cyrilzakka/clinical-trials huggingface dataset:
Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:

Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?

Our study consists of 4 groups:

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.

Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.


Eligibility Criteria:
Inclusion Criteria:

* Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year
* No systemic disease and medication use that may affect periodontal or peri-implanter tissues
* Not receiving periodontal treatment in the last 6 months
* Volunteering to participate in the study

Exclusion Criteria:

* Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease
* Smokers (≥ 10 cigarettes per day)
* Improperly positioned implants
Status of People With Cerebral Palsy and Their Caregivers During COVID-19 Pandemic

COVID-19, as well as the collateral situations that it entails, has been causing panic, anguish and anxiety that has generated biopsychosocial problems in society affecting not only the physical and social level but also the mental health and well-being.

The main objective of this research project is to assess the biopsychosocial status of people with cerebral palsy and related diseases and their caregivers during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy patients and their caregivers

Exclusion Criteria:

* Patients or caregivers with Cognitive impairment
Paula Method Versus Chewing Gum for Postoperative Recovery After Caesarean Section

The goal of this clinical trial is to compare the effectiveness of gum chewing vs Paula exercises in patients after cesarean delivery. The main question it aims to answer is: does the Paula method hasten the time to recovery of bowel function compared to gum chewing after cesarean delivery.

Participants will be asked to either chew gum or to do Paula exercises. The time to restoration of bowel function after the surgery will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Women after an elective caesarean delivery
* Age 18+
* Ability to read and write in Hebrew

Exclusion Criteria:

* Diagnosis of chronic gastrointestinal diseases
* Inability to chew gum
* Use of laxatives.
Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population

According to WHO Reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. Children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.No previous study has been held to assess prevalence of oral manifestations of iron deficiency anemia as a hospital-based cross-sectional study on a sample of Egyptian patients in hematology department (no previous data recorded).

Study will be held in at the Hematology department at El Qasr Al-Einy Cairo University Hospital data collection started from February 2018 till end of April 2018 primary completion.

Clinical examination performed for oral mucosa, the number and type of lesions will be recorded. Patients' age, sex, duration of illness, type of anemia, location of any oral lesion or abnormality, history of drug and alcohol consumption, and presence or absence of dentures, will be recorded participants will not followed up and data will be collected prospectively.

A copy of participant's blood record will be obtained from the hematology department upon its approval.

Participants:

Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included.

For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient.

All participants will be asked to sign a study-related informed consent. Oral manifestations of these patients will be evaluated by an oral medicine master student (the investigator).

Eligibility Criteria:
Inclusion Criteria

1. Patients diagnosed with iron deficiency anemia based on their blood tests.
2. Age: by maximum 70 years old.
3. Males and females will be included.

Exclusion Criteria

1. Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
2. Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
3. Patients on drug therapy that may have oral mucosal manifestations.
4. Lesions appear because of existing local factors for example traumatic ulcer on the tongue because of sharp tooth against tongue, angular cheilitis because of poor denture design and older age patients.
5. Inflammatory diseases, malignancy, or recent surgery were excluded.
Smart Glasses in Emergency Medicine From the Hangzhou Asian Games

The findings of our study will reveal that using smart glasses in the emergency department(ED) could facilitate patient admission. AR Smart Glasses offer the potential to enhance the effectiveness and speed of treatment within ED.

Study Design:

This study will be conducted at Sir Run Run Shaw Hospital (SRRSH), China. This study aims to compare the outcomes of two groups: the intervention group, utilizing the Augmented Reality (AR) smart glasses, and the control group, adhering to the standard conventional triage process without the AR tool, only using a two-way radio connection.

Augmented Reality tool The AR tool used in this study will be a smart glasses manufactured by Rokid AR Studio(Hangzhou, China). It was Rokid glass 2 model released in 2020. The device operated on Android 9.0 and it connected to 5G connection with a bandwidth speed 30-mbps delivering a very low latency. The device supported real time screen sharing and therefore the data were collected from smart glasses including visual and audio with real-time two-way communications. Physicians at the hospital can access the information and video via a mobile app, enabling continuous monitoring of patients. The features facilitate healthcare providers at SRRSH and medical personnel in the HAG2022 polyclinic to discuss the patient's condition, exchange, and deliberate on the pre-hospital medical examinations of the patient.

