cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study

To compare the corneal spherical component (SC), regular astigmatism (RA), irregular astigmatism (IA, including Asymmetry and Irregularity) and visual quality six years after small incision lenticule extraction (SMILE) and laser subepithelial keratomileusis (LASEK) for mild to moderate myopia.


Eligibility Criteria:
Inclusion Criteria:

* (1) patients aged over 18 years; (2) absence of corneal, ocular, or systemic diseases; (3) stable refractive diopter maintained for the past 2 years with a change of ± 0.50 diopter; (4) discontinuation of soft contact lens wear for at least 2 weeks and rigid contact lenses for at least 4 weeks prior to surgery; (5) preoperative manifest refraction spherical equivalent (MRSE) less than -6.00 diopter (D)

Exclusion Criteria:

A history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.

This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in AZD9291 Named Patient Program in Hong Kong
* Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
* Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
* Provision of written informed consent (for patients alive at the time of study enrolment)
* Documented patients with trackable medical records

Exclusion Criteria:

* Enrolment in studies that prohibit any participation in this non-interventional study
Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane

To investigate the effect of two different volumes of bupivacaine 0.25% used in ultrasound-guided erector spinae plane (ESP) block on dermatome spread and postoperative analgesia in patients undergoing unilateral thoracotomy

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 50 patients planned for thoracotomy, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 25 patients each. Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery, patients with a body mass index of 35 or over, patients detected with infection in the intervention site, patients with hematological diseases, patients with a known allergy to local anesthetics, patients that will not provide a written or verbal consent, pregnant patients, and patients with an ASA score of III or IV will be excluded from the study. All the patients will undergo physical examination and their laboratory parameters will be evaluated one day prior to the procedure. Moreover, on the same day, each patient will be informed about dermatome testing (hot/cold), pain prick test (pain test), and pain pump set. Age, body height and weight, duration of block, and duration of surgery will be recorded for each patient

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective thoracotomy
* Aged 18-65 years
* ASA score of I and II

Exclusion Criteria:

* Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery,
* Patients with a body mass index of 35 or over,
* Patients detected with infection in the intervention site,
* Patients with hematological diseases,
* Patients with a known allergy to local anesthetics,
* Patients that will not provide a written or verbal consent,
* Pregnant patients
* Patients with an ASA score of III or IV will be excluded from the study
The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study

Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Apnea/hypopnea index ≥ 10
* A documented successful CPAP titration

Exclusion Criteria:

* Conditions that in the judgment of the investigator would interfere with subject participation in the study
* History of sinus or nasal surgery
* History of psychiatric illness
* Use of sleep aids, sedatives or narcotics
* Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
* Bilevel or other nocturnal ventilation other than CPAP
* Use of supplemental oxygen
* Pregnancy or lactating
* Inability or unwillingness to provide informed consent
* Inability to perform baseline measurements
* Inability to be contacted by phone
Tablet-assisted Training in Exacerbated COPD

Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of a tablet-assisted training in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of exacerbation of COPD.
* To possess pharmacological treatment in the form of inhalers.

Exclusion Criteria:

* Inability to provide informed consent.
* Presence of psychiatric or cognitive disorders.
* Organ failure or cancer.
* Inability to cooperate.
* Patients who had experienced an exacerbation in the last month.
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.


Eligibility Criteria:
Inclusion Criteria:

* Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
* Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

* Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
* Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects

The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.

The objective is to evaluate the incidence and severity of new-onset migraine headache episodes following transcatheter ASD closure in patients treated with aspirin alone compared to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure.

This is a prospective, randomized, double blind, multicenter study, including patients with no previous history of migraine attacks who have been diagnosed with an ASD and for whom transcatheter ASD closure has been clinically indicated. Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure. The occurrence and severity of migraine headaches will be evaluated by a neurologist using a structured headache questionnaire at 1 month and 3 months following ASD closure. An additional 6 month and 1 year follow-up evaluation will be exploratory according to local feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 year old undergoing transcatheter ASD closure with the Amplatzer Septal Occluder device (AGA medical Corp., MN, USA).
* Female subjects must be post-menopausal, surgically sterile, or using an effective method of birth control.
* Signed an informed consent document.

Exclusion Criteria:

* Allergy or intolerance to any of the antithrombotic drugs (aspirin, clopidogrel) used in the study.
* Need for anticoagulation therapy.
* Use of ASD closure devices other than the Amplatzer Septal Occluder device.
* History of migraine headaches (based on migraine headache questionnaire).
* Refusal to sign the informed consent.
* Pregnancy or breast-feeding or planning to become pregnant during the study.
* Previous stroke.
Mindfulness and Education in Patients With Non-oncological Orofacial Pain

To analyze the effects of a program based on Mindfulness plus Pain Neurophysiology Education versus a program based on Pain Neurophysiology Education on perceived quality of life, pain, sleep quality, and functionality, in adult patients with non-cancer orofacial pain.

