cyrilzakka/clinical-trials huggingface dataset:
Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

This study aims to evaluate the short-term effects and safety of prophylactic intra-vitreal injection of triamcinolone-moxifloxacin combination after cataract surgery. 84 patients underwent cataract surgery associated with intra-vitreal injection of triamcinolone-moxifloxacin combination after surgery.

All the patients underwent the surgical removal of cataract by the same surgeon according to the standard protocols for modern phacoemulsification. Surgery was done under local anesthesia by peri-bulbar injection of local anesthetic. All operations were performed in an operating room by using an operating microscope under complete aseptic condition by using 10% povidone iodine solution applied to the skin of eye lid, eye lashes, side of the nose, eye brow and the skin of forehead. Before the operation, sterile drape and eyelid speculum were used, then 5% povidone iodine solution was applied to the bulbar conjunctiva and fornices for about 5 minutes, then was irrigated by balanced salt solution (BSS).

All the patients were followed up at the 1st day, 1st week, 1st month and at the 3rd month after the operation. At each visit the followings should be assessed: the post-operative refraction, the best corrected visual acuity and anterior and posterior segments examination for any sign of postoperative inflammation as cells and flare. Intra-ocular pressure (IOP) assessment and optical coherence tomography (OCT) images were also taken at the 1st and the 3rd postoperative months to assess the central macular thickness in suspected cases of cystoid macular edema (CME) based upon symptoms or signs observed on fundus examination, were confirmed by OCT of the macula through subjective interpretation via presence of cysts or an objective measurement of retinal thickness \> 250 microns.

Eligibility Criteria:
Inclusion criteria: Patients underwent uncomplicated cataract surgery with:

* A significant cataract.
* Good control of diabetes mellitus (DM) and hypertension (HPT) if present.
* Visual acuity not less than hand movement (HM).

Exclusion criteria:

The followings were the exclusion criteria:

* The use of systemic or topical steroids, topical ophthalmic antibiotics, or non-steroidal anti-inflammatory drugs (NSAIDs) for one week before operation.
* Make an additional procedure at the same time with cataract surgery.
* Those with uncontrolled glaucoma or with marked visual field defect .
* Those with a significant macular edema due to DM, HPT, retinal vein occlusion (CRVO) or due to any previous inflammatory condition.
* Those with blepharitis or any other local disease interfering with surgical intervention or affecting on the surgical outcome.
* Occurrence of intraoperative complications as posterior capsular rupture or postoperative complications as retained lens fragment.
The Role of a Private Hospital in Hong Kong Amid COVID-19 Pandemic

Hong Kong public healthcare system is facing tremendous pressure under the COVID-19 pandemic. As the virus spread in Hong Kong, Hong Kong Sanatorium \& Hospital (HKSH) is one of the first private hospitals which immediately provide reliable and rapid COVID-19 test -- Reverse Transcription Polymerase Chain Reaction (RT-PCR). Early provision of the RT-PCR screening test for COVID-19 not only facilitates identification of COVID-19 but also contains the spread of the virus in the community and frontline medical staff.

Since description of role of private hospital in Hong Kong amid COVID-19 pandemic is lacking, this study will describe COVID-19 screening algorithm and methodology. A retrospective analysis on clinical characteristics, laboratory findings as well as outcome of patients who underwent COVID-19 test in HKSH is also performed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent COVID-19 test in HKSH during the study period

Exclusion Criteria:

-
Virtual Reality Instructional Design in Orthopedic Physical Therapy Education

The objective of this study is to assess the effects of virtual reality instructional design on physical therapy students' clinical decision-making skills, as compared with a traditional method of instruction with the same content and duration of exposure.

An online random number generator will be used to randomize students into one of two groups: virtual reality instruction or role-paying instruction. All students will complete self-reported measures of clinical decision-making and metacognitive awareness prior to receiving their allocated instruction. While completing allocated instruction (either virtual reality or role-playing), measures of diagnostic accuracy and diagnostic efficiency will be collected. Following virtual reality or role-playing instruction, all included subjects will complete post-test measures of clinical decision-making ,metacognitive awareness, and engagement. One week later, all included subjects will be assessed on a musculoskeletal objective structured clinical examination (mOSCE).

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in their first year of physical therapy school at SU

Exclusion Criteria:

* Students enrolled in their second or third year of physical therapy school at SU
A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women

This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.

Real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in old women trunk strength, the risk of falling, functional autonomy and other complementary physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled trial in which 80 independent old women will be allocated to a Pilates-based exercise program, a muscular exercise program, and a no-exercise control group. The intervention is divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic balance, the number of falls, and functional autonomy. Secondary outcome will include body composition, habitual physical activity and a standardized gerontological evaluation composed of body composition, daily physical activity, the independence to develop basic and instrumental activities of daily living, and the cognitive, affective and social function assessment. Every item will be measured at baseline, 18 and 30 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women aged from 60 to 80 years, physically and mentally able to enroll in the exercise programs. The level of education, toxic habits, medical treatment and/or diseases that can affect musculoskeletal or cardiovascular systems, mental illness, urinary incontinence, the presence of oedema and high blood pressure will be controlled.

