cyrilzakka/clinical-trials huggingface dataset:
PMCF Study on SMILE Treatment of Myopia With and Without Astigmatism

The primary objective of this PMCF investigation is to systematically collect safety and effectiveness data with the VISUMAX 800 laser in clinical daily routine SMILE use for the purpose of post market surveillance.

The present PMCF study is a prospective, non-randomized, international multi-center study without control group including patients with myopia or myopia combined with astigmatism undergoing SMILE with the VISUMAX 800 femtosecond laser in daily routine use.

In this PMCF study, at maximum 474 eyes of consecutive subjects will be consented, enrolled, treated and followed up to 6 months postoperatively at 4 to 5 sites. The treatments, which will be done bilateral, shall be equally distributed between the sites as far as possible.

The subjects will be 18 years of age or older, who suffer from myopia of up to -10 D with or without astigmatism of up to 5 D, and are suitable for SMILE treatments, fulfil all inclusion criteria and not fulfil any of the exclusion criteria.

The expected duration of the is 16 months (site initiation to closeout visit).

Eligibility Criteria:
Inclusion Criteria:

* Myopia up to -10 D with and without astigmatism up to 5 D
* Age of 18 years or older
* Pre-operative CDVA of 20/25 or better in each eye
* Patient shall be willing to comply with all follow-up visits and the respective examinations
* Patients should be able to understand the patient information and willing to sign an informed consent.
* Contact lens wearers must stop wearing their contact lenses at least 2 weeks before baseline measurements in case of hard contact lenses and 2 days before baseline measurements in case of soft contact lenses

Exclusion Criteria:

* No monovision treatments (target sphere may not be more negative than -0.25 D)
* The patient may not participate in other ophthalmologic studies except in VEMOS study at site Aarhus.
* Any impaired person (minors, pregnant or breast-feeding women or persons incapable of giving consent) are definitely excluded from the study.
* The patients presenting at least one of the contraindications stated in User Manual of the VISUMAX 800 option ReLEx SMILE must not be included in this clinical investigation
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.

A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* T1D ≥ 2 years
* Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
* Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
* HbA1c ≤ 70 mmol/l (8.5%)
* Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
* Use of carbohydrate counting and bolus calculator (self-reported)
* Sensor glucose level \< 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data

Exclusion Criteria:

* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
* Known or suspected allergies to glucagon or related products
* History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
* Patients with pheochromocytoma or insulinoma
* Hypoglycemia unawareness
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Inability to understand the individual information and to give informed consent
* Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Relationship Between Quality of Life, Life Satisfaction and Anxiety Levels of Wheelchair Basketball Players

Today, there are many studies on wheelchair basketball players. However, these studies do not indicate the relationship between the quality of life, life satisfaction and anxiety levels of wheelchair basketball players, in the extent of the knowledge. As a result of this study, it is aimed to obtain information about the quality of life, life satisfaction and anxiety levels of wheelchair basketball players.

The study aimed to examine the relationship between the quality of life, life satisfaction and anxiety levels of wheelchair basketball players. This study was carried out with wheelchair basketball players in Istanbul between March 2022 and May 2022. Twenty-three wheelchair basketball players were included in the study. The scope of the study was explained to the wheelchair basketball players who participated in the study during the face-to-face interview, and the consent forms prepared by the researcher were distributed. The participants, who approved the consent form and agreed to participate in the study, had to fill out the sociodemographic form. The quality of life of the participants was determined by the SF-12 Quality of Life Scale; Satisfaction with life was evaluated with the Satisfaction with Life Scale, and anxiety levels were evaluated with the Beck Anxiety Scale. Statistics were performed using SPSS Version 22.0 program.

Eligibility Criteria:
Inclusion Criteria:

* Being between the age of 18-45
* Participating in a wheelchair basketball team regularly
* Being disabled regardless of the disability score

Exclusion Criteria:

● Being over the age of 45
A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours

The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. The safety and comfort level of the device will also be studied.

The FAS glucose monitoring system is a minimally invasive glucose monitoring device which is not yet approved by the FDA. The FAS system will be used in this study to monitor glucose levels during a glucose tolerance test (GTT) performed in Dr.Orzeck practice. The FAS measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than 1 mm by inserting a small needle-like device. During the 4-hour GTT, the needle-like FAS is left in the skin tissue. The FAS performance has indicated in prior experiments that it is more stable than competitive commercial glucose-sensing devices. Due to its unique design, its glucose response is more accurate, and less affected by certain drugs (such as pain medicine).

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.

Exclusion Criteria:

* Patients with fasting glucose concentration larger than 200 mg/dL will be excluded from the study.
* Children under the age of 18 will not be included because Texas state law would not allow such participants to give informed consent on their own.
* Patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (NSAIDs) and certain high-blood pressure medications will be excluded from the study.
* Pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. Presence of pacemaker or defibrillator.
Study of Thermoregulatory Processes in Ultra-endurance Runners in a Hot and Humid Environment

Human beings are characterized by their extraordinary ability to thermoregulate.

