cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several reports of clinical cases with excellent results for the treatment of this lesion that can differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to define the optimal dosage of the drug for a therapeutic modality and to define its true efficacy in controlled studies of this pre-malignant labial lesion.

Squamous cell carcinoma is the most common malignant neoplasm in the head and neck region, and when present in the lower lip, it is usually associated with prolonged exposure to UV radiation of lip vermilion surface especially in white patients (patients with genodermatosis such as xeroderma pigmentosum have extreme sensitivity to UV radiation, characterized by an even higher risk and patients presenting radiodermatites that can evolve to squamous cell carcinoma). Ingenol mebutate is a natural medicine derived from the sap of the pepense euphoria and much used for its medicinal properties.

The objective of this study was to determine the toxicity profile and the maximum tolerated dose (MTD) of ingenol mebutate for treatment of actinic cheilitis in patients of the Oncology Dermatology Session of the National Cancer Institute of Brazil (INCA) through a phase 1 clinical trial of type 3 + 3 and to determine the therapeutic response with a dose below the maximum tolerated dose (MTD) of metamato of ingenuity, for the treatment of aortic cheilitis in patients of the Oncology Dermatology Session of the National Cancer Institute (INCA) through a prospective clinical trial and phase randomized trial (phase 2).

Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several reports of clinical cases with excellent results for the treatment of this lesion that can differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to define the optimal dosage of the drug for a therapeutic modality and to define its true efficacy in controlled studies of this pre-malignant labial lesion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of actinic cheilitis .
* Histopathological report compatible with the clinical diagnosis.
* Sign the informed consent to be a part of the study.
* Comply with the attendance at the clinical settings during the days the patient will be medicated (D1, D2 and D3), D5, D8, two months, six months and one year after treatment.

Exclusion Criteria:

* Patients younger than 18 years of age.
* Patients without confirmed diagnosis of actinic cheilitis.
* Patients previously treated with ingenol mebutate for actinic cheilitis, including those in the present study, previously excluded at some point during phases 1 or 2.
* Presence of recurrent lesions, prior or during treatment.
* Immunosuppression.
* Use of topical corticosteroids.
* Presence of markedly hyperkeratotic or ulcerated lesions in the clinical evaluation
* Patients presenting with atypical histology (moderate to severe epithelial dysplasia) at the lips.
Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy.

Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on day 29.

Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of paclitaxel

Besides the main objective, there are 3 other objectives as follows.

To determine dose-limiting toxicity (DLT) Of Oraxol. To characterize the pharmacokinetics of HM30181A(pgp inhibitor), paclitaxel and its metabolites following oral administration of Oraxol.

To evaluate anticancer activity of Oraxol.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer.
2. Patients have progressive disease in spite of standard anti-cancer therapy or are not expected to benefit or prolong survival from any existing anti-cancer therapy
3. Patients who received chemotherapy, radiation therapy, surgery must have passed at least 4weeks since the final treatment and must have fully recovered from the toxicities Patients treated by Nitrosoureas or Mitomycin C must wait 6 weeks before becoming eligible.
4. ECOG performance status ≤ 2
5. Life expectancy ≥ 12 weeks
6. Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present

Exclusion Criteria:

1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
2. Patients who have received bone marrow transplant or are to receive bone marrow transplant.
3. Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
4. Pregnant or lactating or with childbearing potential without use of adequate contraception (in case of men, appropriate contraception is required).
5. Patients who are on PGP inhibitor such as Cyclosporine or Verapamil which are prohibited.: Such patients may qualify after two-week wash-out period.
The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke

The goal of this clinical trial is to compare the effect of high chlorine solution such as normal saline and non-high chlorine solution such as sodium lactate ringer's solution on renal function in patients with heat stroke. The main question it aims to answer is whether limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.

Participants will receive a free normal saline infusion during the emergency department according to the study design, or a restricted normal saline infusion while using sodium lactate Ringer's instead.

Researchers will compare the normal saline infusion group and sodium lactate Ringer's group to see if limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* diagnosed as heat stroke
* Informed consent from patients or family members.

Exclusion Criteria:

* need immediate cardiopulmonary resuscitation
* transferred from another hospital
* with original end-stage renal disease or dialysis
* with severe organ damage
* pregnant women
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed CLL or SLL requiring therapy
* Age 18 years of age or older
* ECOG performance status 0, 1, or 2
* Normal organ and bone marrow function
* Resolution of toxic effects from prior therapies
* Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria:

* Any serious medical, psychiatric illness or laboratory abnormality
* Chemotherapy or radiotherapy within 4 weeks of entering the study
* Currently receiving other treatment for CLL/SLL or other malignancies
* Active other malignancies
* History of allergic reactions to bendamustine or ofatumumab
* Ongoing corticosteroid use
* Pregnant or lactating
* HIV positive
* Active hepatitis B
* Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
Spinal Stimulation for Upper Extremity Recovery in the Home

