cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis

The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It affects quality of life and require supportive care and proper treatment plane.

This study had been conducted on thirty cancer patients (head \&neck) receiving chemotherapy \& radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and more), their age ranged from 35 to 55 years, capable of understanding the study assessment method and willing to complete the current study, they were free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes mellitus. Patients were randomly allocated from patients from the National Cancer Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients receiving BLT for about 10 minutes every day for thirty days in addition to routine oral mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections), Group B (Control group): This group consisted of 15 patients receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections) for thirty days The methods of evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment to measure improvement in oral mucositis.

The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS) were assessed first at the beginning of the study and one month after the end of the study; calculation of mean, standard deviation, minimum and maximum for each group was done by descriptive statistics, means comparison between the two groups pre and post-application and within each group was made using The t-test. With a level of significance Alpha point of 0.05


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients (head \&neck) receiving chemotherapy \& radiotherapy
* Males and females
* Age ranged from 35-55 years
* All patients capable of understanding the study assessment method and willing to complete the current study
* Patients free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .

Exclusion Criteria:

* Patients suffering from immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
* Cognitive impairment
Assessment of the Performance of LYoplant® ONlay for Duraplasty

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
* Written informed consent
* Life expectancy \> 6 months
* Age \> 18 years

Exclusion Criteria:

* Active local or systemic infections
* Open cranial trauma
* Open spina bifida
* Known hypersensitivity to proteins of bovine origin
* Representation by a legal guardian or under involuntary commitment
* Pregnancy
* Participation in another clinical study
* Known primary immunodeficiency
Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomy using standard criteria within 24 hours of onset:
* For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above and ASPECTS≥3 on NCCT
* For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusion of core volume \<100ml.
* Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferred participants required if \>4hr)
* Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disability permitted)
* Local legal requirements for consent have been satisfied.

Exclusion Criteria:

* Intracranial hemorrhage identified by CT or MRI
* ASPECTS 0-2 on NCCT
* CTP or MRI perfusion ischemic core volume \>100ml if presenting within 6-24 hours from symptoms onset
* Anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis/occlusion.
* More than six retrieval attempts in the same vessel
* Alteplase being infused within 30 minutes (\~5x half-life) of anticipated trial drug administration
* Contraindication to imaging with contrast agents
* Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated
* Pregnant women.
* Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.
* Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.
* Other standard contraindications to thrombolysis apart from time window.
* Known terminal illness such that the participants would not be expected to survive a year.
* Planned withdrawal of care or comfort care measures.
HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of ICC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* Without distant metastasis, but intrahepatic lymph node metastasis is allowed
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus

To assess the prevalence of hepatomegaly in children and adolescents with type 1 diabetes mellitus, and to find out it᾿s underlying etiology.

Type 1 diabetes is a disorder of glucose metabolism that results from insulin deficiency secondary to autoimmune destruction of insulin-secreting β-cells. The prevalence of liver disease among diabetics is estimated to be between 17% and 100%(1).

Most of these data were obtained from studies of obese adults with non-insulin dependent diabetes(2). Data regarding frequency of aetiological causes of hepatomegaly in children and adolescent with type 1 diabetes mellitus are scanty even in international publication(2).

Diabetes mellitus (DM) is associated with various structural and functional liver abnormalities, including non-alcoholic fatty liver disease (NAFLD) and hepatic glycogenosis (HG)(3).

NAFLD represents the most common liver disease(3) and is more typically found in obese adults with T2DM secondary to insulin resistance, while (HG) is more common in patients with lower body mass index and pediatric patients(4).

HG involves pathological glycogen storage in hepatocytes and is characterized by hepatomegaly and a transient elevation in liver transaminases that is associated with poorly controlled DM, particularly type 1 diabetes (T1D)(5).

The differential diagnosis of hepatomegaly in diabetic patients must consider several other potential causes of liver damage, such as infection (e.g., viral hepatitis), metabolic disorders (e.g., α1-antitrypsin deficiency and Wilson's disease), obstruction, autoimmune liver disease, hemochromatosis and celiac disease(6).

