cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer

It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
2. Male or female patients between the ages of 18-75;
3. Patients diagnosed as gastric adenocarcinoma by histology or cytology;
4. Stage: Locally advanced stage (T3-4aN1-3M0);
5. Have not received other immunotherapy drugs or chemotherapy drugs in the past;
6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
7. Has sufficient organ and bone marrow function

Exclusion Criteria:

1. Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\];
2. A distant metastasis occurs;
3. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
4. Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
5. Patients with any severe and/or uncontrollable disease；
6. Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
7. Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
8. Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
9. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
10. Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
11. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
12. Participated in other anti-tumor drug clinical trials within four weeks;
13. According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
14. Female patients who are pregnant or breastfeeding;
15. Known hypersensitivity to any study drug.
Serum Adiponectin in Chinese Population and Its Correlation to Cardiovascular and Cerebrovascular Diseases

Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to these diseases.

Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes, anti-inflammatory, vascular protective, and anti-ischemic properties. Since its 1995 discovery, Ad has garnered considerable attention for its role in diabetic and cardiovascular pathology. Clinical observations have demonstrated the association of hypoadiponectinemia in patients with obesity, cardiovascular disease, and insulin resistance. There is growing evidence supporting Ad can act as a novel risk factor for cardiovascular and cerebrovascular injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to cardiovascular and cerebrovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* available for 5 years of follow-up study

Exclusion Criteria:

* Death caused other than cardiovascular and cerebralvascular diseases till the study ends
* Floating Population
* Pregnancy, lactation, or child bearing women
* Tumor
* Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
* Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
* Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"

The purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.

The drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat people with untreated CD30-positive Hodgkin's lymphoma.

This survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma patients on concomitant brentuximab vedotin and AVD in the routine clinical setting. The planned number of observed patients will be approximately 100.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

1. Untreated participants
2. CD30-positive participants
3. Participants on concomitant Brentuximab vedotin and AVD

Exclusion Criteria:

1. Participants contraindicated for Brentuximab vedotin
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults

This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults

This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.

Eligibility Criteria:
* Inclusion Criteria:
* Provide written informed consent before any study assessment is performed.
* Male or female at least 18 years of age at screening.
* Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
* Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
* The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
* Exclusion Criteria:
* Diagnosis of psoriasis at screening is not chronic plaque psoriasis
* Severe infection or systemic infection before baseline
* There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
* Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
* The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
* Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
* There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
* Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
* Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
* Women who are pregnant or breastfeeding at screening or at baseline
* The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
Implementation of Nutrition Education Videos for Patients Undergoing Radical Cystectomy

By doing this study the investigators hope to learn if educational videos focusing on nutrition for bladder cancer patients are a good and effective way to help people improve their nutrition and recovery after radical cystectomy (RC).

Bladder Cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is chemotherapy followed by RC. Patients undergoing this surgery are at risk for complications. Being malnourished can increase the risk of mortality by three times. The patients also suffer from taste alterations after chemotherapy and gastrointestinal disturbances such as diarrhea and constipation. These can lead to poor nutritional intake and malabsorption of nutrients.

This study is being done to develop an educational video series for patients undergoing RC and assess their impact. The videos are created to address the nutritional needs of these patients and improve their outcomes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bladder cancer and scheduled to undergo a radical cystectomy or has undergone a radical cystectomy OR be the caregiver of a patient diagnosed with bladder cancer who is scheduled to undergo a radical cystectomy or has undergone a radical cystectomy

Exclusion Criteria:

* 1. Patients who are under 18 years old are not allowed to participate
The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness

Mammography screening has limited performance in young women or women with dense breasts although it is the only proven method for breast cancer screening that reduces the mortality. The investigators propose a multicenter trial of breast cancer screening to assess the effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.

The investigators will screen same consecutive participants using both methods; digital mammography plus supplemental ultrasonography (intervention arm) and digital mammography only (control arm) for 5 years. The investigators will collect follow-up information by assessment of screening records, questionnaire, and official cancer registry. The primary outcome will be sensitivity, specificity, recall rate, cancer detection rate and stage distribution at the end of first round of screening. The secondary outcome will be cost-effectiveness and cost-utility of digital mammography with ultrasonography versus digital mammography only for breast cancer screening. It is hoped that the results of this trial will provide guidance of effective breast cancer screening strategy to women aged 40-59, especially with dense breasts.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 40-59 years
* No history of any cancer
* No breast mammography (and ultrasonography, in case of intervention arm) after the introduction of digital mammography

Exclusion Criteria:

* Interstitial injection
* Women with history of any cancer
Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children

The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.

Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin.

This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete.

In the last few years a new product licensed as "BLIS K-12" has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011.

This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children.

So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects.

