cyrilzakka/clinical-trials huggingface dataset:
1000 Eyes Lens Biometry Study: Artificial Intelligence for Intraocular Lens Power Calculation

The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations.

Cataract surgery is one of the most commonly performed surgeries worldwide and has a high postoperative patient satisfaction rate. Despite significant improvement in measurement methods and artificial lens power calculation formulas, miscalculations and subsequently refractive error still occur after cataract surgery.

Most current artificial lens calculation methods use regression formulas. The concept of artificial intelligence (AI) has only recently found use and only in a rudimentary way. Examples include the Hill-RBF calculator and the Ladas superformula, but at least the "superformula" does not use a true AI approach and the results are no better than those obtained with conventional methods.

The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations. The data will be used for the following analysis:

* To compare the new AI method with conventional and modern formula (main question)
* To compare the refractive error for different eye lengths
* To use a ray tracing method to quantify sources of error in patients with a refractive surprise of at least 1.0 diopter
* To evaluate a novel concept of outlier testing using a modified nonparametric Walsh test

This study will be multi-center and partially prospective. Data from 1000 patients who have already had cataract surgery will be analyzed.

All patients will be invited for a visit to the recruitment clinic and the measurements will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Pseudophakic (at least one eye): cataract surgery between 4 weeks and 24 months prior to recruitment
* If both eyes would be suitable for the study only the right eye will be included, if only one eye is suitable for the study, this eye will be included
* Pre-operative swept-source OCT biometry available (no ultrasound measurement for axial eye length)
* Uncomplicated cataract surgery
* Age 21 years and older

Exclusion Criteria:

* Multifocal IOLs
* Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
* Best corrected distance visual acuity below 0.5 Snellen
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation

The purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Device as single Microsoft sensor Kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. Finally the obtained measures will be compared with the corresponding ones obtained with Three-dimensional instrumented gait analysis (3D-GA).


Eligibility Criteria:
Inclusion Criteria:

* patient with post-stroke chronic hemiparesis (at least 6 month post-acute event)
* ability to stand erect for 30 seconds
* ability to walk with or without aids for 10 meters

Exclusion Criteria:

* Moderate/severe cognitive impairment (MMSE \< 22)
* Moderate/severe depression (Hamilton Depression Scale \> 20)
* Severe spasticity
Cognitive and Physical Functions in Patients With Transient Ischemic Attack. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event

The purpose of this study is to determine whether Physical Activation on Prescription can help patients with TIA to become more physically active.

One group will receives Physical Activation on Prescription (PaP)and the other group will receives usual care.

And to identify if persons with TIA presents with cognitive impairments.

Transient ischemic attack (TIA) is a transient episode of neurologic dysfunction caused by ischemia, i.e. loss of blood flow. The symptoms of a TIA typically resolve within 24 hours. Attacks lasting more than 30 minutes are unusual. TIAs and strokes present with the same symptoms such as sudden weakness, numbness, sudden dimming or loss of vision, aphasia, slurred speech, facial palsy and mental impairments. Subtle problems with cognitive functions and fatigue may not always be addressed before discharge. However, even subtle mental impairments are important to identify, given the problems they might pose.

Eligibility Criteria:
Inclusion Criteria:

* Understand Swedish language (also in and writing), living in Norrtälje community,
* To participate in the assessment of cognitive function: no known cognitive impairments before the TIA event and history of stroke.

Exclusion Criteria:

* Presence of contraindications to exercise, and no history of stroke
(Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) and Relation to Depression and Anxiety in SLE

the study determine the relation between the degree of (Depression and Anxiety) in Systemic Lupus Erythematosus Patients by zung self rating depression scale and zung self rating anxiety scale and (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies).


Eligibility Criteria:
Inclusion Criteria:

1. Patients who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria or 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus.
2. Patients who is able to give informed consent to join the study.

Exclusion Criteria:

* - Any patient with any autoimmune disease other than systemic lupus erythematosus.
Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

Epigenomics is developing a colon cancer screening assay based on differential methylation of specific CpG sites for the detection of early stage disease. A genome-wide methylation analysis and oligonucleotide array study using DNA from various stages of colon cancer and normal tissue have been completed to obtain candidate CpG markers. Based on results obtained in the above studies, Epigenomics has moved to the final stages of feasibility with a specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in blood plasma.

