cyrilzakka/clinical-trials huggingface dataset:
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions

BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions

Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries

Eligibility Criteria:
Inclusion Criteria

1. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
2. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
3. Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
4. De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
5. Reference lumen (vessel) diameter between 5mm and 10mm
6. The target lesion can be successfully crossed with a guide wire
7. The target lesion length is ≤ 100 mm
8. Subjects has more than 70% stenosis in target lesion
9. Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
10. Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting

Exclusion Criteria

1. Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
2. Subject is with a current medical condition with a life expectancy of less than one year.
3. Pre-existing target iliac artery aneurysm or perforation or dissection
4. Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
6. The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
7. Refuses blood transfusion
8. Chronic renal insufficiency (Serum creatinine \>2.5 mg/dL within 30 days prior to index procedure)
9. Subject has IFU listed contraindication(s)
10. Subject has in-stent restenosis
Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting

One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.


Eligibility Criteria:
Inclusion Criteria:

* primary hypertension
* age\>18 years

Exclusion Criteria:

* Cholestatic disorders or severe hepatic/renal failure
* allergy to telmisartan or hydrochlorothiazide
* treatment-resistant hypokalemia or hypercalcemia
* pregnancy and lactation period
Evaluation of Dapagliflozin Taken Twice-daily

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Diagnosis of T2DM
* Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
* HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
* History of diabetic ketoacidosis
* Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
* FPG \>270 mg/dL (\>15.0 mmol/L)
* BMI \>45 kg/m2
"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy

The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
2. able to comprehend and sign the informed consent form
3. able to provide clean-catch urine specimens
4. able to complete a urinary symptom questionnaire pre- and post-operatively

Exclusion Criteria:

1. participants in another research protocol involving an investigational product 30 days before planned randomization
2. pregnant women
3. patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
4. patients known to have a history of recurrent urinary tract infections
Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction

This research will study the effect of Boswellia Sacra versus calcium hydroxide as an intracanal medicament on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in mandibular premolars with necrotic pulp.

Primary outcome Postoperative pain measured using numerical rating scale (NRS)

1. After placement of intracanal medicament at 6, 12, 24 and 48 hours.
2. After root canal obturation at 6, 12, 24 and 48 hours.

Secondary outcomes Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) .

1. Sample 1 (S1): after access preparation and pre-instrumentation.
2. Sample 2 (S2): post-instrumentation.
3. Sample 3 (S3): post-intracanal medicament removal at 3 or 7 days according to the group.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25-45 years old.
2. Males or females.
3. Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
4. Patients' accepting to participate in the trial.
5. Patients who can understand pain scale and can sign the informed consent.
6. Mandibular Single rooted premolars, having single root canal:

   * Diagnosed clinically with pulp necrosis.
   * Absence of spontaneous pulpal pain.
   * Positive pain on percussion denoting apical periodontitis.
   * Periapical radiolucency not exceeding 2\*2 mm radiographically.
   * Normal occlusal contact with opposing teeth.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders (ASA III or IV).
2. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
3. Pregnant women: to avoid radiation exposure, anesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
4. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
5. Patients with two or more adjacent teeth requiring endodontic treatment.
6. Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope:

   i. Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non -restorable vii. Immature roots viii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
7. Inability to perceive the given instructions.
Evaluation of MRI Sequences in Hepatic Overload

MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Patients with or suspected clinically to be with a hepatic overload pathology (hepatic iron and/or fat overload) and who need a diagnostic or pre-therapeutic MRI from his initial management or during his monitoring,
* Patient able to provide written informed consent and can understand and comply with the requirements of the study
* Patient having received the information about the protocol and having not expressed his opposition to participate.

Exclusion Criteria:

Due to MRI :

* pacemaker or defibrillator,
* MRI non-compatible heart valve,
* clips, stents, coils, etc... non-compatible with MRI,
* cochlear implants,
* neuronal or peripheric simulator,
* intra-orbital or encephalic metallic foreign body, foreign body close to eyes, foreign body near the eyes, injury by metallic luster (war, ball),
* endoprosthesis received since less than 4weeks and osteosynthesis equipment received since less than 6 weeks,
* claustrophobia,
* pump, tattoo, permanent make-up, intrauterine device, patch,
* metal, magnetic, non-removable and in the area of the analyse field material

Other criteria :

* unstable hemodynamic state, acute respiratory insufficiency, hemodynamically unstable acute respiratory failure, poor general condition or the necessity of a continuous monitoring incompatible with the MRI constraint,
* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty,
* pregnancy
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.


Eligibility Criteria:
Inclusion Criteria:

At Screening:

* 0 to 3 day old infants
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Apgar score ≥ 7 at three minutes after birth
* Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

* Six weeks of age
* Received a dose of Hepatitis B (HB) in the first three days of life
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

At Screening:

* Illness at a stage that could interfere with trial conduct or completion
* Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth)
* Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
* Acute illness on the day of screening.

At Screening and at Inclusion:

* Blood or blood-derived products received since birth
* Planned participation in another clinical trial during the present trial period
* Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
* Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
* Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

* Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
* Participation in another clinical trial before the first trial vaccination
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
* Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
* History of seizures
* Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Effects on Metabolism and Cognitive Functions of a Commonly Used Commercial Food Supplement

This project evaluate effects of a commonly used food supplement on glucose metabolism and cognitive function.

The test product has previously been suggested to elicit beneficial effects on glucose metabolism and cognitive performance. The purpose with this study is to evaluate metabolic effects and effects on mood variables of the test product provided at breakfast. Test variables are determined at fating and postprandial a standardised breakfast. The results are compared with effects after a placebo product.

