cyrilzakka/clinical-trials huggingface dataset:
Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel or 4 cycles of trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive adjuvant chemotherapy and targeted therapy according to pathologic response and physician's choice.

Eligibility Criteria:
Inclusion Criteria:

* With signed consent
* Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique
* Breast cancer stage at presentation: stage II-III
* HER2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization
* Known hormone receptor status (estrogen receptor and/or progesterone receptor)
* Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1
* Baseline left ventricular ejection fracture \>= 50% measured by echocardiography
* Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male
* Willing to obey the study protocol

Exclusion Criteria:

* Stage IV disease
* Previous anti-cancer therapy or radiotherapy for any malignancy
* History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ,Stage I uterine cancer or thyroid papillary microcarcinoma
* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy
* Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered
* Serious cardiac illness or medical condition
* Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
* Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization
* Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
* Not able to swallow the drug
* Pregnant or lactating
* Positive serum or urine pregnancy test or above mentioned tests cannot be achieved for women with fertility
Efficacy Study for Magnetic Induction to Treat Wrinkles

In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.


Eligibility Criteria:
The inclusion criteria for the study are:

* Male or female 21 to 65 years old,
* Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms \& buttocks as determined by the study investigator,
* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
* Apparently healthy,
* Informed consent signed by the subject.

Exclusion Criteria:

The exclusion criteria for the study are:

* History of skin hypersensitivity,
* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy,
* Infectious diseases (such as HIV) present,
* Are a tobacco smoker,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.
Improving Autism Screening With Brain-Related miRNA

The goal of this project is to identify specific miRNAs that are increased or decreased in the saliva of children with developmental delay and are useful for screening toddlers for ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals to developmental specialists, and expedite the arrangement of early intervention services.

The central aim of this project is to characterize the expression of exosomal microRNA (miRNA) in children with autism spectrum disorder (ASD). Currently, the CDC estimates the prevalence of ASD in U.S. children to be 1 in 68. Yet, the biological causes, diagnosis, and treatment of this disease remain ambiguous. Growing evidence implicates a genetic role in ASD. miRNAs regulate genetic expression and are altered in lymphocytes, neurons and serum of patients with ASD. Recent studies of miRNAs have shown that they can be packaged into exosomal vessels and extruded from neurons as extracellular signaling tools. This knowledge provides a novel approach for examining the genetic regulation of the central nervous system.

We propose to measure the expression of extracellular miRNA in children with ASD. Expression levels of miRNA from blood and saliva will be compared between children with autism and normally developing controls. The goal of this study will be to identify genetic regulatory mechanisms involved in ASD and provide potential biomarkers for diagnostic screening.

The primary endpoints of this study are as follows:

1. Characterization of brain-related miRNA in the saliva of children with ASD and typically developing control children between the ages of two and five years.
2. Identification of sets of miRNAs in saliva and plasma that are predictive of both ASD diagnosis and severity of ASD symptoms. This aim will enroll ASD and control children age 12-24 months (inclusive).

Secondary endpoints include the identification of miRNA expression patterns that correlate with ASD symptom severity measured with standardized neuropsychologic testing and to characterize parental knowledge and attitudes towards epigenetic testing in the context of ASD..

Eligibility Criteria:
Inclusion Criteria:

* • Age at enrollment: 18 months and 6 years (inclusive)

  * Control group documented negative ASD screening on M-CHAT-R
  * ASD group: established DSM-5 diagnosis
  * Parent/guardian must be fluent in written and spoken English (required to complete study specific questionnaires etc)

Exclusion Criteria:

For autistic subjects study exclusion criteria will include:

• Autistic subjects with known syndromic autism (attributed to a known genetic mutation)

Control subjects only exclusion criteria will include:

• A diagnosis of autism

For both groups: wards of the state, active periodontal infection, active upper respiratory infection
Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion

After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye for 24 hours


Eligibility Criteria:
Inclusion Criteria:

* All patients with uneventful vitrectomy

Exclusion Criteria:

* Complicated vitrectomy or corneal lesion
Characteristics and Treatment Outcome of Liver Abscesses: An Observational Study

1. To assess the frequency, clinical presentation, microbiological and radiological characteristics of liver abscesses.
2. To evaluate the management plan and treatment outcome of liver abscess.
3. To study risk factors of liver abscess.

There is a paucity of information on liver abscesses' epidemiology and characteristics in the Middle East in general and Egypt in particular.

The incidence of liver abscess varies from one country to another. The annual incidence of pyogenic liver abscess has been estimated at 2.3 cases per 100,000 populations and 18-20 per 100 000 hospital admissions (Mohsen et al 2002, Kaplan et al 2004).

Liver abscess is a potentially life-threatening condition (Ahmed et al., 2016).

