cyrilzakka/clinical-trials huggingface dataset:
Transcultural Adaptation and Validation to Spanish of the OSPRO Questionnaires

Clinical guidelines for managing musculoskeletal pain recommend first, assessing and identifying any signs of severe physical conditions (i.e."red flags") and then, asessing the psychosocial prognostic factors of poor outcomes (i.e."yellow flags"). The Optimal Sreening for Prediction of Referral and Outcome (OSPRO) cohort studies were designed to develop and validate standard assessment tools for Review Of Systems (OSPRO-ROS) and Yellow Flags (OSPRO-YF).

The objectives of this study were to translate and cross-cultural adapt OSPRO-ROS and OSPRO-YF questionnaires to Spanish and to investigate their psychometric properties for their use in subjects with musculoskeletal pain.To accomplish the objectives proposed, this study was developed in two phases:Phase I: Cross-cultural adaptation process.Phase II: Psychometric properties evaluation.

Eligibility Criteria:
Inclusion Criteria:

OSPRO-ROS:

1. Were coming to the emergency department on their first visit.
2. With acute musculoskeletal pain.
3. Were able to read and comprehed Spanish language.

OSPRO-YF:

1. Were seeking outpatient physical therapy treatment.
2. With chronic musculoskeletal pain involving the cervical spine, lumbar spine, shoulder or knee.
3. Were able to read and comprehend Spanish language.

Exclusion Criteria:

1. Widespread chronic pain syndrome (e.g. fibromyalgia or irritable bowel syndrome).
2. Neuropathic pain syndrome (e.g. complex regional pain syndrome or diabetic neuropathy).
3. Psychiatric history (currently in care of mental health care provider or taking \> 2 precription psychiatric medications)
4. Cancer (currently receiving treatment for active cancer)
5. Neurological disorder (e.g. stroke, spinal cord injury, or traumatic brain injury).
Treatment of Anal Fistula With Lasercoagulation

The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula

Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
2. Subject must be at least 18 years of age
3. Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
4. Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
5. Subject must be able to comply with study and study follow-up requirements.

Exclusion Criteria:

1. Subject with anorectal fistula due to Crohn's disease
2. Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
3. Subject has fistula with side tracts (as seen on transanal ultrasound)
4. Subject is unable or unwilling to provide informed consent.
Electronic Medical Record Review in Monitoring the Effects of Adherence on Myelosuppression and Morbidity in Patients With Newly Diagnosed Brain Tumors Receiving Temozolomide and Radiation Therapy

This research trial studies electronic medical record review in monitoring the effects of adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to having a symptom of disease or medical problems caused by a treatment. Monitoring patients' electronic medical records to compare side effects, such as myelosuppression and morbidity, with treatment adherence may be a way to enhance patient care by organizing data for medical staff.

PRIMARY OBJECTIVES:

I. Retrospectively measure the frequency of nonadherence with established monitoring guidelines in the target patient population.

II. Retrospectively assess the impact of nonadherence events on myelosuppression severity and patient morbidity.

III. Prospectively measure the effect of an automated notification program on adherence rates.

SECONDARY OBJECTIVES:

I. Quantify any time savings realized by patient care staff through the use of such a program.

II. Quantify the number of patient care interventions that directly result from this automated monitoring and notification program.

OUTLINE:

Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.

Eligibility Criteria:
Inclusion Criteria:

* RETROSPECTIVE: All patients seen in Dr. Lesser's clinic who received concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas from 01/01/07 through 03/31/2010 will be analyzed
* PROSPECTIVE: All patients seen in Dr. Lesser's clinic who receive concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study

Exclusion Criteria:

* Patients participating in clinical trials or other deviations from non-standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
Design and Clinical Application of Colonoscopy Position Identification Sheet

Before colonoscopy, the nursing staff need to educate the patient with posture coordination.However, it is difficult for some patients to understand the placement of the correct body position, which takes too much time to conduct repeated education, which wastes medical resources, reduces work efficiency, and even causes conflicts between doctors and patients.In this study, the colonoscopy position identification sheet with indicator function was designed to assist the position placement of patients. Preliminary experiments of small samples have achieved good clinical results. Now, multicenter, randomized controlled research is carried out to further verify the clinical application effect.

