cyrilzakka/clinical-trials huggingface dataset:
SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation

The present study "Elderly person in the risk zone" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www. Vardalinstitutet.net) which comprises research into three interventions. A fundamental principle in the research programme is that it comprises interventions addressing frail elderly person in different phases of the disablement process, from elderly persons who are beginning to develop frailty to very frail elderly persons receiving palliative care in the final period of their lives. The interventions also address the different requirements that arise with regard to professional contributions during the various phases of the ageing and disease process, ranging from health promotion to a need for an increasing degree of medical care, nursing, special care and rehabilitation, and finally, efforts that promote symptom relief, quality of life, security and satisfaction with care during the final period of life. The intervention "Elderly persons in the risk zone" addresses elderly persons that are on the point of developing frailty ("pre-frail") and are beginning to feel that they are being hindered from taking part in everyday activities. The hypothesis is that if an intervention is made when the persons are not so frail, it is possible to prevent/delay deterioration.

1. Can a health-promoting and preventive intervention for "prefrail" elderly persons:

   * prevent frailty, activity limitations and morbidity,
   * be a supportive factor in the social and physical environment,
   * affect life satisfaction
   * have an impact on the consumption of care
   * be cost-effective?
2. How do the frail elderly persons experience the intervention and its importance to health?


Eligibility Criteria:
Inclusion Criteria:

* 80 years of age or older living in the community.
* The participants should live in their ordinary housing
* Independent on formal support
* Independent on informal support
* Cognitive intact defined as a Mini Mental Test score \> 25
Air Pollution, Inflammation and Acute Coronary Syndrome

The objectives of this study are: 1) To determine whether patients with acute coronary syndrome, the level of environmental exposure to particulate air pollutants in the week prior to admission, are related to concentrations of inflammatory molecules and oxidative stress. 2) To investigate whether the level of environmental exposure is an independent prognostic factor in terms of overall and cardiovascular mortality, myocardial infarction or unstable angina at 30 days, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome

Exclusion Criteria:

* Infectious process and / or local or systemic inflammation in the 15 days before admission.
* Thyrotoxicosis.
* Neoplasms - or any other disease that seriously compromise the prognosis of life and / or generate a systemic inflammatory response.
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 10 years
* Lumpectomy with clear margins (negative per NSABP criteria)
* DCIS and/or invasive carcinoma
* If invasive, nodes must be negative
* T stage is Tis, T1 or T2\<=3 cm max diameter
* ER(+) or ER(-)/PR(+)

Exclusion Criteria:

* Pregnant or breast feeding
* Active collagen-vascular disease
* Paget's disease of the breast
* Prior history of breast cancer
* Prior breast or thoracic radiotherapy
* Multicentric carcinoma
* Synchronous bilateral breast cancer
* Surgical margins that cannot be assessed or that are positive
* T Stage is T2\>3 cm or greater
* ER(-)/PR(-)
Effect of Revival Soy on Fibromyalgia Pain

Fibromyalgia is characterized by widespread pain that can lead to significant patient dysfunction and economic burden to society. The management of patients with fibromyalgia is difficult and no single treatment modality has been successful. We propose to study the effect of dietary soy supplement on quality of life associated with fibromyalgia.

Fibromyalgia syndrome is a chronic, generalized pain syndrome that affects the musculoskeletal system (1). This syndrome is typically diagnosed in patients who experience generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific points (2). Although the primary cause of fibromyalgia syndrome is unclear, a growing body of evidence indicates that the widespread pain associated with this syndrome is due to abnormalities in the central nervous system. Therefore, drug therapy for fibromyalgia syndrome is most often aimed at the central nervous system and includes tricyclic antidepressants, selective serotonin reuptake inhibitors, dual serotonin and norepinephrine reuptake inhibitors, analgesics, and anticonvulsants (1).