Presence of hepatomegaly and/or hyperechogenic liver on ultrasound abdomen was an indication for further laboratory work up to investigate other possible liver pathologies .The screening work up included: HBV surface antigen, Anti-HCV antibody, serum immunoglobulins, anti-nuclear antibody, smooth muscle antibody qualitative test , serum ferritin, serum iron, transferring saturation, and total iron binding capacity, urine for organic acids and plasma for amino acids, to evaluate for possibility of viral hepatitis B and C, autoimmune liver disease, hemochromatosis, and metabolic disorder, respectively(7).

It was considered that the finding of hyperechogenic liver and/or hepatomegaly on ultrasound and negative screening work up for underlying liver disease as consistent with a likely diagnosis of hepatic glycogenosis or less likely fatty liver(8).

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 Diabetes mellitus diagnosed according to the diagnostic criteria of the American Diabetes Association 2011.

Exclusion Criteria:

- 1-Patients with type 2 diabetes mellitus 2-Patients with secondary diabetes 3-Patients with type 1 diabetes mellitus with other system affection rather than hepatic affection like ( Central nervous system, Respiratory, Renal, Cardiovascular).

4- Syndromic children. 5-Patients known to have liver disease prior to diagnosis of diabetes.
Translating Data Science to Palliative Care

This research study is intended to 1) better understand seriously ill adults' and their family care partners' (FCP), particularly for persons living with dementia (PLwD), barriers to accepting community-based palliative care (CBPC); 2) develop an intervention to address barriers; and 3) pilot test whether the intervention has an impact on CBPC uptake. The intervention will consist of 1) a set of informational material describing the benefits of CBPC for the CBPC team to use when presenting CBPC to members of a Medicare Advantage plan and their FCP; and 2) processes for tailoring information delivery so that eligible members and their FCP receive information about CBPC that reflects their individualized risk as identified by the Medicare Advantage program's validated 12-month mortality risk algorithm.

The clinical trial portion of the study refers to the pilot test (Aim 3 as described below).

Aim 1. Engage Family Care Partners (FCPs) and Community Based Palliative Care (CBPC) team members to identify barriers to CBPC. Aim 1 will incorporate the perspectives of CBPC team members and Medicare Advantage (MA) plan members and FCPs of person living with dementia (PLwD) and those with other diagnoses who refused CBPC services. Aim 2. Develop and obtain feedback on a) informational materials for CBPC team members to use when speaking with MA members and FCPs about CBPC and b) processes for tailoring information delivery based on a members's algorithm-identified risk profile. Most participants will be recruited from Aim 1 participants. Additional participants will be recruited as necessary. Aim 3. Conduct a pre-post trial to determine the feasibility and acceptability of the materials and using them in existing clinical workflows for their a) impact on CBPC enrollment for CBPC-eligible individuals, including PLwD, and b) end-user satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* VNS Health Total Medicare Advantage Plan member
* identified as eligible for community-based palliative care by the VNS Health Total palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention)
* 18 years of age or older

Exclusion Criteria:

* non-VNS Health Total Medicare Advantage Plan member
* VNS Health Total plan members not identified as eligible for community-based palliative care by the palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention)
* under 18 years of age
Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter

Infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (PD). The aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. The recommendations of the International Society of Peritoneal Dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. Thus each treatment center applies a protocol of its own. Dressing is common practice although its safety and interest are not demonstrated.

The usefulness of dressing is still to be demonstrated. On the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (SA), the most frequent germ found in peritonitis, has been demonstrated. A Spanish study showed that during a peritoneal infection at SA the site most frequently colonized by a similar strain of SA was the emergence of the catheter.

It can be considered that an infection of the dialysis liquid in PD is not only related to the quality of emergency care but also to manipulations during exchanges.

Given the number of patients involved in PD in France, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing.

