cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Measuring Device Study

This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.

In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that:

"Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors."

An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation:

"Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions."

While a smaller mesh size can also be problematic:

"Underestimating the defect size may lead to choosing a prosthetic that is too small, thus increasing the risk of hernia recurrence." In order to aid surgeons in more accurately measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring device. This study aims to obtain feedback from surgeons on the usefulness and design of the device.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hernia defect that requires laparoscopic measurement

Exclusion Criteria:

* Minors
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease


Eligibility Criteria:
Inclusion Criteria:

* Healthy 18-25 year olds

Exclusion Criteria:

* Prior history of vaccination with any meningococcal vaccine
* Prior history of any invasive meningococcal disease
Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis. This study included 40 adult patients (≥ 18 years) with a diagnosis of chronic progressive hypersensitivity pneumonitis. The included patients were divided into 2 groups 20 patients in each one.

Group 1: will receive pirfenidone in addition to the conventional treatment Group 2: will be maintained on conventional treatment. Forced vital capacity (FVC),6 minutes walking test(6MWT), oxygen tension in the arterial blood (PaO2), and St. George's Respiratory Questionnaire (SGRQ ) were measured before and after 6 months of a pirfenidone treatment trial.

Results

Rationale The present data about the treatment of CHP are few and largely based on observational studies and expert opinion. It is suggested that pirfenidone may slow disease progression in cases of CHP as it has some anti-inflammatory in addition to antifibrotic effects.

Hypothesis Pirfenidone will slow disease progression in hypersensitivity pneumonitis patients

Research questions

1. Can pirfenidone slow disease progression in cases of CHP?
2. What about the safety of pirfenidone in cases of CHP?

This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis.

Objectives

1. To compare the functional and radiological parameters between patients group who receive pirfenidone treatment and the patient group who receive conventional treatment: FVC, 6 minutes walking distance, the partial pressure of oxygen in arterial blood ( PaO2), Pulmonary artery systolic pressure, St.George's Respiratory Questionnaire(SGRQ Score) and Quantitative ILD score (QILD), by quantitative HRCT chest.
2. To compare the side effects between patients' group who receive pirfenidone treatment and the patient group who receive placebo treatment

Study design An interventional randomized controlled study

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old with a diagnosis of chronic progressive Hypersensitivity pneumonitis:
* \>10% extent of fibrosis (eg, reticulation) on high-resolution CT (HRCT) scan
* Absolute decline in FVC% predicted \>5% within the previous 6 months despite conventional treatment.

Exclusion Criteria:

* Pregnancy or breastfeeding period
* Patients with peptic ulcer, severe hepatic disease, severe kidney disease, severe cardiac disease, and patients with other chronic pulmonary diseases.
* Presence of active infection
* History of alcohol or drugs abuse
* Active smokers
A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder

The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder
* Have no contraindications or allergies to the treatment administered
* Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis).
* Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses.

Exclusion Criteria:

* Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy
* Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis)
* A history of significant trauma to the shoulder
* Poorly controlled diabetes mellitus, as defined by HbA1c \> 7.5 mmol/L and glucose \> 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis.
* History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA)
* Blood dyscrasias
* Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study
* Prior shoulder surgery
Perioperative Protective Effects of Lidocaine

The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

* elective colorectal surgery

Exclusion Criteria:

* ASA \> 3
* history of anti-inflammatory therapy
* history of inflammatory bowl diseases
* history of chronic pain treatment
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study

Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).

Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.

Eligibility Criteria:
Inclusion Criteria:

* both genders.
* age ≥ 18 years.
* pigmentary, vascular and mixed types of dark halos

Exclusion Criteria:

* pregnancy and lactation
* patients who received treatment in the past 3 months
* patients with active dermatologic diseases or history of atopic dermatitis.
* history of allergy to tranexamic acid or vitamin c
* history of keloid or hypertrophic scars
* pure structural type of dark halos, pigmentary demarcation lines
Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF

Objective To compare, in patients with Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF) undergoing radiofrequency ablation (RFA), whether strict weight management and glycemic control based on Glucagon-like Peptide-1 (GLP-1) receptor agonist treatment reduces the recurrence rate of atrial arrhythmias and rehospitalization rates for cardiac diseases compared to conventional post-procedural management (antiarrhythmic drugs and anticoagulants) and general antidiabetic drugs (excluding GLP-1 receptor agonists).

Study Design

This trial randomly divides participants into two groups:

The GLP-1 receptor agonist treatment-based strict weight management and glycemic control group.

The conventional treatment group


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years. Symptomatic atrial fibrillation (AF) that has been ineffective or intolerable to at least one Class I or III antiarrhythmic drug.

Diagnosed with Type 2 Diabetes Mellitus. Body Mass Index (BMI) greater than 25 kg/m². Ability to understand the purpose of the trial, willingness to participate, and signing of the informed consent form.

Exclusion Criteria:

Permanent atrial fibrillation (failed cardioversion or episode duration \>12 months).

Previous history of AF ablation treatment. History of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment.

History of implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT).

History of stroke or transient ischemic attack within 6 months prior to enrollment.

Severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.

History of left atrial appendage occlusion or planned for one-stop AF ablation and left atrial appendage occlusion.

Pregnant, breastfeeding, or planning to become pregnant. Significant bleeding tendency precluding post-procedural systemic anticoagulation.

Contraindications to oral hypoglycemic agents such as SGLT2 inhibitors or GLP-1 receptor agonists.

Presence of left atrial thrombus identified before the procedure. Previous cardiac surgery (valve repair/replacement, coronary artery bypass grafting).