From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 diagnosis of colorectal cancer

Exclusion Criteria:

* Group 2 diagnosis of colorectal cancer
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General

The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.

In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face.

With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:

1. Compare Kovanaze to conventional needle anesthetic in adults
2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Class I or II
* Preoperative heart rate of 55 to 100 beats per minute
* Maximum blood pressure reading of 166/100 mmHg
* Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
* Adults who require restorations in the maxillary teeth that would need local anesthesia

Exclusion Criteria:

* Inadequately controlled thyroid disease
* Five or more nosebleeds in the past month
* Known allergy to any study drug or para-aminobenzoic acid
* History of methemoglobinemia
* Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
* Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Blood Pressure Reduction in Heart Failure

Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic heart failure for at least 6 months
* ejection fraction of 40% or less, as measured by transthoracic echocardiography
* optimal clinical treatment for chronic heart failure according to current international guidelines.

Exclusion Criteria:

* patient refusal
* rheumatic or degenerative valvular disease
* restrictive cardiomyopathy
* evidence of myocardial ischemia
* alcohol or drug use
* malignant neoplasm
* active infection
* surgical intervention in the 3 previous months
* lactation, childbearing or childbearing potential.
* pulmonary embolism in the 6 previous months
The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania

The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania

The use of mood stabilizers such as lithium and carbamazepine is known to be effective for preventing and treating bipolar disorder. But the use of antipsychotic drugs is more effective in patients suffering severe episodes of mania as it elicits behavioral changes and spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed to respond to mood stabilizers or for the acute management of manic episodes associated with bipolar disorders.

This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating Scale will be also employed to assess the presence of extrapyramidal side effects and other adverse events. The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily for 6 months

Eligibility Criteria:
Inclusion Criteria:

* In- or out-patient
* Diagnosis of bipolar I disorder
* most recent episode manic with or without psychotic features
* YMRS \> 20 (manic)
* Need antipsychotic combination on the basis of clinicians' experience

Exclusion Criteria:

* Rapid cycling
* Risk of suicide or violence
* History of Substance dependence within 3 months
* Comorbidities
* Unstable medical illness
* Previous sensitivity history to risperidone
* Pregnant woman or those without proper contraception
* History of clozapine and one cycle of depot use prior to entry
* History of treatment resistance: at least two mood stabilizers
* Prior history of active treatment with risperidone
* As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded.
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia

The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ACH with genetic confirmation
2. Age between 2 to 10 years old (inclusive) at Screening Visit
3. Prepubertal (Stage 1 breasts for girls or testicular volume \< 4ml for boys) at Screening Visit
4. Able to stand without assistance
5. Caregiver willing and able to administer subcutaneous injections of study drug

Exclusion Criteria:

1. Clinically significant findings at Screening that:

   * are expected to require surgical intervention during participation in the trial or
   * are musculoskeletal in nature, such as Salter-Harris fractures and severe hip pain or
   * otherwise are considered by investigator or Medical Monitor/Medical Expert to make a participant unfit to receive study drug or undergo trial related procedures
2. Have received treatment (\>3 months) of human growth hormone (hGH) or other medications known to affect stature or body proportionality at any time
3. Have received any dose of medications intended to affect stature or body proportionality within the previous 6 months of Screening Visit
4. Have received any study drug or device intended to affect stature or body proportionality at any time
5. History or presence of injury or disease of the growth plate(s), other than Achondroplasia, that affects growth potential of long bones
An Exercise Trial for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

Reduced quality of life, fatigue, and loss of physical function are common in patients getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot study showing that exercise during active chemotherapy for AML is feasible, safe, and may improve symptoms and physical function. The investigators now propose to compare our hospital-based supervised exercise program to usual care to see if exercise can improve symptoms, physical function, and improve treatment tolerability.