The investigators will be giving BLIS K-12 to those children on the trial on a daily basis for 6 autumn-winter months instead of Penicillin and will monitor the children by monthly throat swabs. The investigators will also obtain Anti Streptolysin blood test at the end of the period from all participants to evaluate possible Strep encounters.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatic heart disease with recommended strep prophylaxis

Exclusion Criteria:

* less than one year from first diagnosis
* refusal to take the tablets
Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE

Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. So the investigators will investigate association between sRAGE and FDG-PET uptake in large artery in healthy patient.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis od type 2 DM

Exclusion Criteria:

* Type 1 DM
* Gestational Diabetes
* Severe Liver or Renal disease
* Diagnosis of cancer
* Trauma
* Acute infection or inflammatory disease
* Acute vasculitis or history of vasculitis
* Pregnant or Lactating women
* Dyslipidemia(active state)
* Cardiovascular disease or history of CVD
* Chronic obstructive pulmonary disease
* Any patient by judge of investigator
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer

The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Plan to receive or has received Trastuzumab Deruxtecan monotherapy
4. Available medical history.

Exclusion Criteria:

1. Incomplete medical history.
2. Pregnancy or breast-breeding
Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients

Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke

Exclusion Criteria:

* transferred from another hospital and body temperature \< 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.
Pharmacokinetic Effects of Oral DMAA

1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within "party pills," often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.


Eligibility Criteria:
Inclusion Criteria:

* must be able to swallow pill

Exclusion Criteria:

* self-reported cardiovascular or metabolic problems
* current smokers
Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women

The main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. Forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by DXA in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. The investigators will collect data on: 1) bone (vitamin D) and muscle (myokines) metabolisms through blood sampling; 2) Risk of fall by the OAK device produced by Khymeia; 3) thigh muscle quality through MR.

A grave change associated with human ageing is progressive decline in skeletal muscle mass, a downward spiral that may lead to decreased strength and functionality. The term 'sarcopenia' (Greek 'sarx' or flesh + 'penia' or loss) has been proposed to describe this age-related decrease of muscle mass. Sarcopenia represents an impaired state of health with increased risk of falls and fractures, impaired ability to perform activities of daily living, and loss of independence. The imaging technologies used to detect loss of skeletal muscle mass in sarcopenia include: dual X-ray absorptiometry (DXA), magnetic resonance imaging (MR), computed tomography, peripheral quantitative computed tomography, and ultrasound.

The main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. Forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by DXA in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. Data will be collected on: 1) bone (vitamin D) and muscle (myokines) metabolisms through blood sampling; 2) Risk of fall by the OAK device produced by Khymeia; 3) thigh muscle quality through MR.

A secondary outcome is to evaluate the differences in bone and muscle metabolism, risk of fall, and muscle quality between sarcopenic and non-sarcopenic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Female.
* Aged over 60 yo.
* Classified as osteoporotic with t-score = or \< -2,5 evaluated by DXA.
* Autonomous walking.
* Signed informed consent.

Exclusion Criteria:

* Male.
* Aged under 60 yo.
* Psychiatric disorders.
* Neurological pathologies.
* Endocrine disorders.
* Active cigarettes smoke.
* Recent bone fractures (6 months)
* Surgical treatments for orthopedic pathologies (6 months).
* Pacemaker carrier.
* Use of drugs influencing bone metabolism or limiting physical function.
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation

The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older
* Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia
* Willing and able to provide informed written consent
* Eligible for PCI

Exclusion Criteria:

* Patients presenting with STEMI within 2 weeks
* Bypass graft lesion
* Lesion with left main disease
* Expected length of scaffold \> 40 mm
* Bifurcation lesion requiring side branch stenting
* Small vessels \< 2.75 mm
* Stented lesion
* Suspected coronary spasm even after sufficient nitrate injected
* Cases in which the IVUS or OCT imaging catheter failed to cross the lesion
* Poor quality IVUS or OCT images
* Contraindication to dual anti-platelet therapy
* Chronic total occlusion
* Angiographically large-sized vessel (\>3.5mm of reference lumen diameter)
* Life expectancy shorter than 2 years
* Pregnancy
Circulating Epigenetics in Pancreatic Surgery

The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner


Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic cancer scheduled for the Whipples procedure

Exclusion Criteria:

* Under 18 years of age
* Pregnancy
* Unable to provide informed consent.
Build-up of Action Representation in Autism Spectrum Disorders

Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core feature is social and communications disorders. Motor skill impairments are frequently described in autism, but few studies have addressed the question of their origin and their specificity. Furthermore, it is not clear whether motor problems encountered in autism are related to dyspraxia, or if they present with specific features. This project aims at deciphering the origin of motor problems encountered by children who grow-up with autism in order to propose early interventions that could influence the other developmental trajectories, such as the social one.

Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely: proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory executive control will be correlated to brain oscillation modulation, both topographically and temporally. Two groups of children (aged between 7 and 12) are compared: a group of children with ASD and a control group of typically developing children.


Eligibility Criteria:
Inclusion Criteria:

* Control group: children aged between 7 and 12
* Case group: children aged between 7 and 12 with a diagnostic of Autism Spectrum Disorders

Exclusion Criteria:

* Control group: presence of a neurological pathology, mental retardation or language and motor developmental delay
* Case group: presence of a neurological pathology, mental retardation