cyrilzakka/clinical-trials huggingface dataset:
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy

Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.

Tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. The aim of this work is evaluated the effects of the pelvic physiotherapy (PP) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. The PP will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old;
* No vaginal stenosis at first evaluation;
* Women free of previous intracavitary radiation;
* Women diagnosed with gynecological cancer who are undergoing brachytherapy treatment during the period of research at the Santa Rita Hospital of the Santa Casa de Misericórdia in Porto Alegre;
* Women who agree to participate in the research through the Informed Consent Form (TCLE).

Exclusion Criteria:

* Women who do not sign the ICF;
* Women not being treated for gynecological cancer;
* Women who have a 30% lack of physical therapy sessions (4 sessions);
* Women who present complications that prevent the accomplishment of the protocol of pelvic physiotherapy or that do not perform all the treatment with brachytherapy.
Effects of Blue-light Blocking Lens on Visual Functions

Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity, accommodative response, color vision, and subjective grading of the quality of life and vision.

Purpose: To determine and compare the visual performances after wearing the blue-light blocking lenses in participants with and without presbyopia.

Methods: One hundred and sixty computer users (computer usage \>2 hours/day) with (n=120, aged \>40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of ophthalmic lenses will be prescribed for the participants, in which one pair of them will be the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre- and post-treatment contrast sensitivity, accommodative response and color vision will be measured. The participants will also be asked to complete questionnaires about their quality of life and vision, and the performances of these ophthalmic lenses.

Significance: The blue-light blocking lens reflects the short-wavelength lights and protects the retina from "blue-light hazards"; however, blue lights are essential for various visual function and circadian rhythms. This study will evaluate the impact of the blue-light blocking lenses on visual function and quality of life, and determine whether the blue-light blocking lenses are good choices for extra ocular protection.


Eligibility Criteria:
Inclusion Criteria:

* age: 18 to 35 years OR 40 to 55 years
* daily computer usage over over 2 hours per day

Exclusion Criteria:

* visual acuity worst than 0 logMAR
* abnormal binocular and color vision
* previous history of ocular surgeries
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
* Rett syndrome
* Fragile X syndrome
Teaching Caregivers of Hospice Patients to Administer Reiki

Being a family caregiver for a patient at the end of life is both rewarding and stressful. When the end of life is nearing, caregivers may be unsure of how to help their family member. Reiki, a light touch energy therapy has been shown to increase relaxation and improve sleep quality, and decrease pain, anxiety, depressive symptoms, and medication use in both hospitalized and community-dwelling adults. This feasibility study is designed to evaluate whether teaching caregivers is feasible in addition to evaluating any benefit to FCGs and patients.

The time a patient and family caregiver (FCG) spend together in a patient's final days is filled with emotion. Patients may turn inward and be filled with peace, or they may be bothered by symptoms. Caregivers often experience feelings of helplessness and anticipatory grief. Learning and providing a skill such as Reiki may give caregivers a way to help the patient with symptoms while at the same time feeling useful. Patient and caregiver closeness may be enhanced. Reiki has been shown to be helpful with symptoms such as pain, anxiety, depression, fatigue, and others. However, teaching caregivers of terminal hospice patients, Reiki has not been studied. The knowledge gained from this feasibility study will guide future interventions aimed at the comfort of hospice patients and FCGs.

Approximately 1.49 million Medicare beneficiaries received hospice care during 2017, and most had a FCG. During the final days or weeks, FCGs are unsure of what do or how to best help the patient when everyday caregiving actives such as physical care or nutrition are not required or no longer desired by the patient. Caregiver symptoms of depression, anxiety, or anticipatory grief increase toward the end of life along with increased patient symptoms. Having a specific skill to help the patient with symptoms or simply to show care and provide touch may empower FCGs and improve the quality of life for both caregivers and patients.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for the study if they are

* ≥ 18 years old
* receiving hospice at home.

Caregivers will be eligible if they are

* ≥ 18 years old,
* willing to complete measures, and if they are randomized to the Reiki group
* willing to learn Reiki therapy, provide at least two Reiki therapy sessions with the patient of at least 10 minutes twice per day with at least two hours between sessions and complete one 10-minute self-Reiki session per day. Two caregivers may participate in the study.