Participants:

The study, will be conducted between September 13, 2023, and October 28, 2023, included the recruitment of all patients (older than 16 years old) presenting with acute illnesses who were admitted to the ED of SRRSH from the HAG2022 village polyclinic or the field of injury.

The Cases with incomplete data and cases where the patients would be not found will be excluded from this study. Cases involving technical difficulties encountered by operators using augmented reality (AR) smart glasses and loss of internet connection will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Presenting with acute illnesses like acute coronary syndrome，acute sepsis，stroke，trauma who will be admitted to the ED of SRRSH from the HAG2022 village polyclinic or the field of injury.

Exclusion Criteria:

* The Cases with incomplete data and cases where the patients will be not found will be excluded from this study. Cases involving technical difficulties encountered by operators using augmented reality (AR) smart glasses and loss of internet connection will be excluded from the study.
Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.

To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours.

Exclusion Criteria:

* None
Ultrasound Staging in the Placenta Accreta

The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.

Eligibility Criteria:
Inclusion Criteria:

* Prior lower segment cesarean section
* Low lying anterior placenta
* Singleton pregnancy

Exclusion Criteria:

* Medical disorders
* vasa previa
AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial

This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).

  2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).

  3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.

  5. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.

  7. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.

Exclusion Criteria:

- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.

4. Bone mineral density T-score \<-2.5. 5. Presence of absolute contraindications to exercise.
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).

Eligibility Criteria:
Inclusion Criteria:

* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index \>25.0 kg/m2.

Exclusion Criteria:

* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia

To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.

COVID-19 pneumonia is induced by the newly emerging pandemic Severe acute respiratory Syndrome (SARS) coronavirus 2 and results in progression to the acute respiratory distress syndrome (ARDS). Apart from protective ventilation, fluid restriction, prone positioning and extracorporeal membrane oxygenation (ECMO), no specific therapeutic options exist to treat this devastating disease with a mortality rate of up to 50%. The growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF) is widely recognized to promote differentiation and mobilization of different myeloid leukocyte subsets including neutrophils, tissue macrophages/dendritic cells or their circulating precursors. GM-CSF was found to be crucial for alveolar epithelial repair following hyperoxic and inflammatory lung injury.The aim of the current trial is to prevent progression to ARDS in COVID-19 pneumonia patients by preemptive GM-CSF Inhalation.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form by the patient according to local regulations
2. Man or non-pregnant woman
3. Age ≥18 years
4. Willingness of patients with reproductive potential to use highly effective contraceptive methods by practicing abstinence or by using at least two methods of birth control from the date of consent to the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used \*.
5. Lab-confirmed COVID-19 pneumonia where pneumonia is diagnosed by radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam) AND pulse oximeter oxygen saturation ≤ 94% at room air in patients that do not have chronic hypoxia; or less than their baseline oxygenation in patients that suffer from chronic hypoxia
6. Negative serum pregnancy test in women of childbearing potentia

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Autoimmune thrombocytopenia, myelodysplastic syndromes with \> 20% marrow blast cells
3. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim (e.g. Leucomax®) or to related compounds (e.g. Leukine®)
4. Patient not able to use nebulizer device as well as immediately foreseeable mechanical ventilation of the patient
5. Simultaneous participation in another clinical trial with an experimental treatment
Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia

The investigators would like to know the association of gene polymorphisms and metabolic adversities in clozapine-treated patients with schizophrenia in Taiwan.