Acute myeloid leukaemia (AML) is a life-threatening malignant blood disorder. Curative treatment requires multiple cycles of intensive chemotherapy. The first cycle, induction, is the most intense and intended to achieve complete disease remission (CR). Induction therapy requires 4-6 weeks of inpatient admission and is associated with extended bed rest and multiple toxicities, leading to physical deconditioning. Regular exercise during induction may reduce declines in physical fitness, leading to improved quality of life (QOL), reduced fatigue, improved tolerance of chemotherapy, and potentially greater survival. Four prior studies of exercise in AML patients undergoing induction have suggested improvements in QOL, fatigue, physical function, and treatment tolerability. However, all 4 studies suffered from major limitations including small sample sizes, design limitations, generalizability concerns, and limited safety information. The investigators conducted a pilot non-randomized study in 35 AML patients and demonstrated feasibility, safety, and potential improvements in QOL, fatigue, and physical fitness outcomes. The investigators now propose a rigorous evaluation of the intervention in a phase II randomized controlled trial (RCT).

Primary objectives include: (1) To determine the efficacy of a supervised mixed-modality exercise program during induction chemotherapy on QOL and fatigue; (2) To determine the efficacy on physical fitness. Our secondary objective is to determine the efficacy on AML treatment tolerability (hospital length of stay, development of sepsis, intensive care unit (ICU) admission, delays in consolidation chemotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Is ≥ 18 years old
* Has newly diagnosed AML, or relapsed AML after having been in CR for at least 6 months
* Is initiating induction chemotherapy
* Is ambulatory without need for human assistance
* Has consented to study
* Is medically cleared for participation by the attending physician

Exclusion Criteria:

* Has another active malignancy
* Has life expectancy \< 1 month, physician determined
* Has significant comorbidity
* Has uncontrolled pain
* Has haemodynamic instability
* Lacks fluency in reading and writing English, and there is no translator available for each visit
Incidence of Unresectable Cases of Cervical Cancer

Objective : to calculate the incidence of unresectable cases of cervical cancer in gyne-oncology unit of Alexandria university hospital and to indentify its relation to pathological types, grading and lymph vascular space invasion.

Patients and methods: 70 cases of cervical cancer diagnosed by biopsy taking and histopathological examination will be included in the study, clinicoradiological staging was done to all cases to calculate the incidence of unresectable cases and to indentify its relation to pathological types, grading and lymph vascular space invasion


Eligibility Criteria:
Inclusion Criteria:

* cervical cancer

Exclusion Criteria: none

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Management of Plasma Cell Gingivitis by Two Surgical Techniques

Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection

Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.

Eligibility Criteria:
Inclusion Criteria:

- patients suffering from the plasma cell gingivitis

Exclusion Criteria:

- Patient not eligible for maxillofacial surgery
Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.

The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.

The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).

This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.

Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.


Eligibility Criteria:
Inclusion Criteria:

* patients older men or women 60-75 years
* with a primary or secondary osteoarthritis or osteonecrosis
* having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

* patients aged 76 years or more
* protected adults
* resumption of PTH
* cephalic prosthesis recovery or intermediate
* resumption of cupules
* primary or secondary malignant tumor of the hip
Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.

This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has demonstrated Grade I or Grade II degenerative spondylolisthesis exhibited by maximum slippage on flexion and extension radiographs with symptoms that include back pain and/or leg pain with spinal fusion indicated, or spinal instability as evidenced by greater than 3 mm of translational motion or greater than 10 degrees of angular motion between the involved vertebrae as evidenced by flexion-extension radiographs.
2. This surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved.
3. The patient must be available for yearly follow-up in the study until completion of the 24 month evaluation.
4. The patient must be skeletally mature (epiphyses closed).
5. Bone grafting material must be limited to autograft and/or bone-bank allograft.
6. The patient must be willing to comply with the treatment regimen, follow-up requirements, and have the legal ability to give informed consent.

Exclusion Criteria:

1. Patients with supplemental spinal internal fixation devices previously implanted at any other level and/or a previous fusion attempt at the involved level(s) (no interbody fusions, salvage procedures, or prior hardware).
2. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
3. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
4. Patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc.
5. Patients involved in personal injury litigation.
6. Pregnant or nursing females.
7. Patient in whom unapproved biologicals (e.g. BMP-2) or bone substitute materials (e.g. Grafton) would be used at the fusion site.
8. Patients who are unable to understand and sign an informed consent or who, in the opinion of the investigator, would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unable to participate in the follow-up.