In addition to medical therapies, complementary and alternative medicine therapies have been used to treat fibromyalgia syndrome symptoms (3). Soy is a widely used dietary supplement that has not been previously tested for treating fibromyalgia syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Women and men age 18 - 76
* Able to understand and sign a consent form
* Able to participate fully in all aspects of the study
* Currently participating in Mayo Clinic's Fibromyalgia Treatment Program

Exclusion Criteria:

* Pregnant or lactating women
* Allergy to soy or other study product ingredients
* Diagnosis of bipolar disorder, schizophrenia or dementia
* Diagnosis of diabetes mellitus or inflammatory bowel disease
* Presently on soy product or use of soy within the last 30 days
Upper Extremity Pattern Exercises and Respiratory Functions

The study will be carried out with healthy students between the ages of 18-25 years who are studying at Ege University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation and who voluntarily agree to participate in the study. Informed consent form will be signed before the evaluation of the individuals. The study will be carried out as a single group with the inclusion of a total of 20 individuals. The students who volunteered to participate in the study will actively apply the selected PNF upper extremity patterns for 4 weeks and will be evaluated twice, before and after the application. Demographic information of the individuals; age, height, weight, gender, background, surname, smoking habit, alcohol habit, education level (class), sports habit, COVID-19 disease status and when it occurred will be recorded. Cosmed pulmonary function test device will be used to evaluate the respiratory function of the individuals, Oncomed brand electronic body weight and height measurement device will be used to calculate the body mass index. Body Image Perception Scale will be used for body image perception, Beck Depression Inventory will be used to evaluate psychological status, and Rosenberg Self-Esteem Scale will be used to evaluate sense of self.


Eligibility Criteria:
Inclusion Criteria:

* Not diagnosed with any chronic disease
* No neurological problems
* Has not had COVID-19 for at least 6 months

Exclusion Criteria:

* Diagnosed with respiratory system diseases
* Regular medication use
* Suspected pregnancy
* Individuals with rheumatic or neurological diseases
Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)

Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women;
* Cardiovascular surgery;
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Pregnant women;
* Patients with preexisting psychotic disorders;
* Decline to participate in the study.
EC50 of Anesthetics During Microelectric Recording

The investigators determine the half maximum effective concentration (EC50) of the Cet value of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for the maintenance of general anesthesia during microelectrode recording in the deep brain surgery in patients with Parkinson's disease.

General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug' state. Dexmedetomidine and propofol are both used individually in the sedation for DBS surgery, and were reported to affect the MER (microelectrode recording) to some extent, especially in the higher zone of the dose range. In this study, the investigators plan to use the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given within 0.8\~1.8 mcg/Kg during the MER recording (based on institutional guideline). MER recording will be observed and correlated wtih the dose of propofol. The Dixon "up-and-down" sequential allocation method was used to determine the EC50 of the value of Cet of propofol. The study aims to determine the dose that is adequate for maintaining general anesthesia with endotracheal intubation and least interference with the MER recording.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-85
2. Clinical diagnosis of Parkinson's disease
3. Scheduled for deep brain stimulation surgery under general anesthesia

Exclusion Criteria:

1. Allergic history to dexmedetomidine and propofol
2. Clinical diagnosis of congestive heart failure
3. Clinical diagnosis of liver cirrhosis
4. Clinical diagnosis of third degree A-V block
Telerehabilitation-based Motor Imagery in Nonspecific Low Back Pain

Low back pain is a common problem in society and causes loss of workforce. Its lifetime prevalence reaches 80% and annual hospital admission rates in the adult population reach 15%.Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. Studies have shown that similar brain regions are activated during motor imagery and real movement. However, the level of evidence about the effect of motor imagery on autonomic functions is limited. Today, interest in telerehabilitation has increased due to the Covid-19 pandemic.