This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of 50 men and women, over 18 years of age, will be evaluated, divided into two groups: the experimental group will receive a Mindfulness-based intervention, plus a program Education in Neurophysiology of Pain, lasting 8 weeks; and the control group will only receive an 8-week Pain Neurophysiology Education program.

The variables will be measured for both groups with the same validated tools and the same investigator to avoid information biases and differential incorrect classification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be recorded in a data record that will later be unified in an Excel database, recording a code for each participant to maintain condition of privacy, but at the same time allow the required comparability.

For the independent variables, the sociodemographic characteristics will be addressed; On the other hand, the outcome variables will be the Health-Related Quality of Life \[HRQOL\] with the SF36 questionnaire, the Pittsburgh Index for sleep quality, the VAS scale for pain, and the Craniofacial Pain and Disability Inventory (CFPDI) for pain and functionality. Once the intervention is finished, the final evaluation will be carried out and from the comparative process define if there are significant differences with respect to the results initially obtained.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 18 years, who voluntarily agree to participate in the study, with orofacial pain of more than 24 weeks of evolution, of non-oncological origin.

Exclusion Criteria:

* Oncological origin of orofacial pain. Systemic diseases with a focus on the TMJ. Patients operated on ATM. Population that does not agree to participate in the study or who at the time of entering the program have denied the endorsement of the use of their data for research in the informed consent.
Enhancing Oral Health Care Use by HIV Positive Individuals

The purpose of this study is to investigate the efficacy of a case management linkage intervention designed to increase utilization of oral health care services among HIV+ individuals enrolled in HIV primary care that have not seen a dental provider in the preceding twelve months.

Recent national studies demonstrate that oral health is one of the highest unmet health needs for HIV-positive (HIV+) individuals, although it is recognized as playing a less critical role in the medical management of HIV/AIDS. Social and economic factors have contributed to less than optimal use of oral health services for HIV+s in the United States. According to recent data, from Miami-Dade County, Florida, only 24% of HIV+s served by Ryan White-funded medical clinics had obtained oral health services in the past 12 months.

To address the underutilization of oral health care services, we propose to develop, implement, and evaluate an intervention to assist low-income HIV+s in obtaining access to oral health services as well as increase appropriate utilization of these services. The case management intervention is adapted from an intervention that had been previously tested in a CDC-funded, multi-site study designed to link recently diagnosed HIV+s to primary medical care.

A two-arm randomized trial among HIV+ individuals who are currently enrolled in HIV primary medical care, but not receiving oral health care, will be conducted to test the intervention. The two arms will consist of a case management intervention and standard-of-care. Participants will be assessed at baseline and at 6, 12 and 18 months after baseline to document their utilization of oral health services. An interdisciplinary team of behavioral and clinical research scientists with experience in developing and evaluating health care and prevention intervention targeting low income, HIV+s will conduct this research.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years and older
* Documented HIV infection
* Currently in medical care (defined as having seen an HIV primary care provider in the previous six months)
* Eligible for Ryan White title I funding
* Plans to remain in Miami for the next 24 months
* Provide the name of two verifiable locator persons

Exclusion Criteria:

* Persons not meeting the inclusion criteria as delineated above
Differentiating Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma

This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images. The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning.

The proposed novel Contrastive Language-Image Pretraining-Adapter (CLIP-adapter) model, leveraging transfer learning, framing CLIP and a self-attention mechanism for predicting TSR in PDAC, in order to exhibit high performance in distinguishing low and high TSR PDAC in the test cohort. We speculated the CLIP-adapter model outperformed single-phase models, specifically CLIP models based on arterial or venous phase images alone. The addition of a feature fusion module could enhance the model's differentiation capacity, emphasizing its superiority over single-phase models. Besides, the model we designed utilized both image and text information during network training, instead of focusing on images only. This underscores the importance of comprehensive assessment in PDAC imaging evaluation, with the potential to contribute to risk stratification and personalized treatment planning.

Eligibility Criteria:
Inclusion Criteria:

1. patients with pathologically proven PDAC by surgical resection
2. patients who underwent CT scan within a month before surgery
3. observable pancreatic lesions on available images.

