cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema


Eligibility Criteria:
Inclusion Criteria:

* Male or female, who is at least 18 years of age or older at screening visit.
* Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
* A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
* A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

* More than 2 facial inflammatory lesions (papules, pustules, and nodules).
* Presence of areas of significant scaling or crusting on the face.
* Presence of psoriatic lesions on the face.
* Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
Exercise Training Sequence for Subacromial Impingement Syndrome

Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.

While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises.

The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm
* presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.

Exclusion Criteria:

* concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -
* osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale
* current diagnosis and/or previous history of glenohumeral instability or dislocation
* full-thickness rotator cuff tear
* adhesive capsulitis
* fractures of the scapula, clavicle or humerus
* scapulothoracic or rotator cuff paresis
* shoulder surgery in past year
* inability to speak the English language at a level sufficient to obtain informed consent.
Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy

Grave's ophthalmopathy is the most common cause of orbital disease in adults. The clinical presentation may vary between sub clinic symptoms to severe ones. The eyelid retraction is one of the most important signs of Grave's ophthalmopathy and can lead to cosmetic and functional problems.

The eyelid retraction can be found in the inflammatory stage and in the chronic disease, when it is stable. It can be described when the upper lid is contouring the superior limbus or positioned above that. This condition can lead to dry eye symptoms, exposure keratitis and cosmetic issues. The treatment can may be surgical or medical.

The medical treatment are usually based on controlling thyroid function and in the use of steroids, both are not specific for the lid retraction, but for the inflammation that is common in the disease.

In the longstanding disease, surgery is the most efficient treatment. There are several described techniques, they are based on the concept of weakening the muscles that act on lid elevation (levator and Muller Muscle).

Basically the techniques can be divided in two groups: the first with an anterior approach (with skin scar in the lid sulcus) and the second using a posterior approach (through the conjunctiva).

In the literature there is no consensus in deciding the best technique, regarding cosmetic results, incidence of complications, hypo or hypercorrection.

In this trial we propose to compare two distinct techniques that are already in clinical use. The blepharotomy uses a cutaneous approach and the other a conjunctival approach.

The patients will be divided in two randomized groups and surgical expected outcomes, cosmetics outcomes and complications occurrence will be compared.

After a complete ophthalmic evaluation the recruited patients with inactive graves orbitopathy and upper eyelid retraction eligible for the study will be randomly separated in two groups.

The evaluation also includes a face photography in primary position of gaze, a OSDI questionnaire, a quality of life questionnaire, schirmmer test, lissamine green evaluation and eyelid position measurements.

In the first group the patients will be submitted to blepharotomy for surgical correction of their upper eyelid retraction.

In the second group the patients will be submitted to a posterior mullerectomy and gradual recession of the elevator muscle aponeurosis for surgical correction of their upper eyelid retraction.

The outcomes will be compared between the two groups after a 6 month followup.

Eligibility Criteria:
Inclusion Criteria:

* \> 21 years old
* controlled thyroid function
* absence of strabismus
* absence of other ocular pathology, such as high myopia
* understanding the protocol and according the terms

Exclusion Criteria:

* pregnancy
* history of previous upper lid surgery
* myasthenia gravis
Patient-Centered Dementia Care Practice Coaching Intervention

The goal of this clinical trial is to compare staff outcomes in long-term care communities who participate in the intervention versus those who do not. The main questions it aims to answer are: 1. Is employee satisfaction impacted by the intervention and 2. Is dementia care confidence impacted by the intervention. Participants will include monthly coaching visits for the intervention group and completion of surveys pre, immediately post and three-months post. Researchers will compare the intervention group to the control group to see if the intervention impacted the outcomes.

Over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of Dementia Care Practice Recommendations (DCPR) (published recommendations by Alzheimer's Association) and prioritize areas of need /focus. Teams meet with the coach virtually or in person for 1 hour each month during the six months. Through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the DCPR. Coaches provide ongoing support to the care community through telephone and email support between meetings. Control group will not receive any coaching intervention but receive monthly email (e.g., newsletter about Alzheimer's Association but not related to outcomes) from coaches for check-in. Alzheimer's Association (AA) hires coaches in study areas based on their skills, experiences, interests and enthusiasm. Each coach identifies and invites long-term care (i.e., nursing home and assisted living) communities using existing relationships between the AA Chapter and those communities. In addition, AA staff will work with a national and/or state-wide networking group /association, as well as the Association's Dementia Care Provider Round Tables. The investigators will also pull the list of nursing homes in the study areas from publicly available data (e.g., Definitive Healthcare). Once each care community is selected and has agreed to participate, DCPR coaches will request that the care community identify 4-6 staff members to serve on a Care Team. The consented care communities are randomly assigned to either a control or intervention group (1: 1 block randomization).

