cyrilzakka/clinical-trials huggingface dataset:
Retinal Function in Relation to Long Term Changes in the Glucose Level

The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age \>17 \< 60 years

Exclusion Criteria:

* Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking

Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit

In intensive care unit, various forms of sepsis, undernutrition, surgery, global inflammation, iatrogeny, and mechanical ventilation, contribute to the overall muscular involvement including the diaphragm.

Assessment of diaphragm dysfunction is a critical issue for patients under mechanical ventilation, providing prognosis information and leading to the best therapeutic choices.

Up to now, for sedated ventilated critical care patient, expensive magnetic phrenic nerve stimulation equipment is needed to evaluate diaphragm strength.

In this study, the investigators aim to develop an affordable easy-to-use phrenic nerve stimulation tool, with ultrasonography and a nerve stimulator usually used for neuromuscular transmission monitoring. Hypothesis is that phrenic pacing using this new method is equivalent to the Gold Standard.

Eligibility Criteria:
Inclusion Criteria:

* ICU patient with invasive mechanical ventilation
* Sedated patient with a Richmond Agitation-Sedation Scale of -4 or -5

Exclusion Criteria:

* Contraindication for magnetic stimulation (Pacemaker)
* Hemodynamic or respiratory instability : PaO2/FiO2 \< 200 mmHg, noradrenaline \> 0,3 µg/kg/min, dobutamine \> 10 µg/kg/min
* Neuromuscular disease or recent use of neuromuscular blocking agents (2h30) with a TOF ratio below 4/4 95%.
* Refusal of study participation or to pursue the study by the patient, no consent
* Pregnancy or breastfeeding
* Absence of coverage by the French statutory healthcare insurance system
A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody

International, multicenter, long-term, follow-up study that will enrol HLH participants who have received emapalumab in previous clinical trials, in the context of the clinical development program for emapalumab or under compassionate use (CU).

The aim of this study is to monitor the long-term safety profile of emapalumab in participants who have previously received at least one dose of emapalumab, including survival time after the administration of emapalumab.

Moreover, the elimination profile of emapalumab and the immunogenicity will also be assessed.

Furthermore, safety, tolerability, efficacy, and pharmacokinetic (PK) profile of emapalumab will be closely monitored in the event that some participants, upon request of the treating physician, will receive emapalumab treatment in the follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Having received at least one dose of emapalumab.
* Having signed the Informed Consent by the participant or the participant's legal representative(s), as applicable, with the assent of participant who are legally capable of providing it.

Exclusion Criteria:

* None
Does Antrum Size Matter in Sleeve Gastrectomy?

Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11\[6\]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11\[6\]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.


Eligibility Criteria:
Inclusion criteria:

* informed consent.
* morbid obesity defined as body mass index (BMI) 40 kg/m2

Exclusion Criteria:

* previous bariatric surgical procedures,
* endocrine disorders causing obesity
* pregnancy or lactation
* psychiatric illness
* inflammatory bowel disease
* Barrett ́s oesophagus
* severe GERD with esophagitis B and C
* a large hiatal hernia (\>5 cm)
* GERD-HRQLscore \> 25 dietary restriction despite
REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

This is a pragmatic single-center alternating cluster study. We will enroll adult patients who require general anesthesia for surgery and receive an incentive spirometry device during their PACU stay. Automatic alarms to perform incentive spirometry will be set to either "ON" or "OFF" in alternating weeks. The hypothesis is that patients receiving automatic audible and visual alarms will have increased rates of adequate incentive spirometry breaths compared to patients receiving no alarms.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older;
* have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia;
* have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff;
* not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor.

Exclusion Criteria:

* have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor;
* have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device);
* are a part of a vulnerable population (e.g., pregnant, minors, prisoners).
Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
* Karnofsky Performance Status ≥ 70.
* Age ≥ 18
* Less than 30% involvement of marrow with disease.

Exclusion Criteria:

* \> 30% marrow involvement with disease
* Age \< 18.
* Pregnant women.
Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery

This study is set up to test the robustness of algorithms and models and to optimize them. Furthermore, data are used to investigate the influence of probe orientation on parameters of the common carotid artery.

This study has four objectives:

1. Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
2. Verificate and optimize the arterial blood flow model.
3. Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
4. Determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery.

Sample size and missing data Due to limited time in the operating room, the measurement protocol is divided into four parts. Per protocol part data of 25 patients is deemed sufficient to be able to answer the above-mentioned objectives, which would result in a total of 100 inclusions. However, the investigators expect to perform more than one measurement protocol per patient, due to which a total of 75 inclusions is needed. Patients of whom the data is qualitatively too low to be used for analysis will be replaced. As such, the investigators make sure to have qualitatively good data of 25 patients per protocol part.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) patients.
* Participant should be able to provide informed consent in Dutch.

