cyrilzakka/clinical-trials huggingface dataset:
Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from sporadic cases of systemic anthrax patients treated with AIGIV.

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to systemic anthrax patients as part of their medical care after exposure to Bacillus anthracis (anthrax exposure can be via inhalation, ingestion, injection). Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, in some cases data may be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from systemic anthrax patients who have been treated with AIGIV.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspected systemic anthrax patients in the USA or other jurisdictions (if feasible) treated with AIGIV provided by the Centers for Disease Control and Prevention (CDC).
* Systemic anthrax defined as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e. tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema PLUS confirmation by one of the following:

Epidemiologically linked to a documented anthrax environmental exposure. Laboratory confirmation by isolation of B. anthracis from an affected tissue or site.

Demonstration of B. anthracis antigens in tissues by immunohistochemical staining using both B. anthracis cell wall and capsule monoclonal antibodies.

Evidence of B. anthracis DNA; for example, by polymerase chain reaction (PCR) in specimens collected from a normally sterile site (such as blood or cerebrospinal fluid (CSF)) or lesion of other affected tissue(s) (skin, pulmonary, reticuloendothelial, or gastrointestinal).

QuickELISA™ Anthrax-PA kit manufactured by Immunetics, Inc. for detection of anti-PA antibodies in serum, plasma, and pleural/ascitic fluid.

RedLine Alert™ test manufactured by Tetracore, Inc., for identification of B. anthracis colonies.

* Informed consent/assent (as applicable).

Exclusion Criteria:

* There are no exclusion criteria for subjects enrolling in this study.
Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy

This is a single arm, open-label trial studying the combination of PD-1/PD-L1 Inhibitor (e.g.pembrolizumab, Sintilimab,Duvarizumab，Camrelizumab )and lenvatinib given at the recommended dose in pediatric and young adolescent patients((5 year-old\<age\<14 year-old) with TLCT or refractory hepatoblastoma after chemotherapy.

Transitional liver cell tumors exhibit an unusual phenotype with respect to clinical presentation, histopathology, immunohistochemistry, and treatment response. These apparently novel, unusual, and aggressive tumors occurring in older children and adolescents may form a transition in the putative developmental pathway of hepatocarcinogenesis, and usually refractory, resistant to chemotherapy.

The sPLENTY-pc is a perspective cohort study, investigating the efficiency of sequential combined usage of PD-1 Inhibitor (e.g.pembrolizumab, Sintilimab,Camrelizumab ) or PD-L1 inhibitor (Duvarizumab) plus lenvatinib given at the recommended dose in pediatric \>5 year-old and young adult patients\<14 yo with TLCT or refractory hepatoblastoma after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>= than 5 years and =\< 14 years of age at the time of study enrollment
* pathological diagnosis of TLCT/NOS, or hepatoblastoma（HB）（Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.）
* Failed prior first-line or second-line chemotherapy
* general charactoristics: Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients \> 10 years of age Life expectancy \> 8 weeks Hemoglobin \> 8 g/dL Absolute neutrophil count \> 1,000/mm\^3 Platelet count \> 100,000/mm\^3 Total bilirubin ≤ 5 x upper limit of normal (ULN) for age, Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \< 10 x upper limit of normal (ULN) for age. Serum creatinine ≤ 3 times normal Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate) Not pregnant or nursing No severe uncontrolled infection or enterocolitis
* Recovered from toxicity of prior therapy No chemotherapy within 3 weeks prior to study entry No prior PD1/PD-L1 blockade treatment

Exclusion Criteria:

* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
* Patients who are currently receiving another investigational drug.
* Patients who are currently receiving other anticancer agents.
* Patients with uncontrolled infection.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of PD1/PD-L1 blockade
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3, VEGFR 1-3, and PDGFR α/β. Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for stronger efficacy in those with genomic aberrancies of FGF or PDGF. Abnormalities in the FGF, VEGF, and PDGF-related genes are observed across lung cancer histologies.

The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors. Specifically, patients with FGFR1-amplification appeared to derive particular benefit from lucitanib.

Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF, VEGF, and PDGF genetic alterations.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
* Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3, VEGFA, or PDGFRα amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2, or FGFR3 activating mutation
* Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Measurable disease per RECIST 1.1
* Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting

Exclusion Criteria:

* Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
* Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
* Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
* Symptomatic and/or untreated central nervous system metastases
* Presence of another active cancer
* Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
* Pregnant or breastfeeding women
New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population

This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.


Eligibility Criteria:
Inclusion Criteria:

* patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
* the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
* patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

* intracranial aneurysm correlating to AVM.
* dissection, false, traumatic and infectious aneurysms.
* the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
* patients unwilling to participate in this clinical trial and attach to regular follow up.
Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)

Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.

Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.

Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.

Exclusion Criteria:

* Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.
Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia

Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe multiorgan disease requiring hospitalization. The medium and long-term impact in survivors of COVID-19 on lung function, imaging by thoracic CT, exercise capacity, and health-related quality of life and the relation of these parameters remains to be determined.

Aim: To evaluate medium to late (visit 1: 6-12 months after hospital discharge) effects of COVID-19 on lung function, exercise capacity, thoracic CT findings, symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection and the relation between these parameters.

Material and methods: Prospective cohort of subjects with laboratory and/or thoracic CT confirmed COVID-19 who were treated as inpatients. Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.

The minimum sample size was estimated as 37 participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Covid 19 diagnosis
* Ability to read and speak
* Signed informed consent.
* Able to perform exercise testing and walking

Exclusion Criteria:

- Subjects with limited exercise capacity
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique

The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.

A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.


Eligibility Criteria:
Inclusion Criteria:

* First antenatal care visit
* Able to provide informed consent and signed consent form
* Minimum 18 years of age
* Diagnosed HIV positive at antenatal care visit
* Living in the catchment area of the health facility

Exclusion Criteria:

* Age \<18 years
* No consent form signed
* Being on ART at time of first antenatal care visit
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver

We are doing this research study to evaluate whether continuous positive airway pressure (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. This can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis
* Obstructive sleep apnea diagnosed by sleep study.

Exclusion Criteria:

* Other causes of chronic liver disease
* cirrhosis
* less than 33% steatosis identified on magnetic resonance spectroscopy (MRS)
* Alcohol use \>2 units per day for women or \>3 units per day for men
* Intolerance to or refusal of CPAP therapy
* overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%)
* underlying sever sleepiness (Epworth scale more than 15)
* uncontrolled hypertension
* Severe heart failure (ejection fracture less than 30%)
* cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia)
* those who are commercial drivers
Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.

OBJECTIVES:

* Determine the optimal criteria for determination of ototoxicity in younger cancer patients treated with cisplatin.
* Determine the feasibility of including ultrahigh frequency and evoked otoacoustic emission testing as adjunctive measures of ototoxicity.
* Determine the feasibility and necessity of central review of audiometry data.

OUTLINE: This is a multicenter, prospective, cohort study.

Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin.

Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests before the transplantation and 4 weeks after transplantation.

PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer

  * Treatment does not need to be on a COG therapeutic study
* Planning to enroll on clinical trial ACCL0431

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior cisplatin
Establishment of the Breast Milk Database in China

Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.

The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou.

Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.

Eligibility Criteria:
Inclusion Criteria:

* Lactating mother 25 \~ 35 years old;
* Breast-feeding infants (15 \~180 days old );
* Physically healthy by self-evaluation;
* Does not smoke;
* Does not drink alcohol;
* Have given birth to physically healthy infants;
* Signed the informed consent forms.

Exclusion Criteria:

* Being treated for gastrointestinal symptoms;
* Suffering from mastitis;
* Suffering from infectious diseases (tuberculosis, viral hepatitis and HIV infection);
* Suffering from cardiovascular disease;
* Suffering from metabolic diseases (such as diabetes);
* Suffering from mental system diseases;
* Suffering from cancer and other malignant diseases;
* Having history of taking antibiotics;
* Not able to answer the study questions;
* Participating in any nutritional or pharmaceutical intervention study recently.
Differences Between Breastfed and Formula Fed Infants

This study will help us learn how a child's diet affects growth and development.

This study will see how infants diet affects their growth and development. Up to 170 infants will be enrolled for one visit.

Eligibility Criteria:
Inclusion Criteria:

* Exclusive breast feeding or cow milk formula feeding during the first 3 months of life.
* For formula feeders, exclusively on Similac Advance Formula for at least 1 month prior to visit
* Age 2.5-3.5 months

Exclusion Criteria:

* Infants born to mother with preexisting medical conditions.
* Infants born to mother with medications during pregnancy known to influence fetal growth.
* Infants born to smoking, alcohol drinking or drug use mothers during pregnancy.
* Preterm
Tissue Alterations in Aggressive and Chronic Periodontitis

Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts. Investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.

Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points in the etiopathogenesis of aggressive periodontitis. The existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction. However, the incidence of progression of the disease to the unaffected teeth was not demonstrated. Yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis. Present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.

Eligibility Criteria:
Inclusion Criteria:

Age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; For healthy individuals, the existence of oral health

* For localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
* For chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.

Exclusion Criteria:

* Patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, previous antibiotic use, previous periodontal therapy, the existence of any systemical disease.