cyrilzakka/clinical-trials huggingface dataset:
Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)

The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Participants in the intervention arm will receive five days of TBT-S in addition to treatment as usual. TBT-S is administered to three to six adult anorexia nervosa patients with up to four supports per patient. The treatment structure consists of five consecutive days of treatment, up to 7,5 hours each day. Staff requirements for TBT-S are three clinicians, one dietician and one medical staff. Adults referred to a local psychiatric centre (DPS) for out-patient anorexia nervosa treatment, and their supports, will be eligible to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18, all genders
* A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)
* Willingness to have Support(s) participate in treatment
* Medically stable

Exclusion Criteria:

* Developmental, intellectual or psychotic disorder
* Diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study
* Receiving in-patient treatment at time of study entry
* Presence of other psychopathology that might interfere with ability to participate in the study
An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>= 65 years of age
* Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy
* Having received oral and written information about the study, and having signed a written consent form

Exclusion Criteria:

* Participation in a cancer clinical trial with an investigational medicinal product other than this study
* Patient previously treated with Avastin
* Patient under supervision or guardianship
Community Based Music and Dance Movement Therapy Group for Older Adults With Dementia

This study explores the value of a particular community based music and dance movement therapy group for older adults with dementia?

To answer this question, the investigators intend to address the following two sub-questions:

1. How does participants' use of music and movement change over time?
2. Did a music and dance movement therapy group improve participants' depressive symptoms?

A systematic review identified a need to explore the value of an arts therapies group for older adults with dementia living in the community with early to moderate stage dementia. This client population commonly experience depression, social withdrawal and cognitive difficulties and literature suggests a music and dance movement therapy group could potentially make a contribution to both reducing symptoms and improving communication and wellbeing. However, there is still lack of clarity on clinically meaningful outcome measures, detail regarding the therapeutic process and questions remain regarding the trustworthiness of qualitative observations. This mixed method feasibility study aims to test whether the interventions translate to a community setting, provide richer insight into the meaningful aspect of the therapeutic process and provide some preliminary quantitative findings.

Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old
* Living in the community
* Diagnosis of dementia
* Adequate functional hearing/vision
* Sufficient knowledge of English to understand participant information sheet

Exclusion Criteria:

* Participants excluded if they suffered from any physical or psychological conditions that make it difficult to access a group setting independently.
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Be aged 30 to 85 years.
* Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
* Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
* Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
* Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

Exclusion Criteria:

* Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
* Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
* Have unstable Parkinson's Disease requiring frequent booster doses;
* Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
* Have a history or current diagnosis of psychotic features according to the investigator;

Other protocol-defined inclusion/exclusion criteria applied to the study.
Peer Support Groups for Families With an Infant in the NICU

The goal of this observational study is to learn the impact of race, ethnicity, and language matched peer support groups on parental stress, anxiety, and sense of belonging for families who have or have had an infant hospitalized in the Neonatal Intensive Care Unit (NICU). The main questions aim to answer: Do race, ethnicity, and language matched peer support groups decrease parental stress and anxiety and improve sense of belonging of parents while their baby is hospitalized in the NICU? And, are there any changes that should be made to the format of the peer support group sessions?

Participants will be invited to attend a peer support group that is matched for race, ethnicity, and language. Participants will have the option of filling out a survey on stress, anxiety, and sense of belonging before and after the peer group session. Additionally, participants will have the option of filling out a satisfaction survey after the peer group session.

The study will be observational research wherein participants who want to attend a peer support group, will have the option of filling out surveys before and after peer support group attendance. Surveys are voluntary and the only way of assessing the behavioral outcome (impact on parental stress, anxiety, and sense of belonging); families can attend the peer support groups even if the family member does not want to participate in the survey.

Eligibility Criteria:
Inclusion Criteria:

* Parental or guardian self-identified as Black, African American, African, Latino, Hispanic, Chicano
* Parent or guardian of infant that was or is admitted to Oregon Health \& Science University, Randall Children's Hospital, or Providence Health NICU in Portland, OR

Exclusion Criteria:

* Parent or guardian age less than 18 years old
* Preferred language other than English or Spanish (including if preferred communication is sign language)
Impact of Mobile Phone Application Use on Adult BLS

The aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.

The trial design will be randomized, controlled, cross-over study. Data will be collected between March and May 2023 at the Faculty of health science, University of Maribor. The consentience of nursing students will be collected. The Faculty of health science, University of Maribor already give permission for conducting this study. The goal will be to have around 100 nursing students in the study.

