cyrilzakka/clinical-trials huggingface dataset:
Breath-holding Spells and Its Management Study

The goal of this prospective population-based study is to evaluate the new disease description and management guidelines for breath-holding spells in children (Hellström Schmidt et al, Acta Paediatrica 2024) below the age of 5 years in southern Sweden. The main questions it aims to answer are:

* Does the disease description and management guidelines lead to the expected reduction in diagnostic interventions and are the clinical managements guidelines safe to use?
* If iron supplementation is given, does it reduce the frequency and severity of the spells?
* What information and support does parents to children with breath-holding spells need?

Participants will undergo evaluation by a medical doctor and if typical breath-holding spells are diagnosed, be managed according to the new guidelines. If iron deficiency is found, iron supplementation is recommended. Digital surveys will be distributed and parents of patients with frequent spells will be eligible for participation in an interview sub-study.

Please see the Study plan among the documents.

Eligibility Criteria:
Inclusion Criteria:

* Below 5 years of age
* resident in Region Skåne (Sweden)
* suspected breath-holding spell

Exclusion Criteria:

* previous investigation for breath-holding spell (previous spells are not a reason for exclusion)
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects from 2 up to and including 18 years of age
2. Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age

Exclusion Criteria:

Individuals not eligible to be enrolled in the study were those:

1. Who had a previous confirmed or suspected disease caused by N. meningitidis.
2. Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment.
3. Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
5. Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.
6. Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
7. Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
8. Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
9. Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
10. Who have Down's syndrome or other known cytogenic disorders.
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir

This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy sofosbuvir (SOF) and daclatasvir (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 8-18 years
2. Sex: both sexes
3. Naïve patients, with chronic HCV infection

Exclusion Criteria:

1. Co-infection with Hepatitis B virus (HBV)
2. Other associated chronic liver illness
3. Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
4. Patients with history of hematemesis (non cirrhotic portal hypertension)
5. Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer

Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
* T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
* Age \> 18 years
* WHO 0-2
* Willingness to undergo 18F-FDG-PET-CT
* Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
* Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations

Exclusion Criteria:

* Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
* Refusal of or having contraindications to 18F-FDG-PET-CT
* Refusal of MDT or immunotherapy
* Prior radiotherapy unabling MDT
* Contraindications to radiotherapy (including active inflammatory bowel disease)
* Contraindications to immunotherapy
* Other primary tumor diagnosed \< 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.
Reiki Effects on Pain, Functional Status and Holistic Well-Being in Patients With Knee Osteoarthritis

This study aimed to examine the effect of Reiki therapy on pain, functional status and holistic well-being in patients with knee osteoarthritis.

Knee osteoarthritis is a chronic degenerative joint disease that causes pain in individuals and negatively affects their functional status and overall well-being. Patients often benefit from non-pharmacological methods in pain control. Reiki, expressed as "universal life energy", is a kind of energy therapy that creates the appropriate conditions required by the body's natural healing system in rebalancing and recharging human energy fields. Although Reiki studies in the field of orthopedics are limited, it is revealed that Reiki improves physical function, reduces fatigue and increases emotional well-being in rheumatoid arthritis patients. Studies evaluating the effectiveness of Reiki in patients undergoing total knee replacement have evaluated that Reiki is effective in controlling postoperative pain, reducing blood pressure, respiratory rate, and state anxiety.

The study was conducted with patients with knee osteoarthritis who applied to the orthopedic outpatient clinic of a training and research hospital between June 24, 2022 and December 31, 2022. The data of the study was collected using "Patient Information Form (PIF)", "Visual Analog Scale (VAS)", "Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)" and "Holistic Well-Being Scale (HWS).

PIF, VAS, WOMAC and HWS were applied to the patients who met the inclusion criteria and agreed to participate in the study. Patients were randomized 1:1 into groups by a single therapist according to the block randomization method. There were two arms in the study; Reiki treatment (n=21) and control group (n=21). A second-degree Reiki practitioner applied Reiki to the patients for 40 minutes. On the second day and the third day, 30 minutes distant Reiki were applied to the patients. In the control group, nothing was done. Post-tests were applied to all patients 3 days and 10 days after they were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2-3 osteoarthritis according to the Kellgren Lawrence scale,
* Patients aged 40 and over

Exclusion Criteria:

* Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish,
* Those who refuse to answer the Reiki application and data collection tools,
* Those who want to leave at any stage of the research or cannot be reached by phone,
* Those who underwent an application such as physical therapy, intraarticular injection or prolotherapy during the research process,
* Those who used any Complementary and Alternative Method (CAM) in the last 6 months were excluded from the study.
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores

The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design

The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.

