cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus

To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.


Eligibility Criteria:
Inclusion Criteria:

* (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP
* (Group B) age, sex, and dietary habits matched healthy controls.

Exclusion Criteria:

* (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements
* (2) patients with suspected restoration-related or smokeless tobacco-related lesions.
* (3) patients with any systemic medical condition or pregnant females.
* (4) patients with VD toxicity (VD≥100 ng/ml).
Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury

To investigate the influence of preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.

Acute renal failure (ARF) and the need for renal replacement therapy (RRT) is a major complication after cardiac surgery, associated with mortality and an increased risk to develop end-stage renal disease. Cardiac surgery patients are at increased risk to develop acute kidney failure due to ischaemia-reperfusion injury, cardiopulmonary bypass (CPB) induced inflammation and haemolysis, hemodynamic alterations, vasoconstriction and resulting reduced renal perfusion. According to the current literature, AKI occurs in average in 20-30% after cardiac surgery with an incidence of RRT in 1-5%. Several reviews revealed the literature and concluded that , inter alia, euvolemia, adequate nutrition, the avoidance of nephrotoxic drugs and anemia optimization belong to the most effective prevention strategies.

Patients are instructed to follow the nil per os (NPO) guidelines, including abstinence of clear liquids for \>2 hours preoperative as well as fasting time of light foods for \> 6 hours and fatty foods for \>8 hours prior to surgery. However, these guidelines encourage patients to continue PO hydration until 2 h before surgery in order to optimize the volume status. Besides the fact that NPO lasts in average critically longer than required, surgery delay is a common issue and may lead to an exceedance of NPO up to twice as long as required.

Data about the exact mechanism is still sparse, but preoperative iv hydration may correct or even expand intravascular volume, improve renal perfusion and induce diuresis, stimulate endogenous natriuretic peptides release and inactivate the renin-angiotensin-aldosterone system (RAAS).

Large trials on this very relevant topic in these high risk cardiac surgery patients are absolutely missing. Therefore, this prospective observational study aims to investigate the influence of varied preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age) scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest

Exclusion Criteria:

* Patients not willing to participate or not able to give informed consent
* Patients receiving contrast agents within 72 hours before surgery
* Patients with preoperative need for renal replacement therapy
* Patients receiving an extracorporeal mechanical assist device (e.g. ECLS) or for advanced heart failure therapies (e.g. TAH, VAD) will be excluded.
* Patients participating in another interventional trial
* Pregnant or lactating patients
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)

Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.

This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
* Sex male or female
* Age between 18 and 65 years at the time of signing the informed consent form.
* Diagnosis of an hematologic disease for who a allograft decision has been taken
* not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
* Able to understand and voluntarily sign an informed consent form.
* Subjects affiliated with an appropriate social security system
* Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study
* Each subject will weigh 40 kg or more

Exclusion Criteria:

* Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
* Use of any systemic antifungal therapy within 72 hours prior to study entry
* Known history of allergy, hypersensitivity or intolerance to echinocandin agents
* Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
* Participation in a study testing a new drug or a new conditioning
* HIV, HBV or HCV positive
* Pregnant or breast feeding females.
* Subject protected by law.
Prenatal Screening for Congenital Heart Diseases in the Antwerp Region

No systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in Belgium. Nor are there any population-based studies available on this subject for Belgium. Based on the data of EUROCAT (European Surveillance of Congenital Anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the EUROCAT regions Antwerp (Flanders, Belgium)

Congenital heart defects are a leading cause of infant mortality with an incidence of 0,4-1,3% at birth. Although prenatal detection rates vary widely, morphological (structural) cardiac malformations are among the most frequently missed abnormalities by prenatal ultrasonography.

However, identifying fetal cardiac abnormalities early in pregnancy is essential. Early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care.

It also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis.

The investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. Detailed data for this were made available by the EUROCAT Antwerp registry, a population-based database with controlled, reliable and robust data.

The study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the EUROCAT regions Antwerp (Flanders) and especially the evolution of the prenatal diagnostic rate over time.

In the second phase, a similar study in two adjacent regions, Hainaut (Wallonia, Belgium) and Groningen (The Netherlands) will follow.

On condition of correct statistic processing, these data will be suitable to compare the prevalence and to benchmark diagnostic rates of congenital heart defects in these three regions.

Eligibility Criteria:
Inclusion criteria

* All fetal congenital heart diseases registered in the Antwerp-EUROCAT database,
* In the period 1/1/1997-31/12/2017 period

Exclusion criteria

* All cases of congenital heart diseases where the mother was under \<18 years old.
* All cases of congenital heart diseases were the parents did not allow inclusion in the EUROCAT registered.
* All cases of congenital heart diseases where the mother delivered outside the EC countries.
Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.

Although only approved to combat weight loss associated with AIDS and cancer, MA is frequently prescribed for long periods of time to prevent or reverse weight loss in nursing home residents and in elderly patients with serious illnesses in the community. Little data is available to support this practice. Among its many properties, MA acts as a partial glucocorticoid agonist, and long term and short term use of MA may results in adrenal suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course of resumption of normal adrenal function after discontinuation of MA is completely unknown. As a consequence, it is unclear whether MA can be given safely for short periods of time or whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a substantial risk of adrenal crisis after an illness, requires a clear understanding of these issues. To address these concerns, we will evaluate adrenal function before, during, and after MA administration in healthy volunteers between the ages of 60 and 85 years.


