cyrilzakka/clinical-trials huggingface dataset:
Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography

This multicentre randomised controlled trial included patients aged \>18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure.

This multicentre randomised placebo-controlled trial was conducted in two hospitals in Mexico: the National Institute of Medical Sciences and Nutrition "Salvador Zubirán" (INCMNSZ) in Mexico City, and Bernardette Hospital in Jalisco. The study was approved by both institutional review boards. All patients provided written informed consent.

All patients were given a dose of rectal indomethacin (100 mg) at the beginning of the ERCP. Depending on the experimental group, either 10 ml of sterile water or 10 ml of a 1:10,000 epinephrine dilution (0.1 mg/ml) was sprayed on the ampulla through a biliary balloon or a sphincterotome, avoiding any direct contact with the papilla during irrigation at the end of the procedure.

After the procedure, patients were monitored in the recovery room for 2 hours and then discharged. Symptoms of acute pancreatitis or any other complication were interrogated at baseline while in the recovery room, and then by telephone 24 hours and 7 days after the procedure. Serum levels of pancreatic enzymes were determined only if the patient developed abdominal pain after ERCP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient with an indication for endoscopic retrograde cholangiopancreatography
* Patient without prior endoscopic retrograde cholangiopancreatography
* Patient who accept contact by telephone

Exclusion Criteria:

* Previous sphincterotomy
* Allergy to epinephrine or indomethacin
* NSAIDs use in the prior week
* Pancreatic cancer located in the head
* Chronic pancreatitis
* Renal failure (Cr \>1.4 mg / dl)
* Indication for endotracheal intubation independent of endoscopic retrograde cholangiopancreatography
* Biliodigestive derivation
* Pregnant patients
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; To assess the relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Eligibility Criteria:
Inclusion criteria:

* Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
* Signed written informed consent.

Exclusion criteria:

* At screening visit, age under legal age of adulthood.
* HbA1c \<6.5% or \>10.0% at screening.
* Diabetes other than T2DM.
* Pregnancy and lactation.
* Women of childbearing potential not protected by highly effective contraceptive method of birth control.
* Use of insulin pump in the 6 months before screening visit.
* Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
* Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
* Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
* Body mass index (BMI) \>=40kg/m² at screening visit.
* Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
* The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
Attitudes Towards Influenza Vaccinations Among the Healthcare Workers of Medical University of Warsaw

The study will be conducted in the UCKWUM teaching hospital in Warsaw between 2020 and 2022. The study group will be comprised of UCKWUM healthcare professionals All employees willing to participate in the study will receive an anonymous questionnaire on attitudes towards influenza vaccination . We will distribute information posters of the National Programme for Combating Influenza as part of the educational programme. In order to increase the effectiveness of the educational campaign, we will also send information e-mails, using the internal hospital e-mail system and conduct a series of online training courses to present the latest international reports on influenza vaccinations among health care professionals \[CITATION Abr10 \\l 1045\].

Considering the fact that lack of time \[CITATION Kus11 \\l 1045\] is the most common reason for not getting vaccinated against influenza among healthcare professionals, we will provide this group with an opportunity to receive free influenza vaccination during working hours at the UCKWUM hospital. Information about the possibility of vaccination will be provided in the form of e-mails (mailings) to hospital employees (internal hospital e-mail system), letters of information submitted to the offices of individual departments, and information posters.

The effectiveness of the educational programme will be assessed by re-administering the anonymous questionnaires after the influenza season, also by means of internal hospital e-mail system.


Eligibility Criteria:
Inclusion Criteria:

* Health Care worker of UCK WUM in Warsaw

Exclusion Criteria:

* non
Lot-to-lot Consistency of Sci-B-Vac™ in Adults

A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults

The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.

Eligibility Criteria:
Inclusion Criteria:

* Any gender
* Age 18-45 years
* Healthy, as determined by a physical examination and values of laboratory tests
* If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method
* Able and willing to give informed consent

Exclusion Criteria:

* Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)
* Treatment by immunosuppressant within 30 days of enrollment
* History of immunological function impairment
* Pregnancy or breastfeeding
* Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment
* Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment
* Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period
* Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment
* Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period
* Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease.
* Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
* History of allergic reactions or anaphylactic reaction to any vaccine component
* Unwilling, or unable in the opinion of the investigator, to comply with study requirements
* Immediate family members of study center staff
* Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers
* Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured
* Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening
* Renal impairment with Glomerular Filtration Rate (GFR) \<90 mL/min/ 1.73 m2 at screening
* BMI ≥ 35
* Uncontrolled hypertension
* Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening
* Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.
Cross Fiber Fascial Manipulation and Stretching Techniques in Overhead Throwing Athletes

Athletic training and sports participation is to enhance athletic performance. Performance is however multifactorial i.e., depending upon several parameters including warm-up practice, training regimes and other interventions. Stretching techniques that focus on increasing posterior shoulder soft tissue flexibility are commonly incorporated into prevention and treatment programs for the overhead athletes. GIRD is usually managed by stretching and soft tissue release of posterior shoulder capsule. Fascial manipulation is a manual therapy technique used in the management of musculoskeletal disorders. This study aims to evaluate the comparative effects of cross fiber fascial manipulation with stretching techniques in overhead throwing athletes

