cyrilzakka/clinical-trials huggingface dataset:
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.

Efficacy will be assessed based on:

Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression

Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated\* organs (skin and /or bone-marrow and/or internal organ).
2. Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
3. The absence of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue.
4. Handicap defined as at least one of the following handicaps:

   * a number of flush per day ≥ 1 ,
   * a pruritus score ≥ 9 ,
   * a number of stools per day ≥ 4 ,
   * a Pollakyuria (on a per day basis) ≥ 8 ,
   * a QLQ-C30 score ≥ 83 ,
   * a Hamilton rating scale for depression ≥ 12

Exclusion Criteria:

1. Performance status \> 2 (ECOG).
2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells
Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair

This is a cross-sectional study with an aim to evaluate the variations in self-reporting attitude and practice of restoration repair among Egyptian dental practitioners utilizing a survey questionnaire.

It is undeniable that "Minimally invasive dentistry" nowadays offers solutions to prolong the longevity of resin composite restoration with adhesive technology. Due to the limited lifespan of dental restorations, defects are more prone to occur in the existing restorations and thus require dental treatment. it was stated in the literature that repairing could offer better advantages even though replacement of a restoration is a more common choice by many clinicians.

Since the concept of preserving tooth structure nowadays plays a major part in dental practice, invistigators need to understand where Egyptian dental practitioners stand in understanding and applying the concept of restoration repair. Assessment of knowledge and the missing data regarding the concept of repair that dentists in Egypt have could help understand their awareness in applying conservatism in daily practice. There were some research about knowledge, attitude and practice of restoration repair in of dental practitioners in other countries, but little was known in Egypt.


Eligibility Criteria:
Inclusion Criteria:

* Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate.

Exclusion Criteria:

* Undergraduate dental students
* Dental practitioners that are still in internship
* Dental practitioners that don't have their practice license yet.
* Dental practitioners that are not registered in the Egyptian Dental Syndicate.
Memory and Attention Disorders and Malnutrition in Hospital Setting

This is a cross-sectional observational study that investigates the prevalence of memory disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in Tampere University Hospital (excl. psyciatry, pediatrics, ICU)
* Able to communicate in Finnish

Exclusion Criteria:

* Unable to communicate because of unconciuousness, critical health status, or communication difficulties
* Having a (surgical) procedure at the time of data collection
Interference Between Surgical Magnetic Drapes and Pacemakers

This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.

Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.

This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pacemaker
* 18 years or older

Exclusion Criteria:

* Patients with implantable cardioverter-defibrillator (ICD)
* Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
* Refusal/Inability to consent
* Language other than French or English
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer prior to receiving breast cancer therapy.
* Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.

Exclusion Criteria:

* Poorly controlled diabetes.
* Contralateral mastectomy prior to neoadjuvant chemotherapy.
* Not a surgical candidate.
* No previous axillary lymph node dissection.
Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia

Ylang-Ylang (Cananga Odorata) essential oil has been postulated to have calming effect, which may improve BPSD in persons with dementia. This study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (BDNF) in persons with BPSD.

Behavioural and Psychological Symptoms of Dementia (BPSD) refers to the spectrum of non-cognitive and non-neurological symptoms of dementia, such as agitation, psychosis, depression and apathy. Ylang-Ylang (Cananga Odorata) essential oil is postulated to have calming effect, which may improve BPSD in persons with dementia. Thus, this study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (BDNF) in persons with BPSD. A pre-post quasi-experimental pilot study will be conducted over a two-month period in nursing homes with persons with dementia. Approximately 30 persons with dementia are expected to participate in this study. During the pre-intervention phase, water will be diffused using a diffuser in a common area of the nursing homes. During the intervention phase, Ylang-Ylang essential oil will be diffused using the identical diffuser over the same common area. Both water and essential oil will be diffused twice a day, each for a duration of 20 min during the respective phases. Observation and documentation of behavioural symptoms will be taken using validated instruments during the pre- and post-intervention phases. In addition, 10 mL of blood will also be collected at pre and post intervention for biochemical analyses.If Ylang-ylang essential oil were found to be beneficial based on the laboratory and observational findings, it can be possibly used as an alternative approach in managing BPSD.