In the study a serious smartphone game called MOBI-CPR will be used. The MOBI-CPR game will be available at https://mobicpr.si/. The MOBI-CPR game will be install on the smartphone and will be used at home by nursing students with a goal to obtain adult basic life support knowledge and skills.

Before each nursing student will get MOBI-CPR game for home usage we will 1) measure acute stress, and 2) assess adult basic life support knowledge and skills.

For measuring acute stress the Empatica E4 watch will be used. Measuring will be perform in a quiet room without disruptions. When measuring acute stress each nursing student will be coloring the mandalas circles. Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).

For the knowledge part the online modified questionnaire (available in: https://www.1ka.si/d/en) the multiple choice questions will be used, and for the skills part the Resusci Anne QCPR QCPR manikin and Defibtech Trainer AED will be used. Each nursing student will be given the scenarios to read before the start of the assistance to the victim of a sudden cardiac arrest. The investigators will use a modified checklist to assess students' performance in adult basic life support.

Eligibility Criteria:
Inclusion Criteria:

* Nursing students over eighteen years old
* Without training in adult basic life support or within the past six mounts
* Physically able to perform CPR
* Willingness to perform rescue breathing on a manikin
* A completed and signed consent form

Exclusion Criteria:

* Nursing student younger than 18 years old
* Undergone training on adult basic life support within the past six mounts
* Physically not able to perform CPR
* Do not want to perform rescue breathing on a manikin
* Do not want to participate
Portable Oxygen Concentrator Signal Capture Study

The main purpose of this study is to learn how patients breathe on portable oxygen concentrators (POCs), and to get feedback from patients using POCs.

This study aims to examine patient oxygenation levels and markers of exertion (e.g. breath rate, heart rate and breath pattern) while using a portable oxygen concentrator, with the aim to understand exercise desaturation in hypoxemic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing to give written informed consent
* Patient can read and comprehend English
* Patient is ≥ 18 years of age
* Patient has moderate to severe hypoxaemia (SpO2 ≤ 92%) at rest
* Patient reports shortness of breath on exertion

Exclusion Criteria:

* Patient has musculoskeletal impairment, or other impairment that may be the limiting factor in 6MWT
* Patient has a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
* Patient has acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
* Patient shows signs of acute exacerbation of underlying lung condition
* Patient is deemed to be unsuitable for inclusion in the opinion of the researcher, including for the following reasons:
* they do not comprehend English
* they are unable to provide written informed consent
* they are physically unable to comply with the protocol
Mechanistic Underpinnings of Preeclampsia

Preeclampsia is a dreadful disease with significant morbidity and mortality. Despite decades of research, we still need a proper diagnostic test or therapeutic option to treat this disorder. The proposed study will determine the diagnostic value of PBMC-secreted sFlt1 and determine the molecular mechanisms involved in its secretion. The molecular mechanisms can be novel therapeutic targets to treat this disorder.


Eligibility Criteria:
Healthy Adults:

• Healthy non-pregnant with previous normal pregnant women

Non-Health Adults:

• Patients will be admitted with the diagnosis of preeclampsia according to the internationally accepted definition of preeclampsia: Blood pressure measurement of 140/90 mm Hg or an increase of 30 mm Hg systolic or 15 mm Hg diastolic over baseline values on at least two occasions, six or more hours apart and proteinuria; 300 mg/24 hour after 20th week of gestation.

Pregnant Women:

Groups 3 - 6 will include pregnant women at different trimesters.

Criteria common to all groups:

* The study will be conducted only in females aged 18 or above.
* Patients in all the groups will be matched for age, which will be 18 or above.
* Women will be matched for body mass index; criteria for normal body mass index will be used based on the Center for Disease Control and Prevention Guidelines.
* Patients with premature rupture of the membrane, non-preeclamptic preterm labor, IUGR, placental abruption, twin? Any other complications during the pregnancy will be excluded from the study.
* Patients with any evidence of genetic or non-genetic malformations of the fetus will be excluded from the study.
* The study will be conducted on women who are non-smokers and do not consume alcohol or recreational drugs.
* The study will be conducted only on primigravida females to minimize phenotyping variability.
* The women with a known history of any chronic disorder, including but not limited to hypertension, diabetes, pulmonary, renal, cardiac, or cerebrovascular disorders, will be excluded from the studies.
Carey, a Mobile Coach Application for Patients Undergoing Orthognathic Surgery

Carey is a mobile application guiding patients throughout their orthognathic surgery journey. The purpose of the application is optimizing the patient's experience before, during and after orthognathic surgery improving patient satisfaction and reducing complications. This will be evaluated based on the following outcomes:

1. Patient satisfaction based on a questionnaire
2. Objective parameters (complications, oral hygiene, amount of contacts with department, relapse,...)
3. Patient-reported outcomes (PROM)

The objective of the study is to evaluate whether the use of a mobile coach application in orthognathic surgery can improve patient satisfaction and reduce complications.

