cyrilzakka/clinical-trials huggingface dataset:
Short Term Pancreatic Stenting Registry

The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.

The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study.

Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations:

* Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
* Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery
* Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak
* Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
* Group E: Other - In subjects with other indications

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18 or older.
2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
3. Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study.
4. Subjects satisfying at least one of the following clinical presentations:

   1. high risk of acute pancreatitis post ERCP
   2. impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery
   3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
   4. need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy

Exclusion Criteria:

1. Subjects for whom endoscopic techniques are contraindicated.
2. Subjects with known sensitivity to any components of the stents or delivery systems.
3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
4. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
5. Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.
Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism

Parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood calcium can cause many other symptoms and problems. The standard treatment is surgical removal of the gland(s) causing the disorder. The standard safe and effective operation has been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland \[Minimally-Invasive Radioguided Parathyroidectomy (MIRP)\]. The radiation exposure is minimal and safe. Although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation. All patients (adolescents and older) with PH are candidates to participate. The participants will be randomly assigned to the MIRP group or the BOPE group independently of patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland. Parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured. If not, the standard BOPE procedure will be completed. The total cost of the care will be tracked for each group. Careful testing for complications such as vocal cord dysfunction will be done. General Health status and pain levels will be measured before and after each operation. Patient satisfaction with the operation and care will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Elevated serum calcium concentration on at least 2 occasions; if the value is \<11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated.
* Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means.
* Elevated or non-suppressed serum intact parathyroid hormone level
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged \> 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study);
2. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions.

Exclusion Criteria:

1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ;
2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis;
3. Take phototoxic or photosensitizer within 8 weeks;
4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues;
5. Serious immunocompromised persons;
6. scar constitution;
7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine;
8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
The Clinical Study of Foot Function Index in Adolescent Flatfoot

Using dynamic plantar pressure data during walking, combined with the FFI scores of adolescents, aids doctors and rehabilitation therapists in conducting more accurate, objective, and scientific evaluations of the functional parameters of the foot for appropriate rehabilitation treatment. Clinical studies on flat feet mainly focus on imaging diagnosis, gait characteristics, orthopedic insole studies, and different surgical treatment schemes related to flat foot injuries. However, few studies have analyzed the dynamic plantar pressure characteristics of flat feet to guide clinical interventions, as well as the correlation between the subjective perception of FFI and objective biomechanical parameter characteristics to analyze the validity of FFI and elucidate the physiological characteristics of foot diseases.

Specific purpose of this study Therefore, the purpose of our study was to clarify the reliability and validity of the application of the FFI in flatfoot and the correlation between the FFI and dynamic plantar pressure.


Eligibility Criteria:
Inclusion Criteria:

7-18 years old. Arch development begins to stabilize around age 7 \[19\]; therefore, preschool children under 7 were excluded. Ability to maintain a static standing posture unassisted; bilateral flexible flatfoot (where the heel is valgus and the arch collapses on both sides); no congenital malformation or injury of the lower limbs; normal body mass index (BMI); no previous surgery or corrective treatment for flatfoot problems; and no obvious abnormal gait and posture.

Exclusion Criteria:

Preschool children under 7 years of age are excluded. ① Foot fracture or surgical history in the past six months; ② There are muscular nervous system diseases and syndrome affecting gait and posture, such as knee valgus, knee varus, legs unequal length or scoliosis; ③BMI≥28 kg/m².
Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study

The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient shall meet all of the following criteria in order to be considered eligible for enrollment:

  * Patient has been diagnosed with NMIBC within 24 months of enrollment
  * At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment

Exclusion Criteria:

* Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment.
Prevalence and Predictors of Osteoporosis in the Beijing's Urban Population

1. To establish a BMD reference database of Beijing's urban population, China.
2. To determine the prevalences and risk factors of osteoporosis and osteopenia in Beijing's urban population, China.
3. To describe the 25OHD level and estimate the prevalence of vitamin D insufficiency and deficiency of Beijing's urban population, China.
4. Estimation of the prevalence of osteoporotic fracture (vertebral) in over age of 60 of Beijing's urban population, China.