Eligibility Criteria:
Inclusion Criteria:

* Persons who have been diagnosed with dementia by their physicians and in nursing homes in Selangor, Malaysia.
* Persons with dementia who have at least one symptom of BPSD

Exclusion Criteria:

* Persons with dementia with a comorbid respiratory problem like asthma or chronic obstructive pulmonary disease
* Persons with dementia who are allergic to fragrance/perfumes
* Persons with dementia who had a change in their psychotropic or dementia medications in the 30 days before commencement of the study, namely: acetylcholinesterase inhibitors N-methyl-D-aspartate (NMDA)-receptor antagonist (memantine), antipsychotics, antidepressants, sedatives, or medications with anticholinergic properties
* Persons who have been diagnosed with schizophrenia or mental retardation
* Persons who have no documented behavioral history in the previous three month
* Persons who are currently hospitalized
* Persons with dementia who are unwilling to participate or disallowed by caregivers/family members
Preoperative Survey

This study will examine preoperative concerns in older adults through the use of a self-administered questionnaire. The development of this questionnaire will involve adapting survey questions from previously validated studies, creating new questions, and generating a comprehensive questionnaire.

The primary objective is to assess the preoperative concerns in older adults. This objective will be assessed by using a self-administered questionnaire.

The secondary objective is to examine older adults' attitudes toward preoperative cognitive assessments, functional assessments, and prehabilitation programs. Similarly, this objective will be assessed by using a self-administered questionnaire.

Survey administration will be completed online and in person. Recruited participants will receive an email that contains an external link to the online version of the survey that will be administered on Research Electronic Data Capture (REDCap), an online platform to complete secure surveys. Once received, participants will be able to anonymously complete the survey and not have to provide any identification information except for general sociodemographic variables. Alternatively, study personnel will administer the questionnaire online/ in person at the preoperative clinic to assess surgical population at Mount Sinai Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Older adults, who are aged 65 or older and
* Medical patients in geriatric clinic or surgical inpatients in pre-operative clinics

Exclusion Criteria:

• Lack English language capability
Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy

The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure.

Patient with the diagnosis of acute appendicitis of \>15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study.

30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).

These patients were operated through Mc-Burney incision given in the right lower quadrant.

Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.

In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).

The assessment of the wound was done by using ASEPSIS (Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay) score. A score of more than 20 is considered to be infected.

Fever, raised total leucocyte count, positive pus culture, Ultrasound evidence of fluid collections, removal of sutures and duration of hospital stay were also measured for the evaluation of economic implications due to SSI.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis or Radiological diagnosis of acute appendicitis.
2. Appendectomy through the Mc Burney incision.

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary diseases.
2. Immunodeficiency disease.
3. Patients requiring midline incision.
4. Patients requiring general anaesthesia after failure of spinal anaesthesia.
5. Patients requiring higher oxygen in perioperative period.
An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias

The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10 and 11.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with SCA types 1, 2, 3, 6, 10, or 11, diagnosed by a movement disorder specialist.
* Age 18 years to 80 years.
* Able to ambulate with or without assistance for 30 feet.
* Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
* Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).
* Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
* Diagnosis of peripheral neuropathy. See exclusion criteria 3 for specific types of peripheral neuropathy to be excluded.
* Throughout the study, all possible efforts will be made to maintain subject levels of activity, exercise or physical therapy.
* Subject permission (informed consent).

Exclusion Criteria:

* Any unstable illness that in the investigator's opinion precludes participation in this study.
* Use of any investigational product within the past 30 days.
* Presence of diabetes (as determined by blood glucose labs within the past 6 months), nutritional deficiency causing neuropathy (vitamin B1, 3, 6, and 12 or vitamin E), injuries, autoimmune disorders (HIV, lupus, pediatric Guillain-Barre syndrome, neurosarcoidosis, monoclonal gammopathy), tumors, infections (leprosy), exposures to toxins (alcohol, arsenic, mercury), thyroid disease or hereditary causes (cerebral amyloid angiopathy) known to result in the presence of peripheral neuropathy.
* Dementia or other psychiatric illness that prevents the subject from giving informed consent (MMSE less than 25).
* Legal incapacity or limited legal capacity.
* Presence of severe renal disease (estimated creatinine clearance \<50 mL/min) or hepatic disease (as evidenced by labs reported within the past 6 months).
* Clinically significantly abnormal white blood cell count, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
* Immunoglobulin A, Vitamin B (1, 3, 6, or 12), vitamin E or folate deficiencies (evidenced by screening lab evaluations).
Maternal Autoimmune Disease Research Alliance (MADRA) Registry

This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases.

