cyrilzakka/clinical-trials huggingface dataset:
Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study

Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders.

Primary purpose:

To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation

Secondary purposes:

* To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy
* To study markers of cancer stem cells
* To correlate clinical and molecular markers with patient survival and quality of life questionnaires
* To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers.
* To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.
* To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients


Eligibility Criteria:
Inclusion Criteria:

Gastric adenocarcinoma (any location) or cardia adenocarcinoma

* Age\> 18 years
* WHO Index≤ 3
* Subject having signed an informed consent

Exclusion Criteria:

* Other cancers undergoing chemotherapy treatment
* Pregnant or breastfeeding
* Inability to understand information (understanding with difficulties ...)
Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami

Childhood asthma is the most common chronic respiratory disease in childhood. The essence of asthma is chronic airway inflammation and airway hyperresponsiveness.The physiological characteristics of children and adults are very different, and the compensatory ability is very strong. There are often no obvious symptoms at the early stage of attack, or only intermittent or persistent cough of different degrees, without typical chest tightness and asthma.However, at this time, certain physiological indicators such as blood oxygen, heart rate, respiratory rate may have been significantly abnormal.If the disease continues to deteriorate and progresses to decompensation, it can quickly move from an asymptomatic state to a failure stage.Therefore, dynamic and accurate acquisition of real-time vital signs and assessment is of great significance for early warning and improvement of prognosis of asthma attacks in children.Intelligent wearable devices can be used to acquire real-time physiological index data of users, such as heart rate, blood oxygen, exercise and sleep dynamic data.An in-depth analysis of long-term and multi-scene dynamic data before and after asthma attacks can establish an early warning model for children with acute asthma attacks by wearable wrist smart devices, which may provide important help for severity assessment, follow-up tracking and out-of-hospital prevention and control of the disease.

this project is selected 200 cases of children with asthma diagnosis definitely, collection and heart rate, blood oxygen, exercise and sleep dynamic data, followed up for 3 to 6 months (at least 3 months), records of clinical asthma attacks and clinical data, through the cloud data analysis and deep learning, analysis of children with asthma attacks and multiple physiological parameters (heart rate, blood oxygen, movement and the dynamic data of sleep, etc.), the connection between the building of asthma early warning and illness severity hierarchical evaluation model.Then choose 200 cases of diagnosis in clinical practice to determine follow-up, patients with asthma children to observe to verify the exactness of the model of asthma attack early warning, and according to the collected data to further improve, calibration model, designed to provide children with family members and medical personnel of an asthma attack warning and follow-up management wearable auxiliary equipment and management platform.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of asthma.

Exclusion Criteria:

Severe chronic diseases with organ dysfunction and dyspnea.
Mechanisms of Human Plasticity in the Human System

The purpose of this study is to investigate the physiology associated with plasticity of the motor system. Plasticity refers to the process by which neighboring brain cells assume the responsibilities of damaged or diseased brain cells.

The mechanisms behind this process are unknown. However, researchers have several theories about how plastic changes take place. Possible explanations include the growth of new connections between brain cells and the use of previously unused connections.

Researchers plan to use transcranial magnetic stimulation and drug intervention in order to determine the mechanisms responsible for specific types of plasticity.

Previous studies have shown that certain drugs can affect the mechanisms involved in these changes. By using one drug at a time, researchers plan to evaluate the role of each of several different mechanisms in brain reorganization.

The purpose of this study is to investigate the physiology associated with plasticity of the motor system seen in a number of different circumstances. Techniques used will involve the combination of transcranial magnetic stimulation (TMS) and pharmacologic interventions. We propose to use drugs judged to be safe, that either potentiate GABA related intracortical inhibition, change presynaptic release of excitatory aminoacids like glutamate, or decrease the activity of the NMDA receptors (mostly antiepileptic drugs). If plastic changes expressed as larger motor maps or motor evoked potentials (MEP) to TMS are secondary to intracortical disinhibition, administration of a drug that potentiates intracortical inhibition may result in decreased plasticity and smaller motor maps or MEP. This finding would then identify intracortical disinhibition as the mechanism responsible for this type of plasticity. Similarly, if plastic changes decrease with a drug that inhibits release of excitatory aminoacids, or that antagonize the action of NMDA receptors, the mechanism underlying plasticity is likely to be mediated by modulation in the release of excitatory aminoacids or activity in NMDA-receptors.

Results from this study will then provide information about the relative involvement of intracortical disinhibition, modulation in the release of excitatory aminoacids, and role of NMDA receptors in different settings of human plasticity.

Eligibility Criteria:
Must be over 18 years of age.

Must not have personal history of seizures, loss of consciousness, hypertension, psychosis, heart conditions or allergies to any of the drugs.

Women must not be nursing or pregnant.

Patients may have amputations, spinal cord injuries, blindness or large hemispheric lesions from stroke.
Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease

Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non invasive methods documented in the literature as early signs of coronary artery disease. We wish to study the sensitivity and specificity of both signs by conducting a single blind study involving patients with documented presence or absence of coronary artery disease via angiogram.