Eligibility Criteria:
Inclusion Criteria:

* Licensed skilled nursing facilities
* Licensed assisted living facilities
* Located in the state of Ohio

Exclusion Criteria:

* Under the age of 18
* Without documented endorsement for participation from facility leadership
Observational Cohort Study of a National Extracorporeal Membrane Oxygenation Service for Adults With Respiratory Failure: the NHS ECMO Study.

This is an observational study of outcomes of the NHS England-commissioned national respiratory ECMO service, which has been active at six centres since December 2011.

The primary outcome of interest is the number of patients who survive to ICU discharge at the ECMO centre. The study also aims to identify factors predictive of outcome.

Recent randomised and observational studies suggest there may be a role for extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory failure that have not responded to conventional measures.

In 2011, NHS England commissioned a national service to provide ECMO for severe respiratory failure at six centres across the country. Patients with severe respiratory failure are referred to the network if conventional measures are unsuccessful, and if accepted are transferred to an ECMO centre for specialist care. The criteria for admission is at the discretion of clinicians at each centre.

The NHS ECMO registry has been created by cross-referencing data submitted to the Extracorporeal Life Support Organisation (ELSO) in Ann Arbor, Michigan, with a tracker document identifying patients treated within the network. Analysis has been undertaken from December 2018 to March 2019.

Eligibility Criteria:
Inclusion Criteria:

* Ultimately at the discretion of the clinician at the relevant ECMO centre
* Aged ≥16 years
* Severe acute respiratory failure refractory to conventional management
* No contra-indication to ongoing ECMO therapy

Exclusion Criteria:

* Any contra-indication to ongoing ECMO therapy
* Need for ECMO due to other aetiology than acute respiratory failure (e.g. bridge to transplantation, extracorporeal CPR, isolated acute cardiac failure)
Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.


Eligibility Criteria:
Spinal Cord Injury Patients With Chronic Pain

Inclusion Criteria:

* Age 18 - 65 years old;
* American Society of Anesthesiologists (ASA) I-III;
* Dextromanual;
* Chronic Pain following Spinal Cord Injury;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.

Exclusion Criteria:

* People with mental and behavioral disorders.
* Previous history of craniocerebral disease;
* History of drug and alcohol abuse;
* Patients with aphasia or inability to cooperate with the pain assessments;
* Previous adverse reaction to esketamine, opioids or NSAIDs;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
* Bleeding tendency;
* BMI ≥ 35 kg/m²;
* Pregnancy or lactation.

Spinal Cord Injury Patients Without Pain

Inclusion Criteria:

* Age 18 - 65 years old;
* American Society of Anesthesiologists (ASA) I-III;
* Dextromanual;
* Spinal Cord Injury Patients Without Pain;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.

Exclusion Criteria:

* People with mental and behavioral disorders.
* Previous history of craniocerebral disease;
* History of drug and alcohol abuse;
* Patients with aphasia or inability to cooperate with the pain assessments;
* Previous adverse reaction to esketamine, opioids or NSAIDs;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
* Bleeding tendency;
* BMI ≥ 35 kg/m²;
* Pregnancy or lactation.
Bovine Colostrum to Prevent Absorption of Gluten

To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption.

A double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral gluten with or without the bovine colostrum.

Physiologic double-blind, cross-over, study in which volunteers on a gluten-free diet will ingest gluten with or without colostrum.

Subject Participation and Study Duration

The study will imply 5 visits for each participant. At the second and fourth visit, they will either take gluten with colostrum powder or with a placebo. Follow-up duration will be until three days after the last study visit.

Each participant will be given daily proton pump inhibitor (PPI) therapy (omeprazole 20 mg) at least one week before the first intervention, and for the entire duration of the study.

Each participant will be invited to fill a celiac disease patient reported outcomes questionnaire (Celiac Disease Symptoms Diary) for the 24 hours prior the study intervention and three days after. Blood and urine samples will be collected during the 24 hours following each study intervention (gluten + colostrum or gluten + placebo)

Adverse events will be recorded during the entire study from enrollment to termination (termination will occur 3 days after the second challenge at the end of the patient reported outcome (PRO) recording period).

Eligibility Criteria:
Inclusion Criteria:

* Self-reported strict adherence to a gluten-free diet for at least 3 months. This may be a lifestyle choice, in solidarity with a child or other family/household member with celiac disease, because of non-celiac gluten sensitivity or because of celiac disease.
* Willing to provide informed consent for all study procedures
* Healthy volunteer according to the investigator assessment (history and physical exam)

Exclusion Criteria:

* Definite or probable gluten exposure during the 72 hours preceding each study intervention visit
* Known active gastrointestinal disease.
* Use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit.
* History of severe symptomatic reactions to gluten or milk proteins
* History of allergy to beef or meat
* History of allergy to apple
* Severe lactose intolerance
* Any medication or medical condition which, in the opinion of the investigators, could adversely affect the patient's participation in the trial.
* Allergy to PPI or other contraindication for PPI use (i.e history of interstitial nephritis attributed to PPI, history of PPI-induced diarrhea)
* Pregnant women (according to pregnancy test)
Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics

In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along this Fontan pathway. This passive blood flow to the lungs occurs best when the patient is breathing on their own (spontaneous ventilation). However for certain surgeries and procedures patients need to have an endotracheal tube inserted and need to be muscle relaxed and receive positive pressure ventilation. Prior studies have shown that positive pressure ventilation can reduce blood flow to the lungs and consequently blood returning to the heart resulting in less blood pumped out to the rest of the body (cardiac output). The purpose of this study is to investigate if changing the volume of the positive pressure ventilation (tidal volume) affects blood flow to the lungs and cardiac output in patients with Fontan circulation.

