cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™

The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.

The study objectives are to:

1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.

Eligibility Criteria:
Inclusion Criteria:

* From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system)
* Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:
* No histological evidence of cancer with clinical follow-up data for a period of at least five years; or
* OSCC development (histologic or documented evidence of invasive cancer).
* Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.

Exclusion Criteria:

* Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients.
* Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.
Local Antibiotics for Breast Implants

The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.

The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biologically female
* Signed informed consent
* Scheduled for breast reconstruction with implants or expanders including:

  1. Immediate or delayed reconstructions
  2. Bilateral or unilateral reconstructions
  3. With or without simultaneous flap reconstruction

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Known allergy towards Vancomycin, Gentamicin and Cefazolin
* Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
* Known allergy towards neomycin
* Known impaired renal function with GFR \< 60 mL/min
* Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
* Myasthenia Gravis
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.


Eligibility Criteria:
Inclusion Criteria:

1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
3. Diagnosis of MS.
4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
5. Authorization from healthcare provider to provide data to registry.

Exclusion Criteria:

1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
3. Exposure to known teratogens and/or investigational medications during pregnancy.
Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)

This study aimed to compare refractive measurements using Vision-S™ 700, an immersive and compact phoropter with a tunable-focus lens, and Vision-R™ 800, a phoropter with a tunable-focus lens without immersion, with cycloplegic refraction serving as the gold-standard.

This a retrospective study aimed to enroll 41 children, aged 6 to 16 years, who underwent refractive assessments with Vision-S™ 700, Vision-R™ 800, and cycloplegic refraction. The primary objective involves a comparison of the spherical equivalent between both devices and compared to cycloplegic refraction. Secondary outcomes include the analysis of astigmatism components (J0° and J45°) and subgroup analyses in myopic and hyperopic children.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 16 years old patients followed in the Brest University Hospital Center, in France, between the 1st of November 2022 and the 30th of April 2023 and requiring a cycloplegic refraction not presenting an exclusion criteria

Exclusion Criteria:

* age below 6 years or above 16 years
* presence of other ophthalmological pathologies rather than ametropia
* non-French language proficiency, and absence of parental authorization
Acute Admission to Hallingdal Sjukestugu

The main objective of the project is to assess whether a community hospital may have or should have a role in the Norwegian health care system in the acute treatment of a defined group of patients.

The research project's objective is to analyze whether acute admissions to Hallingdal sjukestugu (HSS) is a real alternative to hospitalization in a general hospital.

HSS is a community hospital and a department under Ringerike General Hospital (RS) and is located in Hallingdal 170 km from the RS. It is an established practice that the general practitioners in Hallingdal send selected patients in need for acute treatment to HSS in place of RS. In 2008 this accounted for 10.1% of the total number of acute inpatients from the six municipalities of Hallingdal.

The research program includes a prospective, randomized study in which all patients intended for acute inpatient at HSS are distributed randomly into two groups, an intervention group who is admitted to HSS, and a control group who is sent to RS. A minimum of 70 patients are included in each group.

The patients are going to be followed through one year after the hospital stay and all contacts with the specialist health services and the municipal health care services will be registered. There will also be collected data on the patients' functioning level and the patients' opinion about quality of the hospital stay. Through standardized questionnaire the involved health professional will be asked about their reviews.

Three studies will analyze the patients' progress, economics and quality in the two groups. The three studies will together constitute a doctoral thesis.

The research project will provide a better basis for assessing the role of local medical centers in the Norwegian health care in the acute treatment of a defined group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who by the general practitioner are intended for acute admission to HSS and where the specialist on call at RS approves such admissions.
* Patients residing in Hallingdal municipalities.

Exclusion Criteria:

* Patients with injuries and acute and/or unclear illnesses in need of diagnosis, treatment or monitoring in an acute hospital.
* Urgent births at HSS.
* Acute psychiatric admissions to hospital.
* Patients with serious mental disorders.
* Patients who during the follow-up year move to a municipality outside of Hallingdal.
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.


Eligibility Criteria:
Inclusion Criteria:

* Equal or over 18 years of age
* Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
* At least 12 months of follow-up post date of surgery (-30 days)
* Undergone open or laparoscopic repairs

Exclusion Criteria:

* Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
* Any prior use of Permacol in abdominal wall repair
Whole Body Vibration Training for Healthy Body Composition in Young Adults

The purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (WBV) exercise program as a method of preventing weight gain in young adults.


Eligibility Criteria:
Inclusion Criteria:

1. BMI that is between 22-29.9 kg/m2
2. History of being weight stable (± 2 kg) for three months prior to beginning the intervention
3. Not currently on a prescribed diet plan to lose weight and no plan to begin one
4. Not consistently engaged in physical activity that meets current public health recommendations of 150 minutes of moderate to vigorous physical activity in the previous 6 months
5. Currently enrolled as an undergraduate student in a degree-granting college or university
6. Planning to reside in the Portland Metro area for the duration of the study

Exclusion Criteria:

1. Health condition that would prevent participation in moderate intensity physical activity program.
2. For female participants, pregnancy or plans to become pregnant during the study period (source documentation: self-report on HHQ)
3. Currently smoking/tobacco products or initiation of smoking/tobacco during the study
4. Alcohol consumption exceeding 3 drinks per day or a total of 18 drinks per week
Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate

Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.

MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.

