cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial

The purpose of this study is to see if noise reduction programs in digital hearing aids help patients hear better than hearing aids without these programs. We also want to know if we can predict how successful patients will be with hearing aids.

The first goal of this project is to examine the efficacy of digital hearing aids incorporating three noise reduction strategies (i.e., directional microphones alone vs. directional microphones with DSP noise reduction algorithm 1 vs. directional microphones with DSP noise reduction algorithm 2) in terms of both speech understanding outcomes and functional outcomes. The second goal is to identify individual characteristics that are predictive of successful functional outcomes with hearing aids.

This study employs a multi-site, randomized, blinded, 2x2 factorial parallel group design. Three hundred subjects will be studied at three VA Medical Centers (Mountain Home, TN; Bay Pines, FL; and Los Angeles, CA) over a period of three years.

Objective (word recognition ability and performance with degraded speech stimuli) subjective (self-assessment questionnaires, personality and depression assessments) and cost-effectiveness assessments will be measured for 4 randomized treatment groups receiving different digital hearing aid technology. Subjects will be randomly assigned to wear hearing aids with directional microphones alone or directional microphones with noise reduction algorithm 1 or directional microphones with noise reduction algorithm 2 for a period of 8 weeks. Subjects will complete post-testing after 8 weeks of hearing aid use.

Eligibility Criteria:
Inclusion Criteria:

1. adult onset sensorineural hearing loss
2. English as the first language
3. bilateral symmetrical sensorineural hearing loss
4. Patient is a candidate for directional microphone technology.
5. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear.
6. no history of hearing aid use in the past 10 years
7. appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale.
8. Patient has a local telephone and address.

Exclusion Criteria:

1. evidence of outer ear, middle ear, or retrocochlear pathology
2. any threshold from 500 to 2000 Hz exceeds 70-dB HL
3. known neurological or psychiatric disorders as determined by chart review
4. known comorbid diseases that would prevent completion of the study as determined by chart review
5. visual impairment that would interfere with reading the questionnaires
Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.


Eligibility Criteria:
Inclusion Criteria:

* Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
* Replace lenses on a weekly or longer schedule
* Other protocol inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Current soft toric lens wearers
* Those who dispose of their soft lenses on a daily basis
* Current NIGHT \& DAY® or Biofinity® lens wearers
* Other protocol-defined inclusion/exclusion criteria may apply
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients

young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Eligibility Criteria:
Inclusion Criteria:

* all females prior and after chemotherapy

Exclusion Criteria:

* do not consent
NAD+ Oral Supplement Pilot Intervention in Adult Females

The goal of this clinical trial is to learn if Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women who identify as Latina and are between the ages of 40-80. The main questions it aims to answer are:

Will executive function change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving the NAD+ to see if the results differ from those receiving the placebo.

Participants will:

Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw


Eligibility Criteria:
Inclusion Criteria:

* Identify as Latina, have three or more adverse childhood experiences, and a BMI of 18.5 or above

Exclusion Criteria:

* Those who are taking hormone medication, pregnant or breastfeeding
EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS

The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition

The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
* Subject wishing to participate in the study by written consent.
* Instituto Mexicano del Seguro Social beneficiaries subject
* Subject who not requiring modification of medical treatment for MS in the recruitment period.

Exclusion Criteria:

* Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
* Diabetic neuropathy.
* Post menopause
* Intestinal malabsorption diseases .
* Type 2 diabetes with HbA1c \> 8.5 %
* Systolic and diastolic blood pressure \>140/90 mmHg.
* Triglycerides \> 300 mg/dL.
* LDL cholesterol \>160mg/dL.
* Systemic autoimmune diseases .
* Cirrhosis or liver failure .
* Subject infected with human immunodeficiency virus or acquired immunodeficiency syndrome .
* Diagnosis of cancer with active disease.
* Subject previously undergoing bariatric surgery.
* Pregnancy or lactation.
* Alcoholism and drug addiction.
* Subject who consume high fiber dietary supplements and / or omega 3 acids.
* Subject taking anorexic drugs.
* Subject under diet for weight loss implemented by a health professional.
Improved Screening for Osteoporosis

Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and deterioration of bone microarchitecture , leading to increased fracture risk for low trauma, such as spinal fractures or femoral neck .

It is estimated that 3 million people are living in France , particularly women , with an incidence that increases with age .

This disease is a major public health issue in terms of morbidity and mortality , costs and risk of recurrence (after a first fracture episode) , including risk factors are identified.

However, although bone densitometry is a reliable diagnostic tool and preventive treatments are at our disposal, screening for osteoporosis is still insufficient .

The objective of our study is to improve the detection of osteoporosis in Hospital Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone densitometry or if risk factors are found. Based on the results , the patient will be sent in rheumatology consultation for implementation of treatment if necessary .

Therefore included women hospitalized in medical services , gynecology, surgery and orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women who could answer a simple questionnaire and those previously treated for osteoporosis or have already received a bone density there is less than 3 years old .


Eligibility Criteria:
Inclusion Criteria:

* Women between 50 and 80 years
* Hospitalized
* In health services, orthopedics, gynecology, surgery
* Able to respond to an easy questionnaire
* Able to give their agreement to participate in the study

Exclusion Criteria:

* Patients with dementia
* Patients can not express
* Patients at end of life
* Patients previously treated for osteoporosis or recent densitometry (BMD) \<3 years
* Patients could not be seen in time by the nurse during their hospitalization
* Patients receiving a measure of legal protection
Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke

The purpose of this study is to test the hypothesis that adding functional strength training to UK conventional therapy improves muscle function and walking than either UK conventional therapy alone or increased intensity of UK conventional therapy.

