cyrilzakka/clinical-trials huggingface dataset:
Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome

The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS).

The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile.

The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?

Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).

Participants will undergo the following tests:

* Ear examinations
* Hearing tests
* Balance tests
* Blood tests
* MRI scans
* CBCT (cone-beam computed tomography) scans


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years old

Exclusion Criteria:

* Contraindications for the MRI or CBCT
* Serious medical disorders
* Neurological or psychiatric disorders of any kind
* Use of medication that is known to influence inner ear function
* Medical history with dizziness or hearing problems (controls only)
The Applanation Tonometry in GCA Pilot

The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:

1. How does PWV, measured by applanation tonometry of temporal arteries, differ between patients with and without a final diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
2. What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:

   1. A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
   2. Inflammation of temporal arteries on high-resolution ultrasound?
3. What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?

ATOM-GCA is a single-center, cross-sectional vanguard study.

Eligibility Criteria:
Inclusion Criteria:

1. adult patient aged \> 50 years;
2. referred for suspected, new-onset or relapsing cranial GCA;
3. ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

1. they had a temporal artery biopsy prior to the study visit;
2. they used systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days.
Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise

Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Non-invasive ventilation(NIV) is increasingly used during exercise training programmes in order to train patients at intensity levels higher than allowed by their clinical and pathophysiological conditions. Patient-ventilator asynchrony (PVA) describes the poor interaction between the patient and the ventilator and is the consequence of the respiratory muscle activity of the patient being opposed to the action of the ventilator.PVA have unfavourable clinical impace on gas exchange, dyspnoea perception, patient comfort and tolerance and reduced adherence to NIV. This study is going to detect whether the PVA will increase when COPD patients exercise with NIV supporingt


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-80, males and females;
2. Stage III and IV COPD;
3. Similar with non-invasive ventilation;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Presented with an acute exacerbation during previous 3 months;
2. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
3. Intolerant with NIV
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People

The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine.

The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information.

We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.


Eligibility Criteria:
Inclusion Criteria:

This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older

Exclusion Criteria:

None
Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression

Pharmacotherapy and psychotherapy, effective management strategies for treatment-resistant depression are limited and yet to be developed. However, nursing interventions focusing on adherence enhancement, symptom reduction, and stress management may be strategic for a better disease management. This study aimed to define the rarely-studied concept of TRD under the cultural context of Taiwan and to identify new feasible and complementary treatment model from nursing perspectives. The project had established important basis on the descriptions of psychosocial features and need assessment of people with TRD over psychiatrist's validation. The findings also built up a cultural-specific non-pharmacological intervention module for effective TRD management in Taiwan. The nursing model of TRD management will further promote the development of integrative depression care in the future and complement current modalities, while providing important evidence-based information for future research and services.

The three-year pioneering project began with observing the psychosocial characteristics and demographic profile of a group of TRD cohort, followed by validating the cultural meanings and recovery constructs of TRD through professional and lay focus groups in the first year. In the second to third year, we examined the effectiveness of a 8-week, nurse-led psychosocial intervention with group approach in a randomized control trial (RCT) compared to the controls receiving usual care with three follow-ups. Detailed psychiatric assessment and study interviews have been performed at baseline, 3, 6, and 9 months after the intervention by a senior psychiatrist and a research assistant using standardized operation forms.Structured measurements have been utilized to collect primary outcome variables of psychological distress, suicide risk and resilience as well as secondary outcome measures of quality of life, community reintegration level, perceived satisfaction, and main clinical variables (e.g., treatment adherence, service use such as ER/OPD attendance or hospitalization days). The control group receives usual care of pharmacological therapy provided by the psychiatrists in the Psychiatric Department of the study hospital in northern Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-85 ;
2. To be diagnosed with Major Depressive disorder or Bipolar II disorder;
3. Failed to respond to at least three weeks of two antidepressant trials ;
4. Able to communicate with Mandarin or Taiwanese ;
5. No severe or foreseeing cognitive impairment during study period judged by the co-PI；
6. Willing to sign the informed consent.

Exclusion Criteria:

1. Unable to cooperate due to psychiatric symptom disturbance ;
2. Unwilling to provide most information in the questionnaire ;
3. Severely suicidal during study period
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer

Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24 months.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Female
2. Aged at least 18 years
3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
4. No prior chemotherapy or radiotherapy for cervical cancer
5. WHO/ECOG performance status of 0-1
6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
2. Intent to administer a fertility-sparing treatment regimen
3. Undergone a previous hysterectomy
4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
5. History of allogeneic organ transplantation
6. Active or prior documented autoimmune or inflammatory disorders
7. Uncontrolled intercurrent illness
8. History of another primary malignancy and active primary immunodeficiency
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies

Patients with head and neck malignancy that are treated with Radiation Therapy \[RT\] are expected to develop Oral Mucositis (OM) in 60% of cases. Mucositis is a side effect of radiation and / or chemotherapy that causes severe pain and inability to eat and drink and a decrease in quality of life. In addition it may impair the treatment protocol and treatment outcomes.

Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics.

