cyrilzakka/clinical-trials huggingface dataset:
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors

In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 64
* Smoked (on average) at least 5 cigarettes per day
* Be motivated to quit smoking

Exclusion Criteria:

* Unstable medical or psychiatric conditions
* Any medical conditions with neurological sequelae
* History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
* Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
* Are pregnant or planning to become pregnant during the study
* Current use of pacemaker, intracranial electrodes or implanted defibrillator
Study of Latiglutenase in T1D/CD Patients

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

Eligibility Criteria:
Inclusion Criteria (select):

* Confirmed CD diagnosis
* Confirmed T1D diagnosis
* Seropositive
* Gluten free diet (12 months minimum)
* Experienced at least one self-reported moderate or greater severity symptom during the last 28 day period
* Willing to take study treatment daily
* Must sign informed consent

Exclusion Criteria (select):

* Wheat allergy
* History of peptic ulcer disease, esophagitis, IBS, IBD
* Active colitis
* Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
* Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
* Known refractory celiac disease (RCD1 or RCD2)
* Inability to give informed consent
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients age greater than or equal to 18
* Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).

In addition one of the following criteria must be fulfilled:

* unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
* unsatisfactory NSAID response in patients with AS or
* unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.

Exclusion Criteria:

* Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC
* Patients participating in another study or clinical trial.
Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects

The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent;
* Healthy subjects with no medical, psychiatric, or current sleep disorders;
* Men and women ages 21 - 55, inclusive;
* Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.

Exclusion Criteria:

* Pregnancy or recent pregnancy;
* Subjects who are unable to read or speak English or French.
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery

This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.

Patients will be evaluated post-procedure on Days 3, 5, 7, 12, 30 and 90 for cosmetic outcome and surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with written informed consent
* Scheduled for a modified radical mastectomy
* Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification

Exclusion Criteria:

* Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit
* Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant
* Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification
* Has inflammatory cancers or skin ulceration
* Has known allergy or intolerance to triclosan
* Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse
* Has serious heart and/or lung disease
* Has skin scar history or family history
* Has direct relationship to or involvement in this or other studies under the direction of the investigator or center
* Received an experimental drug or device within 30 days prior to the planned start of treatment
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

This study consists of a 6-month open label Safety and Dose Confirmation Run-in Period (SRP), 6-month Randomized Control Period (RCP), and an additional 1-year open-label extension (OLE) period. To enter the Screening Period (Day -28 to Day -1) in the SRP or RCP, patients must have a clinical diagnosis of primary or secondary wAIHA due to an underlying autoimmune disorder, have failed at least 1 prior wAIHA treatment regimen, and have a Hgb level of ≥ 7 to \< 10 g/dL with at least one sign or symptom of anemia. For the SRP only, patients with secondary wAIHA due to underlying lymphoproliferative disease may be eligible if they are receiving stable treatment.

All patients in the SRP or RCP are allowed to continue up to 2 failed wAIHA therapies throughout the 24-week study. On Day 1 of the SRP, patients receive obexelimab administered as subcutaneous (SC) injections. On Day 1 of the RCP, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (SC) injections. Patients must return to the study site for the first 5 weeks and then every 2 weeks thereafter. Patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity during the 24-week SRP or RCP.

Following the 24-week SRP or RCP, patients will have the opportunity to receive obexelimab for up to 52 weeks in the Open Label Extension (OLE) Period.

Including screening and follow-up, the maximum duration of participation in this study for an individual patient is 81 weeks (i.e., 28-day screening, 24-week SRP or RCP, 52-week OLE, and an 8-week follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, ≥ 18 years of age
2. Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA.
3. Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin test specific for anti-IgG or anti-IgA.
4. Failed at least 1 prior wAIHA treatment regimen.
5. At least one sign or symptom of anemia as assessed by the investigator at screening.
6. Other inclusion criteria apply.

Exclusion Criteria:

1. Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm, and cold) AIHA, or paroxysmal cold hemoglobinuria.
2. Have any other associated cause of hereditary or acquired hemolytic anemia.
3. For the RCP only, patients with secondary wAIHA not due to autoimmune disorders, including LPDs.
4. Received a transfusion within 2 weeks prior to randomization.
5. Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization.
6. Received IV Ig or epoetin alfa within 6 weeks prior to randomization.
7. Receiving more than 2 concomitant medications for the treatment of wAIHA.
8. Other exclusion criteria apply.
Anal Manometry Examination in Patients With Ulcerative Colitis

Inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-related diseases. IBD symptoms frequently overlap with symptoms of functional GI disorders such as irritable bowel syndrome (IBS) and defecatory disorders, and these symptoms are common in patients with active disease, and also in quiescent disease. Underdiagnosis of abnormal anorectal function may result in an inappropriate escalation of IBD therapy. In this study, the investigators aim to evaluate if damage from chronic inflammation in UC results in anorectal damage such as hypersensitive, hyperactive, poorly compliant rectum, and hypotensive sphincter. If this is the case, early aggressive treatment of the disease is needed.

