cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Diabetic Retinopathy Using Ultra-Widefield Fundus Images Compared With Two-Field Fundus Images

This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.

As of 2030,9.7% (108.4 million) people in the China population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. Diabetic retinopathy (DR) and diabetic macular oedema (DME) are the principal causes of adult vision loss. Nevertheless,DR has few visual symptoms until DME occurs or the lessions located in the peripheral retina.Thus,it is crucial to early diagnosis and treatment of DR patients,which will prevent vision loss and reduce the societal buren of diabetes.

The Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30° color fundus photography is a time-consuming examination requiring pharmacological pupil dilation,experienced photographers and image montage.To simplify the operation process and improve patient compliance,2-field 45° retinal photographs (1 macular-centered field and 1 disc-centerde field) was proposed in the EURODIAB IDDM complications study and widely used in DR screening.Two-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from DR,while may be neglected DR pathology in the peripheral retina.With the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settings,espesially in predominantly peripheral lession(PPL).

Patients with DM, with or without known DR, will be imaged using the optomap and 2-field 45° retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital. Internal validation and continuous quality control will routinely be conducted. According to the International Clinical Diabetic Retinopathy Disease Severity Scale, the data for the ungradable image rate, distribution of DR severity levels, and PPL will be evaluated and compared. Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Diagnosis of diabetes mellitus.

Exclusion Criteria:

1. Diseases involving the posterior pole other than DR, such as age-related macular degeneration，retinal vein occlusion.
2. History of panretinal laser photocoagulation.
AMH and Pregnancy Outcome in IVF

Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.


Eligibility Criteria:
Inclusion Criteria:

Women ≥22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol

Exclusion Criteria:

* Women ≥ 45 years age
* AMH \>0.5
* Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis)
* Endocrine dysfunction or organ dysfunction such as liver or kidney failure.
Retrospective Collection of Safety and Performance Data

This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Bioceramed bone substitutes at the Center.
* Long bone \& extremities: bone grafting after post-traumatic or surgically created bone defects.
* Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.

Exclusion Criteria:

Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.
Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres.

In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.


Eligibility Criteria:
Inclusion Criteria:

* Professional rugby player

Exclusion Criteria:

* impossibility to realise OCT
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.


Eligibility Criteria:
Inclusion Criteria:

* multiple myeloma
* stage I (Salmon \& Durie)
* no cytoreductive pre-treatment

Exclusion Criteria:

* myeloma stages II-III
* asecretory disease
Lidocaine Analgesia For Removal Of Wound Vac Dressings

The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.


Eligibility Criteria:
Inclusion Criteria:

1. wounds to which a split-thickness autologous skin graft applied;
2. infected wounds after debridement;
3. open fracture wounds;
4. acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
5. fasciotomy wounds after compartment syndrome;
6. chronic non-healing wounds;
7. surgical wounds that are difficult to close due to tension; or
8. wounds with external fixation pins or tubes with irritation or drainage.

Exclusion Criteria:

1. allergy to lidocaine;
2. allergy to the polyurethane foam or impermeable seal;
3. malignancy associated with the wound;
4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
5. pregnancy as diagnosed by urine pregnancy test.
Evaluation of Decisional Conflict and Needs Assessment in Asthma Management

Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.

Asthmatic patients will be recruited and asked to fill a decisional conflict scale.

Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* diagnosed asthma

Exclusion Criteria:

* received asthma education in the past 2 years
Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl

Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* Patients of ASA physical status 2-3 with a singleton pregnancy
* gestational age \> 37 weeks
* regular uterine contractions occurring at least every 5 min;
* cervical dilation 2-5 cm
* pain \> 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia .

Exclusion Criteria:

* Refusal to concent
* Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl
* Patients who had opioids or sedatives within 4 h preceding epidural insertion.
* Unintentional dural puncture.
* Patient who deliver within 1 h after initiation of epidural clinician bolus.
* The inability to achieve as VAS score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.
Hydrocephalus iPad-App Based Intervention Study

This is a pilot study examining the feasibility and efficacy of using Apple iPad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI, followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a follow-up MRI.

Long term visuospatial and visuomotor functional deficits are common in pediatric patients with surgically treated hydrocephalus. The deficits are often mild/moderate at early school age although the gap may widen as the children grow older, leading to increasing adverse impact on school performance and academic achievement. The proposed study will generate initial pilot data for the usage of iPad application based therapy intervention for the treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the optimal intensity and duration of training protocol adapted for the study. In addition, the sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated as a biomarker that reflects the neuroanatomical alterations underpinning the outcome changes. This study will generate the crucial data to support the design of future Phase III clinical trial with the long term goal as changing the current standard of care in order to prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry becomes irreversible.

The participants who meet the inclusion criteria and do not opt-out of participation will be called by a study coordinator to ensure eligibility and to schedule the initial assessment date. Participation in this study will include 8-10 study visits. These visits include 2 neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase. MRI visit can be combined with the neuropsychological assessment visit if possible at both the pre- and post intervention time points.

Eligibility Criteria:
Inclusion Criteria:

* Children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention
* Deficits in 2 of more of the following neuropsychological testing categories: visual motor, visual attention, or visual reasoning.

