cyrilzakka/clinical-trials huggingface dataset:
Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the gastroesophageal junction.
* Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
* Eastern Cooperative Oncology Group (ECOG) performance status≤2.
* Informed consent obtained.

Exclusion Criteria:

* Combined with other malignant tumors.
* Eastern Cooperative Oncology Group (ECOG) performance status\>2.
* Combined with severe organ dysfunction.
* Pregnancy
The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.


Eligibility Criteria:
Inclusion Criteria:

* Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT)
* Age≥18

Exclusion Criteria:

* Intubated patients upon arrival
* Time from stroke symptoms onset \> 24h
* Patients post treatment (tPA of EVT)
* Patient in acute psychosis state
* Patients who do not speak Hebrew as their mother tongue
LMWH to Prevent Preeclampsia and Fetal Growth Restriction

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

Eligibility Criteria:
Inclusion Criteria:

* Previous severe preeclampsia
* Previous severe fetal growth restriction
* Heterozygous Factor V Leiden
* Heterozygous G20210A prothrombin gene mutations

Exclusion Criteria:

* renal disease
* chronic hypertension
* preexisting diabetes mellitus
* homozygosity for Factor V Leiden
* homozygosity for prothrombin G20210A mutation
* hyperhomocysteinemia
* protein C deficency
* protein S deficency
* antithrombin deficiency
* positive anticardiolipin antibodies
* positive lupus anticoagulant
Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Oxygen is required for an optimal muscle function. In patients with diabetes mellitus, hyperglycemia can cause vascular complications. The endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. Besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen.

Both conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning.

In this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.

The investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (I) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (II) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (III) healthy persons. Diabetes mellitus will be defined by the guidelines of the American Diabetes Association (ADA).

The examinations for this study consist of a blood pressure assessment, Flow Mediated Dilatation (FMD)-measurement, and a handgrip exercise test. The protocol will take approximately 2 hours.

The investigator who performs the FMD-test followed a course and passed thorough evaluation.

The blood pressure assessment will be continuously for 20 minutes to avoid large bias.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* age 18-85 years old
* diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants

Exclusion Criteria:

* other types of diabetes mellitus than type 1 or type 2
* alcohol abuse
* active cancer
* pregnancy
mHealth Medication Safety Intervention

TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipient between 6 and 36 months post-transplant
* At least 18 years of age
* Transplant MD agrees that patient is eligible to participate

Exclusion Criteria:

* Multi-organ recipient
* Patient is incapable of:
* Measuring their own blood pressure and glucose (if applicable)
* Self-administering medications
* Speaking, hearing and reading English
* Utilizing the mHealth application, after training
High Dose CHOP in Lymphoma

The study hypothesis is that intensification of CHOP by dose escalation of the most active drugs in the combination will improve treatment outcome. Patients with diffuse large-cell lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2 which is 4 times the atandard one. Only 4 cycles are given.


Eligibility Criteria:
Inclusion Criteria:

* large-cell non-Hodgkin's lymphoma
* IPI low-intermediate, high-intermediate and high or bulky mediastinum
* age 18-65

Exclusion Criteria:

* previous treatment for lymphoma
* serious concurrent systemic disease
E7070 in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors. II. Assess the qualitative and quantitative toxicity in terms of predictability, duration, intensity, onset, reversibility, and dose relationship of this treatment regimen in this patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the pharmacokinetics of this treatment regimen in these patients. V. Determine any possible antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor not amenable to standard therapy No brain tumor involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN for liver metastases) Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active bacterial infections (e.g., abscess or fistula) No other nonmalignant disease that precludes protocol therapy No history of alcoholism, drug addiction, or psychotic disorders that would prevent compliance No glaucoma Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy except for localized palliation Surgery: Not specified Other: No other concurrent investigational drugs or antitumor drugs No sulphonylureas or anti-arrhythmic agents
3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion

