Asthma
* Congestive heart failure
* Chronic obstructive pulmonary disease
* Pregnant patients
Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women in a Randomized Controlled Trial

The study aims to evaluate the efficacy of a family-based dietary monitoring during pregnancy on gestational weight gain in pregnant women. The study will be conducted as a randomized controlled trial, women will be randomly allocated into two groups: a group receiving family-based dietary monitoring, and a control group receiving individual dietary monitoring per standard recommendation.


Eligibility Criteria:
Inclusion Criteria:

Adult (+18 years old) Pregnant woman who can be accompanied by a member of the household, adult sharing at least 1 meal per day with her. Affiliated to the social security. French speaking person (read/written and spoken). Single pregnancy between 8 SA and 16 SA. Starting BMI between 18.5 and 35

Exclusion Criteria:

* Person under legal protection or guardianship
* Women suffering from a disease requiring a dietary follow-up:
* Type 1 or type 2 diabetes.
* Gestational diabetes diagnosed on the basis of fasting blood sugar.
* History of bariatric surgery.
* Eating disorders.
* Metabolic pathologies leading to special diets (phenylketonuria).
* Digestive pathologies (with an indication) with special diets
* Women who have lost more than 10% of their weight at the beginning of pregnancy