cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Ocular Biometry in PACD With Two Swept Source Optical Coherence Tomography Devices

Purpose: To investigate agreement between 2 swept source OCT biometers, IOL M.aster700 and Anterion, in various ocular biometry and intraocular lens (IOL) calculations of primary angle-closure disease (PACD).

Methods: This was a prospective study conducted in a tertiary eye care centre involving biometric measurements obtained with 2 devices in phakic eye with diagnosis of PACD. Mean difference and intraclass correlation coefficient (ICC) with confidence limits were assessed, and calculations of estimated residual refraction of the IOL were analysed using Barrett's formula.

Primary angle-closure disease (PACD) is the leading cause of blindness worldwide. PACD is an anatomic disorder, typically of relatively small eye with shallow anterior chamber depth (ACD), thick lens, shorter axial length (AL), small corneal curvature, and relatively anterior lens position. Pupillary block, plateau iris and phacomorphic mechanisms play major roles in the pathophysiology of the disease, and pupillary block is thought to be the most common causal mechanism.

For decades, phacoemulsification and intraocular lens implantation (PEI) has been proposed for initial management of PACD.4 PEI relieves pupillary block, deepening ACD and widening irido-corneal angle.

Biometry is essential in evaluating ocular dimensions and calculating IOL power in PACD, and ocular biometers have been evolving in recent years. Optical coherence tomography (OCT) includes partial coherence interferometry (PCI), and swept source OCT (SS-OCT) is in general use in clinical practice. The agreement of the calculations of these devices has been studied by many investigators; however, research into their agreement in PACD patients has been sparse so far. A newer SS-OCT, Anterion, is now available and its performance needs to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were age \> 40 years old
* phakic eye
* diagnosis of PACD, including primary angle-closure suspect (PACS), primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) as classified by Foster et al

Exclusion Criteria:

* patients who had opaque optical media
* dense cataract
* anterior and/or posterior segment diseases such as advanced pterygium, diabetic retinopathy, or maculopathy
* Participants who had previous history of ocular trauma, ocular surgery
Genetic Analysis of Oculocerebrorenal Syndrome of Lowe

This study will investigate the genetic basis of oculocerebrorenal syndrome of Lowe (OCRL)-a rare X-linked disorder (carried by females and passed to males). Patients with OCRL have abnormal development of the eye lens, developmental delay, muscle weakness and kidney dysfunction.

The study will examine DNA and cell samples obtained and archived from patients with OCRL enrolled in a previous protocol (HG008A) between 1996 and 1999. It will identify mutations in the OCRL1 gene responsible for OCRL in affected males and try to correlate them with specific biochemical or cellular activities (e.g., enzyme activity, protein stability, cellular localization and trafficking). When test results are available, the information will be communicated to the patients, their parents (if the patient is a minor) and their physicians, and families will receive genetic counseling.

Oculocerebrorenal syndrome of Lowe (OCRL) is a rare X-linked disorder characterized by congenital cataracts, mental retardation, and renal tubular dysfunction. Patients with known or suspected OCRL were enrolled under previous protocol 96-HG-0008 that expired in 1998 and was not renewed. We are continuing studies of DNA and cell samples obtained and archived under our previous protocol to identify mutations in the OCRL1 gene responsible for Lowe syndrome and related disorders in affected males and attempt to correlate these mutations to particular biochemical or cellular phenotypes (enzyme activity, protein stability, cellular localization and trafficking). Information about genotypes will not be communicated back to the patients, their parents (if patient is a minor) or their physicians as part of this study.

We are also continuing our investigations of heterogeneity in OCRL by studying collected cell cultures from our collaborator Dr. Steven Scheinman at Suny New York Medical University, Syracuse, from a group of patients with mutations in OCRL1 who have Dent disease, characterized by renal tubular dysfunction. These data, and the variability in the renal and CNS abnormalities that occur in OCRL are evidence for the existence of modifiers. We propose to identify genes that are differentially expressed in cells from OCRL patients, patients with Dent disease and OCRL1 mutations by gene expression analysis of RNA from patient samples.

As part of our study on phenotypic and genetic heterogeneity in OCRL, mutation analysis resulted in the identification of mutations mostly in the second two-thirds of OCRL1. However, the OCRL1 mutations in the Dent disease patients have been found in the first third of OCRL1. We plan to send samples from Lowe syndrome patients without identified OCRL1 mutations to a Dr. Steven Scheinman who will look for such OCRL1 mutations. He will be sent only coded samples and will look for such OCRL1 mutations. He will be sent only coded samples and will not have access to patient identifiers. This information will be used for research purposes only.

Eligibility Criteria:
* INCLUSION CRITERIA:

Male gender, history of congenital cataracts, proximal renal tubular dysfunction, and developmental delay.
Prognosis of METTL-14 in Endometrial Carcinoma

1. To evaluate immunohistochemical expression of METTL14 in type1 endometrial carcinoma.
2. To evaluate the correlation between METTL14 expression and clinicopathological parameters of patients with type 1endometrial carcinoma such as tumor grade, lymhovascular invasion, age of pateints, tumor stage, presence of myometrial invasion and presence of cervical stroma affection.
3. To assess correlation of METTL-14 expression with disease free survival and overall survival.