The aim of this study is to examine the effects of telerehabilitation-based motor imagery training in patients with non-specific low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Those who can read and write
* Patients who have not undergone surgery
* Those with a body mass index less than 30 m2/kg
* To have sufficient computer knowledge to participate in the study or to have a relative who can help in this regard
* Having a computer and active internet connection at home

Exclusion Criteria:

* Medically uncontrolled and uncooperative patients
* Patients who have undergone surgery to the lumbar region
* History of falling in the last 6 months
* Those with serious orthopedic, vascular, neurological, psychiatric problems affecting balance
* Active malignancy
* Pregnancy
* Having severe vision and hearing problems
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study

This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:

1. Evaluation of the graft uptake rate.
2. Evaluation and comparing audiological outcomes.
3. Finding out intraoperative and postoperative morbidity.

Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane.

Fat graft myringoplasty (FGM) has been reported as a suitable procedure to close long-standing TM perforations FGM is an efficient, safe and potentially fast method for TM perforation repairing with a success rate varies from 79% to 91%..Many researches was done to use supporting material in myringoplasty Saliba et al used hyaluronic acid fat graft myringoplasty \[HAFGM\] and results in a higher success rate than using FGM alone. El-Anwar et al proved that Topical autologous platelet-rich plasma(PRP) application during myringolpasty is safe, efficient and enhances healing of TM perforation PRP includes many autologous growth factors that have significant functions like cell proliferation, migration, and angiogenesis. Fibrin and fibronectin are essential proteins in PRP that provide the structural support needed for the cell migration, cell proliferation, and 3-dimensional growth of tissues.

HA has been shown to play a role in cellular signaling, leukocyte growth and migration, Cell adhesion and biological remodeling and is mainly involved in tissue healing with a central role in modulating inflammatory responses also, Its absorption of water causes expansion in volume and formation of a viscoelastic gel which constitutes a favorable scaffold for tissue regeneration and remodeling .

Eligibility Criteria:
Inclusion Criteria:

* Patients with central small or median sized dry perforation
* Aged between 14 and 50 years
* In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
* Conductive gap on audiometry not more than 40 dB.

Exclusion Criteria:

* Discharging CSOM .
* Concurrent URTI .
* CSOM with dry marginal perforation
* Patients who didn't come for follow up.
* Age less than 14 or more than 50.
* Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
* Patients who are suspected of having Eustachian tube dysfunction.
* Suspected ossicular pathology in safe CSOM if the ABG \&gt; 40dB.
* Patients with history of Previous ear surgery.
* Patients unfit for surgery or having chronic medical illness.
* Narrow external auditory canal.
* Patients who refused to enrolled in our study
* Patients with sensorineural hearing loss or only functioning ear.
Immune Modulation by Misoprostol

The present study is designed to address the null hypothesis that there is no difference in the local and systemic immunomodulatory effects of buccally or vaginally administered misoprostol in healthy, reproductive-age women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women 18-45 years of age
* Negative result of urine pregnancy test at screening and prior to each administration of study drug
* Normal, regularly occurring menses (being 25-35 day cycles)

Exclusion Criteria:

* Use of hormonal contraception (current or past 3 months)
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin within two weeks prior to enrollment or planned use of these medications during the study period
* Allergy to prostaglandins
* Previous cervical cancer
* Partial or complete cervical excision
* Previous hysterectomy
* Immunosuppression: either pharmacological or due to comorbidities
* Diabetes mellitus
* Auto-immune disease
* History of lymphoma or leukemia
* Sexually transmitted infection (by self-report) over previous 1 year
* Bacterial Vaginosis or Candidiasis (current or past 3 months)
A Study of Suzetrigine (SUZ) Spray-dried Dispersion (SSD) in Healthy Adult Panelists

The purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of SUZ SDD and assess the impact of the dose on the sensory attributes.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

- Panelists are qualified based on training and experience. They will be required to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

Key Exclusion Criteria:

* History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant
* Sensitivity to SUZ
* Pregnant, nursing, or planning to become pregnant during the study

Other protocol defined Inclusion/Exclusion criteria may apply.
Impact of COVID-19 on Mental Health of Health Care Workers

The impact of the current Covid-19 pandemic on healthcare workers is enormous. This longitudinal study investigates the prevalence of mental health problems and the quality of life of healthcare workers during and after the Covid-19 pandemic. Underlying risk factors are also examined. Health care workers of the different Covid-19 cohort and transit wards, as well as the intensive care unit and (psychiatric) emergency services of the Ghent university hospital will be included, as well as the health care workers of 6 non-Covid-19 wards.