Another important point in this study is to find out which of the anorectal symptoms are due to a hypersensitive, hyperactive, and poorly compliant rectum and not due to mucosal inflammation. The diagnosis of abnormal anorectal function via manometry may help to give the appropriate treatment, such as biofeedback or pharmacological treatment such as loperamide or tricyclic anti-depressants. This may avoid escalation or replacing effective IBD therapy unnecessarily.

The study will include patients with ulcerative colitis in clinical, laboratory, and endoscopic remission, and with one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining and incomplete evacuation.

Patients that will not be included: patients after ileal pouch-anal anastomosis (IPAA), and patients with colonic stenosis that could not be passed with an endoscope.

Patients will undergo an anorectal manometry test and the results will be compared to a control group that will include patients with ulcerative colitis in remission without anorectal complaints, as well as to the normal values in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients with UC in our clinics who have one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining, and incomplete evacuation
* A patient who has had a recent colonoscopy/sigmoidoscopy with endoscopic remission defined as Mayo endoscopic score ≤1

Exclusion Criteria:

* Patient after ileal pouch-anal anastomosis surgery (IPAA)
* Patients with colonic stenosis that did not allow endoscopic passage and did not undergo an endoscopic evaluation prior to the study
Exercise Intervention on Frailty After Kidney Transplantation

Researchers are trying to determine if exercise will improve health and strength in kidney transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years who have received a KT and have a functioning allograft

Exclusion Criteria:

* Neuropsychiatric condition causing patient to be unable to provide consent
* Recipient of a combined organ transplant
Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery

Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* patient requiring a non cardiac surgery
* patient with a coronary stent
* patient agree for personal health data collection and analysis

Exclusion Criteria:

* patient less than 18 years
* patient unable to understand
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.

Thirty patients will be enrolled and randomized equally into two arms.

Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
* Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
* Stable glucocorticoid for 4 weeks.
* Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
* Stable anti-TNF biologics for 4 weeks.
* Written informed consent.

Exclusion Criteria:

* Serum creatinine ≥3.0 mg/dl.
* GPT≥5 times the laboratory's upper limit of normal.
* Pregnant or breast-feeding women.
Impact of NaHCO3- on Exercise Hyperpnea

An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of patients with chronic cardiopulmonary disease that is associated with adverse health outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. The investigators of this trial will compare the effects of orally administered sodium chloride (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy adults aged 20-40 years.

The ventilatory response (V̇E) to exercise-induced increases in the rate of CO2 production (V̇CO2) depends on the regulated level of arterial PCO2 (PaCO2) and the dead space to tidal volume ratio (VD/VT).

An abnormally high V̇E/V̇CO2 response to exercise, reflecting a high VD/VT and/or low PaCO2 equilibrium point, is a key pathophysiological feature of patients with chronic cardiopulmonary disease, including heart failure, pulmonary arterial hypertension, interstitial lung disease and chronic obstructive pulmonary disease. In these patient groups, exercise ventilatory inefficiency is associated with: disease severity and progression; exercise intolerance; exertional breathlessness; and increased risk of hospitalization, major cardiac events and mortality. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. Unfortunately, our ability to enhance exercise ventilatory efficiency is limited by the fact that, with the possible exception of lung volume reduction surgery in chronic obstructive pulmonary disease and pulmonary vasodilator therapy in pulmonary arterial hypertension and heart failure, ventilation-perfusion abnormalities reflecting a high VD/VT are often irreversible.

A largely unexplored approach to decreasing the V̇E/V̇CO2 response to exercise is increasing the PaCO2 equilibrium point by inducing a metabolic alkalosis via administration of an alkalizing agent such as sodium bicarbonate (NaHCO3). Thus, the primary objective of this randomized, double blind, placebo controlled, crossover study was to test the hypothesis that increasing the PaCO2 equilibrium point via induced acute metabolic alkalosis by single-dose oral administration of NaHCO3 would decrease in the V̇E/V̇CO2 ratio at its lowest point ("nadir") during high-intensity constant-load cycle exercise testing in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Habitually active
* Non-obese (Body Mass Index \<30 kg/m2)
* Normal lung function on spirometry

Exclusion Criteria:

* Self-reported gastrointestinal, cardiovascular, vascular, respiratory, kidney, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
* Taking doctor prescribed medications other than oral contraceptives
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Information affecting hip surgery is currently unknown.

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium. The most common bacterium of this family is P acnes, the same bacterium that is responsible for the majority of acne. There is increasing evidence that infection with P acnes and other Propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. However, information affecting hip surgery is currently unknown. Our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of Propionibacterium infection of hip replacement in the community. However, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for Propionibacterium infection following hip replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 to 79 85 years of age
* CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital
* CJR established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant.
* CJR patients without a previous arthroplasty procedure who have established care with our practice.

Exclusion Criteria:

* Previous history of hip infection
* Current antibiotic use or antibiotic use within the past week
* Previous history of Cutibacterium joint infection
* Current immunodeficiency disease or disorder
* Patients with active psoriatic disease or other focal inflammation over the hip
* Previous total hip arthroplasty (bilateral for the case of TKA patients and healthy volunteers, contralateral for THA patients)