Eligibility Criteria:
Inclusion Criteria:

* age 20 to 70 years old
* angiogram within past 12 weeks
* stable during post angio period
* willing to provide informed consent

Exclusion Criteria:

* previous eye surgery including cataract surgery
* previous ophthalmologic disorders
* previous surgeries involving ears or ear lobes
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB\>3 months subject has urinary frequency (average micturition frequency within 24h\>8 times), urgency and/or urge incontinence by micturition diary card during screening period
* Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
* The subject is willing and able to complete the micturition diary card correctly
* Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form

Exclusion Criteria:

* Confirmed by the investigator that subject has severe stress incontinence.
* Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
* Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
* Subject who has a symptomatic acute urinary tract infection.
* Subject who has a recurrent urinary tract infection.
* Subject who has interstitial cystitis.
* Subject who has an agnogenic hematuria.
* Subject who has a bladder outlet obstruction of clinical significance.
* Subject who needs retention catheterization or intermittent catheterization.
* Patient with malignant tumor.
* Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
* Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
* Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.

To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 65 Years or older
* Genders Eligible for Study: Both
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Histologically confirmed gastric adenocarcinoma(including LAUREN type).
* Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
* chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
* Hb \> 90g/L, neutrophil count \> or = 1.5\*10\^9/L, platelet \> or = 100\*10\^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) \< or = 2.5 times ULN, total bilirubin (TBIL) \< 1.5 times ULN, serum albumin level \> or = 30g/L, serum creatinine \< 1 times ULN.
* No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
* Able to accept oral medication
* Compliance with protocol

Exclusion Criteria:

* Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
* Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
* Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
* clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
* Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
* Organ transplantation requires immunosuppressive treatment.
* Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
* Moderate or severe renal impairment(creatinine clearance (CCr) = or \< 50 ml/min), or serum creatinine \> ULN.
* Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
* Allergy to Oxaliplatin or any study medication ingredients.
Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus

The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.

Given that Telitacicept and low dose IL2 have been widespreadly applied in the treatment of systemic lupus erythematosus, this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of Telitacicept and low dose IL-2. 160mg Telitacicept and 1 million IU IL2 were regularly administered according to different circumstances. Then, the investigators evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \>18 years of age at screening visits
2. Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
3. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:

   * Hydroxychloroquine, 400 mg/day;
   * Prednisone, 10 mg/day

Exclusion Criteria:

Any subject meeting any of the following criteria should be excluded:

1. Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.
2. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit.
3. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
4. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
5. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
6. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
7. Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
8. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. However, this does carry a risk of deep thermal injury and perforation.

PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point.

The aim of this trial is to study the use of PuraStat® in reducing the need for thermal haemostasis during ESD.

Endoscopic submucosal dissection (ESD) is an endoscopic technique that involves the use of an endoscopic knife to gently peel off a superficial neoplasia of any size in an en-bloc fashion. It meets the principles of onco-surgery and is associated with excellent outcomes. A difficulty however with the technique is control of bleeding during the procedure. The GI mucosa is a vascular territory and the current method of managing intraprocedural bleeding is electrocautery using either the endoscopic knife itself or the coag grasper. This introduces a thermal injury to the bowel wall and carries the risk of causing a perforation or causing pain. Furthermore, it requires precise targeting of the bleeding vessel. Practically this can be challenging, particularly if the coag grasper is needed which is a bulky device and can be difficult to apply precisely in some locations.

PuraStat® (3-D Matrix Ltd, Tokyo) is a liquid which is applied to a bleeding area which acts rapidly to form a gel coat which induces haemostasis. This transparent adherent barrier permits further endoscopic therapy to be performed. It can be applied in the general area of bleeding and does not require precise application to the exact point of bleeding. It is applied through a small catheter placed through the biopsy channel of the endoscope which can be used in very small spaces.

PuraStat® is licensed as a CE marked device for use in exudative haemorrhage from vessels in solid organs and within the GI tract. Given this indication, the role of PuraStat in ESD needs to be explored as it could reduce the need for thermal haemostasis. This would be of significant clinical benefit during ESD.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or above.
* An ESD is attempted for clinical indications approved by MDT.
* Oesophageal or colonic lesion 2-5cm in size
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Known coagulopathy likely to affect risk of bleeding
* Submucosal tumour
* Anticoagulation or anti-platelet therapy (apart from single modality aspirin or clopidogrel) which cannot be stopped for clinical reasons
* Patient preference
Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants

This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants

A total sample size of 60 subjects (n=60) will be evaluated at 5 centers, by 6 Investigators with approximately 10-subjects per Investigator. Power analysis based on 80% power, past Thoma, Zeltner and González-Martin studies 1,2,3 and a one-sided confidence interval of 0.025, indicates that with a volume change standard deviation between 0.5 and 0.7 mm, 17-31 subjects are required per group (test and control), so 50-60 subjects are an acceptable estimate, with a preference for 60, given potential loss to long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for
* All implants must be at least 6 months post bone graft/implant placement
* have at least 1 mm of keratinized tissue width (KTw),
* have final restoration permanently in place for at least 4-weeks and
* subject have no recession on the implant body
* Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).

Exclusion Criteria:

* participation within the last six months in other interventional studies.
* any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement.
* taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy.
* acute infectious lesions in the areas intended for surgery.
* History within the last 6 months of weekly or more frequent use of nicotine products
* Female subjects who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control
* Untreated, moderate to severe periodontal disease.