cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults

The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.

The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-64 years
* Mild to moderate high frequency hearing loss
* Learned English as a first language

Exclusion Criteria:

* Previous use of hearing aids
* Hearing loss/problems attributed to factors other than aging
* History of: neurologic disorder, middle-ear disease
* Score of \< 26 on the Montreal Cognitive Assessment
Low Level Laser Intervention for Individuals With Knee Osteoarthritis

The purpose of this study was to investigate the intervention effects of low level laser for knee OA group


Eligibility Criteria:
Inclusion Criteria:

* The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3

Exclusion Criteria:

* Uncontrolled hypertension
* Malignant tumor
* Skin cancer
* Pregnant
* Dysesthesia
* Pacemaker inplement
* Cognitive problem
* Fall record within 6 months
* Dysfunction of blood coagulation
Chewing Gum on Postoperative Ileus in Children

Traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. This approach includes earlier mobilization of the patient, and introducing solid food sooner. Additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier.

The aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.

After intestinal surgery, many patients suffer from a "postoperative ileus" (POI). The cause is multifactorial and can be attributed to surgery itself, the lingering effect of the anesthetic, the use of narcotics and decreased mobility of the patient.

An ileus can delay the time to full diet, thus lengthening the hospital stay of the patient - sometimes up to several weeks.

There is evidence that early drinking/eating and increased mobility may accelerate the return of bowel function. "Fast-tracking" is well documented in the adult literature; protocols have been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus. "Fast-tracking" has been done in pediatric patients but not in a large RCT for abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children more than or equal to 4 years of age
* Children who undergo abdominal surgery (both laparoscopic or open)
* Children who have an expected postoperative length of stay more than 24 hours

Exclusion Criteria:

* Children who are less than 4 years of age
* Children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability)
* Children or their parents are not willing to sign consent
* Children or their parents are unable to follow directions regarding gum chewing,
* Children who have a GI dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)
Effect of a Psycho-educational Intervention on Psychological Outcomes of Gynecological Cancer Patients

This study will be conducted to optimize the quality of care rendered for gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria.As well as to assess the effect of implementing a psychoeducational intervention program among gynecological cancer women on the:

1. Quality of life with its different domains (physical, emotional, social and functional). "as a primary objective"
2. Psychological distress and cancer-specific stress. "as secondary objectives"

Cancer is a significant health problem worldwide with wide geographical variation in incidence. Additionally it has become an important item in each country's health agenda.It is a prominent cause of mortality in both economically developed and underdeveloped nations.Unfortunately, the burden is expected to grow globally due to the development and aging of the population.Gynecological cancer, which includes cancers of the cervix, ovary, uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related mortality worldwide.In Egypt, according to the Global Cancer Observatory (GLOBOCAN) 2020, approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new cases for cervical cancer and 744 women died from the disease.

Hence, this study will be carried out to develop and implement a psychoeducational intervention program among gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria and evaluate its effect in improving their psychological outcomes and quality of life.

Eligibility Criteria:
Inclusion Criteria:

Women are eligible to participate if they are:

* Over 20 years old.
* Newly diagnosed cases with gynecological cancers (confirmed within 3 months).
* Scheduled to have surgery as the first-line treatment.
* Willing to participate in the study.

Exclusion Criteria:

Women are excluded if they:

* Are in the late stage (stage IV) as women in this group usually receive palliative/ symptomatic treatment.
* Have additional cancer diagnosis (including metastasis).
* Are diagnosed with severe psychiatric or cognitive disorder.
* Participate in other intervention study.
CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)

This was a Retrospective cohort study based on the PMSI data source

A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (\~99% of French residents).

The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified.

The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay.

CAR-T populations:

KYMRIAH® DLBCL cohort:

* Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
* Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019

YESCARTA®DLBCL cohort:

* Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy:
* Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019

KYMRIAH® ALL cohort:

* Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse:
* Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
* Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
* up to 25 years for patients with ALL

Exclusion Criteria:

* All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
Embryotransfer Operator and Pregnancy Rate

Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate.

The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer.

This study allows following more than 30 different operators in a global period of 20 years with almost 20,000 procedures.

Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate. Until now, the evidences are mixed and inconclusive.

The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer.

The database includes all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles. Only embryo transfers performed by the surgeon on duty for that day ("Gynecologist of the Day") will be included.

Secondary end point is to evaluate if it is possible to draw a learning curve for transfer in terms of pregnancies for the different surgeons.

The strength of this study relies on the completeness of the preoperative factors and follow up and on the vastest dataset in literature that can permit to correct for multiple confounders and analyze a wide group of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* fresh embryos' transfers
* embryo transfers performed only by the surgeon on duty for that day ("Gynecologist of the Day")

Exclusion Criteria:

* cryo thawed embryos' transfers
Chest Pain, Illness Perception Compliance and Psychosocial Outcome After Coronary Arteriography

Chest pain, illness perception compliance and psychosocial outcome after coronary arteriography. A comparison between patients which were diagnosed with slow coronary flow and patients who have been diagnosed with coronary artery occlusion. We hope to prove that the more knowledge and awareness the patient has about his disease the better his compliance and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with slow flow or coronary artery occlusion

Exclusion Criteria:

* All other patients
Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells attached to the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 20,000 cases worldwide.