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* History of traumatic SCI
* Less than 12 months post SCI
* SCI injury level C1-C8
* SCI categorized as AIS B-D
* Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
* Have caregiver support to attend three in-person sessions and ongoing training at home
* Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS
* Able to complete in-person training sessions and return to Craig Hospital for assessments
* Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
* If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures
* Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device
* Able to provide informed consent

Exclusion Criteria:

* Experience unstable chronic cardiac or respiratory complaints
* Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
* Received Botox injections to the UEs, neck, or hands within the last three months
* Pregnant, planning to become pregnant, or currently breastfeeding
* Have breakdown in skin area that will come into contact with electrodes
* Prior nerve or tendon transfer procedure for the UEs
* Concurrently are participating in another drug or device trial that may interfere with this study
* Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
* In the opinion of the investigators, the study is not safe or appropriate for the participant
Nigella Sativa in COVID-19

Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia
* Adult (18 Years and above)
* Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).
* Understands and agrees to comply with planned study procedures.
* Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.

Exclusion Criteria:

* Patients with pneumonia or severe illness requiring admission to ICU.
* Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) \< 30) or end stage renal disease requiring dialysis
* Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) \> 5 times the upper limit of normal).
* Pregnancy or breast feeding.
* Anticipated transfer to another hospital which is not a study site within 72 hours.
* Allergy to any study medication.
Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis

The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.

The proposed work will consist of four key components. The investigators will collect data from the class of 2023 in each of their remaining years at college, producing (i) longitudinal data that will allow them to probe the long-term mental health effects of connections made during the transition to college, as well as mental health issues and resilience in the wake of the COVID-19 pandemic as a function of social connectedness. The investigators will leverage this rich dataset to build (ii) prospective quantitative models to predict mental health outcomes later in college based on a range of social factors measured early in college. They will further collect (iii) a longitudinal replication cohort, the class of 2024, allowing to establish the robustness of their initial findings across samples. Finally, the investigators will add (iv) a neuroimaging component to this dataset in a subset of the class of 2024. This will allow them to examine brain "markers" of connectedness, and add them to a prospective model, providing a novel integration across brain, behavior, and community levels of analysis, and a synthetic assessment of social factors in long-term mental health.

Eligibility Criteria:
Inclusion Criteria: Stanford undergraduate students in the classes of 2023 and 2024, as well as all students who reside in their dorms.

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Exclusion Criteria: People under the age of 18

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Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)

The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the 3-month outcome in participants with acute ischemic stroke.

Xingnaojing is widely used in China, but there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Xingnaojing will increase the proportion of people alive and independent at three months. Xingnaojing, combined with guidelines-based standard care, will be compared to standard care alone in patients with acute ischemic stroke within 24 hours of symptom onset. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 5-20. Patients in each group will be treated according to the guidelines-based standard care, including intravenous thrombolysis if appropriate. The primary outcome will be determined at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke within 24 hours of symptom onset.
* National Institutes of Health Stroke Scale score ≥ 5 and ≤ 20.
* Age ≥ 35 and ≤ 80 years.
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Planned or already received endovascular treatment.
* Suspected secondary stroke caused by tumor, brain trauma, or hematologic diseases.
* Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ).
* Other conditions that lead to motor dysfunction (e.g. severe osteoarthrosis, rheumatoid arthritis).
* Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase, or aspartate aminotransferase value that is twice greater than the upper limit of normal).
* Life expectancy of 90 days or less due to other life threatening illness (e.g. advanced cancer).
* Other conditions that render outcomes or follow-up unlikely to be assessed..
* Known to be pregnant or breastfeeding.
* Currently receiving an investigational drug.
A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Adult females over age 18 with life expectancy of at least 3 months
* Histologically or cytologically confirmed locally advanced or metastatic breast cancer
* One and only one prior chemotherapy regimen (no prior docetaxel)
* Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
* Adequate hematologic, renal, and hepatic function;

Exclusion Criteria:

* Known history of bleeding diathesis or coagulopathy
* Any current evidence of clinically significant bleeding
* Any history of thromboembolic events
* Concurrent hormone therapy
* Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
Prospective Endodontics Database

Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.

However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.

Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged ≥ 18,
* New patients received in consultation by students registered for a Diploma in Endodontics in one of the participating centres (Brest, Bordeaux, Lyon, Nancy, Nantes, Nice, Paris, Toulouse) or received by one of the private practitioners participating in the study;
* Patient with an indication for endodontic treatment or endodontic retreatment on at least one permanent tooth.

Exclusion Criteria:

* Patient unable to understand the purpose and conduct of the study.
Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes

The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.

A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:

* Small samples of patients, mostly low-quality comparative studies
* Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
* Absence of subgroup analysis in significant research fields
* Lack of information on the surgical techniques adopted

A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:

* Achieving a large sample of patients
* Collecting multiple variables, allowing for the making of a comprehensive statistical report
* Standardizing the methodology to be adopted, thus increasing accuracy
* Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric cancer
* Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
* Early Gastric Cancer
* Advanced Gastric Cancer
* Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

* Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
* Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \> 4
* History of previous abdominal surgery for gastric cancer
* Synchronous malignancy in other organs
* Palliative surgery