Exclusion Criteria:

* Current or prior participation in a structured Pilates-based or muscular exercise program in the past 3 months, and visual or auditory impairments not corrected with glasses or hearing aid. Each participant will also be at least 80% compliant to the exercise.
Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.


Eligibility Criteria:
Inclusion Criteria:

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion Criteria:

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of glucocorticoids
* Malignancy
* BMI \> 40
* Dementia or other cognitive dysfunction
* Treatment of anxiety or depression
Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device

This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.

Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.

Eligibility Criteria:
Inclusion Criteria:

* Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope

Exclusion Criteria:

* Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device
* Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device
Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers

BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have devastating effects on the economy, health and relationship, both for the problem gambler and their concerned significant other (CSO). No empirically supported program exists for the CSOs of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles from cognitive behavioral therapy and motivational interviewing. In order to benefit as many CSOs as possible, the program will be delivered via the Internet with therapist support via email and telephone.

METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules over 10 weeks in a secure online environment, and receive support via text messages and over telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline 3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship satisfaction and quality of life.

HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's relationship satisfaction with the problem gambler.


Eligibility Criteria:
Inclusion Criteria:

* The CSO and the gambler are at least 18 years old,
* The CSO is a parent, child, sibling, friend or partner of the gambler.
* The CSO must have had a relationship with the gambler for at least 3 months.
* Neither the CSO nor the gambler has had any treatment in the past 3 months (that is related to gambling).
* The gambler is currently refusing help.
* The CSO is able to read and answer questions in Swedish, and is willing to talk to a counselor each week.
* The gambler is a problem gambler according to Problem Gambling Severity Index, as rated by the CSO.
* The CSO must agree to have their telephone calls recorded.

Exclusion Criteria:

* Presence of psychotic- or bipolar disorder in the CSO or gambler.
* CSO meets PGSI criteria for ongoing problem gambling.
Extracellular RNA Biomarkers of Myotonic Dystrophy

Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with DM1 or DM2 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done). Control non-DM subjects are unknown to have DM or any other muscular dystrophy by history and may have had no genetic testing.
* Able to provide informed consent or assent for participation in the study.
* Demographic characteristics for single biofluid collection: Males and females age 5 years and older (DM1, DM2, and non-DM).
* Demographic characteristics for repeated measurements: Males and females age 14 years and older with DM1.
* Demographic characteristics for biofluid and muscle biopsy: Males and females, ages 18-65 years.

Exclusion Criteria:

* Medical history of any of the following. State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive.
* Medications and other drugs. Use of anti-platelet drugs within 7 days prior to blood draw or biopsy; use of anticoagulants within 60 days prior to blood draw or biopsy; active drug or alcohol use or dependence that, in the opinion of the biopsy surgeon, would interfere with post-procedure wound care.
* Other. Women that are pregnant, or intend to become pregnant, prior to the biopsy; urine pregnancy test that is positive; inability or unwillingness of the subject to give written informed consent.
* Other. Inability or unwillingness of the subject to give written informed consent or assent.
Heart Failure Study: The Atlanta Cardiomyopathy Consortium

Heart failure is a very common cause of hospital admission and there are half a million new cases diagnosed each year in the United States. While some important progress has been made over the last two decades for the treatment of heart failure, there still remains a critical need for further advances in our understanding of this disease in order to significantly improve patient outcomes. Large numbers of heart failure patients need to be studied over time to allow scientists to investigate those factors that influence the responses to therapy.

In this study information will be collected on patients with heart failure and their progress and outcomes will be followed over time. The aim is to understand the natural history, risk factors for improvement or progression, and determinants of response to therapy for heart failure. Of interest are many aspects of heart failure including genetic influences, quality of life issues, how individuals cope with feelings about having heart disease, and how they manage their day-to-day symptoms etc.. A database will be created of approximately 1,000 heart failure patients from Emory, Emory University Hospital Midtown, Wesley Woods, Grady, and the VA Medical Center.

This is strictly an observational study and subjects will not be receiving any experimental therapy nor will their routine medical care be affected in any way. Data to be collected includes:

1. Medical history of the patient
2. Medical history on the patient's family
3. Survey data including health behaviors \& psychosocial variables
4. Blood \& urine samples
5. EKG
6. Six minute Walk Test
7. Hand grip strength

After collecting data, a variety of statistical tests will be run to analyze factors that influence heart failure patients' responses to treatment. The results of this analysis will be used to optimize therapy for future heart failure patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and over
* Sex: Both
* Ethnic Origin: All
* Diagnosis required to participate: Clinical diagnosis of systolic or diastolic heart failure

Exclusion Criteria:

* Congenital heart disease
* Previous heart transplantation
* No primary infiltrative disease i.e. amyloidosis
Correlation of Hospital Stay Length With the Glucose Levels After Cardiac Surgery

The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.

The stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not.