Neuromuscular weakness occurs frequently after stroke and the processes underlying recovery are still poorly understood. Accepted practice in UK physiotherapy is to avoid training of muscle strength after stroke but there is preliminary evidence that it might be effective.

An observer-blind randomised pilot clinical trial (Phase II). Subjects will be within 3 months of first stroke with some voluntary movement in the paretic upper limb.

A Research Physiotherapist, blinded to measurement, will recruit subjects, allocate subjects to one of three intervention groups using sequentially numbered sealed envelopes containing previously allocated intervention cards and provide interventions. Ten participants will be recruited to each group therefore the trial will recuit 30 participants. The Research Assessor, blinded to intervention allocation will undertake all measurements.

Conventional therapy (control) will be provided as normal for the clinical setting, the additional conventional therapy (experimental 1)or functional strength training (experimental 2) will be provided for one hour, five times a week for six weeks. Subjects in the two experimental groups will also receive the conventional therapy standard in their clinical setting.

Blinded measurement will be made before randomisation, at the end of intervention and 12-weeks thereafter. Primary outcomes are the Action Research Arm Test (ARAT)and the Nine Hole Peg Test (9HPT). The secondary outcomes are peak torque around the elbow joint in elbow flexion and extension, grip force, pinch force, smoothness of movement during turning a cranked wheel and reciprocal inniveration of biceps and triceps during turning of a cranked wheel.

Data will be analysed using descriptive statistics and the estimation of standard deviations will be used to inform a power calculation to estimate sample size for a Phase II randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Be between one week and three months after stroke when recruited to the study
* Have some voluntary muscle activity in the paretic upper limb

Exclusion Criteria:

* Obvious unilateral visuospatial neglect
* Upper limb movement deficits attributable to non-stroke pathology
Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study

Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.


Eligibility Criteria:
Inclusion Criteria:

"Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."

Exclusion Criteria:

"The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men \>18 years
* Histologically confirmed prostate adenocarcinoma
* Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score \<=6, and PSA \<15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA \<=10 ng/mL

Exclusion Criteria:

* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Presence of a hip prosthesis
* Pelvic girth \>40cm - Large prostate (\>90cm3) on imaging
* Severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \>3)
Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic retinopathy cases undergoing vitrectomy

Exclusion Criteria:

* History of deep vitrectomy or cataract surgery
* Renal failure
* Silicone oil injection during surgery
* Early rebleeding
* History of antithrombotic drugs usage
A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic lymphocytic leukemia
* active CLL with progressive Binet stage B or C
* ineligible for treatment with fludarabine
* for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
* EOCG performance status \>/=2

Exclusion Criteria:

* patients who have relapsed within \<12 months of first dose of prior rituximab or chlorambucil first-line therapy
* previous or planned stem cell transplantation
* radioimmunotherapy within 6 months prior to starting study treatment
* transformation to aggressive B-cell malignancy
* any other concurrent anti-cancer therapy, or glucocorticoid \>/=20mg daily prednisolone or equivalent
Steep Trendelenburg Positioning on Intra-Ocular Pressure During Surgery for Endometrial Robotics Versus Laparotomy

The purpose of this study is to assess changes of intra-ocular pressure (IOP) and examine preoperative facts affecting IOP in endometrial cancer patients undergoing robotic hysterectomy compared to laparotomy.

All patients that are surgical candidates with endometrial cancer will be screened for this study. Two measurements from each eye will be taken in the following positions: awake at rest, supine before induction, after induction on anesthesia, after insufflation of abdomen with CO2 in supine position, in trendelenburg position, in deep trendelenburg position,at the end of procedure,prior to awakening in supine position and one last reading 45-60 min after awakening in supine position. The time, blood pressure, heart rate, peak airway pressure, plateau airway pressure, end tidal desflurane, end tidal CO2, total IV fluids administered, and blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial Cancer Surgery

Exclusion Criteria:

* Not a surgical candidate
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.


Eligibility Criteria:
Inclusion Criteria:

* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).

Exclusion Criteria:

* Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Pilot Study on Deep Learning in the Eye

Deep learning allows you to classify images using a self-learning algorithm. Transfer learning builds on an existing self-learning algorithm to enable image classification with fewer images. In this study, this technique will be applied to different image modalities in different syndromes. Retrospective study design.


Eligibility Criteria:
Inclusion Criteria:

* Availability of images, which allow discrimination.

Exclusion Criteria:

* No availability of clear data on disease differentiation
Greater Trochanter Epiphysiodesis In Hip Pathology

One of the most common problems in the treatment of pediatric patients with various disorders of the hip joint is the formation of deformity of the proximal femur, such as abnormal growth of the greater trochanter, which causes it to be positioned high in relation to the femoral head. This condition is called "relative overgrowth of the greater trochanter" (ROGT).


Eligibility Criteria:
Inclusion Criteria:

* emerging deformities of the proximal femur with a high position of the greater trochanter, in which its apex was located above the center of the femoral head but below its superior pole; changes in the structure of the femoral neck, accompanied by its shortening; functioning growth zone of the greater trochanter at the time of intervention; and patients without surgical treatment history

Exclusion Criteria:

* hip dislocation upon examination; patients with varus deformity of the femoral neck (neck-shaft angle \<120°), patients with complications of surgical interventions, trauma, rickets, and rheumatoid arthritis; and patients with neurological disorders and Refusal to participate in this study
Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy

This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.

An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects with pelvic organ prolapse (POP)
* Planning a surgical repair of POP with minimally invasive sacrocolpopexy
* Preoperative resting genital hiatus measure between 4.0 and 7.5cm

Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above

\*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)\*