cyrilzakka/clinical-trials huggingface dataset:
Scarring At Donor Sites After Split-Thickness Skin Graft.

The aim of this study was to investigate if previous findings on the association between dressing treatments and subjective opinion on final donor site scar outcome using the patient scale of POSAS could be confirmed objectively.

Scar outcome measurements were assessed by a blinded observer using POSAS and the device: Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) to measure the viscoelasticity of the skin.

This is the third and last part of a clinical project concerning the treatment of split thickness skin graft donor sites. In the first part the Investigators completed a randomised clinical trial (RCT) in which donor sites were randomly assigned to treatment with either hydrofibre covered with film, non-adhesive polyurethane foam, or porcine xenograft. Results from the first study indicated that donor sites treated with hydrofibre and porcine xenograft healed significantly faster than those treated with polyurethane foam. As the hydrofibre was the most comfortable, easy to use, and cost-effective it was implemented as the standard of care for donor sites at the specific centre.

In the initial RCT, patients treated with polyurethane foam showed significantly longer healing times than the other treatment groups. As longer healing time has been shown to be a predictor for pathological donor site scarring it was hypothesised that this group would be the most unsatisfied with their scars, if they had any donor site scar at all eight years after their skin graft. In the second part of the project the long-term scar outcomes of the donor sites included in the RCT was investigated. Study participants were asked to evaluate their scars using the "Patients part" of the Patient and Observer Scar Scale (POSAS). After analysing the data collected in the second part, it was concluded that the fast and moist healing seen with hydrofibre seemed to result in significantly more satisfied patients - and members of the polyurethane foam group, as hypothesised, were significantly more unsatisfied with their donor site scars. The Investigators also found that the dressing associated with the fastest wound healing (the porcine xenograft) also had the poorest long-term outcome for scarring, according to the patients' opinion. This contradicts what is claimed to be the relation between duration of healing and donor site scarring.

In this last, third study, the aim was to investigate if the previous findings could be confirmed by an evaluation done by a blinded observer using POSAS. Donor sites were also evaluated for firmness and elasticity using the device; Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany), which is described in the Method section.

Eligibility Criteria:
Inclusion Criteria:

Participation in part I (RCT) and part II of the project

Exclusion Criteria:

No former participation in the project
Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men

The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are:

* Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
* Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?

Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Indonesian
* Age 18-59 years
* Diagnosis of androgenetic alopecia
* Hamilton-Norwood type III-IV

Exclusion Criteria:

* Use of minoxidil or finasteride topical 1 month prior
* Use of minoxidil or finasteride oral 1 month prior
* Skin infection in the treatment area
* Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior
* History of keloid
The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail

The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS).

Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.

Eligibility Criteria:
Inclusion Criteria:

* Intertrochanteric Fracture
* Age over 55
* Intramedullary nailing

Exclusion Criteria:

* Severe cognitive impairment
* Substance abuse
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension

Background: Prostacyclin analogues (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (PAH) but also inhibit platelets, increasing patients' bleeding risk. The antiplatelet effects of different prostacyclin analogues have never been compared head-to-head. The goal of the PAPAYA (Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension) trial is(i) to compare platelet function (platelet reactivity, extracellular vesicles concentration and thrombus formation) in patients with PAH treated with prostacyclin analogues on top of endothelin receptor antagonists (ERA) and/or phosphodiesterase type 5 inhibitors (PDE5i) and patients treated only with ERA and PDE5i, and (ii) to compare the antiplatelet effect of different prostacyclin analogues.

Venous blood will be collected from patients treated with prostacyclin analogues (study group; n=40) and patients treated with ERA or PDE5i (control group; n=40). Platelet reactivity will be analysed in whole blood by impedance aggregometry using arachidonic acid, adenosine diphosphate and thrombin receptor-activating peptide as agonists. Concentrations of extracellular vesicles from all platelets (CD61+), activated platelets (CD62P+), leukocytes (CD45+) and endothelial cells (CD146+) will be analysed in platelet-depleted plasma using flow cytometry (A-60 Micro). Platelet-rich thrombus formation will be measured using whole blood perfusion system. The study will determine the antiplatelet effect of prostacyclin analogues and compare different prostacyclin analogues head-to-head to identify the best drugs to use in case of thrombosis or bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study
* Pulmonary arterial hypertension confirmed with right heart catheterization
* Treatment with prostacyclin analogues (epoprostenol, treprostinil, iloprost) - study group
* Treatment with endothelin receptor antagonists and phosphodiesterase type 5 inhibitors - control group

Exclusion Criteria:

* Known coagulopathy
* Active pathological bleeding
* Known history of bleeding disorder
* Severe thrombocytopenia (platelet count \< 50,000/μL )
* Need for antiplatelet therapy with acetylsalicylic acid or P2Y12 antagonists
* Severe chronic renal failure (estimated glomerular filtration rate \< 30 mL/min)
* Severe liver insufficiency (Child-Pugh class C)
* Known pregnancy, breast-feeding, or intention to become pregnant during the study period
* Study drug intolerance
* Participation in any previous study with prostacyclin analogues
Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D

To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.