Endometrial cancer(EC) is the second most common gynecologic cancer worldwide(1). In Egypt its incidence rate has increased in recent years, reaching 4.1 per 100,000 women(2). The most common histological subtype is endometrioid adenocarcinoma(3). Endometrial carcinoma can be divided into:Type I and Type II tumors. The incidence of Type I is 60-80% and that of Type II is 20%(4).

N6-methyladenosine (m6A)is the most abundant RNA modification in mammalian mRNA and has a crucial role in the occurrence and development of various diseases, particularly malignant tumors(3). Many factors were found to affect the prognosis of endometrial carcinoma, one of these factors is m6A RNA methylation(5). This modification is dynamic and reversible, and it is catalyzed by three main types of regulators(3). It has been reported that m6A methylation was performed via methyltransferase complex regulators composed of "writer," "eraser," and "reader"(6).

Methyltransferase like 14 (METTL14), a member of "writer", acts to regulate the occurrence of various cancers(7). In most tumors METTL14 acts as an antioncogene, regulating the RNA of genes that help the cell detect and repair DNA damage, acting as a protective mechanism against cancer. Reducing m6A mRNA may be due to METTL14 mutation. Reducing m6A mRNA levels in endometrial cancer cells could enhance cell proliferation and tumorigenicity in vitro and in vivo(8).The role of METTL14 as a risk factor in prognosis of endometrial carcinoma is still unknown.

Eligibility Criteria:
Inclusion Criteria:

* Cases of type1endometrial carcinoma with:

  1. Hystrectomy operation
  2. Available full clinical data about patient (age, complaint, findings in clinical examination).
  3. Full data about previous biopsy and radiology.
  4. Full data about patient survival, disease progression and history of chemotherapy for three years.

Exclusion Criteria:

* 1. Any case of type 1 endometrial carcinoma with missing clinical, radiologic or follow up data.

  2. Cases with no available H\&E stained slides or formalin fixed paraffin embedded block.

  3.D\&C.
The Effect of USM-IAM-based Counselling

According to the most current local data, the rate of patient's adherence to insulin injections is very low. A recent cross sectional study in Klinik Pakar Perubatan (KPP) Hospital Universiti Sains Malaysia (HUSM) among 355 patients with Type 2 diabetes treated with insulin showed only 19% of patients adhered to their insulin regime with the mean fasting plasma glucose of 10mmol/L and mean HbA1C of 10.0%. This condition may lead to undesirable health consequences.

Patients education has been showed to improved adherence. Among the 355 participants involved in the study, 82% of the patients have received consultation by diabetic educators yet their glycemic control were suboptimal. A new approaches using a module-based counseling that emphasized on adherence has been developed and the effectiveness of the counseling need to be evaluated.

General objective: To determine the effect of USM-insulin adherence module (U-IAM)-based counseling on the insulin adherence, glycemic control and inflammatory markers in poorly-controlled type 2 diabetes mellitus patients on insulin therapy.

Specific objective:

1. To determine within group changes and between group differences of insulin adherence score (using IAQDM) between patients in intervention and control group at baseline, 3rd month and 6th month
2. To determine within group changes and between group differences of FBS and HbA1c between patients in intervention and control group at baseline, 3rd month and 6th month.
3. To determine within group changes and between group differences of HsCRP and VCAM-1 between patients in intervention and control group at baseline, 3rd month and 6th month.
4. To identify factors associated with nonadherence (before starting of intervention) among patients on insulin such as sociodemographic, SMBG and treatment factors.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 65 years
* have been diagnosed with Type 2 Diabetes Mellitus
* Patients treated with insulin injections for at least 1 year on either basal insulin, basal plus prandial or basal bolus insulin
* HbA1c between 8 % and 15%

Exclusion Criteria:

* do not understand Malay language or illiterate
* have severe diabetes complications such as chronic kidney disease, heart failure
* recurrent hypoglycemia or hypoglycemia unawareness
* body mass index (BMI) ≥ 40kg/m2
Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1

In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design.

We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.

We will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (DESI) with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical Foundation) and UNC. The primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. Secondary outcomes include the likelihood that they review the DESI and their decision-specific knowledge. The 3 strategies selected by the PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with a healthcare provider and other men; and (3) providing men options by inviting them to a SMA while also providing them a DESI in DVD which they can use individually if they are unable or choose not to attend a SMA. The 3 groups will be compared to a control condition that does not receive a DESI but will be encouraged to discuss prostate cancer screening with their physician. Because of its significantly larger patient population, the PAMF site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening.

Eligibility Criteria:
Inclusion Criteria:

* age 50 or older
* do not have a prostate diagnosis
* have not had a PSA test in the past 10 months
* have not seen their primary care physicians in the last 3 months

Exclusion Criteria:

* Women
Pharmacokinetics of Different CoQ10 Formulations

The objective of this trial is to compare the bioavailability (AUC, Tmax, and Cmax) of different Coenzyme Q10 preparations in healthy adults. Pharmacokinetic parameters of orally ingested CoQ10 such as AUC, Cmax and Tmax, as well as the ratio of reduced CoQ10 levels to total CoQ10 plasma levels (using the AUC) after administration are compared.