A review by Chan KS et al. of 16 pyogenic LA (PLA) articles showed mortality rates ranging from 0% to 15.7 % (Chan et al., 2022).

The etiology of LA can be bacterial (most often polymicrobial), parasitic (amebic essentially), mixed (pyogenic superinfection of parasitic abscess) or more rarely fungal (Nakanishi et al., 2009).

Microbes can invade the liver parenchyma by way of the bile ducts, blood stream (hematogenic, most often portal), or by contiguous spread, especially via the gallbladder bed (Yoo et al., 1993, Thomsen et al., 2007).

Advanced age, diabetes mellitus (DM) and the presence of underlying malignancy are considered major risk factors, and the latter is associated with a worse prognosis (Yoo et al., 1993, Thomsen et al., 2007).

The number of cryptogenic liver abscess cases has been on the rise, and no predisposing conditions (cryptogenic) was reported in 18% (McNeil et al. 2020).

The diagnosis of LA relies essentially on imaging. Sonography and CT scan lead to diagnosis in more than 90% of cases (Halvorsen et al., 1984).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LA will be based on typical appearance on ultrasound (US) or computed tomography (CT) of abdomen with clinical features consistent with the diagnosis (fever, chills, jaundice, right upper quadrant pain/epigastric discomfort).
* US or CT-guided aspiration of pus from a hepatic lesion.
* Complete resolution of radiological abnormalities following antimicrobial therapy.

Exclusion Criteria:

* Liver abscess that occurs secondary to hydatid cyst.
* Liver abscess associated with underlying malignancy.
* Patient with incomplete medical records.
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the investigator
The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

The purpose of this study is exploiting the new drugs for androgenetic alopecia because there are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one of the macrolide antibiotics that has immunomodulatory effects. We firstly found that roxithromycin increases the rate of murine and human hair follicle elongation in vitro. Therefore, we apply this drug on this disease therapy.

The topical therapy for androgenetic alopecia is still not enough to improve cosmetically. Thereforem we try to find new effective and safe topical therapy for this disease. Roxithromycin has not only antibacterial action but also immunomodulatory and anti-inflamatory potency. For example, roxitromycin inhibits T cell responces to mitogens and production of cytokines, IL-2 and IL-5. We firstly found that roxitromycin increased human and murine hair elongation in vitro to inhibit apoptosis of hair bulb. Then, we wish to apply roxithromycin on the therapy for androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Androgenetic alopecia

Exclusion Criteria:

* Cicatricial alopecia
* Allergy to roxitromycin
* Children (19years old or younger)
* Pregnant female
tDCS and Its Therapeutic Effects in CK Fever

One of the major challenges faced by researchers working in the field of rehabilitation science is the ability to provide integrative approaches to the use of clinical practice. In this context it becomes increasingly necessary to construct investigative approaches, so that they can reach clinical practice in a shorter period of time,since the large volume of information produced globally does not impact in the short or medium term on new therapeutic recommendations. Among the various chronic painful entities, there is chikungunya fever as a highlight for having a rich clinical chronology in relation to pain. Its therapy is used done by drugs in almost all national and international consensuses, therefore therapy against pain in chikungunya fever is limited during the rehabilitation process. It is very important that the science of rehabilitation enhances methods of noninvasive brain modulation that enable, through the excitation or inhibition of specific cortical areas to produce pain inhibiting effects, providing a simple and low cost treatment to the clinical routine.Technological advances and non-invasive techniques to modulate brain function have been developed, for instance, Transcranial Direct Current Stimulation (tDCS).

The objective of the present project is to present the tDCS as a new modality of physical rehabilitation for the patient with chronic pain resulting from chikungunya fever. The purpose of the study is to present physical, behavioral and social results of the application of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional status of the individual.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests.

Exclusion Criteria:

* History of seizures or epileptic disease, pregnancy, states associated with other previously diagnosed rheumatic diseases such as rheumatoid arthritis, gout and lupus, under 18 years and over 65 of age, patients with signs of severity and/or indication for hospitalization.
Study of Tesetaxel in Japanese Patients With Solid Tumors

Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.


Eligibility Criteria:
Primary inclusion criteria:

* At least 20 years of age
* Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed
* ECOG performance status not more than 1
* Adequate bone marrow, hepatic, and renal function
* Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1
* At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1

Primary exclusion criteria:

* Brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Neuropathy greater than Grade 1
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.

The primary objective is to evaluate the virologic efficacy of masitinib plus Best Supportive Care (BSC), with respect to placebo plus BSC in reducing viral shedding of SARS-CoV-2 in patients with symptomatic mild to moderate COVID-19.