A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
* Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
* Serum 25(OH)D \<30ng/ml

Exclusion Criteria:

* Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
A Study to Determine the Epidemiology and Evaluate the Burden of Disease in Respiratory Syncytial Virus/Human Metapneumovirus and Influenza A Infected Hospitalized Participants (Adults and Children)

The purpose of this study is to describe the clinical and economic burden in adults and infants/children less than or equal to 5 years of age by type of respiratory pathogen (respiratory syncytial virus \[RSV\], influenza A, and human metapneumovirus \[hMPV\] in adults; RSV and hMPV in infants/children) based on medical resource utilization; rate and type of complications during and after hospitalization; mortality; rate and reasons of re-hospitalization related to index hospitalization; post-discharge care information and International Classification of Diseases 9th/10th revision (ICD-9/10)/Diagnostic-related Group (DRG) codes used (distribution).


Eligibility Criteria:
Inclusion Criteria:

* Adult greater than or equal to (\>=) 18 years of age or infant/child less than or equal to (=\<) 5 years of age
* Participants hospitalized must have documentation of a confirmed diagnosis by PCR during the prespecified recent past season(s): RSV, influenza A, or hMPV infection in adults RSV or hMPV in infants/children (The first hospitalization in the season of data collection with confirmed diagnosis by PCR is considered the index hospitalization)
* Participants may include those hospitalized in the season of data collection with or without symptoms of a respiratory viral infection (including those of nosocomial origin), and/or to treat complications of viral infections, including patients admitted to the intensive care unit (ICU)
* Hospitalized greater than (\>) 24 hours
Silver Acetate and Triclosan Antimicrobial Graft Evaluation for Surgical Repair of Aortic Disease

The number of surgical and endovascular aortic repairs is continuously increasing, and infective graft complications are observed more frequently. (1) Several etiopathogenetic factors may play a role in aortic prosthetic infections, including hematogenous seeding, local bacterial translocation, and iatrogenous contamination. Infectious graft complications represent a critical event requiring a multidisciplinary management. Knowledge on underlying microorganisms, antibiotic efficacy, risk factors, and prevention strategies has a key role in the management of this spectrum of infectious diseases involving the aorta.

the aim of the study is evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (InterGard Synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard Dacron grafts. Results will be reported and analyzed according to the type of aortic disease requiring surgical repair.


Eligibility Criteria:
Inclusion Criteria:

• Patients submitted to aortic surgical repair (elective or emergent) with a silver and triclosan knitted collagen coated polyester vascular graft or standard Dacron grafts, for different aortic pathologies at the Division of Vascular Surgery, San Raffaele Scientific Institute, between 2012 and 2019

Exclusion Criteria:

• not present
Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca

Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer

2 Arms Randomization in patients with metastatic breast cancer.

Arm A = Docetaxel + High dose Vitamin D2

Arm B = Docetaxel + Standard dose Vitamin D2

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven metastatic adenocarcinoma of the breast.
* Gender: female.
* Age ≥18 years.
* ECOG performance status ≤ 2.(see appendix I)
* 25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
* No more than 1 prior chemotherapy regimen not including Docetaxel or Paclitaxel for metastatic breast cancer.
* Patients progressed on Doxorubicin or epirubicin as first line for metastatic breast cancer is eligible.
* Concurrent bisphosphonate therapy allowed.
* Life expectancy more than 6 months
* At least 12 months since prior adjuvant or neo-adjuvant chemotherapy including Taxanes regimens.
* Adequate hematologic, hepatic and renal function.
* Written informed consent.

Exclusion Criteria:

* Pregnant or lactating women.
* Male breast cancer.
* Women of childbearing potential unless surgically sterile or using adequate measures of contraception.
* Metastatic inflammatory breast cancer.
* CNS metastasis.
* Leptomeningeal carcinomatosis.
* Malignant hypercalcemia.
* History of kidney stones.
* History of active primary hyperparathyroidism.
* Normal 25 (OH) Vitamin D level ≥100 nmol/L or ≥ 40 ng/L.
* Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer.
* Patient on any anti-Psychotic medications or Steroid therapy.
* History of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue).
* Any of the following abnormal baseline hematological values:

  * ANC \< 1.0 x109/L, or platelets \< 100.000 x 109/L.
* Any of the following abnormal laboratory tests: total serum bilirubin \>2.00 x ULN (upper limit of normal), AST, ALT \> 2.5 x ULN or ALP \>2.50 x ULN (upper limit of normal).
Relationship Between Hip Extensor Strength and Gait Speed in Diplegic Cerebral Palsy

The hip extensors are essential for upright posture and forward propulsion during gait. Children with diplegic CP often demonstrate reduced muscle strength, which impacts their gait speed and overall mobility. Understanding the relationship between hip extensor strength and gait speed could provide a basis for targeted interventions. This feasibility study will establish whether the handheld dynamometer can reliably measure hip extensor strength and if this strength correlates with gait speed in children with diplegic CP.