Exclusion Criteria:

* Shunt revision within the past one year
* MRI-sensitive programmable shunt or any other MRI-sensitive implant
* Braces or other dental hardware that would interfere with the quality of MRI images (participants with braces are only excluded from the MRI portion of the study)
* Intellectual disability: IQ \< 70
* Deficits in one or none of the three following neuropsychological testing categories: visual motor, visual attention, or visual reasoning
* Age 18 years or greater
* Non-English speaking: We will not enroll non-English speaking participants because the iPad applications are not readily available in other languages. All neuropsychological testing materials are also in English.
Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.

The device is a non-invasive brain pulse oximeter. It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat.

The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels.

The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring.

The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care
* 2. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring that have concomitant continuous electroencephalography (EEG) monitoring as part of standard medical care

Exclusion Criteria:

* 1. Inability to obtain the brain pulse oximeter signal from at least one brain hemisphere due to interface issue such as severe agitation, head dressing, severe skin or bone trauma, or skull removal preventing brain pulse detection for the initial monitoring session.

  a. Note: If unable to obtain brain pulse oximeter signal for subsequent monitoring sessions, the only the recordings that were obtained will be used for analysis
* 2. Hemodynamically unstable patients (defined as increasing vasopressors requirements)
* 3. Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements
Mechanism of Xinglouchengqi Decoction in Improving Nerve Injury in the Acute Stage of Stroke by EEG and Metabolomics

Using EEG and metabolomics to evaluate the clinical efficacy of Xinglouchengqi decoction in improving nerve injury in the acute stage of stroke and the mechanism

Traditional Chinese medicine treatment is the original advantage in China for early stroke intervention. Xinglouchengqi decoction is an important prescription for the treatment of acute stage of stroke proposed by Academician Wang Yongyan. Early intervention can significantly improve the condition of patients and reduce the degree of neurological function deficit, but its mechanism of action is not clear.EEG, network graph theory and metabonomics are applied in evaluating the treatment of stroke, and to explore the mechanism of Xinglouchengqi decoction to improve the nerve injury of acute stroke patients. 30 stroke patients with acute period will be as the research object, using the observational cohort studies, to measure the dynamic of nerve function defect, EEG signals and other clinical information. Based on EEG to construct the brain functional network in the acute stage of stroke and to study the brain network mechanism of Xinglouchengqi decoction in improving the nerve injury of patients. Meanwhile, based on the study of metabolomics, the potential biomarkers and the metabolic pathway will be analyse to explore the pharmacodynamic substance.

Eligibility Criteria:
Inclusion Criteria:

those who met the diagnostic criteria for acute anterior circulation ischemic stroke; first stroke, no previous history of organic encephalopathy; the onset is less than 72 hours; it is in line with the TCM diagnosis of phlegm heat; aged 40 to 80 years old.

Exclusion Criteria:

Transient Ischemic Attack (TIA) ; those who have received thrombolytic therapy; the examination confirmed that the stroke was caused by the brain tumor, brain trauma or blood disease; cerebral embolism caused by rheumatic heart disease, coronary heart disease and other heart disease combined with atrial fibrillation; complicated with liver and kidney hematopoietic system endocrine system and other serious diseases and osteoarthropathy; prior mental disorder or severe dementia; patients with concurrent infection and fever; patients with primary or secondary epilepsy; those who had taken sedative drugs or sleeping drugs 3 days before the examination.
Self-Transcendence Facilitation Psychoeducational Program Applied to Mothers of Children With Special Needs

This study aimed to determine the effect of the Facilitating Self-Transcendence Psychoeducation Program, which will be applied to mothers of children with special needs, on well-being, self-transcendence, self-reflection, and insight.

This study aimed to determine the effect of the Facilitating Self-Transcendence Psychoeducation Program, which will be applied to mothers of children with special needs, on well-being, self-transcendence, self-reflection and insight.

This study is a non-randomized experimental study with pre-test, post-test, follow-up and control groups. A 2x3 split-plot factorial design will be used as the research design. In this design, the first factor shows independent interventional procedure groups, and the second factor shows repeated measurements of the dependent variable (pre-test, post-test and follow-up). Considering the theoretical basis of psychoeducational programs, the follow-up period in this study was planned to be eight weeks after the last session.

The study will be carried out between February 2024 and July 2024. The sample of the study will consist of mothers of children with special needs between the ages of 0-11 who are registered in a special education and rehabilitation center in Kumluca. 30 mothers will be included in the intervention group and 30 mothers in the control group. The ST-Facilitation psychoeducation program is planned for mothers in the intervention group as an 80-minute session (40-minute session + 20-minute break + 40-minute session) once a week for six weeks, in groups of two to four people. Data will be collected using the Personal Information Form, Self-Transcendence Scale, Warwick-Edinburgh Mental Well-Being Scale and Self-reflection and Insight Scale.

Eligibility Criteria:
Inclusion Criteria:

Volunteering to participate in research No cognitive disabilities such as reading, writing, communication and understanding No possibility of leaving the region during the research. Being a mother of a child with special needs between the ages of 0-11

Exclusion Criteria:

Continuing psychiatric treatment during the period when the study was conducted Involvement in another psychosocial intervention that is likely to influence the research outcome.