cyrilzakka/clinical-trials huggingface dataset:
Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse

Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.


Eligibility Criteria:
Inclusion Criteria:

* age 21-80 years old
* Stage III or higher pelvic prolapse

Exclusion Criteria:

-Prior pelvic surgery
Effect of Downhill Training on Ankle Joint

Downhill training help to improve musculoskeletal condition. Applying downhill training could help obese children by improving their muscular strength.

the current study aimed to find the effect of downhill training on the ankle isokinetic parameters of obese children. There were two experimental groups, the first received level walking while the second received downhill training. The ankle isokinetic parameters were assessed pre and post-intervention for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index percentile 95% or more
* age ranged from 8-12 year
* student in one of Taif's elementary schools

Exclusion Criteria:

* suffering from any musculoskeletal problem or chronic disease.
* engaged in regular sports activities during the last 6 months
Study of Thymosin Beta 4 in Patients With Pressure Ulcers

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility Criteria:
Inclusion criteria:

* Informed Consent Form signed by the patient or patient's legal representative
* Inpatients and outpatients
* At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure
* Surface area between 5 and 70 cm2
* Ulcer present and stable for at least 1 month before enrollment

Exclusion Criteria:

* Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
* Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
* History of adverse events to any ingredients of study medication
* Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
* Arterial or venous disorder resulting in ulcerated wounds
* Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
* Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Chongqing Primary Aldosteronism Study

We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.

This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.

Eligibility Criteria:
Inclusion Criteria:

1. hypertensive patients who completed ARR screening and necessary further tests;
2. Voluntary to sign the informed consent.

Exclusion Criteria:

1. patients with severe cardiac, hepatic or renal dysfunction;
2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis et al.
iCBT and ABM for Reducing Depressive Symptoms in Firefighters

The study aimed to examine the impact of a combined internet-delivered Cognitive Behavioral Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 138 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ABM exercises on alternating days and concurrently underwent four modules of iCBT courses delivered through a smartphone application.


Eligibility Criteria:
Inclusion Criteria:

* being an active firefighter and aged between 18 and 50
* having a score greater than zero on the Patient Health Questionnaire-9 (PHQ-9)
* with no history of severe depression

Exclusion Criteria:

* having suicidal ideation or intent
* having an active psychotic disorder other than depression
* prior participation in a cognitive-behavioral intervention
* concurrent participation in another study.
Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression

This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the research
* Gestational age 30-35 weeks
* Be literate
* No history of depression or mental illness in the past
* Healthy fetus on ultrasound

Exclusion Criteria:

* Having a preterm birth
* Refusal to attend training sessions
Whole Body Vibration In Vestibular Rehabilitation

The aim of this study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.

A total of 90 patients who were diagnosed as unilateral vestibular weakness were included in this prospective randomized controlled study. They were randomized into three groups each consisting of 30 patients. Home based vestibular rehabilitation program was given to all groups. Fall risk yielded by posturography, Berg balance scale, Timed Up-and-Go test, vertigo visual analogue scale and Dizziness Handicap Inventory were used for comparison.

Eligibility Criteria:
Inclusion Criteria:

Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness.

Exclusion Criteria:

Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities
GAPcare Fall Prevention Pilot Survey

GAPcare (Geriatric Acute \& Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that surveys older adults who present to the Emergency Department for any illness to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults. In this observational study, older adults will be approached during routine clinical care in the ED and asked about prior falls, prior experiences having falls treated in the inpatient and outpatient setting, and the investigators will solicit feedback on potential improvement to care in the ED setting for falls.


Eligibility Criteria:
Study inclusion criteria for GAPcare

* Adult 65 years-old or older
* Able to communicate in English
* No cognitive impairment (≥4 on SIS)

Exclusion criteria

• Unable to give informed consent due to intoxication or altered mental status
Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit

Burnout among healthcare workers is frequently reported, and one of the factors cited is the stress caused by end-of-life care. It has been reported that nursing staff experience decreased well-being as a result of being involved in end-of-life care, and this is also true in intensive care units. This decrease in well-being is said to lead to lower quality of care, poor communication with patients and their families, absenteeism, and high turnover. Although palliative care interventions such as education and communication tools have been reported to improve the well-being of healthcare professionals involved in end-of-life care, few reports have evaluated the association with burnout. We investigated whether communication-based palliative interventions in end-of-life care in intensive care units (ICUs) improve the risk of burnout among nurses working in ICUs.

