cyrilzakka/clinical-trials huggingface dataset:
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study

This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.

This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy. The investigators will also explore participants' perceptions of acceptability and satisfaction with the yoga intervention. Lastly, the investigators will examine changes in chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related impairment, fatigue, anxiety, depression, and pain following the eight-week yoga intervention.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age,

* self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past week,
* at least three months post neurotoxic chemotherapy completion
* signed informed consent,
* willingness to participate in all study activities
* speak/read English

Exclusion Criteria:

* prognosis of less than three months,
* documented peripheral neuropathy due to other causes (e.g., diabetes),
* planned receipt of neurotoxic chemotherapy during the study period,
* practice yoga \>45 minutes per week over the past six months,
* diagnosis or documented recent history of significant psychiatric comorbidity (i.e., psychosis, suicidal ideation, or substance abuse)
* clinician deems that the patient is physically/functionally unable to participate in a yoga program
COMPARİSON OF HEART FAİLURE PATİENTS AND HEALTHY PEOPLE İN BALANCE AND GAİT PARAMETERS

We aimed to show the difference between balance and gait parameters in heart failure and healthy individuals.

Heart failure is the inability of the heart to pump a sufficient amount of blood into our body. The reason is usually the decrease in the contractile capacity of myocardium due to decreased coronary blood flow. Symptoms and symptoms may be quite diverse in the underlying pathophysiology of heart failure, which is usually the only type. As a result of heart failure; problems such as dyspnoea, anemia, peripheral edema, peripheral muscle involvement and decreased muscle mass, confusion, sleep disorder, dementia, various cardiac symptoms and renal failure can be seen.

Balance body with minimal muscle activity in static or dynamic position on the support base is to maintain the center of gravity. Patients with heart failure may have decreased postural control, exercise intolerance, breathing problems, and decreased cognitive function.

Gait analysis, evaluation of neuro musculoskeletal system functions and interpretation of results with numbers and graphs. Gait analysis is an analysis method that plays a role in many cases of clinical diagnosis and follow-up. Heart failure is characterized by a significant reduction in walking distance, which leads to reduced quality of life. In a study conducted in heart failure, it is stated that gait velocity is a determinant of one year mortality and hospitalization, and should be considered for clinical evaluations and prognosis. All these causes of heart failure in chronic disease groups defined considering it is important to investigate the balance and gait parameters.

This study will show the difference between the balance and walking parameters in heart failure according to the healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction \<40% or less,
* Without acute decompensation,
* No revascularization in the last six months,
* The drug has been stable for the last four weeks,
* Accepts participation in the study,
* Coopere,
* NewYork Heart Association -NYHA Class II- III
* Patients with heart failure who are amputated without support or assistive devices will be included in the study.

Exclusion Criteria:

* Neurological, cognitive or orthopedic diseases that affect the measurements,
* Severe respiratory disease (FEV1 \<35%),
* BNP\> 100pg / ml and above,
* Acute infection,
* Resting heart rate above 140 beats / min,
* Dementia,
* Having a BMI\> 35 or above,
* Individuals with other chronic diseases that may affect their balance and walking will not be included in the study.
The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment

This study will look at the feasibility and acceptability of testing newborn babies who are referred after their newborn hearing screen for an infection called congenital Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby is infected shortly after birth could have significant benefit since a treatment is now available, but screening programs need to be feasible and acceptable. This study aims to evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do not pass their newborn hearing screening. The investigators want to see if we can find a quick, reliable and parentally acceptable way to screen babies who fail their hearing test for this virus.


Eligibility Criteria:
Inclusion Criteria:

* All infants 'referred' for one or both ears following hospital-based newborn hearing screening in North of Tyne and South West London areas. Babies with other known causes of SNHL (e.g. hereditary) and those admitted to Neonatal Intensive Care Units will be included.

Exclusion Criteria:

* Exclusions to this study will be infants with parents/guardians not willing/able to give informed consent or children known to have congenital CMV by antenatal testing or clinical features of CMV infection at birth.
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease

Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:

1. allergic rhinitis to dust mite (AR) isolated (n=12),
2. AR associated with bronchial hyperreactivity (n=12),
3. AR associated with asthma (n=14),
4. control (n=14).

Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma.

Methods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups:

1. allergic rhinitis to dust mite (AR) isolated (n=12),
2. AR associated with bronchial hyperreactivity (n=12),
3. AR associated with asthma (n=14),
4. control (n=14).

