cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis

To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.

To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis.

To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant, non-lactating female ≥ 18 years of age.
* Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
* Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation
* Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area. In addition the target area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or scaling.

Exclusion Criteria:

* Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis
* History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
* Past history of dermatophyte infections with a lack of response to antifungal therapy
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or onychomycosis involving ≥ 20% of the area of either great toenail and/or involving more than five toenails in total or other concurrent dermatophytoses (e.g., tinea cruris) and any other skin disease to an extent that, in the opinion of the investigator, might interfere with the evaluation of tinea pedis or study results
A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
5. No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed.
6. Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL
7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

1. Prior history of peripheral neuropathy
2. Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
3. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
4. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
5. Psychiatric disorder that would preclude compliance
6. Pregnant, nursing women or patients with reproductive potential without contraception
7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
2. Male or female patient with one of the following options:

   * Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
   * Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
   * Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
   * Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
4. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.

Exclusion Criteria:

1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.
2. Pregnant and lactating women and those intending to become pregnant during the trial.
3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas

This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent IDH-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same region. The recurrent tumor may be either histologically confirmed or based on clinical assessment. Any number of prior recurrences is allowed.
* Maxium tumor diameter of 7 cm or less.
* Prior EBRT is ≥ 2 years ago.
* The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.
* Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.
* Life expectancy ≥ 12 months
* At least 18 years of age.
* Karnofsky performance status (KPS) of at least 70%.
* Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).

Exclusion Criteria:

* Leptomeningeal or metastatic involvement.
* Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.
* Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not allowed. If the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician.
* Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
* Pregnant.
Tools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers

This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to identify markers allowing to better understand the phenotypic variability observed on patients with CMT1A, to identify predictive markers of the disease's progression and to provide validated measurement tools that can be used as outcome measures in future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CMT 1A disease
* Diagnosis of CMT 1A confirmed by genotyping (duplication of the 17p11.2 region)

Exclusion Criteria:

* Patients suffering from co-morbidity at the origin of peripheral neuropathy (diabetes, hypothyroidism, renal insufficiency, drugs...) or muscle, articular, rheumatological disease
* With HIV or cancer
* With a significant progressive disease in the previous month
* With a contra-indication for MRI
* With a dislocation, fracture, or recent surgery (less than 6 months before inclusion)
* with alcohol or psychoactive substances abuse
* Treated by an anti-inflammatory drug over the past four weeks
* Pregnant or breastfeeding women
* Homeless patients
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors

The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of gastric subepithelial tumors, with histopathological correlation, and to perform the validation of these criteria.


Eligibility Criteria:
Derivative study

Inclusion Criteria:

* patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 2 cm

Exclusion Criteria:

* Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function
* Extramural structures, vascular lesions or cystic masses were visible by EUS
* Pregnancy or breastfeeding
* Known allergy to fluorescein sodium
* Inability to provide informed consent

Validation study

Inclusion Criteria:

* patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 1 cm

Exclusion Criteria:

* Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function
* Extramural structures, vascular lesions cystic masses or lipoma were visible by EUS
* Pregnancy or breastfeeding
* Known allergy to fluorescein sodium
* Inability to provide informed consent
MyoSense- Automated Muscle Hypertonicity Classification System

It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
* Over the age of five.

Exclusion Criteria:

* Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
* Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
* Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
* Under the age of five.
Perfusion Assessment in Laparoscopic Left Anterior Resection

The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.

Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel.

This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge)
* A negative pregnancy test for women of childbearing potential prior to surgery

Exclusion Criteria:

* Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is a pregnant or lactating female
Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)

The Swan-Ganz catheter is the gold standard to measure cardiac output during liver transplantation surgery. This is an invasive hemodynamic monitoring system.

The VenArt Cardiac Output (Mespere LifeSciences, Waterloo, Canada) is a new, innovative and non-invasive device that permits hemodynamic monitoring.

With a software based on Fick's principle it is able to calculate cardiac output, cardiac index and continuous cardiac output.

The hypothesis of this study is to investigate the precision and accuracy of this method versus the standard of care during liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* liver transplantation patients

Exclusion Criteria:

* age \< 18 years old
* combined liver-kidney transplant
* liver transplant for acute insufficiency
* no consent of the patient
Sensitivity and Specificity of Xpert MTB/RIF Ultra

To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population.

Xpert MTB/RIF was introduced recently and added great benefit in management of TB. Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization (WHO) endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries5.

Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical. Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). It has higher sensitivity especially in smear-negative TB cases. The processing of the new assay is easy to use and does not need special expertise5. Xpert MTB/RIF Ultra has increased accuracy of Rifampicin results and improved detection of mixed infections. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test. There is great need for further research to assess the diagnostic value of Xpert MTB/RIF Ultra in patients with pulmonary tuberculosis.

Eligibility Criteria:
Inclusion Criteria:

- Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included

Exclusion Criteria:

* Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission
Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users

This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.

The research will also consider if general-purpose PALs differ from computer-specific PALs in these user groups, and how presbyopia progression might influence PAL effectiveness for each condition. This information can help eye doctors recommend the most suitable PAL design for computer users with myopia or hyperopia.

Eligibility Criteria:
Inclusion Criteria:

* The age of Participant will be 40 to 55 years
* Participant diagnosed with myopia having -0.50 to -3.00DS and astigmatism up to -0.75DC
* Patient diagnosed with Hypermetropia having +050 to +3.00 DS and Astigmatism up to +0.75DC
* Presbyopia addition will range from +1.00 to +2.50 DS
* Participants who have worked more than 4 hours on the computer screen.
* Participants who will be already progressive users and first-time users.
* Patients with no Ocular disease.

Exclusion Criteria:

* Participants with Pre Presbyopia and above 55 years of age
* Participants with significant ocular disease.
* Participants with uncontrolled diabetes and hypertension
* Participants who will not be willing for PAL,s
* Participants with more than 0.75 astigmatism
* Participants with known allergies and sensitivity.
Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy

This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
2. Presence of confirmed DPN as defined below.
3. Age between 18-70 years.
4. Have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations).
5. Willingness to provide informed consent and cooperate with the medical procedures for the study.

Inclusion Criteria for Healthy Controls:

1. Age-matched non-obese (BMI \< 30) control subjects
2. Normal glucose tolerance
3. Normal blood pressure
4. Normal lipid profile
5. Free of any causes of neuropathy as described above.

Exclusion Criteria:

1. Nursing mothers or pregnant women (excluded by a positive pregnancy test).
2. Patients with a history of previous kidney, pancreas or cardiac transplantation.
3. Patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis C, systemic lupus erythematosus).
4. Participation in an experimental medication trial within 3 months of starting the study.
5. Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
6. Subjects who are unable or unwilling to comply with the experimental protocol.