The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.

The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of recurrent cold sores averaging 2 or more episodes per year
* UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

* History of abnormal reactions to sunlight
* Used antiviral therapy directly prior to entering study
* Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
Huntsman Biopsy Study

Bone and soft tissue sarcomas are currently classified based upon light microscopy supplemented by immunohistochemistry, but within many if not all of these tumor histologic types, considerable heterogeneity exists not only in microscopic appearance but also in biologic behavior and prognosis. Progress in the directed treatment of these tumors, particularly the sarcomas, awaits characterization of the gene profiles for these tumors. Orthopedic oncology researchers at Huntsman Cancer Institute at the University of Utah are establishing a tumor bank for this purpose. The long term objectives of this work include:

1. creating tumor specific gene profiles to improve diagnostic accuracy
2. performing gene set validation for diagnostic predictive power
3. defining a discriminate gene list implicated in pathogenesis

The tissue procured under this protocol at SUNY Upstate Medical University will be limited to excess soft tissue and bone tumor tissue from patients otherwise undergoing clinically indicated procedures for diagnosis or treatment under the care of the local principal investigator (PI) and will be forwarded to the central investigator, R. Lor Randall, MD at Huntsman Cancer Institute for use in the characterization of the gene profiles of these tumors.

as stated in brief summary

Eligibility Criteria:
Inclusion Criteria:

* Bone or soft tissue tumor that has been established to be or is suspected to possibly be a sarcoma AND who will require a diagnostic or therapeutic surgical procedure which will result in procurement of tissue for histologic review

Exclusion Criteria:

* Non cancer patients
One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)

Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation.


Eligibility Criteria:
Inclusion Criteria:

* All subjects are required to be:

  1. From 21-35 years old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to withstand conventional dental procedures
  4. Patients with teeth problems indicated for single all ceramic restoration in maxillary esthetic zone cr

     1. Badly decayed teeth
     2. Teeth restored with large filling restorations
     3. Endodontically treated teeth
     4. Malformed teeth
     5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
     6. Spacing between maxillary teeth in esthetic zone
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient less than 21or more than 35 years
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Patient with periodontal problems
8. patients with malocclusion or parafunctional habits
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum 22 years of age;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
6. Potential for postoperative BCDVA of 20/25 or better in each eye
7. Clear intraocular media, other than cataract.

Exclusion Criteria:

1. Requiring an IC-8 intraocular lens outside the available spherical power range
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Inability to achieve stable keratometric readings for contact lens wearers
4. Irregular astigmatism in either eye;
5. Preoperative corneal astigmatism \> 1.50 diopters in either eye
6. Active or recurrent anterior segment pathology
7. Presence of ocular abnormalities other than cataract as specified in the protocol
8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
9. Congenital cataracts;
10. Previous corneal or intraocular surgery
11. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
12. Systemic conditions as specified in the protocol;
13. Patient is pregnant, plans to become pregnant, or is lactating
14. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
Influence of Daily Activities on Retinal Microcirculation

The daily behaviors such as drinking coffee, wine, reading, exercise and body postural changes may have influence on the function or morphology of the retinal microcirculation in healthy people.A recent study found that the fingertips microvascular bed constricted obviously after the intake of a cup of coffee with caffeine, it significantly reduced blood flow to the fingers; Long reading of electronic products can induce significant dry eye symptoms, affect visual quality, and cause asthenopia. Microcirculation is critical for regulating vascular resistance and blood flow in organs. Fundus blood vessels is the only visible microvascular in vivo, its morphology and function changes not only associated with eye disease, but also with cardiovascular and cerebrovascular diseases. Optical coherence tomography angiography (OCTA) is a new technique which could acquire blood flow information in a non-invasive way without the use of dye. Magnetic resonance imaging (MRI) can quantitatively evaluation of cerebral blood flow and retina-choroid blood flow using the noninvasive arterial spin labeling technique in a large field of view (FOV) without depth limitations.The study tried to detect the influence of daily behaviors such as drinking coffee, red wine, reading , exercise, etc. on the retinal microcirculation with OCTA and MRI, and provide reference for health behaviors.