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patients between 6 and 17 years old
* Patients with allergic rhinitis

Witness:

* Patients between 6 and 17 years old
* Patients without allergic rhinitis and asthma

Exclusion Criteria:

* Rhino-bronchitis infection dated from less than 15 days
* Patients younger than 6 or older than 17 years
Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.

Unfortunately, there is very little data in an unselected series of uneventful patients.

The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years old
* patients undergoing stapes surgery for otosclerosis

Exclusion Criteria:

* patient's refusal to participate in the study
* patient under legal protection
* no medical insurance coverage
* pregnant or breast feeding patient
Supplemental Oxygen Reduces Surgical Infection

Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P\<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.

Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.

Objective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.

Design: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.

Main outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.

Eligibility Criteria:
Inclusion Criteria:

* Elective colorectal resection,
* Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.

Exclusion Criteria:

* Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration \< 30 g/L, and a leukocyte count \<2500 cells/ml.
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

PK and safety profile of Proellex® in females with various stages of impaired renal function

The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Eligibility Criteria:
Inclusion Criteria:

* Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
* Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
* Subject with renal impairment must have evidence of stable disease
* If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
* Negative urine pregnancy test at screening visit
* Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
* Healthy subject must have no significant abnormal findings at the screening physical examination
* Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
* Additional inclusion criteria may apply

Exclusion Criteria:

* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
* Subject with clinically significant abnormal liver function
* Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
* An acute illness within five (5) days of study medication administration
* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
* Additional exclusion criteria may apply
The Relationship Between Vitamin D and Hepatitis B Virus Replication

149 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication were compared before and after treatment.

This is a randomized case-control trial. A total of 149 HBV carriers with inadequate vitamin D (\< 30 ng/mL) level were enrolled. They were randomly divided to two groups: one group receiving vitamin D supplement (1600 IU/day) for 2 months and another group as controls. The serum vitamin D, HBV DNA and qHBsAg levels were measured at baseline and after vitamin D supplement. Whether HBV DNA and qHBsAg have significant change after vitamin D supplement can be determined.

Eligibility Criteria:
Inclusion Criteria:

* \>20 y/o, HBV carrier
* serum vitamin D \< 30ng/ml

Exclusion Criteria:

* Other known causes of hepatitis
EBD RCT Trial in Living Donor Liver Transplantation

This study was designed to demonstrate incidence of biliary complication rates after living donor liver transplantation according to the implantation of external biliary drainage throug duct-to-duct anastomosis site.

Biliary complication is the most common complications after liver transplantation, and it happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation.

Many transplant centers adopted their own methods to improve biliary complications after LDLT. One suggested method is the application of external biliary drainage (EBD).

A prospective study was planned to demonstrate effect of EBD on biliary complication after LDLT. Patients who underwent LDLT with duct-to-duct anastomosis will be randomly assinged to application of EBD or conventional duct-to-duct anastomosis without EBD according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two groups.

Primary outcome is biliary complication incidence 1 year after LDLT.

Eligibility Criteria:
Inclusion Criteria:

* Living donor liver transplantation
* Adult patient (\>=18 years old)
* Patients who are available for at least 3 year follow-up after LDLT

Exclusion Criteria:

* Patients requring hepaticojejunostomy due to anatomical factor or underlying disease
* Re-transplantation
* Multiorgan transplantation
* Emergency transplantation
Arthroscopic Guided Synovial Biopsies

To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

According to a search of previously published studies on accuracy of serology no sensitivity or specificity data was found regarding accurate detection of arthritis through serology, hence the aim of this study is to detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from TEMPOROMANDIBULAR JOINT ARTHRITIS.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent

Exclusion Criteria:

* Patients with any systemic disease that may affect normal healing.
* Pregnant females.
* Patients with acute infection.
* Patients with bony ankyloses.
* Patients with risk of tumor dissemination.
Heart at Work Study

This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.

The current proposal uses a repeated-measures, within-subject design to address our aims. Twenty male participants will report to the laboratory to provide informed consent, complete baseline assessments, and receive ambulatory monitors. Following this session, each participant will wear physical activity and ambulatory cardiovascular monitors for 7 days, including at least one non-work day and one work day. Characterization of work activity will use physical activity data from self-reported time at work (Specific Aim I). The 24-hour cardiovascular load (HR and BP) and nocturnal HRV will be compared across work and non-work days (Specific Aim II). Lastly, whether fitness level or job strain modify the difference in cardiovascular strain between work vs. non-work days will be evaluated (Specific Aim III).