Eligibility Criteria:
Inclusion Criteria:

* • Diagnosed with diplegic CP

  * Ages 6 - 8 years
  * GMFCS Levels I-II (indicating they are ambulatory)
  * Able to follow instructions and participate in strength and gait assessments

Exclusion Criteria:

* • Severe cognitive or behavioral impairments affecting participation

  * Musculoskeletal conditions or recent orthopedic surgery that could interfere with hip function
  * Use of assistive devices for ambulation
Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

This trial is to designed to assess the efficacy and safety of Cryotherapy combine with Icotinib for Advanced NSCLC Patients harboring EGFR mutation.

In this single arm clinical study, enrolled patients, with advanced stage NSCLC and confirmed epidermal growth factor receptor (EGFR) mutation, would receive cryotherapy for tumors and begin Icotinib, an EGFR tyrosine kinase inhibitor administration thereafter. Progression free survival, overall survival and safety wil be observed.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase 3B/4;
* Life expectancy ≥12weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* The number of target lesions in whole body ≤ 8 (and the number of lung lesions ≤ 5, the biggest one's diameter≤ 7 cm, the number of liver lesions ≤ three the biggest one's diameter ≤ 5 cm.
* Adequate hematological function: hemoglobin ≥90g/L (no blood transfusion in 14 days) Absolute neutrophil count (ANC) ≥1.5 \* 109/L, and Platelet count ≥75 x 10\^9/L.
* Adequate renal function: Serum creatinine ≤1.5 \* upper limit of normal(ULN), or Serum creatinine≥ 50 ml/min. Adequate liver function: Total bilirubin ≤ 2 \*ULN and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)\< 2.5 \* ULN in the absence of liver metastases, or \< 5 \* ULN in case of liver metastases.
* Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided.

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
* Allergic to Icotinib.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
* Pregnancy or breast-feeding women.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction with in 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Concordance Between Mini-Mental Stats Examination (MMSE) and an Adapted Version of the MMSE in Reunion Island Population (MMS-Run)

Illeteracy concerns more than 38% of Réunion Island's people older than 65 years old, which makes it an important risk factor for dementia and a limit to neurocognitive test's administration.

The MMSRun is a Mini Mental State Examination's version adapted to illeteracy and Réunionese culture, inspired by Hindi Mental State Examination's work. It allows a way better participation during neurocognitive evaluation, but it has never been validated.

This study is a peliminary study to a validation, where the concordance between scores obtained from MMSRun and from the consensual version of Mini Mental State Examination proposed by GRECO (Groupe de Réflexion sur les Evaluations Cognitives) - the only french version validated - on a hospitalized and eldery population will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patient who needs a cognitive evaluation by MMSe/MMS-RUN during usual medical care
* Patient born and living in Réunion Island
* Patient hospitalized in geriatrics department or in the departement of physical medecine and rehabilitation
* Patient who agrees to participate in the study and who does not oppose to the use of his data

Exclusion Criteria:

* Patient with hearing and visual disorder that can interfere in cognitive test administration
* Patient with altered state of consciousness (Glasgow score different of 15)
* Patient diagnosed or having symtoms compatible with a psychiatric pathology with psychosis (altered perception of reality)
* Patient with a current and severe addiction to Alcohol or any other drug (smoking excluded)
* Patient deprived of liberty by judicial or administrative decision and patient under curatorship or guardianship
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML).

Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (\> RM4.0).

Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.


Eligibility Criteria:
Inclusion Criteria:

* patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
* written informed consent

Exclusion Criteria:

* patient with atypical CML
* patient with a non SMP CML
* patients previously treated with interferon
* patient enrolled in another study therapy or within the exclusion period thereof
* pregnant or breast-feeding women
* patient under guardianship, curator or under the protection of justice.
Comparison Between Sonic Fill and X-tra Fill in Clinical Performance

The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material (sonic fill) in comparison to conventional bulk-fill resin composite (X-tra fill) as posterior restorations. The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment.

Restorations will be evaluated 1 week after placement (Baseline - T0), 3 months (T1), 6 months (T2), 1-year (T3) and 2-years (T4) of clinical service by blinded calibrated examiner using modified United States Public Health Service (USPHS) criteria where score A (Alpha) stands for the clinically ideal restoration. Score B (Bravo) is a clinically acceptable situation except for secondary caries. Score C (Charlie) indicates clinically unacceptable restorations that must be replaced.

The restorations will also be evaluated using revised FDI criteria with five grades for each criterion; scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).

Eligibility Criteria:
Inclusion Criteria:

* They should have an acceptable oral hygiene level.

  * Presence of at least two posterior carious lesions to be restored with two different types of composite.
  * The two materials should be used in approximately the same sized lesions or within the same extension.
  * Age range between 18 and 45 years.
  * A good likelihood of recall availability.

Exclusion Criteria:

* Severe or active periodontal or carious disease.
* Heavy bruxism or a traumatic occlusion.
* Patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
* Alcoholic and smoker patients.
* Patients had participated in a clinical trial within 6 months before commencement of this trial.
* Patients unable to return for recall appointment.