Eligibility Criteria:
Inclusion Criteria:

* age between 40-60 years, normal BMI, healthy, non-smokers

Exclusion Criteria:

* metabolic disorders or gastro- intestinal disease, intake of probiotics- or antibiotics during the last 2 weeks prior to the study.
Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients

This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.


Eligibility Criteria:
1. Inclusion/ Exclusion Criteria:

   1. Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:

      * Male or female, age ≥ 19 years at the time of informed consent
      * Confirmed diagnosis of IBD
      * Participants who are naïve to anti-tumour necrosis factor (anti-TNF)
   2. Exclusion Criteria for IBD participants:

      * Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
2. Inclusion/ Exclusion Criteria:

   1. Inclusion Criteria for non-IBD participants:

      * Participants who have not been diagnosed with IBD
      * Participants who don't have any other intestinal disease except IBD
      * Participants who are naïve to anti-TNF
   2. Exclusion Criteria for non-IBD participants:

      * Participants who have been on medication to treat underlying disease for the previous 3 months
Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.

A fibula free flap can be used for the reconstruction of a mandible or a maxillar when the lack of bonne exceeds 3cm. This flap is made of the fibula bone, some muscle around, the fibular vascular pedicle and a skin paddle to reconstruct the gum. Once this flap has been taken and transposed on the face, the leg is closed with a split thickness skin graft to replace the skin paddle. But the healing on this site is often a problem: this is partly due to the high rate of early graft's loss due to local devascularization (3 to 55% of loss). The skin grafting is generally improved by the application of a dressing sewn and left in place during 5 to 7 days postoperative (standard method). This study will evaluate the efficiency of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites, compared to the standard method. A prospective randomized evaluation will be done, comparing the PICO® to a conventional dressing. The main aim of the study is the evaluation of the impact of this portative system on the healing of the skin grafted donor site, in terms of rate of skin take, time of healing, complications and medical costs. The patients will be seen preoperatively to decide on their inclusion in the protocol. They will be reviewed at day 10 to evaluate the engraftment and possible local complications on the donor site. They will then be reviewed at day 20 and day 30 and until complete healing. The follow up will be of 12 months maximum. A medical cost evaluation will be done comparing the costs generated by the care on the donor site in the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Any patient requiring a fibula free flap with skin paddle
* Theoretical need of a skin graft for the closure of the donor site (evaluated by the surgeon in charge of the patient at the time of inclusion) and performed at the same time as the fibula flap
* Signature of informed consent.

Exclusion Criteria:

* Contraindication to making a fibula free flap:

  * anesthetic contraindication,
  * atheroma in the leg arteries obstructing more than 60% of the arterial lumen (objectified by CT angiography of lower limbs)
* Contraindication to the setting up of a negative pressure therapy:

  * allergy to one of the PICO® components
  * infection in the donor area
  * cutaneous lesions of the lower limb preventing the placement of an occlusive dressing or making it impossible to seal the device
* No affiliation to a social security scheme.
* Minor or major patients who are protected or unable to give their consent (according to article L1121-8 of the Public Health Code (PHC))
* Pregnant or lactating women (according to article L1121-5 of the PHC)
* Vulnerable people (according to article L1121-6 of the PHC)
Effect of Ketamine Addition to Lidocaine in Rhinoplasty

The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.

In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective rhinoplasty operation under general anesthesia
* Patients with ASA (American Society of Anesthesiology) class I
* Patients between 18-50 years old

Exclusion Criteria:

* Age \<18 and \>50
* ASA \> II
* Preexisting neurological or psychiatric illness
* Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
* Having a history of chronic pain and receiving chronic analgesia therapy
* Having a history of drug abuse
Enteral Nutrition Training with Cooperative Learning

Nursing students; education on enteral nutrition has an important place. With cooperative learning, students will make their learning permanent by communicating with each other. This study is carried out to evaluate the effect of cooperative learning on the knowledge level of students.

The cooperative learning method is structured on students\&amp;#39; communication and interaction with each other. Many outcomes such as increasing students; academic success, critical thinking, verbal communication, taking responsibility for learning, improving their ability to take responsibility, increasing their ability to evaluate, and being open to feedback are among the benefits of cooperative learning. In cooperative learning, the basic principle is that students form groups and share their knowledge within each group regarding the basic knowledge and skills they want to learn, and then the groups interact with each other. With this method, students can take on learning responsibilities themselves, and they can also develop their knowledge sharing, collaboration and leadership skills within the group. Therefore, cooperative learning is an effective training method by strengthening self-directed learning, as well as supporting effective communication within team members. In a study conducted with nursing students using cooperative learning, it was observed that higher success, more positive relationships between students, and more psychological adaptation developed compared to traditional education methods. In international studies investigating the use of active learning strategies in nursing education, it has been concluded that collaborative learning is of great importance in transforming critical thinking ability, clinical performance, knowledge adequacy and nursing knowledge into clinical skills. In a similar vein, it has been emphasized that cooperative learning is an effective teaching method in improving the knowledge and psychomotor skill levels of nursing students regarding local drug applications and increasing the permanence of information. This study will focus on students; learning of knowledge and skills regarding enteral nutrition through cooperative learning method. A more memorable learning is aimed by students forming groups and transferring information both within and between groups.

Eligibility Criteria:
Inclusion Criteria:

* Getting training on enteral nutrition for the first time
* Volunteering to participate in the study
* Being required to attend class

Exclusion Criteria:

* Having previously received training on enteral nutrition
* Not volunteering to participate in the study
* Not participating in the final test and follow-up test