A before-and-after study was conducted in a single hospital to evaluate burnout risk and satisfaction with end-of-life situations in 2022 (phase 1) and 2023 (phase 2). The Japanese version of the Burnout Scale was used to assess the risk of burnout, and the QODD (Quality of Dying and Death) was used to assess nurse satisfaction. All nurses who agreed to participate received the questionnaire in a sealed envelope, completed it, and returned it anonymously to the principal investigator. Data from those who declined to participate were not recorded. During the first and second phases, an intensive communication strategy on end-of-life practice was implemented based on the framework developed at the International Delphi Conference. The following data were recorded for all participating nurses: age, gender, marital status, years of practice since certification, and years of critical care experience; the following data on ICU status were also collected from the electronic system: total number of patients, length of ICU stay, ICU mortality rate, in-hospital mortality rate, ICU admission APACHE-II score, SOFA score at ICU admission, and medical costs at ICU admission. Continuous variables without normal distribution are shown as median and interquartile range. Categorical data were summarized numerically or as percentages. In univariate analyses, Mann-Whitney's U test was used to compare continuous variables and Fisher's exact test to compare categorical variables. Data were assumed to be missing at random, and no imputation or interpolation of missing values was performed. Statistical tests were two-tailed and statistical significance was set at p\<0.05. All statistical analyses were performed using EZR (R Foundation for Statistical Computing, Vienna, Austria), a graphical user interface for R. The study was approved by the Maebashi Red Cross Hospital Ethics Committee (ID: 2022-47), which waived the requirement for informed consent from patients and their relatives, given the retrospective and observational nature of the study.

Eligibility Criteria:
Inclusion Criteria:

* Registered nurses working in our ICU

Exclusion Criteria:

* None
Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase

Conduct a prospective, longitudinal study to evaluate nutritional status in adults with phenylketonuria (PKU) before and during treatment with pegvaliase (Palynziq™).

The investigators will compare intra-subject change in adults with PKU who follow a protein-restricted diet (protein intake less than the RDA for protein based on weight (0.8 g/kg/day) with or without a PKU medical food) within 90 days of starting pegvaliase (baseline) and 9 and 15 months later. The investigators will collect laboratory measures of nutrition status, anthropometrics, Dual-Energy X-Ray Absorptiometry (DXA) to measure body composition and bone mineral density (BMD), and indirect calorimetry to measure resting energy expenditure (REE). In addition, three-day food records will be obtained to assess protein intake and overall diet quality.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of phenylketonuria
* Aged 18-65 years
* Following a protein-restricted diet with or without medical food within the last 30 days
* Routine natural protein intake from food is less than the RDA for protein based on weight (0.8 g/kg/day).
* If not consuming animal proteins, recommended protein intake is 115% RDA due to lower bioavailability of plant proteins.
* Within ±90 days of starting treatment with pegvaliase at time of study enrollment

Exclusion Criteria:

* Unable to consent to study
* Under age 18 or over age 65 years
* Routine natural protein intake is greater than the RDA for protein (0.8 g/kg/d) within the last 30 days.
* Females who are currently pregnant or lactating
Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease

To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease


Eligibility Criteria:
Inclusion Criteria:

* Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease

  1. Benign teratoma
  2. Endometrioma
  3. Mucinous cystadenoma
  4. Serous cystadenoma
  5. Benign Brenner tumor
  6. Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
  7. paratubal cyst, parovarian cyst
  8. Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
  9. Other benign adnexal disease requiring surgery
* American Society of Anesthesiologist Physical Status classification I-II.
* Patient who have signed written informed consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Patient who requires further procedure excluding adnexal surgery
* Patient who has other pain source excluding adnexal disease
* Pregnant and lactating woman
Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning

Medical devices are designed and manufactured by subjective design process that was only based on engineers' direct concepts to essential principles sets for the device. A home user may not easily use or operate the piece of medical device through the interfacing components as the designer's expected such as the meaning when pushing a button or switching a knob, even the required procedure needed when a certain display shown to fulfill some knowledge dependent judgment. In addition, the incompatible interfacing designed communication between a user and the device may cause possible errors that may trigger further negative consequences during the use of the device to a innocent home user.

The aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (BPM) in real use.

The aim of this research is to closely understand the consequent results of human factor engineering or usability engineering practices of various types or models of marketed home-use blood pressure monitors (BPM) in real use. Participants of the intended user population interact with marketed BPMs in research to assess ease of learning, ease of use, effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many possible attributes of interest. With these understanding and analysis of human factors engineering / usability engineering (HFE/UE) practiced status, it can help manufacturers to capture the required and diversified HFE/UE essences with the minimum or limited professional technical resources in hand some more efficiently.

Eligibility Criteria:
Inclusion Criteria:

* age between 20-75 years
* capable of operating the blood pressure measure machine provided by the study
* willing to operate the provided device and accept video taping from shoulder and below
* willing to fill the study questionnaire and to provide feedback after use of the device

Exclusion Criteria:

* vulnerable population (including pregnant woman, disabled, etc)
Comparison Between 4 Different Nasal Dilators

Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far, and would help the clinicians to advise the use of any of these dilators. From clinical experience, endonasal dilators are well supported and improve breathing better than the external dilators

Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far,

Eligibility Criteria:
Inclusion Criteria:

Patients with nasal obstruction due to external nasal valve problems and with positive Cottle sign.

Age \> 18 and \< 60 years. Ability to give reliable information and written informed consent.

Exclusion Criteria:

Patients with nasal obstruction due to other endonasal anatomic deformities besides external nasal valve dysfunction.

Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and/or other conditions that interfere with the generation of a reliable Peak Nasal Inspiratory Flow (PNIF) result.
Leveraging Clinic to Promote Literacy in Young Children

Our primary aim of this study is to assess the impact of an early literacy text messaging program (TipsByText, TbT) for parents of children between 3 to 4-years old during an office visit without access to preschool. To assess this aim, our objectives are to specifically assess (1) child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and (2) caregiver involvement using the Parent Child Interactivity Scale (PCI) pre- and post-intervention, comparing with a control group not receiving the TipsByText intervention. A secondary outcome of this study is to compare trust among families that participate in the Tips by Text (TbT) Program with families that do not participate in TbT using the Trust Evaluation Scale. Children will complete the PALS-PreK and caregivers of the children will complete the PCI and Trust Evaluation Scales.


Eligibility Criteria:
Inclusion Criteria:

* Parents of participants must be last least 18 years of age.
* Parents must be English and Spanish speaking, as the Tips by Text texting platform is currently in those languages.
* Child must be 3-5 years old at the time of their clinic visit.

Exclusion Criteria:

* Parent does not speak English or Spanish. This applies given that the texting intervention has the capacity to be conducted in these two languages.
* Parent does not have cell phone that would allow texting.
* For the literacy texting intervention, the child must NOT be enrolled in Head Start,Transitional Kindergarten or other subsidized preschool. Parents will be provided with a list of preschools that would warrant exclusion. Childcare is ok. For the trust and no-show evaluation arm, participants may be enrolled in any form of early childhood education.
* Child is currently receiving services for delay (speech, motor, or cognitive). If the child briefly received services for delays over a year before start date of the study, they are still eligible.
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.

This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.

Eligibility Criteria:
Inclusion Criteria

Volunteers must have:

* Good health as determined by medical history, physical examination, and clinical judgment.
* Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
* In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).

Exclusion Criteria

Co-existing Condition:

Volunteers with the following symptoms or conditions are excluded:

* Significant acute systemic infection.
* Occupational or other responsibilities that would prevent completion of participation in the study.
* Any condition that might interfere with the evaluation of the study objectives.

Volunteers with the following prior conditions are excluded:

* History of immunodeficiency, autoimmune disease, or any serious chronic illness.
* Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
* History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.

  1. Immunosuppressive medications.
* Live, attenuated vaccine within 60 days of study entry.

NOTE:

* Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions.
* Experimental agents within 30 days of study entry.
* HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.

Engaging in high-risk behavior within 6 months of study entry, i.e.:

* injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.