Different studies pointed out the importance of patient information prior, during and after orthognathic surgery. It results in better recovery, less postoperative complications and improved patient satisfaction. In other words: a higher health care quality. Insufficient or omitted information about the procedure, surgical complications and/or postoperative care are an important cause of patient dissatisfaction.

Nowadays, patients receive a large amount of explanations, instructions and advices during their admission. Prior to surgery the surgeon will supply information about the procedure, sometimes aided by a website or online videos. Additionally the surgeon informs about the surgical complications, such as postoperative pain, restricted jaw movements, weight loss, swelling, scarring, jaw fixation, absenteeism from work, mood swings, and lip numbness.

The surgeon also supplies information by leaflets, oral and/or written instructions before discharge after surgery. This information however is often bulky, non-specific and incomplete. Furthermore, the surgeon knows that memory for medical information is poor and inaccurate resulting in nescient patients after returning home. For the surgeon it is a challenge to supply the right information at the right time, questioning the effectiveness of this conventional approach.

Some studies already showed that the use of multimedia represents a more effective method for patient education in comparison to the conventional approach. Patients prefer information through videos, interactive and moving images deriving better informed patients.

Furthermore, information provided by other patients was seen an added value. Adequate medication, dietary, oral hygiene and general advice could prevent complications.

Therefore, the use of interactive platforms such as a mobile application with phased information partition (the right information at the right time) could improve patient satisfaction, prevent unplanned consultations and even readmissions.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing orthognathic surgery
* Patients must be able to handle a smartphone.

Exclusion Criteria:

* Patients without smartphone
* Patients who have been submitted to orthognathic surgery in the past
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Nowadays features for the diagnosis of delirium are:

1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
2. A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;
3. The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
4. There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.

Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.

The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.


Eligibility Criteria:
Inclusion Criteria:

* Over 60 year old
* Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
* informed consent (legal representatives)

Exclusion Criteria:

* unable to swallow pills
* previous allergy to donepezil
* Atrioventricular block of 2nd and 3nd degree
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 18 and 65 years of age.
* A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
* At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.

Exclusion Criteria:

* Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
* Use of phototherapy or tanning beds within 6 weeks of screening
* History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
* Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).
Cataract Surgery on Advanced Age Related Macular Degeneration Patients

The degree at which cataract surgery improves visual function in patients with advanced age-related macular degeneration (Advanced AMD) has been an on-going topic of discussion. Our objective in this study is to determine if patients with Advanced AMD and concurrent cataracts will experience greater improvement in their quality of life from having cataract surgery on one or both eyes. The findings from this project will provide evidence for clinical decision making on whether performing bilateral cataract surgery on Advanced AMD patients is cost-effective and worth the second surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

Patients above the age of fifty with both Advanced AMD and Cataracts bilaterally from the Okanagan Valley will be selected for this study.

Patients who chose to have bilateral cataract surgery, were able to understand the research parameters, and had no other severe eye disease that may distort the studies results.

Patients will be selected for the study according to the National Eye Institute definition of Advanced AMD.

"Advanced AMD (AREDS category 4) is characterized by one or more of the following (in the absence of other causes) in one eye:

Geographic atrophy of the RPE involving the foveal center.

Neovascular maculopathy that includes the following:

* Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
* Serous and/or hemorrhagic detachment of the neurosensory retina or RPE
* Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
* Subretinal and sub-RPE fibrovascular proliferation
* Disciform scar (subretinal fibrosis)"

Exclusion Criteria:

* Severe intraoperative or postoperative complications such as retinal detachments, and capsule ruptures
* Inability to complete the required testing (auto-refractive and visual acuity)
* Inability to attend appointments
* Inability to complete the questionnaire with Co-I assistance
* Severe eye disease that may distort the studies results such as but not limited to Epithelial Basement Membrane Dystrophy (EBMD) and retinal detachments.