This study was a prospective, multicenter, randomized controlled study involving patients who first underwent colonoscopy in 11 centers in China. Patients were randomly divided into two groups: the experimental group used colonoscopy position identification sheet, and the control group used ordinary clean sheets. The main evaluation index was the time required from the nurse guide to the patient complete the position placement, and the secondary indicators were doctors' satisfaction, nurse satisfaction and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 and signed informed consent
* with first colonoscopy
* with complete self-care (ADL 100)

Exclusion Criteria:

* patients with emergency colonoscopy
* communication or cognitive impairment
* patients requiring endoscopic intervention
The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power

The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Recently, VILI has been linked to mechanical power, or the amount of energy the mechanical ventilator sends to the respiratory system in a given time. The hunt for lung damage-reducing characteristics, notably after VILI and ARDS (Acute respiratory distress syndrome), has increased after Covid-19. Mechanical power must be used more to promote lung protection. We examined the effects of bilateral rectus sheath and OSTAP (Oblique Subcostal Transversus Abdominis Plane ) block on mechanically powered patients.

MP is the energy transmitted over time to the respiratory system during mechanical ventilation. Although mechanical ventilation is a life-supporting treatment, it has the potential to cause damage to the lung structure in a process referred to as VILI. Recently, the degree of VILI has been associated with the amount of energy transmitted to the respiratory system by the mechanical ventilator within a specific time frame, which is referred to as mechanical power. After the occurrence of Covid-19, the search for parameters to reduce lung damage, especially following VILI and ARDS, has become more prominent. In this regard, promoting lung protection requires the more widespread use of mechanical power. We aimed to investigate the effect of bilateral rectus sheath and OSTAP block applied to patients on mechanical power.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years
* ASA 1-2 patients
* Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Mental retardation,
* Severe presence of COPD,
* Uncontrolled Bronchial Asthma,
* Decompensated Heart Failure (NYHA 3-4),
* History of previous lung surgery,
* Patients unwilling to participate in the study,
* Local anesthetic allergy,
* History of chronic pain and treatment,
* Morbid obesity (body mass index (BMI) \>35),
* Pregnancy,
* Patients converted to open cholecystectomy
Isometric Exercise Training in Participants With Heart Failure With Preserved Ejection Fraction

Heart failure with a preserved ejection fraction (HFpEF) is a major cause of morbidity and mortality. Hypertension remains one of the major modifiable risk factors in HFpEF development and progression. The role of aerobic exercise training for blood pressure (BP) reduction is well established, with positive cardiac, vascular, and neurohumoral adaptations all cited as potential mechanisms for improving arterial haemodynamics. However, recent evidence has shown that a specific type of resistance exercise alone, known as isometric exercise (IE), produces greater mean BP reductions than what has traditionally been seen with both aerobic and dynamic resistance exercise training programmes. Indeed, short duration IE training causes significant improvements in both cardiac structure and function, in addition to inducing significant reductions in resting BP in normotensive, pre-hypertensive and hypertensive individuals. This study aims to compare the acute and chronic effects of an IE training intervention on diastolic function parameters in patients who have been diagnosed with HFpEF compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with HFpEF.
* Patients under the care of a St George's Heart Failure cardiology consultant.
* Patients willing and able to provide informed consent.
* Male and female, aged 18 years or above.
* Medically optimised patients.

Exclusion Criteria:

* Recent myocardial infarction or electrocardiographic changes, complete heart block, unstable angina.
* Inability or unwilling to provide informed consent.
* Male and female, aged 17 years or younger.
* Patients with HFrEF.
* Patients with musculoskeletal injury that could conceivably be affected by their involvement.
* Resting BP values of ≥180/110 mmHg.
* Patients unable to understand verbal and written English.
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain.

Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Surgery lasting more than 90 minutes with planned use of morphine analgesics during post-operative hospitalization (outside the PACU stay),
* ENT surgery, plastic and reconstructive surgery, digestive and visceral surgery, urological surgery and gynecological surgery,
* Surgery that does not involve any bone procedure,
* Written consent of the patient,
* French-speaking patient, able to understand and answer a questionnaire,
* Social security affiliation

Exclusion Criteria:

* Pregnant, breastfeeding or parturient woman,
* Person deprived of liberty by judicial or administrative decision,
* A person who is subject to a legal protection measure,
* Person unable to express consent,
* BMI \< 18 and \> 39 kg/m2,
* Drug contraindications, in particular hypersensitivity to the active substances of one of the study drugs (in particular lidocaine hydrochloride or amide- or clonidine-linked local anaesthetics) or to one of the excipients,
* Porphyria,
* Heart failure or unstable coronary artery disease,
* bradyarrhythmia due to sinus node disease or conduction clock, or Adam-Stock's syndrome, not fitted,
* Hepatocellular insufficiency with TP \< or =50%,
* Chronic renal failure with glomerular filtration \< 60 ml/min.
* Long-term treatment with Imipraminics, Neuroleptics, Baclofen, and all other molecules at risk of QT prolongation,
* Uncontrolled epilepsy,
* Chronic treatment with beta-blockers,
* Need for induction in fast sequence,
* Severe psychiatric or cognitive disorder that interferes with the evaluation through questionnaires.
The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.

