cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars

Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.

The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.

autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years old.
* Both sexes.
* All types of atrophic acne scars

Exclusion Criteria:

* • Pregnant or lactating women.

  * Coagulation disorders or anemia.
  * Skin infections.
  * Patients with hormonal disturbance.
  * Chronic disease e.g: diabetes, renal disease....etc.
  * Refusal to participate.
Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.

PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.

OBJECTIVES:

* Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
* Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
* Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
* Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
* Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.

OUTLINE: This is a multicenter study.

Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.

* Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.
* Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.

Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.

PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation
* Prior diagnosis of breast cancer allowed

  * Must not be undergoing active treatment
  * Patients with prior bilateral mastectomy are eligible for study but not eligible for randomization

PATIENT CHARACTERISTICS:

* Female only
* No psychiatric or cognitive disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Quality of Life Model for Older Patients With AML

The purpose of this study is to describe the differences in quality of life (QOL) among newly diagnosed patients diagnosed with acute myeloid leukemia (AML) to help design a patient decision-making QOL model for aligning patients' choice of treatment with what matters the most to them.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Newly diagnosed with pathology-confirmed diagnosis of Acute Myeloid Leukemia
* Within 7 days of starting a new treatment
* Must be able to read and speak English at the 8th grade level

Exclusion Criteria:

* Under 60 years of age
* Other malignancy, dementia, traumatic brain injury or individuals with central nervous system involvement of their leukemia
Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain

National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.


Eligibility Criteria:
Inclusion Criteria:

1. Age 16 years and over
2. Under palliative care/oncology service review
3. Diagnosis of incurable cancer
4. Clinician-predicted life expectancy \>2 months
5. Anticipated to be clinically stable for duration of study involvement
6. Receiving daily regular strong opioids
7. Able to take study drug/placebo in its current form
8. Prescribed and taking paracetamol 1g four times a day
9. Average pain \>3 and \<9 in past 24 hours
10. Able to provide written informed consent
11. Able to complete necessary assessments required as part of the trial
12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation

Exclusion Criteria:

1. Pain which the clinician deems to be unstable
2. Clinically significant renal or liver disease
3. Weight less than 50kg
4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
5. Co-enrolment in other drug trials
6. Known to be pregnant or breast-feeding at the time of recruitment
7. Previously enrolled in this study
Rotational Stability of Different Intraocular Lenses in The Capsular Bag

To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
* The operation was smooth and there were no surgical complications.

Exclusion Criteria:

* Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
* History of ocular trauma or surgery before this cataract surgery;
* intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
* Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of metformin as defined by the protocol
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis

Ertapenem is an antibiotic that is highly bound to plasma protein (\> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet.

In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins.

It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.


Eligibility Criteria:
Inclusion Criteria:

* Age: from 18 to 80 years
* Patients with infection due to ertapenem susceptible bacteria.

Exclusion Criteria:

* Patients who received ertapenem within 7 days prior to inclusion
* Known allergy to ertapenem or any excipients
* Neutropenia \< 500/mm3
* Hemoglobin concentration \< 9g/dl
* Renal failure (creatinin clearance \< 30ml/min/1.73m²)
* Decompensated heart failure
* Patients receiving vasopressor (adrenalin, noradrenalin), \> 0.5µg/kg/min
* Known hypersensitivity to Elma®
* Positive pregnancy test or currently lactating
A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial

This clinical trial compares the effect a financial intervention, called Financial Compass, to usual care in identifying and addressing financial hardship in patients with head and neck cancer. Previous research has shown that head and neck cancer patients experiencing financial hardship have decreased overall and cancer specific survival. Using a financial intervention, Financial Compass, may be more effective than usual care in identifying and addressing financial hardship in patients with head and neck cancer.

PRIMARY OBJECTIVES:

I. Examine head and neck cancer patients' experiences with financial hardship to understand barriers across the socioeconomic spectrum and inform intervention refinement. (Aim 1) II. Apply community-engaged intervention mapping to tailor the Financial Compass intervention to address the needs and experiences of head and neck cancer patients. (Aim 2) III. Conduct a pilot randomized control trial of Financial Compass to assess feasibility, acceptability and preliminary efficacy among head and neck cancer patients. (Aim 3)

OUTLINE:

AIM 1: Patients complete interviews on study for Financial Compass intervention development and refinement.

AIM 2: Participants take part in a community advisory board and/or a health care delivery advisory board on study to discuss, develop and refine the Financial Compass intervention.

AIM 3: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive the Financial Compass intervention on study including a patient needs assessment, a tailored care pathway and weekly individualized navigation and support to access resources.

GROUP II: Patients receive usual care on study including medical consultations and supportive care.

After completion of study intervention, patients are followed up at week 12.