With one of the biggest populations in the world, China was heavily suffered from osteoporosis. The prevalence of osteoporosis in China even is increasing fast in recent years, which are especially notable in urban population. This change maybe due to the conditions including rapid economic growth, increase in life expectancy, and changes in lifestyle. Studies in 1998 including 13 separately small samples (no more than 1000 people) from 9 provinces in China showed that the prevalence of osteoporosis and osteopenia were 5.3-6.2% and 5.8-11.2%, respectively. These estimates were higher by approximately 1% than those reported in 1995. In 2002, according to DEXA results in connection with population census in 2000, Xiaoguang Cheng et al. took a survey in 600 people who were separately studied in previously 10 research projects and find that patients with osteoporosis account for approximately 6.97% of the total China population.

Although these studies have documented a remarkable increase in the prevalence of osteoporosis in China, these estimations were all based on small samples. No risk factors related with osteoporosis and osteopenia, esp. hypovitaminosis D on osteoporosis and osteopenia, have been analyzed yet. So it is impossible to make any forecast of osteoporosis or give any instruction for intervention.

Thus this study designed to provide current and reliable data on the prevalence of osteoporosis and osteopenia and associated risk factors correlation coefficients in the Beijing's urban adult population.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 79 residents in urban Beijing, China.

Exclusion Criteria:
A Study of Migalastat in Fabry Disease

Fabry disease is a rare metabolic condition characterised by the widespread deposition of sphingolipids in multiple organ systems. Cardiac involvement is common, it occurs in fifty percent of patients and it is the leading cause of death. Despite this, heart and blood vessel (cardiovascular system) manifestations of Fabry disease remain poorly characterised, and it remains unclear which patients benefit from therapy, or when therapy should be initiated. Migalastat is increasingly used to treat fabry disease however the impact of Migalastat on the cardiovascular system is poorly understood. Detailed assessment of the impact of Migalastat on heart and blood vessel structure and function is urgently needed. This observational study will use state of the art, non-invasive investigations to provide greater understanding of the cardiovascular manifestations of Fabry disease and the effects of Migalastat. It will provide insight into which patients respond more effectively to Migalastat, which in turn will facilitate personalisation of therapy, optimisation of the timing of therapy initiation and more cost-effective care.

This is a prospective longitudinal observational study of patients starting Migalastat as part of routine care. Participants will be recruited from outpatient clinics and have a number of investigations before starting therapy and after twelve months of therapy.

Investigations will include a detailed assessment of symptoms and clinical features, blood tests, echocardiography, detailed cardiac MRI scans, heart rhythm monitoring and exercise capacity assessment.

Parameters will be assessed at baseline and at twelve months.

Eligibility Criteria:
Inclusion Criteria:

Confirmed Fabry disease Aged 16 or over Beginning clinical treatment with Migalastat

Exclusion Criteria:

Contraindication to cardiac MRI
Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining

The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation.

This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

Eligibility Criteria:
Inclusion Criteria:

Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.

Exclusion Criteria:

After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.
COVID-19 in Patients With HIV

Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2.

Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.

Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV (PWH)/AIDS, or people with HIV who have not achieved viral suppression through antiretroviral treatment may have at higher risk for SARS-CoV-2 infections and disease progression. At present there is no evidence to suggest that there is an increased risk of infection and increased severity of illness for PWH. We know that during the SARS and MERS outbreaks, there were only few case reports of mild disease among PWH. Current clinical data suggest the main mortality risk factors are linked to older age and other co-morbidities. However, some healthy people have also developed severe disease from the SARS-CoV-2 infection.

This is a multi-center prospective observational study. Our aim is to characterize the clinical presentation and clinical course of COVID-19 in patients with HIV.

Patients with HIV and confirmed SARS-Cov-2 will be identified during routine clinical care in the inpatient or outpatient setting.

