cyrilzakka/clinical-trials huggingface dataset:
Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions

The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions

Ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.The aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions.

Conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. Features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. The investigators define the pathological results of EBUS-TBNA combined with results of six months follow-up as the "Gold Standard". The receiver operator characteristic curves are drawn to obtain area under the Curve (AUC) and the best diagnostic threshold values of each parameters. According to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography

Eligibility Criteria:
Inclusion Criteria:

* Hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( CT) scan and/or positron emission tomography-computed tomography (PET-CT)
* With normal Coagulation function
* With normal cardio pulmonary function and be able to tolerate bronchoscopy
* No syphilis,acquired immune deficiency syndrome(AIDS) and other infectious diseases
* Willing and able to give written informed consent

Exclusion Criteria:

* Unable to lie in bed
* Allergy to narcotics such as lidocaine.
* Suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal.
* With abnormal Coagulation function or take anticoagulant drugs within the previous week.
* Hematological abnormalities, fever or highly suspected active tuberculosis patients.
* Women in the menstrual period.
* Excessive anxiety and can not tolerate bronchoscopy.
* Other conditions that are not suitable for inclusion in the study.
miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis (TB)

The detection of miRNA (non-coding ribonucleic acid) in the blood in the context of active tuberculosis is an innovative approach to the detection of new disease-specific biomarkers.

The primary goal of this analysis is to define, for the first time, an miRNA fingerprint for tuberculosis in sweat. Samples that were collected as part of the Sweatb Study (NCT03667742) project are examined for the occurrence of disease-specific, non-coding miRNAs to define new biomarkers in the sweat. These biomarkers can be detected non-invasively and will help in the detection of patients with active tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
* In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)

Inclusion criteria Healthy Donors:

* negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria:

* Written rejection of the consent for the further use of the data
Gastric Mucosal Changes in Patients With Dermatomyositis

There are a large number of reports in the literature that patients with dermatomyositis often have various malignant tumors, and reports of gastric cancer are not rare. At present, the widely recognized gastric cancer occurrence patterns are: normal gastric mucosa-chronic superficial gastritis-chronic atrophic gastritis-intestinal metaplasia-dysplasia-gastric cancer, so the research about the gastric mucosal performance of patients with dermatomyositis is clinically meaningful


Eligibility Criteria:
Inclusion Criteria:

* 1、18-70years old，no gender limit. 2、Clinical diagnosis of dermatomyositis. 3、dermatomyositis group conform to 1 and 2，control group conform to 1 .

Exclusion Criteria:

* Contraindications for gastroscopy.

  * Past history of malignant tumors of the esophagus and stomach and or history of surgery.

    * Pregnant or lactating women. ④ Participated in other clinical studies within 3 months. ⑤Patients cannot express their main complaints correctly and cannot cooperate with the research.
Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer

NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectable NAC have been shown to reduce fatigue and improve recovery from exertion which has interesting implications for exploring cancer-related fatigue.

In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in the development and progression of breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Demographic • Females ≥18 years of age

Disease related

* Stage 0/I breast cancer by biopsy (patients may be consented and screened with suspected breast cancer, but no treatment will occur until cancer is confirmed by their biopsy).
* Awaiting surgery which will consist of either lumpectomy or mastectomy.
* ECOG performance status 0-1

Laboratory

* Laboratory values that would not prevent the patient from receiving treatment as determined by the PI or study oncologist
* Serum creatinine ≤2.0 mg/dL
* Serum bilirubin ≤2.0 X ULN
* Serum HgB ≥8.0 mg/dL

General

* Competent to comprehend, sign, and date an IRB-approved informed consent form
* Female subjects of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Disease Related

  * History or known presence of metastases
  * History of another primary cancer, except:
* Curatively treated cervical carcinoma in situ, or
* Curatively resected non-melanomatous skin cancer, or
* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≤ 3 years prior to enrollment

  * Other concurrent anticancer chemotherapy within 4 weeks as determined by the PI
  * Any co-morbid disease that would increase risk of toxicity as determined by PI

Medications/Treatments

* Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
* Recent infection requiring a course of systemic anti-infectives that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection (\[UTI\])

General

* History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
* History of bronchospasm or severe asthma as determined by the PI
* Subject unwilling or unable to comply with study requirements
* Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
* Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma

The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.

Objective The primary objective with this study is to investigate the feasibility of an internet-delivered psychological intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.

Trial design We will first pre-pilot test the intervention- and assessment procedures in five participants (no randomization) which will be followed by a randomized controlled trial with waitlist control. The wait list control group will also receive treatment after the first group has finished.

SAMPLE SIZE 5 plus 30 participants.

ENDPOINTS Self-report assessment of daily intrusions at baseline and post-treatment

SECONDARY ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at baseline (and post-treatment Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) at baseline and post-treatment.

Euroqol, EQ-5D at baseline and post-treatment.

Recruitment Self-referral. Advertising will be made through national newspapers, social media, patient organisations' and ads directed to health care units, such as emergency departments, in Sweden.

Safety parameters Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.

Data collection: Data will be collected electronically via the treatment platform and a safe app.

Main statistical analysis:

Between-group estimates on outcome are done using a mixed-effects regression model with a Poisson distribution. All analyses will be done according to intention to treat and post hoc per protocol analyses will also be conducted. The primary criterion is the estimated regression slope of daily intrusive memories between day 0-7 and day 28-35.