The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with malignant neoplasm in the oral cavity, pharynx or salivary glands.
2. The patient should receive a continuous course of radiation therapy (IMRT) with all of the following criteria applicable:

   * For a period of 3-7 weeks, 5-6 fractions per week.
   * A minimum cumulative dose of 30Gy expected to cause OM (ORAL MUCOSITIS) by the third week. Or: Based on the clinical judgment of the Radiation Oncologist and BED2 ≥ 30 Gy
   * The treatment field will include at least one oral site (buccal mucosa, floor of mouth, tongue, hard palate, retro-molar trigon, lips or oropharynx)
   * With or without chemotherapy and / or immunotherapy at the same time.
3. A patient with an ECOG PS functional status equal to or less than 2
4. Able to read and understand the informed consent form (ICF) and voluntarily provided informed consent
5. The patient is able to undergo intra-oral treatments
6. The patient is willing to perform the protocol.

Exclusion Criteria:

1. The patient underwent previous radiation to the current therapeutic field
2. The patient has health conditions of the teeth or mouth that will prevent the application of intra-oral treatment
3. The patient receives non-standard treatment for mucositis such as benzidamine, palifermin, etc.
4. The patient is enrolled to any other clinical trial that includes treatment or intervention that may affect the course of mucositis.
5. The patient has a diagnosis that affects the healing of wounds (eg diabetes, lupus, etc.)
6. Pregnancy
Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis

Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score.

The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria.
* All patients may present a chronic acquired pendular nystagmus due to MS, observed over a period of 6 months.
* All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee.
* Age: above 18
* Able to understand the instructions
* Having a health coverage
* Able to sit down for 1 hour
* Stable dosage of previous medications (beginning 3 weeks previously and terminating at the end of the trial duration), except for steroids, gabapentin or memantine.

Exclusion Criteria:

* Ophthalmological

  * Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy...)
* Neurological

  * Ongoing seizure
  * Severe handicap that does not allow sitting down position for 1 hour
* Suicidal behavior or risk
* Treatment

  * Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine)
  * Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan
  * Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration)
  * Known hypersensitivity to memantine or gabapentin
* General

  * Unstable medical state
  * Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption
  * Moderate renal failure (creatinine clearance \< 50 mL/min on bioassay dated from less than one month)
  * Recent heart infarction (\<3months)
  * Unstable congestive heart insufficiency
  * Unstable arterial hypertension
  * Leucopenia (\<2500/mm3)
  * Transaminase increase (\>5 time normal values)
* Pregnancy (on questioning)
* Tutelage or any legal protection measure
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* All participants are healthy males
* Age range from 21 to 50 years
* Broca-Index: within +- 20% of their normal weight
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half-life (\>= 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
* Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
* Volunteers who participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who drink more than 60g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
* Volunteers who have donated blood within the last 4 weeks (\>= 100 mL)
Portal Vein Thrombosis in Neonate With Umbilical Catheter

The aim of this study is to identify incidence of portal vein thrombosis after umbilical catheter and to identify the risk factor of this condition ,location of PVT and prognosis of PVT.

The use of umbilical venous catheters (UVCs) in the neonatal period may be associated with severe complications including the occurrence of portal vein thrombosis (PVT )(1) The placement of an umbilical venous catheter (UVC) is a common procedure in neonatology and has multiple clinical indications driven by the need for quick and secure access for medication administration. Umbilical venous catheters allow quick access for administering drugs, blood products, fluids and parenteral nutrition to acutely ill neonates; however, they are have many complications. The most common complication is nosocomial sepsis ranging from 3% to 16%, followed by thromboembolism and catheter malposition in the heart, great vessels or portal system(2,3) The diagnosis is made by abdominal Doppler ultrasonography . In the cases with portal venous thrombosis, the location, extent, and size of the thrombus were recorded occlusive was defined by hyperechogenic thrombus replacing the entire lumen and no-flow in color Doppler or Partial which defined by non-occlusive hyperechogenic intraluminal thrombus and persistent stream in color Doppler.(4) A prospective observational study of newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital ,neonates who had undergo UVC for any cause between 10/2023 to 9/2024 will enroll in these study with serial ultrasonography of the UVC to determine the incidence and location of thrombi in infants after umbilical catheterization.

All cases included in the study will be evaluated by Birth weight, gender, gestational age, type of catheter, duration of catheter use, types of infused fluids, and location of the catheter tips (UVC), Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins, hepatic veins, splenic vein, and superior mesenteric vein will done in the Department of Pediatric Diagnostic Imaging by a radiologist after removal of the catheter and in case of PVT subsequent serial U/S will preformed until clot resolution.

Eligibility Criteria:
Inclusion Criteria:

* the study population: all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates \<28-day chronological age.

Exclusion Criteria:

* Neonate who has PVT but not had UVC before .
Implementation of the D-Foot at the Department of Prosthetics and Orthotics

Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.

The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"

Eligibility Criteria:
Inclusion Criteria:

* diabetes
* patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers
* be able to read and understand the Swedish language

Exclusion Criteria:

\*being unable to read and understand the Swedish language
Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.

We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

* refusal of the patients to give informed consent