Contributors will share de-identified demographic data, health history data, and clinical data pertaining the patient's presentation with COVID-19 and outcomes obtained during routine care for their patients, using the secure online data collection tool REDCap.

Eligibility Criteria:
Inclusion Criteria:

* HIV disease
* Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay

Exclusion Criteria:

* None
The Effectiveness of Idazoxan in Treating TRD

Assessing the effectiveness of Idazoxan as a treatment for depressive patients who did not respond to treatment with SSRI


Eligibility Criteria:
Inclusion Criteria:

* MDD patients
* Did not respond to at least one treatment of 4-6 weeks of SSRI in adequate dose
* In or out patients

Exclusion Criteria:

* Psychotic symptoms
Effect of Water Biking in Hot Versus Neutral Water for Heat Acclimatation

The goal of this clinical trial is to compare the efficiency of water biking training in hot (35°C) versus neutral (25°C) temperature water to elicite heat acclimation in healthy recreative athletes.

The goal of this clinical trial is to compare the efficiency of water biking training in hot (35°C) versus neutral (25°C) temperature water to elicite heat acclimation in healthy recreative athletes. The main questions it aims to answer are:

* Does the water biking training protocol in hot versus neutral temperature water improve the time trial in an artificially hot and humid indoor environment?
* Does the water biking training protocol in hot versus neutral temperature water improve the VO2 max performance and force/velocity profile in neutral indoor environment?
* What are the main acclimation adaptations (central and cutaneous temperature), heart rate, cardiac function, sweating quality, sleep quality, haematologic profile.

Participants will have to do pre and post training tests in both normal environment (cardiorespiratory stress test, force/velocity profile test, echocardiography) and artificially hot and humid indoor environment (time trial). The training protocols consists in 10 sessions of 1 hour of water bike aerobic training (5 times a week for 2 weeks) at an intensity based on the heart rate corresponding to the 1st respiratory threshold, in hot (interventional group IG: 35°C) versus neutral (control group CG: 25°C) water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy people
* Sports practicing

Exclusion Criteria:

* Acclimatation already done (recent training in hot and/or humid) less than 2 months
* Heart disease recent or non controlled
* Heat intolerance
* Water phobia or inable to swim
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria
* Completed one full treatment course with either Rituxan® or MabThera®
* Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate

Exclusion Criteria:

* RA functional status class IV (ACR 1991 revised criteria)
* Systemic manifestation of RA
* Positive serology for hepatitis B or hepatitis C infection
* Active systemic infection
* History of cancer
* Known severely immunocompromised state

Other protocol-defined inclusion/exclusion criteria may apply
BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT

The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diffuse large B-cell lymphoma patients
* Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision
Testing The Effectiveness Of Two Interventions To Reduce Vaccine Hesitancy Among Adolescents

Vaccines currently prevent several million deaths every year and more lives could be saved if vaccination take up increased. The World Health Organization identifies vaccine hesitancy as one of the ten most important threats to global health and emphasizes the importance of devising interventions to reduce vaccine hesitancy. The two most promising interventions rely on consensus messaging, which has robust but small effects, and interactive discussion, which has larger effects, but is difficult to scale up. School-based interventions aimed at adolescents have the potential to make the best of both types of interventions. Interventions that take place in schools can be conducted over longer periods of time (up to several hours) and are rolled out by a figure that is typically trusted and respected (the teacher). Moreover, intervening during adolescence is particularly timely since important vaccines are delivered at that age (most notably the human papillomavirus vaccine), and because attitudes towards vaccination during adolescence might have a long-lasting impact, as is the case for other health related attitudes.

This study tests the effectiveness of two interventions, a pedagogical intervention based on consensus messaging, and a chatbot intervention designed to mimic interactive discussion, on 9th grade French pupils.


Eligibility Criteria:
Inclusion Criteria:

* French 9th grade students (equivalent to "troisième")'
* One class per school

Exclusion Criteria:

* Do not understand French