The impact of the current Covid-19 pandemic on healthcare workers is enormous. Previous studies during the SARS outbreak demonstrated a significant burden and increase of mental health problems in health care workers.This longitudinal study aims to investigate the prevalence of mental health problems and the quality of life of health care workers during and after the Covid-19 pandemic. Health care workers of the different Covid-19 cohort and transit wards, as well as the intensive care unit and (psychiatric) emergency services of the Ghent university hospital will be included, as well as the health care workers of 6 non-Covid-19 wards. Participants will receive a monthly online survey during the government issued restrictions. After cessation of the restrictions participants will receive three-monthly surveys for a one-year-period.

Sociodemographic data, data regarding employment and previous mental health problems will be collected at the first survey. The Covid-19 status of the health care workers will be inquired at every survey. The Depression, Anxiety and Stress Scale (DASS-21), the Dutch translation of the Covid-19 Peritraumatic Distress Index (CPDI), the WHO Quality of Life-BREF (WHOQOL-BREF), and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and three items measuring social support will be administered at every survey.

Eligibility Criteria:
Inclusion Criteria:

* health care worker
* employed at inclusion at Covid cohort/transit or (psychiatric) emergency services or intensive care unit or 6 specified wards of the Ghent University Hospital

Exclusion Criteria:

* none
Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination

The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B will be evaluated to assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV

Hepatitis B virus (HBV) infection is a global health issue; it is estimated that 257 million persons have chronic HBV (Asgeir et al., 2021). The major routes of HBV transmission include blood, sexual contact, vertical (from infected mothers to her children) and horizontal (between the spouses or children) transmission (Şükran et al., (2018). The household transmission of HBV is also a major health issue; it represents a challenge to the health system. Higher rates of HBV infection were reported among the household contacts of chronic HBV carriers; the prevalence of HBV infection among the family members of patients with chronic HBV can reach to 57%. Factors affecting the risk of transmission include socio-demographic status, family role (infected mothers increase the risk of transmission) and viral markers of the index case (Masomeh et al., 2016).The diagnosis of HBV infection is generally based on serological (hepatitis B surface antigen) and molecular assays (hepatitis B virus deoxyribonucleic acid) (Chen et al., 2017).Although the three-dose vaccination for hepatitis B provides more than 90% seroprotection rates (Van Den Ende C, et al, 2017); approximately 10% of vaccinated persons may be at risk of getting infected.

Available data about the current status of intra-familial transmission of HBV among our community members are lacking; we need to determine the magnitude of such a major public health problem

Eligibility Criteria:
Inclusion Criteria:

* : The household contacts of patients with chronic HBV infection will be included in the study.

Exclusion Criteria:

* Those with prior diagnosis of HBV infection following the date of the primary case infection.
Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis


Eligibility Criteria:
Inclusion Criteria:

Systemically healthy patient (ASA I or II).

Mandibular first molar teeth with:

* Preoperative sharp pain and symptomatic apical periodontitis
* Absence or slight widening in the periodontal ligament (PDL).
* Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
* Positive response to percussion test

Exclusion Criteria:

1. Medically compromised patients.
2. Pregnant women.
3. Patients reporting bruxism or clenching.
4. Patients allergic to ciprofloxacin or metronidazole.
5. Teeth associated with acute periapical abscess and/or swelling.
6. Greater than grade I mobility or pocket depth greater than 5mm.
7. Size of periapical radiolucency is greater than 8 mm.
8. No restorability: Hopeless tooth.
9. Immature teeth.
10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.