Exclusion Criteria:

* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.
Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy

Hypertensive disorder complicating pregnancy is a set of diseases of pregnancy coexisting with elevated blood pressure. The incidence of it is approximately 5-12%. Pregnancy-induced hypertension is a pregnancy-specific disorder, severely impairing both maternal and fetal health, and the major cause of maternal and perinatal mortality rate increased. But so far, the specific etiology is still unclear.

Recently, fibroblast growth factor 23 (FGF23) has emerged as key endocrine regulators of the metabolism of vitamin D and calcium and phosphorus by combining FGFR-α- Klotho receptor complex. Current studies showed that α- Klotho involved the development of gestational hypertension via the production of endothelial nitric oxide, angiogenesis, and the formation of antioxidant enzymes. On the other hand, vitamin D deficiency during pregnancy has an adverse impact on maternal and fetal health, including gestational hypertension. Therefore, the relationship of the expression of FGF23 and the development of gestational hypertension has attracted the attention of relevant scholars.

The aim of this study is to detect the difference of the expression of FGF23 between the hypertensive women and normal pregnant women.

100 pregnant women with hypertensive disorder complicating pregnancy and 200 normal pregnant control women matched for maternal and gestational age were enrolled in the study. All the subjects underwent antepartum screening in the First Affiliated Hospital of Sun Yat-sen University. Blood samples were obtained after overnight fasting at the first, second and third trimester respectively. Serum FGF23 levels were determined by enzyme-linked immunosorbent assay (ELISA) and were correlated with anthropometric, metabolic, and endocrine parameters.

Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard deviations or median with interquartile range. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. Correlation analysis was performed using the Spearman rank correlation method. To identify independent relationships and adjust the effects of covariates, multiple linear regression analyses were performed. P values of \<0.05 were considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy;
* Regular antenatal examination from the first trimester;
* Give birth in the university hospital (The 1st affiliated hospital of Sun Yat-sen University)

Exclusion Criteria:

* Younger than 18 years old;
* Older than 40 years old;
* Multiple pregnancy;
* Complicated with other diseases such as hypertension, eclampsia, thyroid diseases, etc.
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight \> 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.

Stavudine is a nucleoside inhibitor larged used in HIV treatments and has been associated to mithocondrial toxicity. As it is still largely used in developping countries,the evaluation of reducing dose is of importance.

A single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4T 40 mg to 30 mg bid in patients with body weight \> 60kg to maintain full viral load suppression. Clinical and biological evaluations were carried out at baseline, W24 and W48. Primary end-point is viral load suppression (\<400 coies/ml) at W24.

Secondary end-points are : Evolution of CD4 count at W24 and W48, neurological examination at Baseline, W24 and W48, metabolic parameters and stavudine PK at W24.

Eligibility Criteria:
Inclusion Criteria:

* HIV patients
* Patients with an antiretroviral treatment containing stavudine at standard doses (40mg BID) for at least 3 months
* Patients with viral load \< 400 copies/ml for at least 3 months

Exclusion Criteria:

* Patients receiving an antiretroviral therapy containing stavudine at 30mg BID
* Current Opportunistic Infection
* Current chemotherapy or under cytokines treatment (PEG, INF, IL2)
* Pregnant or feeding Women
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. NYHA ≥ 2 and/or syncope and/or angina.
3. Symptomatic severe calcified aortic stenosis with AVA \< 1 cm2 AND peak velocity \> 4 m/s or mean gradient \> 40 mmHg or DVI \< 0.25'.
4. Patient judged by the Heart Team as indicated for TAVI.
5. Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
6. Estimated life-expectancy \> 1 year.

Exclusion Criteria:

1. Age \< 18 years
2. Asymptomatic patients
3. Estimated life expectancy \< 1 year
4. Pure aortic regurgitation.
5. LVEF \< 20%
6. No baseline MSCT evaluation.
7. Unsuitable aortic root anatomy for Navitor.
8. Unsuitable peripheral vasculature for transfemoral Navitor.
9. Type 2 bicuspid aortic valve
10. Excessive leaflet calcifications
11. Moderate or severe raphe calcifications
12. Severe LVOT calcifications
13. Perimeter-derived annular dimension exceeding IFU recommendation
14. Dilated ascending aorta \>45 mm
Group Cognitive Behavioral Therapy and Acupressure for Insomnia

This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation. CBT-I is widely used in western countries but it fails to address patient preference among Chinese adults with insomnia, as demonstrated in a previous study examining the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of psychological interventions for insomnia, integrative medicine with a combination of CBT-I and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of their combination.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents who are able to communicate in Cantonese;
2. Aged ≥ 18 years;
3. A current clinical DSM-5 diagnosis of insomnia disorder according to the Sleep Condition Indicator (SCI) ≥ 21;
4. Insomnia Severity Index (ISI) score ≥ 8; and
5. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 ;
2. Receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure treatment for insomnia in the past 6 months;
3. Pregnancy; and
4. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment.
Music's Effects on Anxiety During Epidural Placement

The objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.


Eligibility Criteria:
Inclusion Criteria

* Females ages 18 years and older committed to delivery by the obstetrical team (natural labor or induction of labor)
* English speaking
* Able to give informed consent
* Having an epidural placed Exclusion Criteria
* Patient refusal
* Intrauterine fetal demise
* Imminent delivery
* Existing music use
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.


Eligibility Criteria:
Inclusion Criteria

- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.

i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.

ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.

* Participants received 1 to 3 prior lines of antimyeloma therapy.
* Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy.

Exclusion Criteria

- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.

* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
* Participant has had prior treatment with mezigdomide or pomalidomide.
* Other protocol-defined Inclusion/Exclusion criteria apply.