Eligibility Criteria:
Inclusion Criteria:

* They have been diagnosed with head and neck cancer
* Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure
* Are able to participate in English or Spanish

Exclusion Criteria:

* Adults unable to complete the process of informed consent
* Adults whose primary language is not English or Spanish
* Individuals who are not yet adults (i.e., infants, children, teenagers)
* Unwilling or unable to follow protocol requirements
IDH1 and OCT4 in High Grade Astrocytoma

observation of IDH1 and OCT4 markers level and high grade astrocytoma patients prognosis after excision.

explore the relationship between prognosis and IDH1 and OCT4 biomarkers after high grade astrocytoma excision , according to progression free survival and overall survival , in prospective and retrospective samples.

Eligibility Criteria:
Inclusion Criteria:

* patients of high grade astrocytic glioma patients fit for surgery

Exclusion Criteria:

* patients of low grade glioma patients unfit for surgery
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People

Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.

Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.

As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:

* Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.
* Whether ASP is responsible for any positive SPT reactions, should they occur.
* And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.

The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.

In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo \[food containing no ASP\]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.

This is a multi centre study which is taking place in the UK.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-60 years.
* Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.
* Written informed consent from the subject.
* Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.
* No allergic symptoms on the day of investigation.

Exclusion Criteria:

* Pregnancy or lactation.
* Failure to comply with the protocol.
* Medication that may interfere with wheal formation in the skin or response to DBPCFC
* Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.
* Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).
* Subjects with a condition the Investigator believes would interfere with the evaluation of the subject, including proceeding to DBPCFC, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the DBPCFC matrix other than ASP.
Hemolysis in Blood Samples in the ER

In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the ED.


Eligibility Criteria:
Inclusion Criteria:

* \> 16 years

Exclusion Criteria:

* In vivo hemolysis
Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer

Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who could apply the optimal pressure with OEB and CPG-EB.

For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The efficacy of compression bandage considerably depends on the applied pressure and it is therefore largely dependent on the individual applying bandages. The lower pressure leads to treatment failure while the higher pressure leads to skin complication.

The use of objective devices to proof that the bandage is sufficiently applied is not available for every patients. To help the patients to apply the bandage with optimal pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by using sub-bandage pressure guidance.

Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition,investigators compared the percentage of inexperienced staffs who could apply the optimal pressure with OEB and CPG-EB.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic venous insufficiency CEAP (clinical, etiologic, anatomic, and pathophysiologic) C4,C5 and C6

Exclusion Criteria:

* Patients who can not perform bandaging by themselves
Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis

This study is a retrospective case-control study. In the study, the data of 304 patients who were evaluated in our clinic between January 2017 and January 2020 with a pre-diagnosis or diagnosis of postmenopausal osteoporosis were retrospectively reviewed. Lumbar 1-4 and femoral neck bone mineral densitometry values T scores, ages, sedimentation, C-reactive protein, neutrophil, leukocyte and platelet levels, and mean platelet volume values of the patients were recorded. The neutrophil-lymphocyte ratio was calculated by dividing the neutrophil count by the lymphocyte count, and the platelet-lymphocyte ratio was calculated by dividing the platelet count by the lymphocyte count. The systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count. The aim of this study is to evaluate the prognostic value of the systemic immune inflammation index in postmenopausal osteoporosis and to examine the SII, N / L, PLT / L, MPV, sedimentation (ESR), C reactive protein (CRP), femur and lumbar BMD values and their relationships with each other.


Eligibility Criteria:
Inclusion Criteria:

* Having applied to our clinic with the diagnosis or pre-diagnosis of postmenopausal osteoporosis or osteoporosis with pathological fractures

Exclusion Criteria:

* Having a diagnosis of osteoporosis due to conditions other than postmenopausal osteoporosis
* Those with acute or chronic infection, malignancy and systemic diseases that may change the hematological inflammation parameters to be checked
* Persons who are missing one or more of the parameters planned to be considered among the obtained data
Synovitis in Patients With Osteoarthritis

To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.

Exclusion Criteria:

- revisions, bilateral procedures, alcohol or medical abuse, administration of any glucocorticoids during the 3 months prior to surgery, and/or a history of serious cardiac or cerebrovascular problems, severe liver or kidney failure, and/or connective tissue disease including rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus.
Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients

1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence.
2. Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.

The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.

Eligibility Criteria:
Inclusion Criteria:

* In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
* Bulge of paries anterior vaginas stage III-IV
* Uterine prolapse stage II-II
* Without symptoms of stress urinary incontinence
* Screening tests of occult stress urinary incontinence(OSUI) should be positive
* ≥55 years old.

Exclusion Criteria:

* Pregnancy
* Illegible to follow up after surgery
* Previous surgery for stress urinary incontinence
* Unfinished data collection before surgery
Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm.

The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* \< 40 years old
* anterior glenohumeral joint dislocation proved by radiography
* dislocation needing a reduction manoeuvre
* home close to evaluation site for 24 months follow-up visits
* signed consent form

Exclusion Criteria:

* associated fracture
* Hill-Sachs lesion = or \> than 30%
* neurovascular deficit
* hypermobility
* pre-existing instability of the injured shoulder
* systemic neurological disease
* allergy to gadolinium
* functional sequel to the shoulder due to previous injury
* incapacitated adult patient
* minor patient
* home far from evaluation site
* refusal to sign the consent form