This was a randomized clinical trial that was conducted at Pakistan sports board and Coaching center, Lahore. Non probability convenient sampling technique was used to collect the data as per inclusion criteria. 40 Participants of this study were randomly allocated into 2 Groups. 20 participants in each group. The group A received three sessions of fascial manipulation for two weeks. Group B received three sessions of sleeper stretch in a side lying position in 90o abduction, elbow at 90o flexion and then performed shoulder IR and cross-body adduction stretch in sitting position. Three sets of the each stretch positions were held for 30 seconds with a 1 minute break between sets. A universal goniometer was used to measure internal rotation, external rotation, horizontal abduction, ROWE score to assess function, pain, stability and motion, Numeric pain rating scale (NPRS) was used to assess pain. The data was analyzed via SPSS version 22.

Eligibility Criteria:
Inclusion Criteria:

* Active male and female athletes were included.

  * Age group was (18-40) .
  * Overhead throwing athletes(tennis, volleyball, bowlers) were included in this study)
  * Screening tests were taken to identify subjects with GIRD. GIRD was defined as more than 20o decrease in IR at 90o abduction in the dominant side compared to non-dominant side .
  * Subjects who rated shoulder pain 5 or more in NPRS/symptomatic with GIRD were recruited

Exclusion Criteria :

* Any deformity
* Any radiculopathy
* Shoulder traumatic injuries( dislocation, subluxation, fracture)
* Systemic illness
* Subacromial impingement signs
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
* Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a kidney
* Patient has received a kidney transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
* Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
* Patient is pregnant or lactating
* Patient is unlikely to comply with the visits scheduled in the protocol
* Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.


Eligibility Criteria:
Inclusion Criteria:

* preventive ileostomy in laparoscopic rectal surgery

Exclusion Criteria:

* ileostomy due to anastomotic leak
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients

* Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world.
* Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005.
* The aim of the suggested study is to examine the acute effect of oral intake of sildenafil on exercise tolerance and functional capacity in Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy patients.
* The investigators hypothesize that oral ingestion of sildenafil prior the exercise may enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy patients.
* Patients and Methods:

Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD III-IV) \[9, 39\] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.

* All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on bicycle ergometer in different days; 60 min after intake of placebo and 60 min after intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.
* In first meeting prior exercise test at rest standard pulmonary function test, diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood samples for NT-proBNP will be taken prior and post each CPET.
* After 15-20 minute of passive recovery post exercise test all patients will perform 3 short functional tests including 6 minute walk test to assess functional capacity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe COPD GOLD stage III- IV, FEV1 30-50% or less of predicted values, greater shortness of breath, reduced exercise capacity, repeated excretions and\\ or with chronic respiratory failure \[9, 39\].
2. IPF patients diagnosed essentially according to the American Thoracic and European Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of: (a) High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or "possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or impaired gas exchange (can exist during exercise alone) (c) Exclusion of other known causes of interstitial lung disease (e.g.: connective tissue disease, environmental exposure,etc.)\[31\].
3. Patients post Pneumonectomy more than 6 month from the amputation surgery for any diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).

Exclusion Criteria:

1. Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5) inhibitor therapies will be excluding from the study.
2. Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion scan.
3. Patients with a history of left-sided heart failure will be excluded.
4. Patients will also exclude if they are on regular treatment with nitrates or PDE-5 inhibitors (Sildenafil, Tadalafil, Vardenafil).
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.

While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, \> 10 cc).

This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.


Eligibility Criteria:
INCLUSION CRITERIA

* Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
* Up to 4 lesions may be considered.

  * For a single lesion, the sum of three orthogonal diameters can be no more than 20 cm.
  * For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.
* Both peripheral and central tumors are accepted for this trial.
* Age ≥ 18 years old
* Patients may be enrolled more than once (eg, for a new tumor lesion)

EXCLUSION CRITERIA

* Contraindication for radiotherapy
* Pregnant and breastfeeding women are excluded
* If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators).
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)

This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ages 18-85 years
* Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
* Subject with intact skin in the targeted treatment area
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
* Subject must be willing and able to complete screening and study procedures as described int he protocol.
* Subject must voluntarily provide written Informed Consent prior to participation.

Exclusion Criteria:

* Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.
* Subjects pregnant, nursing or planning to become pregnant.
* Subjects who are immunocompromised or have clinically significant hematological abnormalities.
* Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
* Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
* Subjects having other sever pain which may confound assessment of PHN.
* Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)

The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity.

The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions.

The nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :

* Food balance and diversity
* Eating behaviour and representations
* Level of knowledge in nutrition
* Level of physical activity and physical inactivity
* Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity
* Behavioural barriers and educational levers to improve women's cardiovascular health

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25kg/m² and/or with a waist circumference \> 88 cm
* Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids

Exclusion Criteria:

* Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
* Consuming omega-3 rich food supplements within 3 months of inclusion
* Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months
* Suffering of eating disorders
* Presenting a medical contraindication to the practice of physical activity
* Having previously participated in a similar prevention program
* Suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)