cyrilzakka/clinical-trials huggingface dataset:
Prodromal Markers in Recurrent Dream Enactment Behaviors Without REM Sleep Without Atonia

REM sleep behavior disorder is a novel and distinct parasomnia characterized by recurrent dream enactment behaviors (DEBs) and REM sleep without atonia (RSWA) during polysomnographic assessment, with a male predominance and typical onset age at early 60's. The majority of patients with idiopathic RBD (iRBD) will eventually develop α-synucleinopathy, for instance Parkinson's disease (PD). Thus, iRBD has been considered as a highly specific precursor of α-synucleinopathy-related neurodegeneration. Recently, increasing studies have found that some participants present with only RSWA or DEBs (but without sufficient RSWA), which does not meet the diagnostic criteria for RBD. It has been suggested that these participants with subclinical features (either DEBs or RSWA) might represent a condition known as prodromal RBD. Several emerging evidence, including our own study, have implied a link between isolated RSWA (RSWA without DEBs) and markers of α-synucleinopathy-related neurodegeneration. However, it is still unclear whether the other condition related to RBD, i.e. recurrent DEBs but without sufficient RSWA, is related to a certain degree of α-synucleinopathy. In this regard, the novel concept of recurrent DEBs but without sufficient RSWA, also termed as prodromal/isolated RBD by some researchers, requires validation by further evidence in terms of clinical feature and neurodegenerative prodromal markers perspectives.

This proposed study is a case-control study, which aims to determine whether recurrent DEBs but without sufficient RSWA represents an early stage of α-synucleinopathy. The investigators will recruit 62 participants with recurrent DEBs but without sufficient RSWA and their age-, sex- matched controls from the community and on-going projects. All participants will undergo clinical interview, comprehensive measures of prodromal markers of neurodegeneration (including excessive daytime sleepiness, olfactory functioning, constipation, erectile dysfunction, urinary dysfunction, symptomatic hypotension, depression, and clinical motor markers) as suggested by the International Parkinson and Movement Disorder Society (MDS) research criteria. In addition, a subset of the sample (n = 26 in each group) will undergo the triple-tracer positron emission tomography/computed tomography (PET/CT) imaging protocol of 18F-DOPA, to determine dopamine functions in putamen. This proposed study will help to disentangle the core features of RBD and validate the concept of prodromal RBD with reference to prodromal markers related to α-synucleinopathy neurodegeneration.

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 65 years old
* RBDQ-HK behavior factor greater \> 8
* Recurrent DEBs by interview and/or video analysis
* Absence of sufficient RSWA

Exclusion Criteria:

* Age- and sex- matched with cases
* RBDQ-HK behavior factor \< 8
* No DEBs by either interview or video analysis
* Absence of sufficient RSWA
Measurement of Blood Perfusion in Response to Loading in Patients With Wounds

The purpose of this study is to monitor the skin blood flow in the lower leg, with different levels and types of applied loads. These loads will not be placed over the patient's wound nor will they be higher than loads the skin normally experiences in daily activities. The results of this research will help investigators understand the development of pressure ulcers, commonly known as bedsores and stasis ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if he/she has a wound on one or both legs.

Exclusion Criteria:

* under the age of 18
* individuals with mental illness
* individuals who are unable to sit for an hour
* individuals whose wound care method prohibits testing
Physiologic Pacing Registry

The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

The Physiologic Pacing Registry will be conducted to gain a deeper understanding of physiologic pacing device implants and follow-up workflows, including device and programmer measurements to help inform Abbott's product and clinical data development efforts. Additionally, the registry will provide a broader understanding of the clinical utility in mapping physiologic pacing structures with the use of Abbott's EnSite Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to physiologic pacing device implant.

The registry will include patients undergoing implantation of an Abbott pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care. Only patients scheduled to receive an Abbott device may be enrolled to ensure proper device data collection for future software and other physiologic pacing product development. The decision to provide physiologic pacing therapy and selection of devices for implant are at the discretion of the implanting physician. Abbott will collect data on the use of all commercially available leads and associated implant tools based on the physician's discretion as part of routine clinical practice within the registry.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D device with any commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care.
2. At least 18 years of age.
3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Provided written informed consent prior to any registry-related procedures.

Exclusion Criteria:

1. History of tricuspid valve repair or replacement.
2. Currently participating in another clinical study with an active treatment arm and belong to the active arm
3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results.
4. Chronic physiologic pacing lead implanted
5. Life expectancy of \< 6 months.
6. Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).
National Registry of Obesity Treatment by Endosleeve

Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass.

