cyrilzakka/clinical-trials huggingface dataset:
CXCL10 As a Biomarker Of ILD in Patients WithRA

Rheumatoid arthritis is a chronic inﬂammatory disease that affects the joints, causing symmetric pain, stiffness, swelling, and limited motion and function of multiple joints, its ﬁbro inﬂammatory manifestations may develop in other organs.

Rheumatoid arthritis is complicated by lung manifestations, such as interstitial lung disease which is the most common cause of morbidity and mortality in rheumatoid arthritis patients. Rheumatoid arthritis-interstitial lung disease is a progressive fibrotic disease of the lung parenchyma that includes a broad spectrum of disorders such as nonspeciﬁc interstitial pneumonia, usual interstitial pneumonia , desquamative interstitial pneumonia, cryptogenic organizing pneumonia, diﬀuse alveolar damage, acute interstitial pneumonia, and lymphocytic interstitial pneumonia . Rheumatoid arthritis-interstitial lung disease in which available data indicate that dysregulated inflammatory cascades can elaborate a host of cytokines, chemokines, and growth factors that collectively promote epithelial and endothelial cell damage, angiogenesis, fibroblast differentiation/proliferation, and lung fibrosis . Given the clinical implications of putative signaling cascades involved in these processes, biomarkers that can be used to clarify disease pathogenesis and identify factors governing disease progression are clearly needed .

Eligibility Criteria:
Inclusion Criteria:

1. Adult rheumatoid arthritis patients who fulfilled the 2010 American College of Rheumatology/European league against rheumatism criteria for the classification of Rheumatoid Arthritis.
2. Adult rheumatoid arthritis patients with interstitial lung disease.

Exclusion Criteria:

1. Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis and inflammatory bowel disease).
2. Individuals with hepatitis, Rhinovirus infection, cerebral malaria.
3. Individuals with colorectal carcinoma, syndrome of frailty, vetiligo.
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk per criteria.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
Effects of Sodium Bicarbonate Supplementation on Intermittent and Intense Task

The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. Each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3 g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered: electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to verify possible differences between groups.


Eligibility Criteria:
Inclusion Criteria:

* resistance trained men (minimum 12 moths resistance training experience)

Exclusion Criteria:

* diabetes mellitus;
* respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;
* acid-base balance disorder;
* continuous use of some type of medication;
* use of high-protein supplementation and creatine supplementation;
* users of anabolic steroids.
Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement

The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.

Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
2. Preoperative clinical TNM stage：cT1b-3N0-1M0;
3. Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
4. No evidence of suspicious neck lymph node metastasis (LN short diameter \< 0.8cm or LN short/long diameter \<0.65 by cervical CT and/or ultrasound);
5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail

Exclusion Criteria:

1. Previous use of anti-cancer therapy;
2. Preoperative clinical TNM stage: N2-3 or M1;
3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
4. Previous malignancy history.
5. Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
6. Unwilling to participate the clinical trial and refuse to sign informed consent.
NCGENES: North Carolina Clinical Genomic Evaluation by NextGen Exome Sequencing

This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. This sub-project is investigating benefits and harms of providing WES diagnostic and different types of incidental findings to adult patients and parents of pediatric patients who undergo WES because they have symptoms suggesting genetic disease.

This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. Participants are patients who were either seen in the University of North Carolina Cancer and Adult Genetics Clinic or referred to the study by their physician. They will be approached by their physician or a genetic counselor for recruitment. Once enrolled, a clinical geneticist or genetic counselor will obtain consent and collect blood samples to be analyzed using WES. Results may include information related to a diagnosis and incidental information. Medically actionable incidental findings will be CLIA (Clinical Laboratory Improvement Amendments)-certified and returned to participants in a routine genetic counseling session, along with diagnostic findings. Eligible adult participants will be randomized to have the opportunity to choose to get certain types of non-medically actionable incidental findings, as well. Their decisions will be investigated, as will psychosocial and behavioral responses to sequencing and receiving sequencing information. This is a longitudinal, mixed methods study (i.e., multiple assessments pre- and post-return of results, with both quantitative and qualitative methods used to gather data). Because only the quantitative component of the study uses randomization, only measures and procedures associated with that component are described here.

Eligibility Criteria:
- To receive whole exome sequencing in the study, adult or child patients must have a significant chance of having a genetic disorder, as determined by experts on the study team using criteria that depend on the genetic disorder in question. Representative criteria are listed below and will be considered together to determine whether patterns indicate a likely genetic etiology.

Cancer

* Age of diagnosis
* Presence of bilateral (or multiple) cancers
* Diagnosis of a rare type of cancer
* Details of the family history

Cardiovascular Conditions

* Certain clinical findings, such as prolonged QT interval on electrocardiogram.
* Presence of hypertrophic cardiomyopathy or aortic aneurysm
* Age of diagnosis
* Presence of family history

Pediatric neurodevelopmental disorders

* Specific brain structural brain abnormalities
* Presence of certain seizure types
* Dysmorphic features
A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma

This study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of 610 in adults with severe eosinophilic asthma. Plan to recruit 24 subjects, and the subjects divided into 3 groups: 610 30mg group，100mg group, 610 300mg group，8 subjects in each dose group, of which 6 received the trial drug and 2 received placebo. The study is divided into screening period of 2 weeks, treatment period of 32 weeks and follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with asthma for ≥12 months
* Within 3 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily.）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
* In the past 12 months prior to screening， at least one time asthma exacerbations history
* Pre-bronchodilator FEV1 \<80% predicted value
* Asthma-related blood eosinophils ≥ 150 cells/μL within 3 months before administration

Exclusion Criteria:

* With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
* With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
* In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
* with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
* poorly controlled systemic disease
* Active infection 7 day before screening
* Parasitic infection within 6 months before screening
* At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
* Subjects who have received any monoclonal antibody treatment of anti IL-4Ror anti-IL-5/5R
* Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
* Participated in any interventional clinical trial and received intervention within 3 months before screening
Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation

The purpose of this study is to evaluate the safety and efficacy of the combination of donafenib and TACE in the perioperative period of liver transplantation.

