cyrilzakka/clinical-trials huggingface dataset:
High Tone Pelvic Floor Dysfunction

Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs in \>50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm). Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD.

How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment includes treating both conditions. If only one is treated, then sexual pain is likely to continue. There are several available treatments for HTPFD that have been studied including physical therapy, botox and intravaginal diazepam.

This is an area where clinicians may be under treating a condition and limiting the possibility of restoring normal sexual function to many women. Treating only vaginal atrophy without appropriate evaluation and treatment of HTPFD leaves a cohort of women still struggling with sexual pain. With a better understanding of the relationship between HTPFD and vaginal atrophy, the investigators hope to bring awareness concerning the importance of treating both in restoring normal sexual function.

This is a retrospective chart review that will be performed to identify all female patients in the electronic medical records with a diagnosis of vulvovaginal atrophy (VVA).

The records of these patients with VVA will be examined for demographics, symptoms, answers to standardized questionnaires ( e.g. Female Sexual Function Index - FSFI - that is routinely assessed during clinical evaluation), work-up, diagnosis, and/or treatment of high tone pelvic floor dysfunction (HTPFD). Symptoms of HTPFD include but are not limited to pelvic pressure or pain, and dyspareunia. These data will then undergo statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of vulvovaginal atrophy (VVA)

Exclusion Criteria:

* not meeting the inclusion criteria
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.

Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18-89 years of age
* Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.

Exclusion Criteria:

* Patients contraindicated against MRI
* Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal
* Patients unwilling or unable to give written informed consent
* Pregnant women
* Prisoners
* Patients with an Effective Orifice Area index (EOAi) \<0.85 cm2/m2
Effect of Phosphate Exposure on Workers Health

To minimize negative health effects on health of workers in phosphate mining, it is important to assess, and diagnose health related effect of phosphate exposure \& health hazards related to miners. Early reporting, diagnosis, and intervention can limit the severity of health hazards, improve the health services. To our knowledge no local previous studies were done in this area.

Mining continues to be a dangerous activity, whether large-scale industrial mining or small-scale artisanal mining. Not only are there accidents, but exposure to dust and toxins, along with stress from the working environment or managerial pressures, give rise to a range of diseases that affect miners. Beneficiation is the process of removing the unnecessary minerals, which is used to increase the grade of mining product (concentrate). Phosphate ores can be beneficiated using one or a combination of different methods. The most common ones are: flotation, crushing, desliming, separation, grinding and washing thus keeping workers in Phosphate mines employ exposed to respirable dust pollution and to high silica dust levels presented in silicosis in many job areas, Silicosis is the most common occupational lung disease in Egypt where its prevalence rate ranges from 18.5 % to 45.8% among workers exposed to free crystalline silica dust. Despite its high prevalence, there is a lack of enforcement of exposure limits, availability and use of personal protective equipment, and occupational health education programs .

In Egyptian phosphate miners' study (2011), The study involved of three groups: 50 silica-exposed workers with radiological evidence of silicosis, 50 silica-exposed workers without evidence of silicosis, and 50 healthy unexposed subjects. , There were significant differences between pulmonary function parameters, values of C-reactive protein, rheumatoid factor, complement component C3, IgA, IgG, and IgM in exposed groups with and without silicosis, and healthy unexposed control subjects (p\<.001).

Exposure to acid fumes in the phosphate mining was significantly associated with dental erosion and deteriorated oral health status, As working in phosphate mines had 8 and 28 times the risk for developing respectively oral lesions and teeth abrasions. This supported by Tunisian 2017 on 37 workers\& 37 controls, found that frequencies of fluorosis, teeth abrasion, and oral lesions were significantly higher among the exposed group.

Eligibility Criteria:
Inclusion Criteria:

* Active working miners working in phosphate mines with minimum exposure 5 year.
* Had free pre-employment records.

Exclusion Criteria:

* Workers don't record phosphate exposure as in administration department.
* Workers with less than 5-year exposure
* Workers known to had autoimmune disorder before joining job.
Health Outcomes After Participating in Exercise (HOPE)

Aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. Obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. The overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

Obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. Although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. Weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. Because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. The goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

Eligibility Criteria:
Inclusion Criteria:

* All former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview.

Exclusion Criteria:

* None - all former participants from the five intervention trials are eligible
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

NOTE: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.

Eligibility Criteria:
Inclusion Criteria:

Participants will:

1. be between the ages of 18 and 65 years
2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization

Exclusion Criteria:

1. Presence of current psychotic or autism spectrum disorder or current delirium
2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
3. Current pregnancy or breastfeeding
4. Reading level \<5th grade as per WRAT-3 reading subtest
5. Past intolerance or hypersensitivity to ketamine
6. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
7. Patients who have received ECT in the past 6 months prior to intake
8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
9. Patients who, based on expressed preference and/or home geographic location, are deemed by the Psychiatric Consultation/Liaison service to be likely to receive inpatient psychiatric hospitalization at an alternate location outside of Western Psychiatric Institute \& Clinic
ASSIST 1.0 an Intervention Program Addressing Reablement Services

Reablement holds a potential to become a new rehabilitation model and has been implemented in some western countries including Norway and Denmark. At present, there is a lack of scientific evidence for the effectiveness of reablement and lack of an explicit theoretical underpinning, leading to a gap in knowledge. Trends show, however, that reablement is beneficial for the person and their significant others, increasing quality of life. There is a need for further investigation of the effects among community-dwelling adults in terms of clinical and economic outcomes. This research project will investigate the effectiveness of reablement including smart products (digitally based) (ASSIST) to facilitate and manage reablement services in home-dwelling adults compared with standard home help services in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs.