Eligibility Criteria:
Inclusion Criteria:

* Experienced psychological trauma according to criterium A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence) the past two months.
* Ongoing intrusive memories from this traumatic event
* ≥ 18 years
* Situated in Sweden
* Informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
* Not fluent speaking in Swedish
* Receiving CBT for trauma
* Ongoing trauma-related threat (e.g. living with a violent spouse)
A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).


Eligibility Criteria:
Inclusion Criteria

Patients must have:

Within 15 business days prior to randomization:

* CD4 cell count greater than or equal to 100 cells/mm3.
* HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Bilateral peripheral neuropathy.
* Intractable diarrhea.
* Proven or suspected acute hepatitis within 30 days prior to study entry.

Concurrent Medication:

Excluded:

- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.

Concurrent Treatment:

Excluded:

Therapy for any co-existing disease that may interfere with patient ability to participate in this study.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

* Therapy for any previous disease that may interfere with patient ability to participate in this study.
* Excluded within 14 days prior to randomization:

Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.

* Excluded within 3 months of the start of this study or expected need at time of enrollment:
* Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential.
* Inability to tolerate oral medication.

Prior Treatment:

Excluded:

Therapy for any previous disease that may interfere with patient ability to participate in this study.

Risk Behavior:

Excluded:

Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain

NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent;
* Willing and able to understand the study procedures, and comply with all study procedures;
* Females or males, age ≥ 18 years old;
* Body mass index 18-39, inclusive;
* In good general health;
* Clinical diagnosis of OA in one or both knees;
* Have been on a stable regimen of pain medication for the management of OA knee pain;
* Not experiencing adequate pain relief with their current dosing regimen;
* Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control. Male subjects must agree to use contraception.

Exclusion Criteria:

* Females who are pregnant or lactating;
* Known history of hypersensitivity, intolerance, or allergy to opioids;
* Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA;
* Presence of any medical condition that would preclude study participation in the opinion of the investigator;
* Clinically significant abnormalities of vital signs or clinical laboratory results;
* Clinically significant electrocardiographic abnormalities;
* Received systemic corticosteroids within 30 days prior to signing the consent form;
* Subjects who are known or suspected to be currently abusing alcohol or drugs;
* Positive urine drug screen, or alcohol breath test during Screening Period testing;
* Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C (anti-HCV) during Screening Period testing;
* Known to be human immunodeficiency virus (HIV) positive;
* Donation of blood or plasma within 30 days prior to signing the consent form;
* Participation in another drug or biologic study within 30 days prior to signing the consent form;
* Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns

The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.

The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Maternal decision of breastfeeding
* Born between 28 and 34 weeks of amenorrhea
* No important congenital pathology except prematurity
* Efficiency of the breastfeeding compatible with the research by the investigator
* Information and authorization of the parents or the parental authority

Exclusion Criteria:

* Maternal decision of not breastfeeding
* Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea
* Important congenital pathology
* Efficiency of the breastfeeding incompatible with the research by the investigator
* Opposition from parents or the parental authority to participate to the research study
Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection

Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection

This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of EDP1815 in patients hospitalized with COVID-19 infection.

The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related Complications (CRC)

Eligibility Criteria:
Key Inclusion Criteria:

1. Hospitalized within the last 36 hours.
2. Receiving any form of supplementary oxygen therapy at baseline.
3. Confirmed COVID-19 viral infection by RTPCR at screening.
4. Age:

   1. 18-65 years old, OR
   2. \>65 year-olds can be included after Data Monitoring Committee (DMC) approval

Key Exclusion Criteria:

1. Contraindications/hypersensitivity to P histicola or any of the capsule excipients
2. Patients with chronic hypoxia or underlying significant chronic respiratory disease (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or Bronchiectasis).
3. Admission to ICU at time of screening.
4. Mechanically ventilated, on continuous positive airway pressure (CPAP), or on non-invasive ventilation at the time of screening.
5. Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of COVID standard of care treatment.
6. Patient has a diagnosed primary immunodeficiency.
7. Patient has a diagnosis of HIV/AIDS
8. Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (eGFR) \<30ml/min/1.73m2)
9. Patient has pre-existing known significant liver disease with Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)
10. Patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with GI delivery and transit time.
11. GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or 4 event.
12. Patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to Screening.
13. Currently participating in an interventional clinical trial (observational studies allowed).
14. Moribund at time of screening
Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures + BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee

The study consists of 3 phases (Identification of eligible patients, follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients):

* Identification by trained medical personnel of subjects who meet the study inclusion criteria.
* Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted.
* Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged between 18 and 75 years;
* BMI up to 30 kg/m2;
* Patients without subsequent surgery on the patellofemoral cartilage of the knee undergoing treatment;
* Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
* Signature of informed consent
* availability
* Competent patients

Exclusion Criteria:

* Patients no longer available;
* Patients who do not agree to undergo assessment;
* Deceased patients
A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors

Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
4. Subjects volunteered to participate in this clinical trial and signed informed consent.

Exclusion Criteria:

1. PEG-rhG-CSF was used in the current chemotherapy cycle;
2. Have received hematopoietic stem cell transplantation or bone marrow transplantation;
3. Other drug clinical trials are currently underway.
Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer

A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* age 45-75years old
* Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
* The patients have not received the surgery or chemo-radiotherapy.
* Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
* ALT、AST≤2.5\*N,Cr≤1.5\*N.
* performance status score 0-2

Exclusion Criteria:

* pregnant, lactating women
* Oxaliplatin or fluorouracil Allergy or metabolic disorders
* Radiotherapy contraindications
* History of organ transplantation
* Brain metastasis
* The peripheral nervous system disorders
* Severe infection
* Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
* Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
* Other malignant tumor in recent 5 years.