Research data will represent the real natural course of UIA in China.

For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
2. Patient with premorbid mRS of 3 or less.
3. Patient older than 18 years
4. Patient consenting to participate to the study

Exclusion Criteria:

1. Subarachnoid hemorrhage with unknown causes
2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
3. Patient with malignant tumor
4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
5. Inability to obtain informed consent.
6. Patients with a life expectancy less than 1 year
7. Participating in the other clinical studies of intracranial aneurysm
8. Refusal of follow-up
Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids

Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.

This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.


Eligibility Criteria:
Inclusion Criteria:

* III degree Hemorrhoids
* written informed consent
* mental ability to understand the procedure

Exclusion Criteria:

* Previous treatments for hemorrhoids or other proctological diseases
* Fecal Incontinence
* Chronic inflammatory bowel disease
* Anal sphincter lesions
* coagulative defects
* obstructed defecation
Salivary Bacteria and Oral Health Status in Children With ADHD

Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies reported higher prevalence of caries and restorations among children with ADHD. Methylphenidate is the drug of choice to treat ADHD. according to the medical literature methylphenidate can cause xerostomia.

Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer capacity), oral hygiene and diet habits and their influence on caries among children with ADHD and among healthy children.

Our hypothesis is:

* Children with ADHD will have more caries.
* Children with ADHD will have more detrimental oral hygiene and diet habits.
* There will be a difference in the saliva parameters between children with ADHD and healthy children.


Eligibility Criteria:
Inclusion Criteria:

* test group- diagnosis of ADHD.
* control group- ASA1

Exclusion Criteria:

* control group
* administration of medicine at the time of the check-up.
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants

The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.

This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese participants aged 20 to 80 years at screening
* A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
* Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).

Exclusion Criteria:

* Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
* Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
* Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
* Malalignment \>10° in the target knee (varus/valgus)
Autistic Women's Experiences of Self Compassion and Receiving Their Diagnosis in Adulthood

Research highlights strong links between self-compassion and mental health, but there is very limited research specifically exploring autistic individual's experiences of self-compassion. The process of receiving a diagnosis on the autism spectrum can be complex and autistic women tend to experience several barriers to diagnosis. This study adds to the growing area of research exploring autistic women's experiences of receiving a diagnosis in adulthood. This study employs Interpretative phenomenological analysis to explore if receiving a diagnosis of Autism influences women's perceptions of self-compassion. The findings may inform client-centred practices in health care settings and potentially present positive aspects of autism diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent to participate
* Cisgender female (female at birth and raised as female).
* Speak English fluently
* Received an Autism Spectrum Disorder diagnosis, aged 18 years old or above

Exclusion Criteria:

* Lack capacity to consent to participate in the study
* Unable to speak English fluently
* Have not received an Autism diagnosis
* Have received Autism diagnosis prior to their 18th birthday
* Have an intellectual disability
* Born male
Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients with Binge Eating Disorder

This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating disorder. Participants will be randomized to one of two groups. Both groups use a VR headset for 10 minutes (5 upon waking, 5 before sleep) daily for 1 month. One group will use the CRT software on the headset and the other group will use a software intended to be a control. Measures will be taken at baseline and 1-month. The researchers anticipate that use of CRT will improve sleep quality leading to increased appetitive control.

This is a clinical trial with total of 40 individuals with Binge Eating Disorder ages 18 or older will be enrolled to use a VR headset with CRT or without. Examine whether 1-month of CRT alters binge eating frequency. Secondary outcomes include examining whether 1-month of CRT alters sleep quality, appetite regulation, fMRI measures of functional connectivity, food-based impulsivity/craving, and mood. Assessments are completed at baseline, weekly for 1 month, and then a final 1-month follow-up. Procedures include a screening/baseline phase to determine eligibility, gather baseline measures, and set-up on VR headset. Weeks 1 through 4 include using a VR headset twice a day for 5 minutes each. An online weekly survey will be completed, as well as daily EMA surveys related to eating patterns throughout each day. The final visit will include a repeat of the baseline procedures including the fMRI. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18+
* Diagnosed with Binge Eating Disorder using EDA-5
* English-speaking

Exclusion Criteria:

* Pregnancy
* Acute suicide risk/active suicidal ideation
* PSQI score \<5 indicating good sleep quality
* A condition that may create a risk while using the VR headset including risk of falls, seizures, a heart condition, migraines, an eye or vision condition, or an inner ear condition.