During a physical exercise, only 20% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 80% is released as heat. In temperate environments, so-called metabolic heat is dissipated by several physical phenomena (radiation, conduction, convection and evaporation). However, if the dissipation capacity (in a hot and humid environment for example) is lower than the production of metabolic heat, the body temperature increases progressively until exercise stops or heat-related pathologies develop. This pathological entity defined by the acronym EHI for Exertional Heat Illness gather a wide spectrum of clinical forms ranging from oedema or heat rash, to muscle cramps, to syncope; up to more serious forms such as heat exhaustion or heat stroke during exercise.

Heatstroke during exercise is the second most common cause of death in athletes after heart disease.

However, the results of the epidemiological studies and the recommendations are limited to events with effort durations or distances not exceeding those of the marathon. They therefore do not consider ultra-endurance disciplines.

These disciplines, defined by durations of effort of at least 6 hours, have specific characteristics (duration of effort, intensity, steep gradients, exotic destinations, extreme environments) which means that extrapolation of the results and knowledge of the physiology of thermoregulation from "classic" endurance events, such as marathons, to ultra-endurance events is hazardous. There are therefore significant areas of uncertainty in understanding the thermoregulatory function, prevalence of EHI (Exertional Heat Illness) and health implications of ultra-endurance running in a hot environment. This is the context of ERUPTION-2.


Eligibility Criteria:
Inclusion Criteria:

* Runners participating in " La diagonale des fous " race of the "Grand Raid" 2021 on Reunion Island

Exclusion Criteria:

* Runners who do not understand French
Facilitating Optimal Routines in Aging

Loss of cognitive abilities leading to Alzheimer's disease is progressive and destructive, leaving older adults disabled and unable to recall their past. The number of older adults with Alzheimer's disease is expected to triple by the year 2050, yet little research examines amyloid beta deposition, executive function, and progression of disability. This study will test the influence of a novel and promising non-pharmacological intervention, Strategy Training, on the progression of disability in a sample of 150 older adults with Mild Cognitive Impairment who have the option to complete a Positron Emission Tomography (PET) Imaging with Pittsburgh Compound B (PiB).

This trial will test the effect of Strategy Training compared to Enhanced Usual Care on change in disability among older adults with Mild Cognitive Impairment (MCI) and assess the extent to which Central Nervous System amyloid-beta deposition and neurocognitive function modify the relationship between Strategy Training and Enhanced Usual Care on change in disability. Assessments will be obtained at Baseline, 8 week short assessment, 6 and 12 months post intervention. Interventions, such as Strategy Training, focused on slowing emergence of disability despite underlying pathology may keep older adults as engaged in meaningful daily activities for as long as possible. This project tests a novel and promising non-pharmacological intervention and will inform our understanding of important effect modifiers- amyloid beta deposition and executive function- on change in performance of cognitively challenging daily activities. Enhancing our understanding of amyloid beta deposition, executive function, disability, and a promising non-pharmacological intervention could support aging for millions of older adults who, in the near future, will experience disability related to MCI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mild Cognitive Impairment
* Acknowledge difficulty with a daily activity
* Community dwelling

Exclusion Criteria:

* Pregnant
* Central Nervous System disorder (other than MCI)
* Substance disorder in past 5 years
* Lifetime history of bipolar disorder, schizophrenia, or deemed unsafe to proceed in the study (e.g., untreated Major Depressive Disorder)
* Severe medical condition that limits engagement in daily activities
Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis

Osteoarthritis (OA) is the main cause of pain and disability in elderly. For knee OA, a total knee replacement (TKR) is an effective surgical treatment, and the majority of patients report substantial pain relief and functional improvement following surgery. However, 20-40% of patients undergoing TKR are dissatisfied with postsurgical outcome. Even after revision, some patients keep complaining of persisting pain.

In this study, the investigators will examine putative prognostic factors on the basis of the biopsychosocial model. Besides several psychological factors (measured with questionnaires), the investigators will assess structural impairments (such as radiographic severity of OA), functional impairments (muscle weakness and proprioceptive deficits), anesthetic procedures, immediate postoperative pain management, metabolic factors (body composition and hemoglobin A1c), inflammatory factors (C-Reactive Protein) and the investigators also will examine the role of altered central pain processing (CPP) (primary and secondary mechanical hyperalgesia, mechanical temporal summation, thermal primary and secondary hyperalgesia, endogenous pain modulation).

With a longitudinal study design, this study will explore which factors are predictive of poor outcome in knee OA patients after TKR. Moreover, the interrelationship between CPP, structural, functional, metabolic, inflammatory and psychological factors, and the clinical expression of knee OA (pain, symptoms, physical performance and quality of life) will be investigated.

