cyrilzakka/clinical-trials huggingface dataset:
A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores

The goal of this observational study is to evaluate a new classification system for obstructive sleep apnoea in patients with newly diagnosed obstructive sleep apnoea and monitor for long-term objective and subjective improvement.


Eligibility Criteria:
Inclusion criteria

1. Adult patient ≥40 years at the time of signed informed consent
2. Diagnosis of predominant obstructive sleep apnoea with a total apnoea-hypopnoea index of ≥5 /h based on a diagnostic sleep study (polysomnography or polygraphy, as per local standard). Predominant obstructive sleep apnoea defined as ≥70% of respiratory events classified as obstructive.
3. Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations

Exclusion criteria

1. \>30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
2. Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
3. Use, or need for chronic use, of any non-invasive positive pressure ventilation device
4. Participation in an interventional study and/or receiving investigational treatment(s)
5. Significant disease or condition, which, in the opinion of the investigator, may interfere with study procedures or cause concern regarding the patient's ability to participate in the study
6. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant)
Psychological Impact of Amenorrhea in Women With Endometriosis

The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.


Eligibility Criteria:
Inclusion Criteria:

* Clinical, echographical or surgical diagnosis of endometriosis

Exclusion Criteria:

* Comorbidity
* Psychiatric diseases
* Refusal or inability to sign informed consent
Acceptability and Feasibility of MOL in Acute Inpatient Units

The current study aims to test the acceptability and feasibility of a psychological therapy called Method of Levels (MOL) as an intervention for people in acute psychiatric inpatient units who are experiencing psychosis and/or suicidality.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years
* Current service user in an acute inpatient ward in the Greater Manchester area
* Capacity to provide informed consent for participating in research
* Good command of English language
* WS1: Experiencing psychosis (this will be screened for using a clinical cut-off score on the CAPE (Mossaheb et al., 2012))
* WS2: Experiencing suicidality (this will be screened for using a cynical cut-off score on the Suicidal Behaviours Questionnaire - revised (SBQ-R) (Osman et al., 2001))

Exclusion Criteria:

* Problems of an organic nature or a learning disability that might affect cognitive functioning
Psycho-social Impact of Anti-NMDAR Encephalitis

NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.

The proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.


Eligibility Criteria:
Inclusion Criteria:

* Patients with anti-NMDAR encephalitis
* Year ≥ 18 ans
* Patients affiliated to the social security scheme

Exclusion Criteria:

* Patients with no anti-NMDAR encephalitis
* Minor patient
* Patient under guardianship or curatorship
* Patient with preexisting neurological symptoms
Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.


Eligibility Criteria:
Inclusion Criteria:

* Required Coronary Artery Angioplasty with a drug-eluting stent deployment

Exclusion Criteria:

* The last drug-eluting stent placed greater than 2 weeks prior
* Aspirin or Plavix (Clopidogrel) allergy or contraindication
Intracept Intraosseous Basivertebral Nerve Ablation

This is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site.

The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent.

Study data will be collected by the University of Utah research staff via 4 telephone study visits under the direction of the Sponsor Investigator. The study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit.

Data will be analyzed by a statistician under the direction of the Sponsor Investigator for this single-site study.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure
* OR Participant had an Intracept Procedure for their low back pain and completed standard of care questionnaires at their procedure appointment.

Exclusion Criteria:

* Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure
* Intracept procedure for different location other than low back pain
Mindfulness Training for Seniors

The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are between 60 and 95 years of age
* Individuals who are fluent English speakers
* Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have an Internet connection
* Individuals who are willing and able to consent to participate in the study

Exclusion Criteria:

* Individuals who are cognitively impaired and not independent in daily activities, such as the use of the telephone, preparing meals
* Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.
The Effect of Bruxism on Temporomandibular Disorders

This case-control study consists of 120 participants aged between 18 and 65 years. Case group included 60 patients with bruxism who presented to physical medicine and rehabilitation outpatient clinic between May 2021 and August 2021. Control group included 60 healthy participant. Patients who had temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were also excluded. Assessments including age, gender, body mass index (BMI), education level, and symptom duration were recorded. Patients was evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments. Patients was evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4) , Oral Behaviors Checklist were applied within the scope of Axis II.

The aim of this study was to effect of bruxism on temporomandibular disorders (TMD) diagnosed by means of the research diagnostic criteria for temporomandibular disorders (RDC/TMD).

This case-control study consists of 120 participants aged between 18 and 65 years. Case group will be included 60 patients with bruxism who presented to physical medicine and rehabilitation outpatient clinic between May 2021 and August 2021. Control group will be included 60 healthy participant. Patients who had temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were also excluded.

Assessments including age, gender, body mass index (BMI), education level, and symptom duration will be recorded. Patients will evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments. Patients was evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4) , Oral Behaviors Checklist will applied within the scope of Axis II.