Unable to perform physical exercise due to illness or disability. Significant hyperthyroidism or hypothyroidism. Drug abuse or chronic alcoholism. Comorbidity with other serious illnesses with an expected survival less than 12 months.

Any condition that does not align with the best interest of the subject. Other conditions determined by the investigator as unsuitable for inclusion in this study, such as psychiatric disorders or psychological impairments.
TPE in Septic Patients and Influence on Organ Failure

Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.

Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study.

Investigators will study three groups:

1. untreated control group;
2. TPE group, plasma separation carried out by filtration;
3. TPE group, plasma separation carried out by centrifugation.

All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma. The study will focusing on the organ functions of the patients, especially liver-, kidney- and nervous function and also displayed in the SOFA score on study days 3 and 7.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock, beginning of shock \< 24 hours

Exclusion Criteria:

* Participation in an another clinical trial within the last 30 days
* Participation in this study at an earlier date
* Simultaneous participation in another clinical trial
* Pregnancy
* Unpredictable Bleeding (over 2 erythrocyte concentrates daily)
* Polyneuropathy (known before the beginning of sepsis)
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen

The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.


Eligibility Criteria:
* Male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;
* Documentation of positive Hepatitis B e antigen (HBeAg) status.;
* The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
* The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
* Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)
* Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)
* ≥1 continuous permeable leg axis directly injecting the plantar arch
* Rutherford 2-5

Exclusion Criteria:

* Patient under personal protection regime (tutorship, guardianship)
* Absence of arterial axis in permeable leg
* Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)
* Patient without favorable element to consider healing
* History of stents on the femoropopliteal axis
* History of femoropopliteal bypass
* Untreated stenosis ≥30% on the iliac axis and common femoral upstream
* Popliteal lesion beyond the intercondylar notch (P2)
Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

The addition of tDCS as an adjunct to pharmacotherapy is a novel approach but one that is grounded in a growing evidence-base.The primary objective of this research is to provide preliminary evidence of the effectiveness of tDCS as an adjunct treatment to pharmacotherapy for smoking cessation. The investigators hypothesize that the addition of active tDCS to the left DLPFC will improve the effectiveness of varenicline as reflected by higher quit rates at end of treatment compared to the sham group. Smoking status will be biochemically confirmed at various time points using expired cotinine measures. Furthermore, the investigators will be collecting neuroimaging (fMRI) data as well as measures of attentional bias to explore the neurological and physiological correlates from using adjunct tDCS and varenicline therapy.

While varenicline on its own is the most effective medication for smoking cessation, long-term abstinence is still relatively poor. The primary objective of this study is to evaluate the effectiveness of adjunct active tDCS with varenicline in treating tobacco dependence. This study is a double-blind, sham-controlled, randomized clinical trial where 50 daily dependent treatment seeking smokers will be recruited at the Nicotine Dependence Clinic in Toronto, Canada. Participants will be receiving twelve weeks of varenicline treatment (1mg b.i.d.) and randomized 1:1 to either active tDCS (active: 20 minutes at 2 mA) or sham tDCS (30 seconds at 2 mA, 19.5 minutes at 0 mA), daily (M-F) for the first 2 weeks and then every 2 weeks for the next 10 weeks. There will be 2 fMRI scans at baseline and 1 scan at end-of-treatment. Eye-tracking viewing tests will be conducted at baseline, weeks 4, 8, 12 and at 6 months follow up. During the 6 month follow-up, participants will be answering questions regarding their smoking behaviour and craving. Smoking status will be biochemically confirmed at each study visit using expired cotinine.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Aged 19-65
* Treatment seeking smoker
* Daily smoker of CPD\>8
* Able to attend daily appointments for tDCS for the first 2 weeks and booster sessions for the next 10 weeks.
* Wiling to undergo 3 fMRI sessions

Exclusion Criteria:

* Current/recent DSM-IV Axis I diagnosis
* Current use of psychoactive drugs or medications
* History of seizures/epilepsy
* Current use of NRT, e-cigarettes or other medications for smoking cessation
* Metal embedded in skull or implanted electrical devices
* No head injury (concussion or loss of consciousness for more than an hour)
* Contraindications to fMRI
* Contraindications to varenicline
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream.

Funding Source - FDA Office of Orphan Products Development (OOPD)


Eligibility Criteria:
Key Inclusion Criteria:

* Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)
* If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
* Between 2 and 10 sickle cell-related pain crises in the past 12 months

Key Exclusion Criteria:

* On a chronic transfusion program or planning on exchange transfusion during the study
* Hemoglobin \<4.0 g/dL
* Planned initiation, termination, or dose alteration of hydroxyurea during the study
* Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

Removal of colorectal adenomas prevents occurrence of cancers. It is recognized that colonoscopy can miss colorectal adenomas and early cancers. Proximal colon polyp detection rate is lower compared to distal colon detection rates. This may be partially due to the higher prevalence of flat polyps and sessile serrated adenomas (SSAs) which are harder to visualize. There is a need to further improve performance of colonoscopy. A second evaluation of the right colon within the same procedure may yield an additional detection rate of 5-10%, however retro-flexion has not proven to be superior to a second forward viewing examination. The use of chromo-endoscopy has been shown to improve detection of flat adenomas. Narrow band imaging was introduced in year 2006. It is similar to chromo-endoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromo-endoscopy. In pooled analysis, NBI is comparable to chromo-endoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE.

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects undergoing screening colonoscopy
* age \> 50.
* average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of FAP or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years and, ability to provide a written consent to trial participation

Exclusion Criteria:

* unable to consent