Further research on the role of the aforementioned putative prognostic factors on postsurgical outcome could contribute to better management of these patients, since these factors may be particularly important for patient-tailored treatment.


Eligibility Criteria:
Inclusion Criteria:

* Knee OA patients \>40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.

Exclusion Criteria:

* Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
* Patients who are not capable of understanding and speaking Dutch
* Revision surgery
Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces

Several studies suggested that dysbacteriosis usually happened in patients with intestinal failure (IF). However, differences of microbiota diversity in small intestine stoma effluents and colonic faeces were rarely studies. Thus this study is aimed to investigate the microbiota compositions and differences of output of small intestine stoma and colon in pediatric IF patients. Fecal samples from IF patients. Each patient received fistula closure in our centre and fecal samples from both small intestinal stoma and colon were collected. Fecal microbial compositions were determined by high-throughput sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with intestinal failure. Patients showed good tolerance to parenteral and enteral nutrition administration. Proportion of enteral nutrition is more than 80%.

Stool output maintained at less than 50mL/kg/day. No complications occurred for at least 1 week.

Exclusion Criteria:

* Patients depend mainly on parenteral nutrition. Symptoms like fever, abdominal distention and diarrhea. Complications like parenteral nutrition-associated liver disease, pneumonia and catheter related infection.
Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique

The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.

Type of study: Multicentric, prospective and randomized trial

Patients: PEP high-risk patients underwent ERCP for benign biliary pathology

Number of patients: 320 patients (160 for each group)

Aim:

Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.

Eligibility Criteria:
Inclusion Criteria:

* high risk patients for post-ERCP pancreatitis

Exclusion Criteria:

* age \< 18 yrs
* allergy to the contrast medium
* previous surgery
* neoplastic bilio-pancreatic disease
* previous EBS
PET-CT Imaging Features of Meibomian Glands

Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively

Medical records of patients who visited the ophthalmology department between January 2021 and December 2023 and had a PET-CT examination in our hospital within one month were collected. The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of PET-CT were collected and the SUV values of the tarsal gland were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who visited the ophthalmology Department of Zhongnan Hospital from January 2021 to December 2023 and had a PET-CT examination in the hospital within one month

Exclusion Criteria:

* Dry eye analysis was not performed
* History of eye surgery or trauma
* Other systemic diseases affecting the eyes
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>/=18 years
* Adequate bone marrow, liver, and renal functions
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Diseases as defined below:

PART1

* Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥1 prior therap(ies) and the last prior regimen must have included venetoclax plus an anti-CD20 antibody and/or a BTKi and did not produce complete remission. Subjects with CLL with either del(17p) by FISH or TP53 mutation who have received ≥2 prior regimens and are intolerant to BTKi and/or venetoclax are also eligible.

or

* Subjects with CLL transformed to DLBCL who have relapsed after, or been refractory, to at least 1 prior line of therapy for DLBCL

PART2

* Subjects with CLL who are currently on an approved BTKi (monotherapy only) at the dose and schedule per the local label for ≥ 12 months who have only achieved SD, PR or PRL

Exclusion Criteria:

* Active clinically serious infections of Grade \> 2; requiring parenteral therapy
* Subjects who have new or progressive brain or meningeal or spinal metastases.
* Anticancer chemotherapy or immunotherapy during the study or within one week prior to the first dose of study drug
* Major surgery or significant trauma within 4 weeks before the first dose of study drug
* Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment
Effect of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in Intramuscular Injection Application

This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. The sample of the study consisted of a total of 120 patients over the age of 18 who applied to the Emergency Service of a public hospital and were requested Diclofenac Sodium 75mg / 3ml. The patients were included in the experiment I (shotblocker), experiment II (manual compression) and the control group with the randomization list created on the computer.

In the ShotBlocker group, the ShotBlocker was kept throughout the injection, and in the manual compression group, manual pressure was applied to the injection area for 10 seconds before injection, and in the control group, IM injection was applied without using any tools. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. Visual Comparison Scale and Injection Satisfaction Scale were administered to the patient in the first minute after the injection. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Parametric or nonparametric statistical tests and correlation test were used in the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* He has not had an IM injection in the last week,
* Upper respiratory tract infection patients in the Examination Department, where green field patients of the Emergency Service are located,
* Over the age of 18,
* No complications related to IM injections such as pain at the IM injection site, abscess, infection, tissue necrosis, hematoma,
* Does not have pain anywhere in the body that will affect the work result,
* Are conscious and have no communication problem,
* No vision or hearing problems,
* Not taking analgesic in the last 24 hours,
* Does not have any known chronic disease,
* No psychiatric disorder,
* Diclofenac sodium ampoule has been ordered,
* Can evaluate "Visual Comparison Scale and Injection Satisfaction Scale" correctly,
* Individuals who volunteered to participate in the study and signed the written informed consent form were included.

Exclusion Criteria:

* Not wanting to participate in the study,
* Patients who did not meet the study acceptance criteria were not included.