Eligibility Criteria:
Inclusion Criteria:

* middle age (35-59 years)
* male
* self-report working full-time in the food service industry (≥30 hours/week)
* self-report predominantly completing light intensity activity job responsibilities (≥75% work time walking, light movement, or standing)

Exclusion Criteria:

* Resting blood pressure of ≥150 mmHg systolic and/or ≥95 mmHg diastolic
* currently taking medications that are known to affect blood pressure or heart rate (e.g. Beta-blockers, ACE inhibitors, etc.)
* greater than low risk to participate in physical activity as determined by PAR-Q (answer of yes to any of the 7 physical activity readiness questionnaire questions)
* report working a second job in addition to their primary full-time job
* report working overnight shifts (10pm-6am)
* reported physical dysfunction (inability to walk 2 city blocks or climb 2 flights of stairs)
* inability to complete the sub-maximal exercise test to completion (80% age-predicted heart rate maximum)
* Currently being treated for a serious medical condition such as kidney disease, liver disease, cancer, or heart disease.
Effect of Asynchronies on Sleep Disruption During Mechanical Ventilation

Mechanically ventilated (MV) patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity).

Patient-ventilator interaction is frequently poor leading to asynchronies of varied type and consequences. Moderate-to-severe asynchronies are associated with longer mechanical ventilation, weaning failure and mortality.

The goal of this study is to look for an association between poor sleep quality and patient-ventilator asynchronies.

This study is an observational, physiological study investigating sleep quality and quantity in MV patients by recording portable PSG (from 22:00 to 08:00) at night while continuously monitoring 24h/day of patient-ventilator interaction (BetterCare system).

This clinical physiological study took place after MV patients have survived the initial critical admission phase (severe hypoxemia or shock) and before approaching weaning.

After enrolment, a single night, sleep architecture was recorded using standard PSG (electroencephalography, right and left electrooculography, submental electromyography and electrocardiography) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate will be recorded continuously during the PSG.

Assessment of delirium was performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) every 8 hours (at 08:00, 16:00 and 24:00) from day 0 until discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Intubated and mechanically ventilated

Exclusion Criteria:

* Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8 with intubation
* Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included.
* Severe hemodynamic instability (high dose of vasopressors).
* Receiving muscle paralysis.
Epidemiology of Stress and the Metabolic Syndrome

To examine the effects of psychological stress on the metabolic syndrome.

BACKGROUND:

The metabolic syndrome identifies the clustering of lipid abnormalities, hypertension, hyperglycemia and abdominal obesity. It is a common and strong contributor to heart disease and diabetes and disproportionably affects older persons. Animal and small clinical studies have suggested that psychosocial stress is a risk factor for the metabolic syndrome. Underlying mechanisms may be through activation of the hypothalamopituitary-adrenal (HPA) axis causing hypercortisolemia, and, partly in turn, elevated inflammation and decreased sex hormone levels. However, longitudinal data showing that psychosocial stress indeed contributes to the onset and sequelae of the metabolic syndrome in the population at large, are lacking.

DESIGN NARRATIVE:

The primary objectives are to conduct data-analyses and biological sample analyses to examine the effect of psychosocial stress, as indicated by mood problems (depressive symptoms) and stressful social circumstances (poverty, negative life events, occupational stress, lack of emotional support), on the onset and sequelae of the metabolic syndrome. Secondary objectives are to examine underlying biological mechanisms in the effect of psychosocial stress on the metabolic syndrome. The investigators will use available data from two ongoing longitudinal community-based studies among older persons: the Health Aging and Body Composition (Health ABC) study (n=3,075, mean age=74 years, 52%=female, 42% African American) and the InChianti study (n=1,453, mean age=69 years, 56%=female). In both studies psychosocial stress and the metabolic syndrome are well defined, longitudinal data on sequelae (CVD events and diabetes onset) and onset of the metabolic syndrome are available, and potentially underlying biological variables were, or will be, assessed including 24-h urinary cortisol, serum sex steroid hormones (estradiol, testosterone, SHBG, DHEAS) and inflammatory markers (IL-6, IL-10, TNF-alpha, CRP, and various soluble cytokine receptors). The results of this study will help in designing future intervention trials that evaluate whether reducing stress and/or its physiological consequences, either by pharmacological treatment or behavioral intervention, could reduce incidence of the metabolic syndrome in the older general population.

Eligibility Criteria:
Age \>70 years Community swelling