Exclusion Criteria:

* Participant has a known stenosis of the carotid artery.
* Patient has open wounds in the measurement area (area in the neck around the carotid artery).
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

Under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. SVF and ASCs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase Type-1 solution for 45 minutes at 37°C). Cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. PRP will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. The injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml PRP will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 Diabetes Mellitus
* Age 20-60 years (Male/Female)
* Body mass index 20-30 kg/m2
* Suitable for liposuction
* Condition or Disease: Diabetic Neuropathy
* Wound Type: Chronic foot ulcer
* Approx. wound area: 2 cm2 - 8 cm2
* Wound Condition should be of Wagner's grade I (Limited to soft tissue)
* Duration of wound persistence: 6-24 Weeks
* Transcutaneous oxygen pressure \> 30 mmHg, and an ankle brachial pressure index \> 0.5.
* Already following an adequate off-loading method
* Provided signed informed consent

Exclusion Criteria:

* Uncontrolled hyperglycemia (HbAlc \> 9%)
* Presence of severe clinical sign of infection
* Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.
* Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases
* Patients with critical limb ischemia and osteomylitis
* Withdrawal of informed consent
Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure

The goal of Nourish is to help adults with high blood pressure enjoy an eating pattern called DASH (Dietary Approaches to Stop Hypertension) to lower blood pressure and improve health. Nourish will use a mobile app and information about DASH to help study participants follow the DASH dietary plan by tracking what they eat and drink every day. The primary outcome of the study is 6-month change in following the DASH eating plan, as measured by 24-hour dietary recalls. The secondary outcome is change in blood pressure. Study participation will last one year.

Over 100 million Americans suffer from high blood pressure and are at increased risk for cardiovascular disease. Evidence supports the DASH (Dietary Approaches to Stop Hypertension) dietary pattern to reduce blood pressure. DASH is rich in fruits and vegetables, legumes, lean protein, and low-fat dairy, and reduced in red meats, sweets and processed foods. The Nourish trial will look at the effect of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure. Participants who join Nourish will be asked to track what they eat and drink every day through a smartphone app and to participate in online study visits. Some participants will also receive additional support from a registered dietitian. We are doing this study to understand how technology can help adults with high blood pressure follow a heart-healthy eating plan to improve their blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
* BMI ≥ 18.5 kg/m2
* Smartphone with a data plan
* Willing to receive daily text messages
* Valid email address
* Willing and able to participate in online study videoconferencing visits (Zoom)
* Lives in the U.S.
* Reads and writes in English

Exclusion Criteria:

* Participating in another related research study
* Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
* Bariatric surgery in the last 12 months or planned during the study period
* Active cancer
* Recent hospitalization due to psychiatric condition or event
* Pregnancy- current or planned during the study period
* Documented dementia
* Lives with someone else participating in the Nourish study

To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org
Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)

Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the neurodegenerative process and stops the clinical progression of disease.

There is no more extensive information

Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years.
* Over 18 years old. Forced vital capacity ≥ 40%.
* One year of evolution.
* Adequate nutritional state

Exclusion Criteria:

* Severe bulbar ALS involucre.
* Inadequate nutritional status.
* Spondylotic myelopathy, or abnormalities in imaging study.
* Having concomitant neurological or psychiatric disease.
* Systemic disease with poor-control.
* History of treatment with steroids or immunoglobulins in the last year.
* Participate in the past three months in a Clinical Trial.
* History of malignancy or cancer today.
* Intracranial hypertension.
* Clinical suggestive data of infection in the site of lumbar puncture.
* Tracheostomy.
* Use of mechanical ventilation. Forced vital capacity less than 40%. HIV-seropositive or presence of antibodies against hepatitis B or C in the serological studies.
Dane County Safety Assessment (SAFE) Research Study

A randomized controlled trial to assess the effectiveness of an at-home comprehensive approach to preventing falls among adults 65 years and older at high risk for falls.

A randomized controlled trial to assess the effectiveness of a comprehensive approach to preventing falls among adults 65 years and older at high risk for falls. This intervention includes a comprehensive health assessment in each participant's home combined with tailored risk reduction strategies such as individualized strength and balance exercises. The study is also conducting a community-based program to engage and educate physicians about fall prevention.

The goal of the study is to demonstrate a 40% decrease in fall rates. Other expected outcomes include decreased hospital and nursing home stays, improved physical function, and a decreased fear of falling.

Eligibility Criteria:
Inclusion Criteria: Adults age 65+, at high risk for falls, -

Exclusion Criteria: Adults \<65 years

-
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity in each eye
* Ability to provide informed consent and follow study instructions

Exclusion Criteria:

* Narrow anterior chamber angles or disqualifying corneal thickness in either eye
* Clinically significant ocular disease in either eye
* Previous complicated surgery or certain types of glaucoma surgery in either eye
* Incisional ocular surgery or severe trauma in either eye within the past 6 months
* Uncontrolled systemic disease
Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes

The aim of the analysis is an evaluation of the current performance of the Swiss Trauma Registry (STR) with respect to providing a reliable basis for (scientific) investigations on the management of trauma patients in Switzerland. The current project tries to address this question by considering central aspects of completeness and by exemplifying the use of the registry for research questions. The aim is to identify potential shortcomings of the registry.


Eligibility Criteria:
Inclusion Criteria:

* documentation in the STR
* Injury Severity Score (ISS) ≥ 16

Exclusion Criteria:

* none
Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients

To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops.

The proposed study strives to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard-of-care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using MydCombi to achieve pupillary dilation compared to standard-of-care eye drops in patients.

Participants 2 years or older undergoing standard pupillary dilation will be randomized to use MydCombi in one eye and standard of care pupillary dilation in another eye.

Eligibility Criteria:
Inclusion Criteria:

* Receiving pupillary dilation in both eyes as part of the participant's standard of care.

Exclusion Criteria:

* Pupillary or anterior segment abnormality
* Participants with pre-existing health conditions that would prevent pupillary dilation.
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children

The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.

Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.

Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.

Eligibility Criteria:
Inclusion Criteria:

Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia

Exclusion Criteria:

Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier