cyrilzakka/clinical-trials huggingface dataset:
Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal

The present study is a prospective, single-center study. A total of 88 patients, who had placed a pancreatic stent for preventing post-ERCP pancreatitis, will be included in the study. Aim of the study is to establish a new algorithm based on a sonographic approach to remove the placed pancreatic stents. Another aim is to compare high-end sonographic devices with devices of medium price scale one's used on the ward.

On the day of removal of the pancreatic stent, all patients receive a sonography by an experienced investigator on the ward and by another, uninformed investigator with a high-end device. If a pancreatic stent is visualized in the pancreatic duct, the patient will have an esophagogastroduodenoscopy to remove the pancreatic stent. If sonography cannot find a pancreatic stent in the pancreatic duct an x-ray will be performed as suggested by the European and international guidelines. If the pancreatic stent spontaneously dislocated into the small bowel tract according to x-ray, no further investigation will be performed. If a stent is visulized in situ by x-ray, it will be removed by endoscopyl.

Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.


Eligibility Criteria:
Inclusion Criteria:

* placement of prophylactic pancreatic stent to prevent post-ERCP-pancreatitis
* age of at least 18 years
* written informed consent

Exclusion Criteria:

* diseases that prevent sonography, x-ray or esophagogastroduodenoscopy
* no given consent
* other indication for pancreatic stenting
A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

This study will collect real-world safety and efficacy data from Japanese relapse/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) participants treated with venetoclax.


Eligibility Criteria:
Inclusion Criteria:

-Prescribed and treated with venetoclax

Exclusion Criteria:

None
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.

Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.

Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation

Only those participants whom are previously diagnosed with an AHI \>5 can be approached and enrolled into the study.

Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.

The titration session will take place as per the lab's routine practice.

Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.

At the end of the session the Sleep Technician will complete a questionnaire in relation to the titration experience for that participant/mask. The data will be collected in the CRF that FPH staff will provide to the site.

Eligibility Criteria:
Inclusion Criteria:

* AHI equal or greater than 15 from the diagnostic night.
* Equal or greater than 18 years of age

Exclusion Criteria:

* Inability to give informed consent.
* History of intolerance to CPAP.
* Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

The purpose of this study is to create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. The registry will record side-effect and outcomes related to the treatment using different surveys and biological measures.

The primary purpose of this protocol is to create a registry of elderly patients with high-risk invasive bladder cancer undergoing radical cystectomy with or without preoperative chemotherapy.

Secondary objectives will include an exploration of the association between functional status, surgical complications, and laboratory markers with complications and survival. In addition, exploratory analyses may evaluate the association of expression of the senescence marker p16INK4a and the morbidity and mortality associated with treatment.

Patients will be asked to complete a Geriatric Assessment (GA) and FACT-Bl serially over the course of the study in order to evaluate their functional status and quality of life during the course of treatment. Additionally, complications will be tracked in an inpatient and outpatient setting using the Memorial Sloan Kettering Cancer Center (MSKCC) complications grading system.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment.
* Signed, IRB approved written informed consent.
* Completion of baseline Geriatric Assessment

Exclusion Criteria:

* Inability to read and speak English
* Inability to comply with study for any other reason than language
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Acute Effects of Cold Exposure on Cardiovascular System

This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.

The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* Right-handed;
* Receiving or having received higher education;
* With the ability to read and understand Chinese smoothly.

Exclusion Criteria:

* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases;
* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Subjects with color vision disabilities.
A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)

A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)

Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.

Eligibility Criteria:
* according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes.
* according to the diagnostic standard of diabetes peripheral nerve lesions.
* age range 30-70 years.
* Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis.
* FBG \< 13.9mmol/L, HbA1c\<10%.
* signed the informed consent

Exclusion Criteria:

* did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
* repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
* blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
* TG≥ 5.6mmol / L;
* diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis \> 50%).
* pregnancy, to pregnant or lactating women;
* the ingredients allergy of Chinese herbal medicine and allergic constitution person;
* psychiatric patients;
* have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases;
* other patients had participated in clinical trials or are in other clinical trials before the test in January;
* in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence;
* according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost
* hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value);
* demyelinating lesions or from other causes of polyneuropathy patients.
A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.
* Patient has an ECOG performance status of 0 - 1,
* Patient has adequate hematologic, hepatic and renal function,
* Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),
* Patients must have a life expectancy of at least 12 weeks.

Exclusion Criteria:

* Unresolved toxicities (\> Grade 1) of previous chemotherapy,
* Patients with primary tumors of the central nervous system (CNS),
* Prophylactic hematologic growth factors administered \</= 2 weeks prior to start of therapy,
* Patient has history of or existing clinically significant cardiovascular disease,
* Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
* Patient has a seizure disorder not controlled on medication,
* Patient has a known or suspected viral, parasitic, or fungal infection,
* Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,
* Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.
Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent

Knowledge of the precise location of endometriosis is essential for a successful surgical treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative assessment of endometriosis, especially in superficial peritoneal lesion detection. The purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up of endometriosis

Pelvic endometriosis is a cause of pelvic pain, dysmenorrhea, urinary symptoms and infertility. MRI is considered as the best imaging technique to detect and to predict the extent of the disease. Susceptibility Weighted Imaging is routinely performed to identify haemorrhagic lesions in brain MRI protocols and has proven to be a sensitive technique to detect blood by-products. A pelvic MRI protocol including SWI will be performed in all women addressed for diagnostic assessment or pre-operative work-up of endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman (over 18yrs old) addressed for diagnostic assessment or pre-operative work-up of endometriosis;
* Informed signed consent
* Affiliated or beneficiary of a social security system

Exclusion Criteria:

* Patient \<18yrs old
* Pregnant or nursing woman
* Patient under legal protection
* Contraindication to MRI
The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer

Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* A biopsy proven histological diagnosis of gastric adenocarcinoma or high-grade intraepithelial neoplasia
* Tumor located at stomach
* Chest/abdomen/pelvis CT scans or gastric cancer staging CT scan evaluate the clinical stage of tumor as stage III:

A. preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0)

* Eastern Cooperative Oncology Group (ECOG) score ≤1
* Willing to participate and informed consent signed

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous or heterochronic malignant carcinomas
* History of malignant carcinomas
* Clinical evidence of metastasis
* Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy
* Mental illness or other serious cardiovascular disease
* Emergency procedure
SUrgical Versus PERcutaneous AXillary Artery International Registry

The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received a surgical or percutaneous access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting, between January 2010 and May 2020
* Adult patients ≥18 years

Exclusion Criteria:

* Introducer sheath internal diameter (ID) used \< 5F or \> 22F
* Patient with previous surgical axillary access on the puncture side (Pacemaker excluded)
* Patient with subclavian / axillary / brachial occlusive disease with stenosis greater than 50%
* Patient with previous bypass surgery or stent placement in the vicinity of access site (ie. Axillary extracorporeal cannulation with, axillo-femoral bypass, patch (venous or synthetic repair of previous axillary access, etc)
* Bleeding diathesis or coagulopathy
* Patients with active systemic or cutaneous infection or inflammation
* Patients who are pregnant or lactating
* Patient younger than 18 years of age
* Patients who are morbidity obese (BMI \> 40 Kg/m2)
Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section

In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery

Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS.

The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Caesarian Section. The Pfannenstiel incision was performed.

Exclusion Criteria:

* body mass index (BMI) \>35
* allergy to local anesthetics
* skeletal and/or muscle abnormalities of the spine
* primary and/or secondary neurological diseases
* psychiatric diseases
* history of chronic pain and/or neuropathic disorders
* history of drug abuse
* state of sepsis
* infection and/or tumors within the skin on the back
* primary or secondary coagulopathies
* pre-eclampsia or eclampsia.
EFFECTS OF SHOCK WAVE THERAPY IN WOMEN WITH PAIN IN TRAPÉZIO MUSCLE

The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They underwent an initial assessment, with a visual analogue pain scale, followed by an assessment of pain threshold, and manual muscle strength.Then, they were allocated into three groups: control group with 20 volunteers without intervention, placebo group with 20 volunteers with shock wave simulation and an intervention group with 20 volunteers with shock wave therapy.

All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p \<0.05).

The objective was to investigate the effects of shock wave therapy on the pain of trigger points in the upper fibers of the trapezius muscle.

A randomized, blinded clinical trial of 60 women (mean age 22.8 years and mean body mass index of 22.8 kg / cm2) with presence of trigger points in the upper fibers of the trapezius muscle. These were submitted to an initial evaluation (AV1), composed of the visual analogical pain scale, followed by an evaluation of the pain threshold, using algometry.

Then, the evaluation of the electromyographic activity of the upper trapezius muscle was performed, as well as of its muscular strength by manual dynamometry. Then allocated randomly in 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).

Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, 15 Hz frequency and pressure of 1 Bar. All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours After the intervention protocol (evaluation 48 hours). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Women with painful symptoms, compatible with the referred pain pattern of trigger points in the upper trapezius muscle.
* Age range of 18 to 35 years.
* No upper limb injury in the last 6 months.
* Featuring trigger points identified in the upper trapezius muscle.
* Present pain and / or moderate and / or severe disability after application of specific instruments.

Exclusion Criteria:

* Present unbearable pain during the evaluation procedures.
* Missing or not executing the solution correctly.