Therefore, the investigators propose a descriptive, exploratory study of events that may occur in PD when a dressing is not applied. This is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* patient who has been informed and has given free and informed consent
* patient affiliated to a social security scheme

Exclusion Criteria:

* inclusion of the patient in another biomedical research protocol that influences the risk of infection
* burial of the catheter before the initiation of dialysis treatment second attempt at treatment with peritoneal dialysis following catheter removal and resection
* patient under curatorq
* pregnant woman
Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After Total Knee Arthroplasty

The goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ;
2. Age : 18 years old ≤ age ≤ 80 years old ;
3. ASA grade I-II ;
4. Informed consent was signed by patients or immediate family members before operation.

Exclusion Criteria:

1. There are known pain abnormalities, mental disorders, cognitive dysfunction ;
2. patients with long-term use of opioids and a history of drug dependence ;
3. patients with alcohol dependence ;
4. the patient refused to use the analgesic pump ;
5. Difficult to understand the VAS score ;
6. body mass index ≥ 40 ;
7. hand nerve abnormalities, hand loss ;
8. plan postoperative ICU patients ;
9. In other cases, the researchers believe that is not suitable for this researcher.
Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care

Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".

Hypothesis:

H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.

H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.

H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 10-20,
* Child and adolescent with palliative care needs
* At least 3 months before diagnosis
* Child and adoescent have completed the induction phase of treatment,
* İntermediate-high-risk group defined under a treatment protocol,
* Child and aolescent can utilizecomputer, mobile phone and tablet
* Children and adolescents who agreed to participate in the survey and their parent.

Exclusion Criteria:

* Newly diagnosed with physical and mental disabilities,
* Child and adolescent with severe anxiety according to the anxiety score scale,
* Out of diagnosis in the last 6 months (loss of parents, natural disaster, etc.) are children and adolescents who experience high levels of stress and have an important psychiatric diagnosis that affects their mental health.
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.

Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An enzyme involved in the production of free radicals in various experimental models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial is to determine the effect of allopurinol administration on the prevention of muscle mass loss in immobilized subjects.

This is a prospective, randomized study in which fifty young male subjects (aged between 25 and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization the patients will be assigned randomly to one of two experimental groups, one treated with allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization period, which will last fifteen days. This medication will be delivered to the patients when they agree to participate in the clinical trial. They will be immobilized by posterior knee splint, preventing use of that leg.

We will determine muscle mass loss by performing two magnetic resonances of both legs before and after the immobilization period. We will also take two blood samples (before and after immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls, and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin), as well as vitamin D levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients with grade II sprain.
* Boys
* Age 20-40 years.
* Patient without regular medication.
* All patients must provide written informed consent specific to this study complete.

Exclusion Criteria:

* Liver and gastrointestinal disease.
* Untreated hypothyroidism.
* Alcohol and / or drug addiction.
* Vitamin supplements.
* Eating Disorders.
* Drugs that decrease the concentration of lipids.
* Antihypertensive drugs.
* Athletes who exercise intensely.
* Mental disorders, depression or anxiety intensive. These conditions make the patient unable to understand the nature or the scope and possible consequences of the study.
* Patients presenting an infectious process and / or inflammatory before collecting the sample.
* Patients may not follow the protocol because of its lack of cooperation, to their inability to return to subsequent visits and there is little chance of completing the study procedures.
* Hypersensitivity to allopurinol
Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis

Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in ALS and PLS patients with severe spasticity should be studied. The investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in ALS and PLS patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS or PLS
* Age greater than 18 years
* Clinically significant spasticity.

Exclusion Criteria:

* Individuals currently taking carbidopa-levodopa or with known hypersensitivity of any component of carbidopa-levodopa
* Narrow-angle glaucoma
* Current use of a non-selective monoamine oxidase inhibitor (MAOI)
* History of malignant melanoma or suspicious skin lesions
* History of depression, suicidal ideation, or psychosis
* History of myocardial infarction, ventricular arrhythmia, or severe cardiopulmonary disease
* Uncontrolled hypertension
* Asthma
* Renal disease
* Hepatic disease
* Endocrine disease
* History of peptic ulcer
* Pregnant and/or breastfeeding
* Current participation in another interventional study