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive PLIF surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their PLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and BMP.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
2. Lumbar spine abnormality requiring treatment at more than two levels
3. Systemic or local infection; active or latent
4. Previous failed fusion at the operative level
5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
7. Pregnant, or plans to become pregnant during the study
8. Subject is a prisoner
9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
11. Participating in another clinical study that would confound study data
Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

This study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks.

This is a 2-period, randomized, crossover, controlled feeding study examining the effect of 2020-2025 Dietary Guidelines for Americans adherent dietary patterns containing 2 eggs/day/2000 kcal (HD+E) compared to 3 eggs/week/2000 kcal (HD) on biomarkers of cardiovascular health and function after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C ≥115 mg/dL and ≤190 mg/L
* BMI of 25-35 kg/m2
* Intake of \<14 eggs/week for the prior 3 months
* Blood pressure \<140/90 mmHg
* Fasting blood glucose \<126 mg/dL
* Fasting triglycerides \<350 mg/dL
* ≤10% change in body weight in the prior 6 months

Exclusion Criteria:

* Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
* Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
* Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
* Diagnosed liver, kidney, or autoimmune disease
* Prior cardiovascular event (e.g., stroke, heart attack)
* Current pregnancy or intention of pregnancy within the next 6 months
* Lactation within prior 6 months
* Follows a vegetarian or vegan diet
* Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
* Antibiotic use within the prior 1 month
* Oral steroid use within the prior 1 month
* Use of tobacco or nicotine containing products with in the past 6 months
* Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
* Participation in another clinical trial within 30 days of baseline
* Currently following a restricted or weight loss diet
* Prior bariatric surgery
* Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits
Vestibular Evoked Myogenic Potential: A New Device Propose

The bioelectrical responses of muscle, evoked by sound, obtained with a device considered the gold standard (widely used in clinics and hospitals) are similar to those obtained with a new device developed


Eligibility Criteria:
Inclusion Criteria:

* hearing thresholds equal to or less than 20 dB HL with differences between the ears, by frequency, equal to or less than 10 dB.

Exclusion Criteria:

* Occupational noise exposure
* Ear surgeries
* More than three ear infections in the current year
* Use of ototoxic medication
* Tinnitus, vertigo, dizziness or other vestibular-cochlear diseases
* Systemic diseases that may contribute to cochlear-vestibular pathologies, such as hypertension and dyslipidemia
* Hormonal diseases
Non-Invasive Determination of Cardiac Output by Electrical Velocimetry

The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). Therefore the aim of the study at hand was to evaluate the electrical velocimetry technique as a new method for determining the CO and to compare this new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance Tomography


Eligibility Criteria:
Inclusion Criteria:

* Indication for CMR
* Ability of following instructions for electrical velocimetry test, rebreathing test and spirometry
Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

The primary objective will be the correlation between the appearance of EPW recorded by the CompuFlo and the correct placement of the epidural catheter as assessed by the occurrence of adequate bilateral labor analgesia.

Secondary objectives will be the effects of the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter on the EPW.

The study will enroll consecutive parturients in active labor who have received effective epidural labor analgesia with an epidural catheter. After epidural catheter priming, the occurrence or the absence of EPW will be investigated.

Endpoints (quantitative measurements required by the objectives)

Primary end points:

1. appearance and recording of EPW by using the CompuFlo instrument.
2. absence of EPW in case of inadequate analgesia, intravascular placement or unilateral analgesia 3) successful analgesia, defined as the occurrence of a visual analogue pain score less than 10/100 during the study period

Secondary end points:

* time from the last epidural bolus and the EPW recordings
* EPW recordings between uterine contractions and at the apex of a uterine contraction
* EPW recordings when the patient is supine or in left lateral decubitus
* EPW recordings during 10 sec Valsalva maneuver
* priming volume of saline necessary to detect EPW (5,10,15,20 ml)

Tertiary end points:

* epidural actual pressure (mmHg)
* EPW disappearance or absence during catheter removal or during ineffective analgesia

Eligibility Criteria:
Inclusion Criteria:

* healthy women in active labor who received epidural analgesia

Exclusion Criteria:

* healthy women in active labor who received ineffective epidural analgesia
QUANTRA® References Range Protocol in Pregnancy and Postpartum

Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
* Delivering vaginally without postpartum hemorrhage for 60 patients
* Delivering through a programmed C-section for 20 patients
* Having given a non-opposition agreement to participate in the study.
* Major patient with social insurance

Exclusion Criteria:

* Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.