Eligibility Criteria:
Inclusion Criteria:

* Elderly males and females
* Age 65-80 years
* With stable (no history of urgent/ emergent care visits with health care provider/s in the preceding 2 months), medical conditions

Exclusion Criteria:

Subjects will be excluded if they have a history of (H/O):

* Dementia
* Adrenal disease
* Thromboembolism
* Diabetes mellitus
* Liver disease
* Electrolyte abnormalities; or
* Vaginal bleeding
* Hypertriglyceridemia
* CAD with CHF
* Unstable depression
* Schizophrenia; and
* Morbidly obese subjects.
Familial Hypercholesterolemia in Turkey (A-HIT2)

A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution.\[14\] Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.

At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution. Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology. The primary objective of this cross-sectional study, is to detect the clinical status and management of the patients diagnosed with FH in Turkey. The secondary objectives are; to detect the pattern of clinical presentation, to know the medication use, to define the clinical response to LLT, to evaluate the attainment of LDL-cholesterol goals and to identify resistance and/or intolerance to LLT. Defining the CV risk factors and approach to these factors by the physicians, and comparing the attitudes in different specialty groups (cardiology, endocrinology and internal medicine) are also among the secondary objectives of the registry. Eligibility for screening was defined as having LDL-cholesterol levels \> 160 mg/dl either as on treatment or untreated values. Centers may enroll both incident and prevalent patients. The inclusion criteria included age \> 18 years and being diagnosed as possible FH. The possible FH was defined as having a total score of \> 2 according to Dutch lipid clinic network (DLCN) criteria. Patients with triglyceride levels \> 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study. Two different data sets will be collected for A-HIT2. The physicians will complete electronic case report forms for each patient Patients will also complete a short survey to assess the level of disease awareness. This survey is also designed to give information on the patients' perceptions and knowledge on cholesterol, its harm, and LLT. All data will be collected in a single visit. Data verification will be based on the source document control of 5% sample randomly selected per center.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years and being diagnosed as possible FH.
* The possible FH was defined as having a total score of \> 2 according to Dutch lipid clinic network (DLCN) criteria

Exclusion Criteria:

* Patients with triglyceride levels \> 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study.
Crossover Versus Stabilometric Platform in Parkinson's Disease

The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform.

Parkinson's disease (PD) is a neurodegenerative disorder characterized by different motor symptoms (rigidity, akinesia, tremor and impairment of balance and gait). Even though pharmacological treatment has changed the natural course of the disease, balance worsens over time and leads to falls. The aims of this study is to assess the efficacy of the crossover (group 1) on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform (group 2). The group 1 executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of resistance and a training which lasts at most 5 minutes. The group 2 executed 6 days/week for a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in bipodalic standing.

Eligibility Criteria:
Inclusion Criteria:

* PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score \> 26

Exclusion Criteria:

* MMSE \< 26
* Coexistence of other neurological diseases
* PD patients with relevant orthopedic, rheumatic and muscular conditions
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.

Eligibility Criteria:
Inclusion Criteria:

* Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;
* Evaluation and selection for TAVR by the multidisciplinary heart team;
* Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan
* Anatomic suitability for a transfemoral vascular access;
* Life expectancy of more than 12 months;
* Age ≥65 years.

Exclusion Criteria:

* Pure aortic regurgitation;
* History of surgical or transcatheter aortic valve replacement (valve in valve);
* History of any aortic surgery;
* Emergent surgery;
* Patients who refused to be randomized or unable to complete regular follow-up.
Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline

In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.

Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles

Eligibility Criteria:
Inclusion Criteria:

* Severe cerebral palsy patients(GMFCS level 3,4,5)
* 2 to 10 years old

Exclusion Criteria:

* Those who disagree with the study.
* other than cerebral palsy.
The Effectiveness of Calistenic Exercise Training in Adolescents

Objective: The aim of this study is to examine the effectiveness of calisthenic exercise training applied via video chat application on physical activity, physical fitness, quality of life and sleep, and anxiety and depression levels in adolescents during distance education. Material and methods: In our study, 38 adolescents were randomly divided into two equal groups as exercise training group and control group. Calisthenic exercise training was given to the exercise training group for eight weeks, three days a week, via video chat application and under the supervision of a physiotherapist. The control group was evaluated before and after the study period. Physical activity levels of individuals; International Physical Activity Scale, quality of life; Children's Quality of Life Scale, anxiety depression levels; Beck Anxiety Scale, Reynolds Depression Scale and sleep quality were evaluated with Pittsburg Sleep Quality Index.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescent children

Exclusion Criteria:

* Individuals with a disease that could prevent them from doing our exercise training were not included in the study.
STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors

This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.

The phase 1a portion of the study is a dose escalation design to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion of the study includes dose expansions to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.

Eligibility Criteria:
Selected Inclusion Criteria:

1. Participants enrolled to STK-012 monotherapy dose escalation and expansion and STK-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment.
2. Participants enrolled to STK-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease.
3. Participants enrolled to STK-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have NSCLC and may not have received treatment for metastatic disease.
4. Participants enrolled to STK-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have PD-L1 negative NSCLC and may not have received treatment for metastatic disease.

Selected Exclusion Criteria:

1. Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
2. Received radiotherapy within 2 weeks of the first dose of study treatment.
3. Received prior IL-2-based or IL-15-based cytokine therapy.
4. Participants with NSCLC may not have any known actionable genetic aberrations with approved therapies.
Firefly ANKLE Sprain Study

The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years and over
2. Referred to physiotherapy for treatment of ankle sprain
3. Clinical diagnosed ankle sprain with evidence of swelling
4. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements

Exclusion Criteria:

1. Has an ankle sprain grade 3
2. Evidence of fracture
3. Has a pacemaker
4. Chronic Obesity (BMI Index \>40kg/m2).
5. Pregnancy.
6. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
8. Not able to fit firefly device
Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)