This study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Physical status classification of the American Society of Anesthesiologists (ASA) II-IV
* Patients programmed for cardiac surgery
* Any body mass index

Exclusion Criteria:

* Pregnant women
* Chronic Kidney Disease (CKD) Stage 2 or higher
Study of Safety and Efficacy of Genome-edited Hematopoietic Stem and Progenitor Cells in Sickle Cell Disease (SCD)

This study evaluated a genome-edited, autologous, hematopoietic stem and progenitor cell (HSPC) product - OTQ923 to reduce the biologic activity of BCL11A, increasing fetal hemoglobin (HbF) and reducing complications of sickle cell disease.

CADPT03A12101 was a multicenter, multi-part, first-in-human, proof-of-concept, open label non-randomized, clinical study in Sickle Cell Disease (SCD) subjects. This study included apheresis of mobilized hematopoietic stem and progenitor cells (HSPCs), ex vivo CRISPR/Cas9-mediated genome editing and expansion, followed by myeloablative conditioning and autologous hematopoietic stem cell transplant (HSCT) with follow-up for a minimum of one year and up to two years.

The study was divided into the following parts:

* Part A - Adult subjects were dosed with OTQ923.
* Part B - Assessment of OTQ923 in pediatric patients, however Part B was not opened.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects age 2-40 years inclusive
2. Confirmed diagnosis of sickle cell disease with globin typing (e.g. HbSS, HbSC, HbS/β0-thalassemia or others)
3. Performance status \>70% (Karnofsky for subjects \>16 years of age and Lansky for subjects \<16 years of age)
4. At least one of the following indicators of disease severity as defined in the protocol - Vaso-occlusive pain crisis, Acute chest syndrome, Recurrent priapism, prior stroke, receive chronic transfusions, Red cell alloimmunization
5. Subjects, who have failed, not tolerated or refused hydroxyurea therapy.

Exclusion Criteria:

1. Available matched related donor for HSCT
2. Clinically significant active infection
3. Seropositive for HIV or HTLV
4. Active known malignancy, myelodysplasia, abnormal cytogenetics or immunodeficiency
5. Prior HSCT or gene therapy
6. Known hepatic cirrhosis, bridging hepatic fibrosis or active hepatitis
7. Protocol defined iron overload
8. Cerebrovascular procedure within one year, including pial synangiosis for Moyamoya
9. Severe or progressive arteriopathy or cerebrovascular disease, including Moyamoya

Other protocol defined inclusion/exclusion criteria may apply
Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

This study incorporates a virtual reality (VR) simulated walking environment, with audio component of patient education, into the treadmill portion of outpatient cardiac rehabilitation (CR). The VR program was developed by Plas.MD and is named Bionautica Trails.


Eligibility Criteria:
Inclusion Criteria:

* Participants must independently choose or be referred to Jefferson Health Methodist Cardiac Rehabilitation Program for outpatient cardiac rehabilitation.
* Participants must have a referring cardiac condition requiring cardiac rehabilitation therapy.

Exclusion Criteria:

* Physical inability to use treadmill
* Medically unsafe to use a treadmill for 15 minutes
* Inability to understand English
* Unable to provide consent
Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology

In this prospective study, we aimed to investigate whether serum and abdominal washing fluid CA-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma.

Endometrial cancer was diagnosed with histopathological examination of the samples obtained by dilatation and curettage. Preoperative serum CA-125 levels were determined in all patients. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. In addition to routine preoperative investigations, MRI was done in patients who were thought to have an extension outside the uterus.

During surgery, abdominal exploration was performed first, and then an abdominal fluid sample was obtained for cytological examination and measurement of CA-125 level. One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Subsequently, total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH + BSO) were performed.

Eligibility Criteria:
Inclusion Criteria:

* Women with endometrial carcinoma

Exclusion Criteria:

* Previous history of any other malignancy
* Endometriosis
* Diagnosed with pelvic infection or with any other potential disease such as acute pancreatitis, colitis, diverticulitis, pericarditis, polyarteritis nodosa, Sjögren's syndrome and SLE
A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair

The aim of this study was to evaluate the effects of a 8-week pain neuroscience education programme compared to a biomedical education programme on the rehabilitation of patients who undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients' attitudes and beliefs about pain, disability and quality of life.

This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal physiotherapy along with pain neuroscience education, and the control group- PME (n=13) received multimodal physiotherapy along with biomedical education. The multimodal treatment included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a one-to-one basis, once per week at the start of the programme.

Physiotherapists involved in the delivery of the interventions were previously trained on both, the theoretical and practical aspects related to the protocols of multimodal physiotherapy and specially on the education component.

Outcome measures included pain intensity (pain intensity numerical rating score), catastrophizing, kinesiophobia, disability and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* People aged 30 to 59 years with shoulder pain for more than three months, with torn rotator cuff repaired by arthroscopy.

Exclusion Criteria:

* Subjects unable to understand, read or speak Spanish, or participated in a programme for psychological management of chronic pain, or presented with generalised pain.