Patients will be randomized into one of the following treatment groups (all patients will receive BSC):

1. Masitinib 3.0 mg/kg/day for 10 days versus corresponding placebo
2. Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 8 days versus corresponding placebo
3. Masitinib 3.0 mg/kg/day for 2 days then 4.5 mg/kg/day for 2 days then 6.0 mg/kg/day for 6 days versus corresponding placebo Treatments will be administered for 10 days and patients will be followed for 1 month. The treatment groups will be compared to pooled placebo after unblinding.

Regarding Best Supportive Care, for patients with a score of 2 and 3 (ambulatory) on the 10-score WHO clinical progression scale, Best Supportive Care is best available therapy in the country at the choice of the investigator excluding any antiviral treatment whether indirect (Ribavirin, Hydroxychloroquine or Chloroquine) or direct (anti-polymerase or antiprotease, including lopinavir/ritonavir fixed dose combination), other investigational treatments for SARS-CoV-2, plasma from a person who recovered from COVID-19, monoclonal antibody therapies and vaccine. For patients with a score of 4 and 5 (hospitalized) on the 10-score WHO clinical progression scale, Best Supportive Care is dexamethasone.

Eligibility Criteria:
Key Inclusion Criteria:

- Male or non-pregnant female with: A. Symptomatic ambulatory male or non-pregnant female adult ≥ 18 years of age at time of enrolment with mild COVID-19 with score 2 or 3 of the 10-score WHO clinical progression scale OR B. Hospitalized male or non-pregnant female adult ≥ 18 years of age at time of enrolment with COVID-19 with score 4 or 5 of the 10-score WHO clinical progression scale.

* Symptoms consistent with COVID-19, as determined by investigator, with onset ≤5 days before randomization
* Positive test for COVID-19 ≤72 hours prior to randomization
* Negative test for the IgG anti-SARS-CoV-2

Key Exclusion Criteria:

* Any use of anti-viral medications up to 7 days before participating in the study
* Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) any time before participating in the study
* Receipt of last recommended dose of a SARS-CoV-2 vaccine up to 30 days before participating in the study
* Receipt of a monoclonal antibodies up to 30 days before participating in the study.

Other protocol-defined inclusion/exclusion criteria may apply
Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation

Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.

In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.

Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.

As a control cohort, blood samples are obtained from patients undergoing resection for glioma.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing resection for meningioma or
* Patients undergoing resection for glioma or
* Healthy controls
* written consent for study participation

Exclusion Criteria:

-
Hyperlactatemia in Critically Ill Patients With Acute Kidney Injury

The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients.

A retrospective and observational study was conducted in which the investigators included participants who were hospitalised in the Department of Internal Intensive Care Medicine at the University Hospital Maribor and who required replacement haemodialysis treatment during their hospital stay. The decision on haemodialysis treatment was made after an agreement between the attending specialist in intensive care medicine and the nephrologist if there was a clear indication for starting replacement haemodialysis treatment. It should be emphasised that each of the patients received an appropriate form of treatment according to indication and clinical condition, in line with all relevant recommendations and guidelines.

The investigators collected data on the underlying comorbidities, the indication for ICU treatment, the indication for starting haemodialysis treatment, the type of haemodialysis (continuous venovenous haemodialysis, continuous venovenous haemodiafiltration) and the basic parameters of haemodialysis (level of ultrafiltration and total ultrafiltration, anticoagulants used, duration of procedures, complications during haemodialysis, prescribed and achieved haemodialysis dose with emphasis on the amount of dialysate/substitute/ultrafiltrate used (Qe, effluent dose), number of haemodialysis procedures, dialysis membrane used with or without immunoadsorbent membrane). The investigators collected data on laboratory results (haemoglobin, leucocytes, platelets, C-reactive protein, procalcitonin, lactate, urea, creatinine, bilirubin, albumin, partial pressure of oxygen in arterial blood, myoglobin, lactate dehydrogenase, Interleukin-6, beta-2-microglobulin, cystatin C), some measured haemodynamic/vital parameters (mean arterial pressure, diuresis, oxygen demand) and the dose of vasopressor drugs during treatment. The investigators analysed all the data obtained and attempted to objectively evaluate the success of the treatment. The investigators compared different haemodialysis membranes (standard membranes for continuous haemodialysis vs. newer membranes such as Emic-2® and Oxiris membrane®), different dialysis techniques (haemodialysis vs. haemodiafiltration) and the effects of using the Cytosorb® immunoadsorptive membrane. The investigators have obtained data on the duration of hospitalisation and survival of participants after treatment (up to 1 year).

We analysed the data using basic statistical methods, where a value of p \< 0.05 is considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* presence of acute kidney injury, stage 3 according to Kidney Disease:Improving Global Outcomes (KDIGO) criteria
* treatment with renal replacement therapy (RRT)

Exclusion Criteria:

* patients with chronic kidney disease (CKD) receiving chronic RRT
* previous known malignancy