Exclusion Criteria:

Patients will be excluded if:

* they have a diagnosis of atrial fibrillation
* they have an active pacemaker, or
* death is expected in less than two weeks.

Caregivers will be excluded if they

* cannot understand or speak English
* have severe, uncorrected hearing loss
* have self-reported uncontrolled atrial fibrillation
* have a self-reported diagnosis of dementia
* have a self-reported psychiatric disorder (bipolar disorder, schizophrenia)
* are unwilling or unable to complete measures (both groups) or perform Reiki and self-Reiki (intervention cohort).
USCOM Parameters in Preterm Infants: Reference Ranges

The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.


Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth below 32 weeks and/or
* birth weight (BW) below 1500 g

Exclusion Criteria:

* congenital heart diseases,
* hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X

Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital readmissions. Management of this syndrome represents a major challenge to the treating physician. Evidence for the important role of endothelial dysfunction and oxidative stress in the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that basal superoxide production predicts future cardiovascular events in this patient group. The investigators have recently shown that high-dose allopurinol abolishes vascular oxidative stress and improves endothelial function in patients with chronic heart failure, which makes allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be tested in this study is whether allopurinol offers dual benefits of improving vascular function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study may discover a novel way to improve endothelial function and anginal symptoms which are often debilitating in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Typical history of angina
* Positive exercise treadmill test and normal coronary angiogram

Exclusion Criteria:

* Significant valvular heart disease or left ventricular hypertrophy
* Age \<18 years
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.

Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.

Eligibility Criteria:
Inclusion Criteria:

1. Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
2. Planned femoral access

Exclusion Criteria:

1. Age ≤ 18 years
2. STEMI
3. Absence of palpable femoral pulse
Online CBT Intervention for Students With Adjustment Disorder

The aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on Unified Protocol and mediators of obtained changes among polish students with adjustment disorder. The intervention is fully self-helped and based on Unified Protocol principles. Control conditions contain of online progressive muscle relaxation group and waiting list.

Adjustment problems are highly prevalent among students around the world (Conley et.al., 2013). Unfortunately only half of students in need receive psychological help (Eisenberg et al., 2018). For these reasons, there is a need to develop and evaluate new, more scalable forms of treatment for students with adjustment disorder - such as internet therapeutic programs. Therefore the aim of the present research is to evaluate the effectiveness of online cognitive-behavioural therapy intervention. Mediators of obtained changes will also be evaluated. The present study has a potential for the development of a scalable, well researched treatment option for students experiencing adjustment disorder - internet psychological intervention.

Eligibility Criteria:
Inclusion Criteria:

* having a student status
* 18 years old or older,
* having access to the internet and using computer or smartphone,
* meeting the diagnostic criteria of adjustment disorder based on a total sum score \> 47,5 in ADNM-20 questionnaire
* meeting diagnostic criteria for AjD in MINI Interview.

Exclusion Criteria:

* an increased risk of suicidality intent or ideation (at least moderate scores on the MINI and/or a score \> 2 on item 9 from the PHQ-9),
* psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the MINI
* receiving another psychological treatment at the start of the study
* having no time for participation in program
* receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study
Study of the Size of the Operating Fields Depending on the Morphology of the Patients

This is a prospective, single-centre, observational clinical study.

Patients who have not expressed their non-opposition, who are of age and who are undergoing open surgery on the abdominal aorta by laparotomy will be included.

The aim is to mathematically model the working volume for abdominal aortic surgery as a function of the preoperative CT scan, the length and orientation of the incision and the morphometric characteristics of the patient, and thus predict the surgical risk.

To meet this objective, the dimensions of the working volume of open abdominal aortic surgery will be measured using a camera to create an algorithm by associating them with the preoperative images and morphometric data of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patient undergoing open surgery on the abdominal aorta by laparotomy.
* Patient who has been informed of the terms of the study and who has not expressed non-opposition.