Rationale: Osteoarthritis (OA) is mainly characterized by cartilage degeneration. In knee OA, measuring the distance between the tibia and femur, known as the joint space width (JSW), is an often-used method to quantify the progression of the disease or the effectiveness of treatments, because it is an indirect measure of cartilage degeneration. However, JSW is often measured while the patient is standing (weight-bearing) with slightly flexed knees, with a flexion angle of around 7-10 degrees, while direct cartilage thickness measurements are usually performed while the patient is lying down (non-weight-bearing) with an extended leg \[1\]. Because of this difference in positioning, it is difficult to compare different JSW and cartilage thickness measures, as it is not clear what happens with the JSW distribution in the joint when a patient changes position between weight-bearing/non-weight-bearing and flexion/extension. In this study, we aim to identify the changes that occur in the knee of OA patients under the influence of weight-bearing and/or flexion, to enable comparing joint space measures from different positions. In this research we want to use MRI as a three-dimensional imaging technique because there is no radiation involved..

Objective: To evaluate how the 3D knee joint space distribution in knee OA patients changes under the influence of weight-bearing (upright) and flexion MRI scanning.

Study design: Explorative cross-sectional study. Study population: 21 patients with symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) are included from the orthopaedics department of Medisch Spectrum Twente in Enschede.

Main study parameters/endpoints: The primary study parameter is the change in medial joint space width between the different positions (weight-bearing/non-weight-bearing and flexion/extension).


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic knee osteoarthritis in at least one knee
* \> 18 years old
* Kellgren-Lawrence grade (severity) 2 or 3
* Good knowledge of the Dutch language
* Signed informed consent

Exclusion Criteria:

* Previous surgery in (both) symptomatic knee(s)
* Inability to stand for 15 minutes, without assistance
* Unable to fit knee in the MRI coil (knee width \> \~15 cm)
* Not eligible for MRI, in response to the MRI safety checklist
The Effects of Pain Neuroscience Education in a Spanish-Speaking Population

Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown to alter beliefs among middle school children. This study plans to assess the effects of PNE within a group of Spanish-speaking individuals.

Chronic pain is a topic of discussion that is becoming increasingly prevalent among healthcare professionals. With the ever-growing opioid epidemic, there are a variety of discussions on different modes of treatment other than opioid prescription. Pain neuroscience education, or PNE, is one of these alternative treatment options. PNE focuses on a patient's understanding of pain itself and relates this to the current pain they are experiencing. PNE is often a discussion between provider and patient that utilizes a series of stories, metaphors, and examples where pain is described from a point of view that is not strictly medical. Recent literature suggests there is a lack of knowledge regarding pain in the United States, particularly in the Spanish-speaking population. This population is also less likely to seek a physician's advice for pain management. For these reasons, this study will focus on the Spanish-speaking population within the Winchester community. Due to success within prior PNE studies, this study will be conducted through a classroom lecture. The overarching purpose of this study is to examine the change in knowledge of pain in the Spanish-speaking population immediately following a PNE lecture composed of stories, metaphors, and examples about pain. Because Spanish-speaking individuals are less likely to seek out a medical provider, the study may support an additional treatment option for managing chronic pain. Not only will this provide further research to support the benefits of PNE, but there is the potential to modify a participant's perception of their own pain through this educational lecture.

Eligibility Criteria:
Inclusion Criteria:

* Participants must speak Spanish at least 50% of the time at home OR Spanish must be the first language learned. Participants must also be willing to sit and listen to lecture and fill out quiz before and after.

Exclusion Criteria:

* Any individual under the age of 18 will be excluded from the study.
A Study of HR19024 in Subjects With Advanced Solid Tumor

To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor


Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histologically confirmed advanced solid tumor
3. Life expectancy of greater than or equal to (\>=) 12 weeks
4. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
5. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Subjects with unresolved toxicity （\> CTCAE G1）of prior therapy at the time of enrolment
2. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hepatic function
* Adequate renal function
* Adequate bone marrow function
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Able to understand and complete study-related questionnaires
* Anticipated life expectancy \>12 weeks

Key Exclusion Criteria:

* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
* Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway)
* Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (\>6 months) in adjuvant setting.
* Untreated or active brain metastases or spinal cord compression
* Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810

Other protocol-defined inclusion/exclusion criteria will apply
Association Study to Evaluate TFPI Gene in CAD in Han Chinese

The cases were hospitalized patients from two medical centers in Beijing and Harbin respectively. Venous blood was collected by standard vein puncture in fasting condition.