If it can be shown that changing the tidal volume does affect the blood flow to the lungs and cardiac output in patients with Fontan circulation the information can be used to learn from this study to optimize the tidal volume ventilation, and therefore pulmonary blood flow and cardiac output when Fontan patients come for general anesthesia. This is important because the population of patients with Fontan circulation is increasing and an increasing number will present for cardiac and non cardiac surgery when positive pressure ventilation will be required. They may also spend time on the cardiac intensive care unit on a ventilator and improving our knowledge on how best to ventilate them may help improve their overall hospital outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 2- 50 years of age
2. Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.

Exclusion Criteria:

1. Patients presenting for cardio-thoracic surgery without Fontan circulation or those not coming for completion of Fontan circulation.
Surveying Patient's Interest in Robotic Rehabilitation Device

This is a survey study to understand the stroke survivor's interest in robotic training. Investigators will use a questionnaire and show a video of robotic therapy to ask questions on their interest.

The purpose of this research is to investigate the interest of individuals with recent stroke in robotic therapy. Investigators will introduce a novel robotic platform to train ADLs of stroke patients. Investigators will examine the usability of this device as a home trainer for training rotational hand manipulation tasks such as opening a pickle jar, turning a key, missing a pot with a ladle, etc. The device will especially target stroke patients with ischemic stroke to enhance the performance of ADL. Also, investigators will examine the frequency and dosage of the current occupational therapy, followed by the satisfaction of the current therapy. Participant's participation will contribute to the development of a new therapy method using a robotic device for home-based training.

Eligibility Criteria:
Inclusion Criteria:

* Adults with stroke
* Adults with no cognitive difficulties

Exclusion Criteria:

* Adults with pregnancy,
* Adults with other neurological disorders than stroke
* Adults with hemorrhagic stroke
Colorectal Cancer Dataset in Xijing Hospital From 2011

To compare the differences of clinical pathological, treatment and prognosis in the guided subgroups in colorectal cancer, the investigator enrolled all the colorectal cancer patients who underwent surgery and were hospitalized in the Xijing hospital.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically confirmed colorectal adenocarcinoma, including hereditary colorectal cancer syndrome, such as Lynch syndrome and familial adenocarcinoma tumor polyposis, Peutz Jeghers syndrome, juvenile polyposis syndrome, and serrated polyposis syndrome;
* 2. Visit our center with complete medical records and pathological information;
* 3. Colorectal cancer patients diagnosed between 2013 and 2023.

Exclusion Criteria:

* 1. The patient has other colorectal malignancies other than adenocarcinoma;
* 2. Malignant tumors adjacent to organs invading the colon and rectum;
* 3. Malignant tumors from distant organs metastasize to the colon and rectum;
* 4. Benign colorectal lesions; 5. Patients with recurrent colorectal cancer.
Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery

The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia.

CO was measured using the NICOM® monitor. Bioreactance, a development from impedance technology, is also emerging as an accessible mode of continuous CO monitoring in the operating room and can provide valuable insight into the hemodynamic effects of our interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.

Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were labeled "study drug". She was not involved in patient's care or study assessment.

The hypotension was defined as systolic blood pressure \<80% of baseline or \< 90 mmHg, and managed with study drug (1 ml) intravenously. The bradycardia was defined as HR \< 60 beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR \< 45 beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron (4mg) intravenously.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I and II, term pregnancy (gestational age\>37weeks), planned spinal anesthesia for elective cesarean section

Exclusion Criteria:

* preexisting or gestational hypertension, cerebrovascular or cardiovascular disease, any contraindication to the spinal anesthesia, fetal anormaly, weight\<50kg or \>100kg, and height\<140cm or \>180cm.
Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room

Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. The investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (COVILUS score) could predict the occurrence of a positive RT-PCR in patients suspected of COVID-19 infection admitted to the emergency room. The investigators are going to conduct a new study to validate this COVILUS score in this type of patient. The main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected COVID19 infection.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to ER for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound as part of the BLUE protocol
* Age\> 18 years old

Exclusion Criteria:

* patients \< 18 years of age
* patients under guardianship or curators
* pregnancy
* poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.)
* patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS))
* patients with chronic interstitial lung disease
* patients who will refuse to give their consent.