Exclusion Criteria:

1. any anti-cancer therapy before CT scanning
2. conspicuous interference or significant motion distortions found on images
3. partial clinical data
4. patients with liver metastases or peritoneal carcinomatosis prior to surgical intervention.
Comparing the Effects of Neck Stabilization Exercises Verses Dynamic Exercises Among Patients Having Nonspecific Neck Pain With Forward Head Posture

the objective of this randomized clinical trial is to compare the effectiveness of neck stabilization exercises versus neck dynamic exercises in patients having non specific neck pain with forward head posture for pain intensity, correction of forward head posture, increasing Range of movement and decrease functional disability. the study is being conducted at physiotherapy department of institute of physical medicine and rehabilitation (Dow university of health sciences) total 60 patients with non specific neck pain with forward head posture recruited by non-probability sampling technique initially screening done by consultant physicians who is blinded to the treatment given to patients. patient are included in study who fulfill inclusion criteria and sign the consent form. patients then randomly allocated to both treatment groups using computer generated randomization sheet. baseline assessment is taken at first session after providing 9 treatment of stabilizing exercises to group1 and dynamic exercises to group 2 session post assessment will be done on goniometry, NDI, VAS and plumb line at last session at third week.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nonspecific neck pain more than 3 weeks less than 6 months.
* Patients with forward head posture on plumb line assessment.
* Pain on VAS moderate 4-7
* NDI score with moderate; 50-64%.
* Age ranges from 18-40.

Exclusion Criteria:

* Previous history of any accident (whiplash), fracture, tumor etc.
* Patients not willing to participate.
Genes Contributing to Hereditary Ovarian Cancer in Women and BRCA1/2 Wildtype Families

The investigators propose to test for non-BRCA1/2 mutations in new and existing families with hereditary ovarian cancer in order to better define penetrance and associated malignancies of rare ovarian cancer susceptibility genes. The hypothesis is at least one third of hereditary ovarian carcinoma families wildtype for BRCA1/2 can be solved using an updated version of BROCA (BROCA-HR) that targets 47 genes, including all known ovarian cancer genes and additional candidate genes in related pathways. The objective is to identify families with mutations in rare ovarian cancer susceptibility genes and test both affected and unaffected family members, thereby generating a rough estimate of penetrance for each mutated gene as well as identify new ovarian cancer susceptibility genes. The investigators also plan to enroll self identified African America women, who have been drastically under-represented in clinical cancer genetic testing programs and in OC susceptibility research.

There is more to hereditary ovarian cancer than the breast and ovarian cancer susceptibility genes BRCA1 and BRCA2 (BRCA1/2). Next generation sequencing techniques have made it possible to sequence multiple candidate ovarian carcinoma susceptibility genes simultaneously. The King Laboratory has developed a targeted capture and massively parallel sequencing test called BROCA to evaluate mutations in known or suspected breast and ovarian cancer genes. In a prospective series of 360 unselected women with ovarian carcinoma, the investigators found that nearly one fourth of women carried mutations in one of 13 genes, and mutations in genes other than BRCA1 and BRCA2 accounted for 26% of all inherited mutations. While BROCA and similar gene panels are already in clinical use, little is known about the relative risks of carrying these non-BRCA1/2 mutations, making it difficult to counsel unaffected family members and develop optimum prevention protocols.

Eligibility Criteria:
Inclusion Criteria:

* ovarian cancer diagnosis with secondary criteria as noted above

Exclusion Criteria:

* age less than 18 yrs
Dynamic Focusing Evaluation for Prostate Cancer Treatment

Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.


Eligibility Criteria:
Inclusion Criteria for primary care patients:

* Age \> 70 years
* T1 or T2
* PSA \< 15 ng/mL
* 12 randomized biopsies
* Gleason score ≤ 3+4
* Normal anal and rectal anatomy
* American Society of Anesthesiologists risk (ASA) 1 or 2

Exclusion Criteria for primary care patients:

* T3 patients
* American Society of Anesthesiologists risk (ASA) 3
* Metastatic disease (Bone scan...)
* Previous prostate cancer therapy
* Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
* Prostate volume over 50cc
* Previous bladder cancer
* contraindication to MRI
* previous rectal or urinary fistulae

Inclusion Criteria for salvage patients:

* Age \> 50 years
* T1 or T2
* Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
* 12 randomized biopsies
* Normal anal and rectal anatomy
* ASA 1 or 2

Exclusion Criteria for salvage patients:

* T3 patients
* ASA 3
* Metastatic disease (Bone scan...)
* Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
* Prostate volume over 50cc
* Previous bladder cancer
* contraindication to MRI
* previous rectal or urinary fistulae
Testing a Self-Management App for Symptoms of Posttraumatic Stress

The purpose of this study is to evaluate the acceptability and efficacy of a self-guided behavioral health tool delivered by mobile app (called "Renew") for people who are experiencing symptoms of posttraumatic stress. This study also aims to determine the necessity of coaching support over and above support from peers, shedding light on the critical question of level of support resources needed to maintain mHealth app engagement.


Eligibility Criteria:
Inclusion Criteria:

* Veterans 18 years or older
* own an Android smart phone (as the app is only available for Android)
* self-report having experiencing symptoms of posttraumatic stress (defined as a PCL-5 score of 31 or higher).

Exclusion Criteria:

* None