Eligibility Criteria:
Inclusion Criteria:

* Participants are required to meet the following criteria to be eligible for enrollment: male or female aged 21-65 years or older
* Participants must complete an online health questionnaire on their medical history (pregnancy must be excluded) upon study enrolment.
* Voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Unstable medical condition; use of any acute medications during study period.
* Use of Coumadin Warfarin; use of supplements containing Coenzyme Q10, including the intake of any other supplements within 2 weeks of the beginning of the study (except for vitamin D and calcium). The use of any supplements except for vitamin D and calcium, are prohibited for the duration of the study.
* History of serious acute or chronic diseases such as gastrointestinal disorders, liver-, kidney-, cardiovascular, or hematological disease or diabetes; or other diseases; intolerances or food allergies such as gluten (in terms of the standardized meals).
* Using any form of nicotine or tobacco; participation in another investigational study
Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents

The investigators aim to identify the effect of a 12-week fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on the active participation in physical recreation activities and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with autism spectrum disorders (ASD) (pre-post) through in-person or via phone interviews with parents and children with ASD.

Participants will be randomly assigned to one of three protocols: 1) Workshop group, 2) Home-based group, and 3) wait-listed home-based group. Participants in all groups will receive an activity booklet and physical education-related activity items (e.g., ball, hoop). The hypothesis is that both the workshop and home-based groups will improve in all measures from pre to post compared to the wait-list control group. The investigators want to determine if the differences in the workshop and home-based groups differ significantly or are equitable in terms of gains in all areas.

Note: Due to COVID-19 for the post-test, instead of parents attending the UW-Facilities, they will be asked to videotape themselves and their children while performing the test of gross motor development (TGMD) activities. For the follow-up test (Fall 2020) we will expect to conduct these in person. However, if the situation due to COVID-19 remains the same, the investigators will ask families to follow the same procedures (videotape themselves and their children).

Eligibility Criteria:
Parents (one per family) and children with ASD ages 4 to 11 will be included (recruited as a dyad).

Inclusion Criteria:

* ASD must be the primary disability of the child
* Children will be considered to have ASD if they score above the clinical cutoff or 15 on both the lifetime and current versions of the SCQ. Diagnostic severity of ASD will not be a factor in recruitment.
* Children must be able to participate in the program activities.
* Children must be ambulatory and able to follow verbal or picture directions with support
* Children with significant communication needs will still be considered for the study
* No age restriction for adults (parents of children with ASD)
* Parents should be ambulatory and not have any restriction to do physical activity

Exclusion Criteria:

* Parents of children with other primary disabilities, or parents who do not have children with ASD will be excluded.
* Participants cannot exhibit aggressive behavior
* Children who are non-ambulatory, or participants (children) with significant behavioral or sensory impairments will also be excluded based on application information, including existing behavior intervention plans and existing school information
Repeated High-dose Inhaled Corticosteroids for Asthma

The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.


Eligibility Criteria:
Inclusion criteria:

* Physician diagnosis of asthma.
* Age ≥18 years and ≤50 years
* Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.
* Treatment for asthma with:

  * daily inhaled corticosteroids and long-acting beta2-agonists, AND
  * as-needed use of a short-acting beta2-agonist

Exclusion criteria:

* History of \>10 pack-year tobacco use
* Other pulmonary or cardiac diagnosis that is actively being treated
* History of adverse events or allergy to fluticasone
* Systemic corticosteroid therapy within 7 days of study visit
* Inability to obtain written informed consent
Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 60 years old.
* Patients with morbid obesity (IMC \> 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
* Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
* Patient with a previous medical examination.
* Patient giving its well-informed and free consent after information.

Exclusion Criteria:

* diabetes
* concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
* untreated sleep apnea syndrom, hypoxia (PaO2\<70mmHg) or hypercapnia (PaCO2\>45mmHg), anaemia \<10g/dL, ASAT or ALAT\>3N
Ileocolic Resection for Complex Crohn's Disease

Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.

From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed Crohn's disease
* previous appendectomy trough a mcburney incision

Exclusion Criteria:

* patients with major comorbidities
* age\>75
* previous midline laparotomy
Effect of the 3C Model in Students and Teachers From Vaupés, Boyacá and Amazonas

This study will evaluate the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion in students and teachers from three regions from Colombia: Vaupés, Amazonas and Boyacá. It will also evaluate its relevance in the design of programs aimed at mental health in educational settings.

Colombia has experienced a long-lasting internal armed conflict that has impacted society at all levels and on people of all ages. This has led to changes in behavior and the way people cope with psychosocial distress. Focusing on children and adolescents, this study aims to assess the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion. The changes in the scores of the CD-RISC and ECOM instruments will be evaluated through a mixed methods analysis that will evaluate the pre and post intervention results and the perception of all the actors involved in the development and implementation of the 3Cs program.

Eligibility Criteria:
Inclusion Criteria:

* Students and teachers from public institutions

Exclusion Criteria:

-