This study plans to enroll about 20 patients with hepatocellular carcinoma (HCC) who do not meet the UCSF standard, they will receive donafenib combined with TACE in downstaging period and donafenib only in adjuvant period.

Before the liver transplantation, the safety and efficacy will be evaluated every 3 and 6 weeks, respectively, until liver transplantation or the disease progression that couldn't be treated by TACE.

After transplantation, the safety and efficacy will be evaluated every 6 and 12 weeks, respectively, until intolerable toxicity, recurrence or up to 12 months treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HCC either by biopsy or according to AASLD criteria;
2. At least one measurable lesion according to mRECIST;
3. The previous palliative TACE treatment did not exceed one time, with an interval of ≥ 6 months; For patients who had received one prior TACE treatment, the treated lession progressed or lipiodol deposition was less than 50%;
4. Child-Pugh class ≤ 7;
5. ECOG Performance Status 0-1;
6. Intrahepatic tumors meet any of the following conditions:

   * Beyond the UCSF standard, no more than 5 intrahepatic tumors with the longest diameters ≤ 10cm, no tumor thrombus in the main portal vein
   * Meet the UCSF standard, but AFP \> 1000 ng / ml

Exclusion Criteria:

1. The pathological diagnosis was hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed type or fibrous lamellar hepatocellular carcinoma;
2. There were inferior vena cava cancer thrombus, hepatic vein cancer thrombus, regional lymph node invasion or extrahepatic metastasis;
3. HCC recurred within 2 years after radical resection or ablation;
4. Patients who have received prior liver transplantation, ≥ 2 times of palliative TACE or other palliative local treatment (including HAIC, radiotherapy, etc.), but who have received prior radical hepatectomy, radical ablation and preventive TACE for the purpose of anti-recurrence can be enrolled;
5. Prior or ongoing systemic therapy (including systemic therapeutic drugs under research, excluding antiviral therapy), including but not limited to TKI such as sorafenib, lenvatinib, regofinib, apatinib, and ambrotinib, PD-1 / PD-L1 monoclonal antibody or immunotherapy against PD-1 / PD-L1, etc;
6. There are contraindications to TACE determined by the investigators (e.g., portal vein trunk obstruction without formation of collateral vessels, etc.);
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia

The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
* Signed informed consent

Exclusion Criteria:

* Severely reduced systolic ejection fraction of the left ventricle (EF \< 35 %)
* Severe renal impairment (eGFR \< 30ml/min/1.73m2)
* Severe chronic obstructive pulmonary disease (GOLD D)
* Contraindication for application of papaverine or regadenoson
Fluoxetine in Pediatric Body Dysmorphic Disorder

This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female children and adolescents aged 16 and younger
* BDD or its delusional variant present currently and for at least 6 months prior to the study
* Ability to communicate meaningfully with the investigators and competent to provide written assent

Exclusion Criteria:

* Presence of Schizophrenia or Bipolar Disorder
* Recent suicide attempt or suicidal ideations that warrant hospitalizations
* Previous allergic reaction to fluoxetine
* History of a seizure disorder
Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)

Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be evaluated for the treatment of common warts.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 and 65 years of age, inclusive
* Subjects presenting with at least one verruca vulgaris (common cutaneous, plantar, and periungual) warts for at least 4 weeks, but no more than 3 years
* Subject's common warts for treatment must measure between 3 and 20 mm and be located on hands, feet, limbs and/or trunk. A maximum of four (4) cutaneous single warts or one (1) area of clustered or adjacent warts up to 80 mm will be treated

Exclusion Criteria:

* Genital warts may not be selected as target warts
* Subjects that are immuno-compromised
* Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function
Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving Psoriasis Area and Severity Index (PASI).

Human amniotic membrane extra-cellular matrix was purchased from National center for radiation research and technology, Egypt, under commercial name REGE pro gel.

Eligibility Criteria:
Inclusion Criteria:

* patients have psoriasis lesion

Exclusion Criteria:

* must stop other line of treatment
Prediction of COPD Severity Using Electrical Impedance Tomography

The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD.

Methods: By collecting pulmonary function data, CT visual scores, and EIT data, and employing deep machine learning algorithms to compare the predictive capabilities of EIT and PFT for CT visual scores of pulmonary emphysema, this study aims to validate the ability of EIT to assess the progression of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
* Age \> 20 years, and be able to communicate with doctors.
* Willing to sign informed consent for the course of the study.

Exclusion Criteria:

* Patient refusal of EIT examination.
* The CT scan information is incomplete, and the interval between the pulmonary function test and the CT scan is more than 180 days.
Oral Nicotine Pouch Marketing Features Influence on Perceptions

This study tests the effects of three oral nicotine marketing features on product perceptions.


Eligibility Criteria:
Inclusion Criteria:

* Live in the US
* For youth age \<21: Never used any nicotine pouch
* For adults: Smoked greater than or equal to 100 cigarettes in during lifetime
* For adults: Currently smoke some or all days
* For adults: No regular use of oral nicotine pouches
* For adults: No past 30-day pouch use

Exclusion Criteria:

* Do not live in the US
* For youth age \<21: Ever used nicotine pouches
* For youth age \<21: Greater than or equal to 100 lifetime uses of any other nicotine or tobacco product
* For adults: Smoked \<100 cigarettes in life
* For adults: Does not currently smoke some or all days
* For adults: Regular use of oral nicotine pouches
* For adults: Past 30-day pouch use