In our study, the CAD was defined by one of the following criteria: (1) based on World Health Organization criteria in terms of elevations of cardiac enzymes, electrocardiography (ECG) and clinical symptoms (angina, chest pressure, or shortness of breath); (2) angiographic evidence of more than 50% stenosis in one or more major coronary arteries; (3) previous history of PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft). The controls were selected from the two medical centers meeting the following criteria: (1) with no family history for CAD; (2) no clinical symptoms for CAD; (3) resting ECG showed normal results. The subjects with two or more risk factors of CAD (age\>45 for man and \>55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms. Those with history of cardiomyopathy, valvular disease, peripheral vascular disease, stroke, severe hepatic and kidney deficiency were excluded in our study.

Venous blood was collected by standard vein puncture in fasting condition. Four single-nucleotide polymorphisms (SNPs) (rs7586970, rs6434222, rs10153820 and rs8176528) were detected with polymerase chain reaction-direct sequencing method. And the genotypes of these SNPs were determined in both CAD patients and non-CAD controls.

Eligibility Criteria:
Inclusion Criteria:

The coronary artery disease was defined by one of the following criteria-(1) based on World Health Organization criteria in terms of elevations of cardiac enzymes, electrocardiography (ECG) and clinical symptoms (angina, chest pressure, or shortness of breath); (2) angiographic evidence of more than 50% stenosis in one or more major coronary arteries; (3) previous history of PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft).

The controls were selected from the two medical centers meeting the following criteria: (1) with no family history for CAD; (2) no clinical symptoms for CAD; (3) resting ECG showed normal results. The subjects with two or more risk factors of CAD (age\>45 for man and \>55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms.

Exclusion Criteria:

* Those with history of cardiomyopathy, valvular disease, peripheral vascular disease, stroke, severe hepatic and kidney deficiency were excluded in our study.
Group Counseling for Smoking Cessation

The purpose of this study is to evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings.

The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup.

Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate.

Eligibility Criteria:
Inclusion Criteria:

* Regular daily smokers interested in quitting

Exclusion Criteria:

* Significant suicidal ideation
Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

1. Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
2. Research center: Single-center study.
3. Design of the research: A prospective and cohort study.
4. Object of the research: Patients with age≥18 years those who meet the diagnostic criteria of sepsis 3.0 complicated with GI and grouped into GI group and non-GI adults as control.
5. Sample size of the research: Not less than 30 patients in each group.
6. Research approach: After admission to ICU, patients were assigned to the indicated groups according to the criteria. In addition, blood samples were collected within 24 hours for detecting serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers.For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained.
7. Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients.
8. Statistical analysis: Analytical study.
9. The estimated duration of the study#1-2 years.

This study is a single-center, prospective, cohort study. In this study, the serum samples of septic patients complicated with or without GI are detected. The serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers are compared in different groups. For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained. Meanwhile, the clinical symptoms, intestinal motility indicators and intestinal barrier indicators are recorded. In addition, a biomarker model was established to provide important reference for diagnose and management of gastrointestinal dysfunction in septic patients.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Patients with sepsis who meet the criteria for sepsis 3.0
3. Patients complicated gastrointestinal dysfunction with AGI grade II or above
4. Agree to participate in this study and sign informed consent

Exclusion Criteria:

1. Refuse to participate in this study
2. Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
3. Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
4. Those who are participating in other drug clinical trials
5. Patient with HIV infection, patients in pregnancy or breast stage
6. In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study