The atypical antipsychotics, such as olanzapine, risperidone, quetiapine, and ziprasidone, are effective in treating both the positive and negative symptoms in schizophrenia (Kelleher et al., 2002). However, atypical antipsychotics have been linked to several forms of morbidity, including obesity, hyperlipidemia, and type 2 diabetes mellitus (DM) (Bergman and Ader, 2005; Jin et al., 2004; Melkersson and Dahl, 2004). Compared with the general population, life expectancy in schizophrenic patients is shorter by as much as 20%, attributable to higher rates of suicide, accidental deaths, and natural causes such as cardiovascular disease and DM (Harris and Barraclough, 1998). Several studies have suggested that these metabolic abnormalities may lead to a greater vulnerability to cardiovascular disease and thus may contribute to the excessive mortality among schizophrenic patients.

Eligibility Criteria:
Inclusion Criteria:

* fulfilled DSM-IV criteria of schizophrenia or schizoaffective disorder
* 18-65 year of age
* receiving clozapine for at least 6 months

Exclusion Criteria:

* diabetes mellitus patients
Hyperventilation in Patients With Traumatic Brain Injury

Elevated intracranial pressure is a dangerous and potentially fatal complication after traumatic brain injury. Hyperventilation is a medical intervention to reduce elevated intracranial pressure by inducing cerebral vasoconstriction, which might be associated to cerebral ischemia and hypoxia.

The main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the intracranial pressure without inducing cerebral ischemia.

In patients with severe traumatic brain injury (TBI), and with intracranial pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes hyperventilation-tests are performed in the acute phase after trauma. Data are collected and TCCD measurements are performed at baseline, at the beginning of moderate hyperventilation, after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline.

The present study aims to quantify potential adverse effects of moderate short-term hyperventilation during the acute phase of the severe TBI on cerebral hemodynamics, oxygenation, and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* nonpenetrating traumatic brain injury
* Glasgow coma scale \<9 at presentation
* Intracranial pressure monitoring
* brain tissue oxygen tension monitoring and/or microdialysis monitoring
* invasive mechanical ventilation with FIO2 \<60% and PEEP \<15 mbar

Exclusion Criteria:

* decompressive craniectomy
* pregnancy
* pre-existing neurological disease
* previous traumatic brain injury
* acute cardiovascular disease
* severe respiratory failure
* acute on chronic liver disease
* sepsis
* failure to obtain satisfactory bilateral TCCD signals
* persisting hypovolemia or hemodynamic instability
Comparison of the Efficacy of Diclofenac Sodium and Subcutaneous 5% Dextrose Injection in Low Back Pain.

The aim was to compare the effectiveness of intramuscular diclofenac sodium and subcutaneous 5% dextrose injection in patients presenting to the emergency department with low back pain using the visual analog scale (VAS).

The aim was to compare the effectiveness of intramuscular diclofenac sodium and subcutaneous 5% dextrose injection in patients presenting to the emergency department with low back pain using the visual analog scale (VAS).

The study is planned to include 150 volunteer patients with low back pain who applied to the emergency department of Aksaray University Education and Research Hospital. The patients will be randomly divided into two groups. The first group will receive subcutaneous 5% dextroseprolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection (approximately 75 patients). In all patients, pain intensity will be measured and recorded using the VAS immediately before the injection (baseline), 30 minutes, 1 hour, 2 hours, 12 hours and 24 hours after the injection, and evaluations will be made.

Eligibility Criteria:
* Applying to emergency clinics
* Having isolated low back pain
* Being between the ages of 18-55

Exclusion Criteria:

* Patients under 18 and over 55 years of age,
* intolerance to NSAIDs or allergy to Diclofenac sodium,
* history of gastrointestinal bleeding,
* pregnancy
* patients with red flags for BP (trauma history, recent lumbar surgery, stenosis, spondylolisthesis, lumbar spondylosis with myelopathy)
* documented symptoms as red flags (new leg/foot weakness, new loss of -balance or walking ability, new fever, new night sweats, new urinary retention, new loss of bowel/bladder control)
* known cancer
* long-term steroid use
* patients requiring rescue treatment during the study
Lofexidine for Opiate Withdrawal - 1

The purpose of this study is to evaluate lofexidine for opiate withdrawal.

An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Eligibility Criteria:
Inclusion Criteria:

Male or female as least 18 yrs of age \& above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

Exclusion Criteria:

Additional criteria available during screening at the site