cyrilzakka/clinical-trials huggingface dataset:
Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus

Background: Oral Lichen planus (OLP) is one of the most common oral diseases that has an unneglectable rate of malignant transformation. Recently malignant transformation has been definitively linked to epigenetic changes. One of those most common changes is DNA hypermethylation that causes tumor suppressor genes to downtranslate and thus carcinogenesis begins. ZNF582 gene hypermethylation is emerging as an exclusive biomarker to differentiate between normal and dysplastic changes that occur over the epithelium. Aim: To evaluate the Melatonin epigenetic potential in preventing malignant transformation of OLP. Material and methods: an epigenetic randomized clinical study will be conducted on 50 patients suffering from OLP, recruited from the outpatient clinic of Oral medicine department, Alexandria Faculty of Dentistry, Egypt. Patients will be assigned to either Control group who will receive topical corticosteroids and antifungal treatment, or test group who will receive melatonin supplement in addition to conventional treatment. All patients will be genetically evaluated for the level of DNA hypermethylation 8 weeks after treatment, and clinically evaluated for disease severity and pain, by Elsabagh scoring system 4. 8, and 12 weeks after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients clinically and histopathologically diagnosed to be suffering from OLP in the following forms has been reported in the literature to have the highest potentiality for malignant transformation (plaque-type lichen , Erosive lichen planus, ulcerative lichen planus), with or without histopathological dysplasia.
* Patients who have symptoms (i.e. pain and burning sensation) secondary to OLP.

Exclusion Criteria:

* Patients suspected to have lichenoid drug reaction or lichenoid contact allergy.
* Patients suffering from systemic diseases (such as diabetes, cardiovascular or liver disorders, renal dysfunction).
* Patients with findings of any physical or mental abnormality that would interfere with or be affected by the study procedure.
* Patients who have adverse habits of chewing tobacco and smoking.
* Pregnant and lactating women.
* Patients under treatment with corticosteroids and immunosuppressants.
* Patients exhibiting any skin manifestations of OLP
Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR

ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. Elderly patients undergoing TAVI will be evaluated for the presence of ATTR-CA in Jordan.

ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. Two hypotheses may explain this association

1. Amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification.
2. The increased myocardial strain induced by AS may locally favor the process of amyloidogenesis and tissue infiltration.

Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without ATTR undergoing TAVI.

The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without ATTR.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Severe aortic stenosis
* Patient underwent TAVR procedure
* Positive pyruvate PO4 scan

Exclusion Criteria:

* Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune electrophoresis.
Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors & Lymphomas

Studies of PEG-paclitaxel have been terminated


Eligibility Criteria:
None - Study has been terminated.
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects

This study will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 29.9 kg/m2; and a total body weight \>=50 kg (110 lbs).
* Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.

Exclusion Criteria:

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception
* Consumption of grapefruit-containing products within 7 days prior to the first dose of study medication and while in the study protocol from at least 14 days prior to the first dose of study medication and for at least 28 days after the last dose of study medication
Augmentation Cystoplasty Using an Autologous Neo-Bladder

Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Eligibility Criteria:
Inclusion Criteria:

* subjects with neurogenic bladders secondary to myleodysplasia

Exclusion Criteria:

* prior augment procedures
* recent urologic surgery
* requires concomitant urologic intervention
TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with high myopia in order to determine the genetic basis of large myopic shifts causing severe visual impairment and complications.

Seventy-four children with high myopia (≥6 diopters \[D\]; study group) and 77 emmetropic children (±0.5D; control group) were included. Genetic and polymorphism analyses were performed in the Medical Genetics Laboratory using DNA purified from the patients' blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Patients under the age of 13
* Patients with cycloplegic refraction values ≥6 D (for study group)
* Emmetropic patients (for control group)

Exclusion Criteria:

* Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease)
* Patients with history of ocular surgery
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

To evaluate and compare the performance of a new contact lens to a marketed contact lens.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
* The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
* The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
* The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
* The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
* The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
* Any cylinder power must be:\<=0.75D.
* The subject must have visual acuity best correctable to 20/25 or better for each eye.
* The subject must have normal eyes (no ocular medications or ocular infection of any type).
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Any color deficiencies (color blindness) - to the best of the subject's knowledge.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
* Subject presents with one dark iris color and one light iris color
* Subject has heterochromia iridis (a difference in color between parts of one iris)
* The subject is an employee or family member of the clinical study site.
Seroma of the Mammary Gland

The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.

Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).

The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.

Eligibility Criteria:
Inclusion criteria study group and control group 1:

* Written informed consent
* Age ≥ 18 years
* all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER/PR positive, ER positive/PR negative, Her-2/neu positive and triple negative)
* Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion

Inclusion criteria control group 2 and 3:

* Written informed consent
* Age ≥ 18 years
* Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy

Exclusion criteria:

* Age \<18 years
* Male sex
* Breast cancer patients planned for breast conserving therapy
* Recurrent breast cancer disease
* History of breast surgery
* Diagnosis of LCIS only
* Pregnancy at time of diagnosis
* Patients with a known immunodeficiency
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.


Eligibility Criteria:
Inclusion criteria:

1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
2. Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA \> 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce effect).
3. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.

   1. Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
   2. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes.
   3. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.
   4. Combination of a, b, c with a maximum of 4 metastases.
4. Age \> 18 years.
5. Recent PSMA-PET/CT scan within 60 days prior to randomization.
6. PSA \< 10 ng/ml.
7. In case of chronic use of finasteride the PSA value should be \< 5 ng/ml.
8. WHO performance state 0-2.
9. Signed informed consent prior to registration/randomization.

Exclusion criteria

1. Visceral metastases.
2. PSA ≥ 10 ng/ml.
3. PSA-doubling time ≤ 3 months.
4. ADT or chemotherapy for recurrent PCa.
5. Testosterone \< 1.7 nmol/l
6. Painful metastases needed pain medication (\> level 1 pain medication) .
7. Invasive active cancers other than superficial non-melanoma skin cancers.
8. Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia

This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.

Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.


Eligibility Criteria:
Malaria cohort

* Age ≥5 years of age
* Malaria microscopy and / or Malaria RDT confirmed malaria infection
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Written informed consent Febrile controls
* Age ≥5 years of age
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Absence of a malaria episode confirmed by malaria microscopy
* Written informed consent
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability, and immunologic response also will be evaluated throughout.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests). Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs).
* Male subjects must agree that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
* Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, or clinical findings at screening excluding untreated, asymptomatic seasonal allergies at time of dosing.
* Clinically significant abnormalities in laboratory test results.
* Previous exposure to a monoclonal antibody or current use of other biologics.
* History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
* Use of prescription or non prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants

The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index between 18 and 30 kilograms per square meter (kg/\^m2), inclusive.

3. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.

4. For participants ≥ 55 years of age, ongoing conditions must be considered by the Investigator to be stable and adequately controlled by allowed concomitant medications.

Key Exclusion Criteria:

1. Plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the follow-up visit.
2. Any condition affecting study treatment absorption.
3. History of gastrointestinal surgery, gastroesophageal reflux disease, or other clinically significant and active gastrointestinal condition per the Investigator's discretion.
4. Clinically significant acute gastrointestinal symptoms within 30 days prior to study Check-in (Day -1).
5. Chronic, recurrent, or serious infection, as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
6. For participants \< 55 years of age: Use of any prescription medication (excluding oral contraceptives and hormone replacement therapy), OTC oral medications including proton pump inhibitors (PPI), histamine H2-receptor antagonists (H2 blockers), and antacids (excluding acetaminophen and aspirin ≤ 100 mg daily), or nutraceuticals including vitamins/mineral supplements/herbal medicines within 28 days prior to Day -1 and throughout the study.
7. For participants ≥ 55 years of age: Up to 5 medications are allowed if they are taken at a stable dose level and regimen.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Group Exercise Program Supported by Audiovisual Media During Hemodialysis

People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.

A 4-week randomized experimental study will be conducted, using an exercise protocol during HD, broadcast simultaneously on television. The frequency of exercise completion, reasons for non-completion, adverse events, as well as sarcopenia, muscle strength, muscle characteristics through ultrasound and electrical bioimpedance, and physical activity levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old of both sexes;
* Undergoing HD for at least three months in three sessions per week, four hours, totaling 12 hours per week.

Exclusion Criteria:

* Lower limb amputations;
* Neurological, musculoskeletal, or osteoarticular disorders;
* Severe and unstable comorbidities;
* Undergoing high doses of corticosteroids (\>30 mg/day);
* Inability to understand the measurement methods used.
Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy

Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

Healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. The two groups will be compared regarding the mean duration till complete healing and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers)

Exclusion Criteria:

* Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas.
* Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.
* Patients under chronic corticosteriod or immunosuppressive therapy.