Exclusion Criteria:

* Emergency surgery
* Patient without preoperative CT scan
Dexamethasone and Post-tonsillectomy Pain in Children

The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:

* Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
* Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
* Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.

(See brief summary as well)

The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital

Exclusion Criteria:

* Known hypersensitivity to dexamethasone
* Developmental delay
* Taking chronic analgesics
* Taking chronic systemic steroids
* Treatment with steroids in last 30 days
* Cushings or Prader-Willi or Nephrotic Syndromes
* Diabetes Mellitus
Neurocognitive Exercises for Ankle Instability

In the general population, 19.0-26.6 per 1000 cases of ankle instability have been reported, while in the athletic population, the rate is 11.3 per 1000. Ankle instability also predisposes individuals to recurrent instability, leading to persistent symptoms. After ankle injuries, temporary increases in afferent activity, along with long-term deficits in somatosensory information from ligaments, may cause central neuroplasticity that affects sensorimotor function. This central neuroplasticity can lead to permanent dysfunctions in the affected limb, thereby increasing the likelihood of developing and maintaining chronic ankle instability (CAI). In addition to the association between impaired balance and reduced proprioception with CAI, it has been reported that the central nervous system may fail to manage joint stress due to its inability to discern load on the ligaments.

Impaired neurocognition has been linked to decreased performance and higher rates of re-injury. Deficiencies in neuromuscular control, motor learning, or other neurocognitive components related to an individual's performance and safety may affect the ability to respond appropriately in a dynamic environment. Any deficiencies in these neurocognitive processes can hinder the successful completion of tasks.

The aim of this study is to comparatively examine the effects of neurocognitively enriched rehabilitation versus traditional rehabilitation on re-injury risk, balance, and proprioception in individuals with a history of ankle instability.

Voluntary participants who have been diagnosed with lateral ankle instability will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Study groups will be as follows: a) Neurocognitive Enriched Exercise, b) Multimodal Exercise.

Eligibility Criteria:
Inclusion Criteria:

* The documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and MRI in cases requiring differential diagnosis.
* A history of an initial ankle sprain occurring at least 6 months ago.
* The presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent.

Exclusion Criteria:

* Presence of a history of previous surgery in the lower extremity.
* Identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes.
* The existence of a fracture accompanying instability in the foot-ankle.
* Presence of congenital deformities in the foot-ankle.
* Diagnosis of talus osteochondral lesion.
* Diagnosis of ankle arthritis.
* Presence of medial ligament lesion.
* Existence of peripheral neuropathy.
* Presence of additional rheumatological diseases.
* Regular moderate-level exercise for at least 3 days a week in the last 6 months.
TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery

This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.

This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergo thoracolumbar Decompression and Stabilization Surgery
2. Age between 18-65 years old
3. BMI \>18,5 kg.m2, and BMI\< 30 kg/m2
4. ASA 1-3
5. No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done

Exclusion Criteria:

1. Obese patient, with BMI\>30 kg.m2
2. Alergic to local anesthetics
3. Underweight patient with BMI \<18,5 kg/m2"
Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris

The purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.


Eligibility Criteria:
Inclusion Criteria:

* Class I, Class II and Class III stable angina pectoris, angina attack more than 3 times one week;
* Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;
* In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during non-attack period, or ST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during angina attack;
* Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standard should be reached. And the difference of total exercise time between before and after run in period should ≤15%;
* Other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence;
* Signed the informed consent form.

Exclusion Criteria:

* Chest pain caused by acute myocardial infarction(AMI), Class IV/serious angina pectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, Cervical Spondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia, aortic dissection, aortic valve disease;
* Not well controlled hypertension(systolic pressure≥160mmHg，diastolic pressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc);
* Serious diseases of heart, lung, liver, kidney and blood;
* Allergic constitution or allergic to the components of total Flavonoids of Propolis dropping pill;
* Women during pregnancy or lactation;
* Received any major operation within 4 weeks;
* Have been in other clinical trials within 30 days;
* Using but can not withdraw anti-angina medicine as long acting nitrates;
* Not well controlled hyperglycemia;
* Not fit for this trial judged by investigator.