Methods and analysis: This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention program as the fidelity, reach and dose, and potential outcomes by using a pre-post test design involving an intervention group and a control group (n=30). All participants will be living at home and with a need of home care services. Qualitative interviews among home care providers delivering ASSIST and older adults and their significant others receiving the intervention will be conducted to explore aspects affecting the intervention.

Ethics and dissemination: The results will form the base for refinement of the "ASSIST" program and planning of a large-scale randomized, controlled trial investigating the effect of the program on quality of life as physical health, mental well-being, conditions for social community when focusing on supporting the older person's to meaningful everyday life. Dissemination will include peer-reviewed publications and presentations at national and international conferences.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years or older and live at home,
* home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff,
* two or more identified challenges in everyday activities that can benefit from everyday rehabilitation,
* are able to understand and express themselves in Swedish.

Exclusion Criteria:

* have cognitive limitations that make reablement unappropriate,
* in need of care in institutional dwelling or are terminally ill ,
* the older adults have had home help services more than three years.
Macular Edema Incidence/Severity Reduction With Nevanac

The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
* History of Type 1 or Type 2 diabetes.
* History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
* Able to understand and sign an informed consent approved by an IRB/IEC.
* Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
* Absence of clinically significant macular edema in the study eye as detected by clinical exam.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
* Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
* Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
* Corneal transplant in study eye.
* Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
* Other protocol-defined exclusion criteria may apply.
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to transcricoid injection or spray as you go lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the use of transcricoid injection in one group.

During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure.

Post procedure, patients will record the pain experienced while undergoing the procedure on the VAS scale.

Eligibility Criteria:
Inclusion Criteria:

* Indication for EBUS TBNA
* Age \> 18 years

Exclusion Criteria:

* Refusal of consent
* Known documented hypersensitivity to lignocaine
* Procedure performed under general anaesthesia
* Pregnancy
* Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
* Bronchoscopy done through endotracheal or tracheostomy tube
* Midline neck mass or thyroid enlargement making the identification of
* cricothyroid membrane difficult'
* Patients with central airway obstruction
* Patients with active ongoing hemoptysis
Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

In this study, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure.

Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than 35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated will be excluded from the study. Patients will be divided randomly into 2 groups as direct laryngoscopic and fiberoptic intubation group. Patients will be preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen saturation,perfusion index will be recorded and intraocular pressure measured by ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction, 1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be accepted as application time and recorded. Study will be terminated after 5th minute values taken.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologist) Grade 1-2,
* Mallampati score 1 or 2,
* Age between 18 to 65
* Patient planned to undergo nonopthalmic surgery.

Exclusion Criteria:

* Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA Grade III and IV, BMI more than 35,
* Patients with difficult intubation,
* Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium contraindicated.
EXALT: EXercise Attenuates Liver Tumors Trial

The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.

Primary liver cancer is the leading cause of cancer worldwide. The majority of primary liver cancers are hepatocellular carcinoma (HCC) and occur in the setting of cirrhosis of the liver. Body fat and systemic inflammation are determinants of HCC risk. Cirrhotic patients with HCC are often treated with locoregional therapies including transarterial chemoembolization (TACE) as a bridge to liver transplantation. Despite this, HCC recurrence rates approach 80%. There is a growing body of evidence to suggest the benefit of exercise in cancer patients. Exercise decreases disease recurrence and improves survival in other primary cancers by altering tumor biology and influencing response to treatment. Although animal models suggest biologic plausibility, whether or not exercise prevents HCC recurrence in cancer patients remains unknown. The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.

Eligibility Criteria:
Inclusion Criteria:

* Adults age \>=18 or \<70 years
* Liver transplant candidates (under evaluation or listed for transplant with HCC)
* Hepatocellular Carcinoma diagnosis (HCC)
* Complete response to LRT

Exclusion Criteria:

* Active cardiac symptoms
* BMI \<18 or \>45 kg/m2(16)
* CPT Class B or C liver disease
* ECOG \>2
* Hepatic decompensation
* Institutionalized/prisoner
* Pregnancy
* Severe medical comorbidities/psychiatric illness
Effects of Physical Exercise in Type 2 Diabetics

The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.


Eligibility Criteria:
Inclusion Criteria:

* sedentary adult with type 2 diabetes
* BMI between 25 and 35 kg/m²
* Hba1c \< 10 %

Exclusion Criteria:

* unstable coronary artery disease
* advanced peripheral occlusive arterial disease
* proteinuria \> 3 g/d and / or creatinine clearance \< 30 ml / mn
* advanced diabetic neuropathy