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients diagnosed with bruxism according to self-reported bruxism and examination.
* Sixty healthy volunteers

Exclusion Criteria:

* Patients with temporomandibular region surgery
* Congenital teporomandibular joint pathologies
* Previous temporomandibular region trauma were excluded from the study.
Perspectives on Spinal Manipulative Therapy for Low Back Pain

The goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. Participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. Participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pain between 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
* Meets NIH Task Force criteria for chronic low back pain

Exclusion Criteria:

* Prior surgery to the lumbosacral spine
* Currently pregnant
* Not currently receiving spinal manipulative therapy or exercise interventions from another healthcare provider such as a chiropractor or massage therapist.
* No neurogenic signs indicating radiculopathy
* No "red flags" of a potentially serious condition (e.g., cauda equina syndrome, fracture, cancer, infection, etc.)
Perineal Physiotherapy in Postpartum

Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive exercises plus training in lifestyle advice; Control group: just training in lifestyle advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: 240 subjects will be included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that 17% of women in the intervention group may develop pelvic floor dysfunction (urinary incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1 in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive analysis will be done of all variables. A confidence level of 95% (p \<0,05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.

Eligibility Criteria:
Inclusion Criteria:

* Postnatal women (6 and 8 weeks after vaginal delivery)
* Primiparous
* Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital
* Women have not been already treated for pelvic floor dysfunction
* Women reading, understanding and freely signing an informed consent form

Exclusion Criteria:

* Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery
* Women with a history of conservative treatment or PFD surgery
* Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria
* Postnatal women with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed IBS diagnosis per Rome II criteria for diagnosis of IBS.
* Colonoscopy within 2 years as part of IBS diagnostic evaluation.
* Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

* Symptoms of constipation.
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet.
Sudden Unexplained Death in Childhood (SUDC) Registry

The purpose is to increase the understanding of the characteristics, circumstances, medical histories and pathologies of children from ages 11 months through 18 years who have died suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and Research Collaborative will analyze cases of sudden unexpected deaths in these children to understand risk factors and causes, and develop preventative measures.

* Review the child's death, medical and family history by our study pathologists (including forensic, pediatric, cardiac and neuropathologists) to determine whether a possible, probable or definite cause of death can be identified and whether additional studies might be helpful in determining a specific cause of death.
* For case investigations that are open/active, the registry offers cardiac pathology, and neuroimaging/neuropathology consultations.
* For those cases determined to be unexplained/undetermined- access to genetic analysis (whole exome sequencing) when viable samples are available. Additional genetic analysis opportunities for biological parents and some family members. For more information, please see our Genetics Frequently Asked Questions.
* Study the risks that lead to sudden unexplained death in childhood (SUDC).
* Provide families with a review of their child's death through a case review report.
* Identify at-risk individuals with the hopes of gaining knowledge to establish prevention strategies to reduce the chances of sudden unexplained death in the future.

Eligibility Criteria:
Inclusion Criteria:

Retrospective SUDC Cases

* 11months to 18 years of age.
* Subjects whose cause of death was sudden and unexplained-"Postinfancy SIDS," "Sudden Death of Childhood," "Undetermined," "Late SIDS," a vague description of symptoms of "undetermined etiology," or a diagnosis acknowledged to be speculative by the prosecting pathologist
* If the retrospective case has banked DNA specimens.

Prospective SUDC Cases

* SUDC cases, parents and eligible family members from 11months-100 years of age.
* SUDC Subjects whose death was sudden and unexplained after the initial autopsy, and in whom a scene investigation and full autopsy was performed.

Family Members Subjects

* If the SUDC case has DNA viable specimens, family members will be asked if they would also like to participate in the DNA portion. One or both biological parents if willing and able will be considered as a family subject.
* Biological siblings and second degree relatives from age of 0-100 years of age that have had a history or currently have a heart condition and/or neurology condition.

Exclusion Criteria:

SUDC Subjects

* Subjects that are younger than 11months or older than 18 years of age will be excluded as a SUDC case.
* Prospective SUDC cases of apparent suicide, homicide, and accident where the external cause was the obvious and only reason for the death will be excluded from this study.

Family Member Subjects Any siblings or second degree family relatives that did not have a history or current heart or neurology condition will not be able to enroll in the study.
Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 55 years
* Healthy Adult

Exclusion Criteria:

* Non-Healthy
Development and Testing of Nutritional Algorithms (NACHO)

The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment.

The name of the intervention used in this research study is:

Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)

This is a longitudinal, mixed-methods, pilot descriptive study to develop a nutrition algorithm for cancer patients based on the Cancer Nutrition Consortium (CNC) study findings and refined through a dietitian panel participants and from feedback from participants and Family Advisory Council (PFAC) members.

Research study procedures include screening for eligibility, interviews and/or focus groups, dietitian panel meetings, and surveys.

Participation in this study is expected to last about 12 months.

It is expected about 130 people will participate in this research study.

Eligibility Criteria:
Inclusion Criteria for Dietitians/Oncology clinicians - Have worked with at least 3 patients at the study site who had nutritional challenges

Inclusion Criteria for Patient and Family Advisory Council (PFAC) participants

* Current member of adult PFAC
* \> 18 years old

Inclusion Criteria for Patient participants

* \> 18 years old
* Able to speak and read English
* Completed primary treatment (aim 2b) or actively undergoing treatment (aim 2b and aim 3, exploratory)
* Access to a device (e.g., computer, tablet, smartphone) through which they can receive and engage with a REDCap link

Exclusion Criteria for Patient Participants

• Provider does not recommend
Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.

In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).

The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.

In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.

The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Participation in the standard physical activity lesson twice weekly

Exclusion Criteria:

* Age under 3 years or above 6 years
* Serious atopic dermatitis
* Genetic conditions
* Metabolic diseases
* Acute infectious diseases