The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy.

Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.

At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care.

Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery.

The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved.

Enrollment in the registry does not significantly increase risks for a patient.

Eligibility Criteria:
Inclusion Criteria:

* Desire for pregnancy within 6 months or currently pregnant
* Women with systemic autoimmune disease, including:
* Lupus (systemic lupus erythematosus or cutaneous lupus)
* Antiphospholipid Syndrome or positive antiphospholipid antibodies
* Rheumatoid Arthritis
* Scleroderma (systemic sclerosis)
* Sjogren's Syndrome
* Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
* Undifferentiated Connective Tissue Disease (UCTD)
* Vasculitis
* Myositis (Polymyositis or Dermatomyositis)
* Positive Ro/SSA or La/SSB antibodies

Exclusion Criteria:

* Unable to speak English
* Unable to provide informed consent
* Unable to travel to Duke University for follow-up visits
Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)

Alzheimer's disease is the most common form of dementia and is the fourth leading cause of death among people 65 years of age and older. The global prevalence of the disease will increase significantly as the population ages, unless preventative treatments can be identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an approved medication (donepezil) shown to improve cognition and function in patients with Alzheimer's disease.

This is a double blind, positive comparator, randomized, multicenter, parallel group study to assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild to moderate dementia of the Alzheimer's type (AD). Approximately 300 subjects will be randomized and divided into 2 cohorts. Actual randomization was 293 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of AD per NINCDS-ADRDA criteria; mild to moderate severity as defined by Mini-Mental State Examination (MMSE) scores of 12 to 22.
2. AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.
3. Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of \</= 4.
4. Presence of a caregiver with significant proportion of time in contact with subject and who will oversee administration of study drug during the trial
5. Able to complete test assessments and to sign informed consent with the help of a caregiver if needed

Exclusion Criteria:

1. Diagnosis or presence of other dementing illnesses
2. Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
3. Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)
4. Tobacco user within 4 months prior to Screening
5. Use of smoking cessation therapy within 4 months prior to Screening
6. History within past 6 months of alcohol abuse or illicit drug abuse
7. Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator
8. Myocardial infarction within the 12 months prior to Screening
9. Hypothyroidism, vitamin B12 or folic acid deficiency
10. Known systemic infection (HBV, HCV, HIV, TB)
11. Vascular dementia per NINDS-AIRENS criteria and as defined by a modified Hachinski ischemia score (HIS, Appendix 4) score of \> 4 (i.e., vascular dementia is consistent with a modified HIS \> 4).
Radiographic Influences of Bisphosphonate Treatment on Femur

Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic fractures, there are concerns that these medications may be associated with rare atypical femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and AFF is unclear. In this study, the investigators would like to analyze the long term effects on femur by bisphosphonate treatment.The participants are treated in the investigators hospital more than four years.

Bisphosphonates have been widely used in the treatment of osteoporosis. Recently, long-term use of bisphosphonates increases the risk for AFFs in older women, according to the results of a population-based, nested case-control study. Unique radiographic pattern of AFF is reported, such as simple transverse or short oblique fracture with breaking of medial cortex and cortical thickness. But radiographic evaluation were performed for fracture patients in previous reports and the femoral condition of long-term bisphosphonate treatment patients before fracture is not known.

The main objective of this study is to reveal the effects of long-term bisphosphonate treatment on femur.

Eligibility Criteria:
Inclusion Criteria:

* Patients using bisphosphonate more than four years

Exclusion Criteria:

* patients who could not use bisphosphonate
Epicardial Ablation in Brugada Syndrome

This prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected BrS patients and to verify if RFA could normalize the consequences of a genetic disease.

The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial.

Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure.

Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation.

Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes
* Patients with an ICD already implanted
* Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation
* Age ≥ 18
* Willingness to attend follow-up examinations
* Written informed consent to the participation in the trial

Exclusion Criteria:

* Pregnancy or breast-feeding
* Patients with low arrhythmic risk (Brugada pattern III)
* Life expectancy \< 12 months.