Eligibility Criteria:
Inclusion Criteria

1. Healthy adults
2. The age range was from 18 to 35 years old
3. Without another eye disease besides ametropia
4. The spherical equivalent is equal or above minus 3.00 diopters
5. No smoking or drinking
6. Average daily caffeine consumption no more than 1 cup of coffee
7. No diabetes, hypertension, heart disease, liver or kidney dysfunction
8. No medication taken recently

Exclusion Criteria

1. Mental disorders such as depression and anxiety
2. Intellectual disabilities
3. Female in menstruation, gestation period, perinatal period or lactation period
4. Unable to cooperate with eye examinations and test procedures
5. Heart disease, hypertension, diabetes, liver and kidney dysfunction and other chronic diseases
6. Patients with fever, acute infectious diseases
7. Other conditions that are not suitable for drinking alcohol or coffee, such as allergic to alcohol or coffee
Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome

this study was conducted to assess the insulin resistance indices in the subjects undergoing Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days period.

Insulin resistance is a feature of a number of clinical disorders, including type 2 diabetes/glucose intolerance, obesity, dyslipidaemia and hypertension clustering in the so-called metabolic syndrome.The prevalence of the metabolic syndrome, as defined by the 2001 ATP III criteria, was 22 percent, with an age-dependent increase.Data demonstrates that the prevalence has continued to increase, particularly in women.Hyperinsulinemia occurring in response to insulin resistance may play an important role in the genesis of metabolic syndrome. Prevention or reduction of obesity, particularly abdominal obesity, is the main therapeutic goal in patients with the metabolic syndrome .Weight reduction is optimally achieved with a multimodality approach including diet, exercise, and possible pharmacologic therapy, as with orlistat .It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, by reducing insulin resistance may be effective in improving the metabolic syndrome .During the month of Ramadan (The ninth month of the Islamic calendar), Muslims fast every day from dawn to sunset. They refrain from drinking and eating for about 12h intervals. There are currently no reports on the effect of Ramadan fasting (only two meals per day) on metabolic syndrome. Therefore, this study was conducted to assess the insulin resistance indices in the subjects undergoing this type of fasting for a thirty days period.

Eligibility Criteria:
Inclusion Criteria:

* Males with metabolic syndrome

Exclusion Criteria:

Conditions with insulin resistance including:

* Type 2 diabetes mellitus
* Infections
* Stresses
* Uremia
* Acromegaly
* Glucocorticoid excess
* Hypertension
* Cirrhosis and;
* Any addiction or drug therapy
Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain

The current project will use the Complete Health Improvement Program (CHIP) as an intervention for patients with chronic pain. CHIP is a nationally recognized program that encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that patients who complete CHIP will have increased telomerase activity and longer relative telomere length at follow-up when compared to those who do not enroll in the program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres are the caps on these chromosomes that protect them from damage. Telomere shortening occurs normally with aging and once they are too short to replicate cellular death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by extending the ends of chromosomes. Research has shown that patients with chronic pain may have shorter telomeres relative to others of the same age. This study will investigate this association further.


Eligibility Criteria:
Inclusion Criteria:

* 40-70 years old
* Physician confirmed chronic pain diagnosis for at least 6 months

Exclusion Criteria:

* Pregnancy
* Physical or mental condition that limits ability to provide consent or answer questionnaires
Awareness Among PT Regarding Sensory Integration Therapy on CP Population

The study is to interrogate the awareness level of physiotherapists that are working in the region of Baluchistan, to access weather know about sensory integration therapy or they use it for the patients of cerebral palsy in their treatment plan or not.

The study title is ''AWARENESS AMONG PHYSICAL THERAPISTS OF BALUCHISTAN REGARDING EFFECTIVENESS OF SENSORY INTEGRATION THERAPY ON CEREBRAL PALSY POPULATION.' it is a cross-sectional study that will be conducted in the province of Baluchistan, Pakistan. The data will be conducted by 200 physical therapists on a self designed tool, that will allows us to know about the awareness among the physical therapist of this particular region to know if they are using sensory integration therapy in the treatment plan of the children suffering from cerebral palsy to know weather the sensory issues are being addressed over there by this therapy or not. Another purpose of this study is to make the therapists aware about sensory integration therapy and its efficacy in treating sensory processing and sensory integration issues present in the children that are suffering from cerebral palsy. The data will be collected by the physical therapists that are currently working in various hospitals of Baluchistan located in different regions of the province.

Eligibility Criteria:
Inclusion Criteria: Physical therapists working in province of Baluchistan, specifically.

Exclusion Criteria: Physical therapists working in areas other than Baluchistan.