With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Patient with a body mass index (BMI) ≥ 30 kg/m²;
* Signed informed consent

Exclusion Criteria:

* Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
* Presence of an ulcer in the gastric body or fundus;
* Achalasia, severe esophagitis (Los Angeles grade C or D);
* ENT or esophageal malformation;
* Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
* Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
* Positive Helicobacter pylori status with failed eradication treatments;
* Uncontrolled or severe eating disorder or psychiatric illness;
* Substance abuse or chronic alcoholism;
* Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
* Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
* Coagulation or hemostasis disorders (PT \< 60%, platelets \< 60,000/mm³);
* Mental deficiency of the subject making participation in the trial impossible;
* Patient not affiliated with a social security scheme;
* Pregnant women, breastfeeding individuals;
* Inability to understand or sign the informed consent.
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females age 12 and older.
* Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Exclusion Criteria:

* Under 12 years of age.
* Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
* Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
Routine Use of RUSH Protocol in the Intensive Care Unit

The RUSH protocol has been used for several years for the rapid evaluation of a patient admitted to the emergency room with shock. Traditionally, its use was especially common in trauma victims, but later its use was extended to patients admitted to the emergency room with shock from any reason. The protocol includes rapid assessment with the guideness of ultrasound of heart contraction, assessment for pleural effusions, assessment of intra-abdominal blood (FAST), diagnosis of venous thrombosis (DVT), and rulling out hydronephrosis. It can also add a pupil size assessment and an evaluation of the gallbladder and bile ducts, as well as the size of the bladder. In intensive care, we use this protocol (or part of it) for the evaluation of a patient who is deteriorating in the ICU for an unknown reason . In some patients we use this protocol as a routine part of the physical examination as part of the daily patient evaluation.

We would like to investigate whether the routine use of the RUSH protocol as part of the daily patient evaluation in the general intensive care unit will lead to any change in the patient's management.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were admitted to the intensive care unit for any reason and were evaluated daily using the RUSH protocol.

Exclusion Criteria:Patients who were not evaluated using the RUSH protocol or for whom data were missing.

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Treatment of Peripheral T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of GDPT regiment (gemcitabine，cisplatin,Prednisone ,Thalidomide

) for patients with Peripheral T-cell lymphoma.

Patients with Peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment GDPT regiment (gemcitabine，cisplatin,Prednisone ,Thalidomide

) in the patients with Peripheral T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months Histological confirmed Peripheral T cell lymphoma None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato
Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* are male or female outpatients at least 18 years of age
* provide written consent to the release of their data after being informed of the study
* diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
* are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
* are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient

Exclusion Criteria:

* are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
* are currently taking insulin.
* are pregnant or have intentions of becoming pregnant within the duration of the study.
* are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.
Post-operative Pain Management in Children With Supracondylar Humerus Fractures

There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.

Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.

Eligibility Criteria:
Inclusion Criteria:

* Closed, Gartland type III supracondylar humerus fracture
* Fractures treated with closed reduction and percutaneous pinning (CRPP)
* Patients expected to follow up at Texas Children's Hospital
* Patients/guardians must speak English or Spanish

Exclusion Criteria:

* Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit
* Patients who have impaired ability to report pain severity such as intellectual delay.
* Patients who have a problem with bone healing such as osteogenesis imperfecta.
* Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc).
* Patients who are on chronic NSAID or opioid medication prior to injury.
* Patients with injury from suspected non-accidental trauma.
THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA

The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age less than 32 weeks and birth weight less than 1500 g.
2. Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).

Exclusion Criteria:

* Gestational age ≥ 32 weeks.
* Newborns with congenital cyanotic heart diseases.
* Obvious major congenital malformations, known syndromes or chromosomal anomalies.
* Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
* Current use of steroids.
PrediSuisse: Automatized Assessment of Difficult Airway

In the "PrediSuisse" research project, the investigators aim to create a reliable, reproducible, ultra-portable and radiation-free automatized software, able to identify automatically collected features, facial characteristics, and range of movements, to predict intubation difficulty. The software will generate a difficulty intubation score tailored to three commercially available videolaryngoscopes with different type of blades, corresponding to the predicted endotracheal intubation difficulty while providing the anaesthesiologist a reliable and non-subjective tool to assess individual patient's risks with regards to airway management.

The Swiss multi-institutional research project "PrediSuisse" aims to automatically predict and classify the difficulty of intubation and airway management using three commercially available videolaryngoscopes (VL) by acquiring face/profiles photos and sequences on a training set of 900 patients during the pre-anaesthesia consultation. For each patient, with the help of recently developed Machine Learning (ML), Artificial Intelligence (AI) and Convolutional Neural Network (CNN) techniques, a specially developed software will be trained to provide a predicted airway management difficulty index. This will be performed by correlating those photos/sequences and the real difficulty level of intubation, determined by three experts by reviewing the recordings of the intubations of the training set patients. The software will then be used in routine on a set of 900 other patients to validate the prediction performance.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old) presenting at the pre-anesthesia consult for an elective general anesthesia necessitating a tracheal intubation
* Signed informed consent.

Exclusion Criteria:

* Patients not speaking French (in Geneva and Lausanne) or Italian (in Lugano).
* Patients previously operated on the airway with anatomical modifications (ENT Flaps, tracheotomies).
* Patients unable to follow procedures or to give consent will also be excluded.
Development and Validation of a Comorbidity Index in Crohn's Disease

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 59 years old
2. Established diagnosis of CD with a minimum disease duration of 3 months
3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

Exclusion Criteria:

1. Subject unable to comply with study procedures
2. Surgery for CD 3 months prior to inclusion visit