cyrilzakka/clinical-trials huggingface dataset:
Effect of Functional Relaxation on Patients Undergoing Colonoscopy

Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is the most common reason for low acceptance of colonoscopy. Several methods have been used to minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to participate in administration of medication. Although a potential benefit from some of these methods has been suggested, no clear recommendations have been made so far. We hypothesized functional relaxation reduces discomfort during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Previous colorectal resection
Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block.

Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.

Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone.

The primary outcome will be time to the first rescue analgesics.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology(ASA) physical status II
* Able to read and understand the information sheet and to sign and date the consent form
* Scheduled for elective CS planned with Spinal anesthesia
* Gestational age \> 37 weeks and \< weeks assessed on the dating scale.

Exclusion Criteria:

* Complicated pregnancy; defined as having preeclampsia or placenta accreta,increta and percreta
* Opioid addiction or dependence
* Contraindications to TAP block( Ski infection, abdominal wall muscle defects)
* Allergy to any medications used in the study
* Case converted to General Anesthesia
* Cases who develop postoperative hemorrhage, amniotic fluid embolism
Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.


Eligibility Criteria:
Inclusion Criteria:

* the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement

Exclusion Criteria:

* the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis
Photofunctionalization With UVC

Summary:

Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the amount of bone that binds to the implant, making it possible to load these photofunctionalized implants in less time.

Design: Pilot, clinical, randomized, prospective, controlled, single-center, prospective study.

Scope of the study: Master's Degree in Oral Surgery and Implantology. Faculty of Dentistry. Complutense University of Madrid.

Subjects of the study: patients attending the Master's Degree in Oral Surgery and Implantology for rehabilitation with dental implants, regardless of the sector in which they have missing teeth.

Key words: ISQ (implant stability quotient), inmediate loading, UVC, dental implants.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients requiring dental implant surgery with or without bone or soft tissue regeneration surgery.
* Acceptance of the informed consent document.

Exclusion Criteria:

* Subjects with systemic diseases leading to untreated or uncontrolled haemostasis or coagulation disturbances.
* Subjects with active infectious diseases (tuberculosis, HIV, syphilis, hepatitis, etc).
* Patients under pharmacological treatment with monoclonal antibodies, bisphosphonates, chemotherapy or prolonged treatment with corticoids.
* Patients with alcoholism or drug addiction.
* Pregnant or breastfeeding women.
Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.

The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.

Circumferential pulmonary vein isolation (CPVI) is an important radiofrequency catheter ablation strategy for AF. The recurrence rate of non-paroxysmal AF (non-PAF) after CPVI remains unsatisfactory, despite the use of additional strategies, such as linear ablation and complex fractionated atrial electrogram ablation. Non-PAF initiation and maintenance depend on a critical mass, which allows reentry. The left atrial anterior wall contains a series of substrates that are associated with AF, such as low-voltage zones, Bachmann's bundle, and the LAA, which are important for AF initiation and maintenance. Combining CPVI with left RL, left ASL, and MIL ablation can create a box lesion set on the anterior wall which compartmentalize the left atrial anterior wall into small regions to modify the substrate. We hypothesized that this substrate modification strategy would improve the success rate of non-PAF ablation. However, functional damage to the LAA resulting from the above-mentioned ablation strategy may increase stroke risk. The combined use of AF ablation and LAA occlusion is safe and can reduce stroke risk. Therefore, we examined the safety, feasibility, and efficacy of a new treatment strategy for non-PAF, defined as the CPVI; left ROof linear, Mitral Isthmus linear, and left anterior SEptal linear ablation; and LAA Device occlusion (PROMISED) procedure. Cases were prospectively treated in a 2-arm 1:1 design according to ablation strategy, divided into the Promised group (n = 83) or the PVI combined LAAC group (n =83).

Eligibility Criteria:
Inclusion criteria:

1. Age \> 18 years;
2. Persistent AF (AF duration \> 7 days);
3. CHA2DS2-VASc score ≥2;
4. Presence of at least one of the following conditions:

   * Unsuitable for long-term standardized anticoagulation therapy;
   * Stroke or embolism still occurred based on long-term standardized anticoagulation therapy;
   * HAS-BLED score ≥3;
   * Unwillingness for long-term anticoagulation therapy;

Exclusion Criteria:

1. Previous atrial fibrillation ablation
2. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 60 mm;
3. persistent AF that lasts \>10 years
4. Scheduled cardiac surgical intervention.
5. Documented left atrial thrombus/ left atrial appendage thrombus or another abnormality that precludes catheter/LAAC introduction
6. Life expectancy less than 1 year
C-MAC Video-stylet for Double- Lumen Tracheal Intubation

C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.

It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-60 years,
* of both sex
* of American Society of Anesthesiologists (ASA) physical Status II and III
* undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -\< 35 kg/m2,
* with Mallampati score of 1 or 2

Exclusion Criteria:

* Mallampati score \> =3;
* inter-incisor distance \< 3 cm;
* thyromental distance \< 6 cm;
* neck extension \< 80°from neck flexion;
* cervical spine instability;
* history of difficult endotracheal intubation
* r difficult mask ventilation; - severe pulmonary ventilation dysfunction
* risk of pulmonary aspiration.
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.


Eligibility Criteria:
Inclusion Criteria:

* The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization.
* The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study.

Exclusion Criteria:

* The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
* The subject has a history of inflammatory bowel disease.
Upper Limb Biofeedback Rehabilitation System (RAPAELⓇ Smart Glove Digital Treatment System) Training for Stroke Recovery

This study is to investigate whether the RAPAELⓇ Smart Glove digital treatment system improves the upper extremity function of stroke patients compared to other clinical treatment by measuring serial behavioral and neuroimaging assessments and to find out therapeutic effect or adverse effect and patient's feed back responses

80 stroke patients(subacute=40, chronic=40) were recruited and randomized to receive either occupation therapy(OT) with or without RAPAELⓇ Smart Glove digital therapy. Groups were divided as follow: Group 1 (5times/4wks, total 20 sessions) Conventional occupation therapy + additional occupation therapy(30min). Group 2 (5times/4wks, total 20 sessions) Conventional occupation therapy + RAPAELⓇ Smart Glove digital treatment(30min).

After the baseline assessment, patients are divided into two groups by drawing for simple random sampling. Total four times of behavioral and neuroimaging assessments were evaluated at baseline, immediately and 2 weeks after each 10 sessions and at 4 weeks after the final session. Assessment tools are as follow:

1. Primary outcome.

   -Fugl-Meyer assessment,
2. Motor and sensory function. MMT\&ROM, Motricity index(MI),Action Research Arm test(ARAT), Box\&block test, Box\&Block test, 9-hole pegboard test, Jebsen-Taylor hand function test, Modified Ashworth scale(MAS), Grip strength test, Grasp/pinch power, Visual analogue scale(VAS), Sensory test(two point discrimination, monofilament)
3. Activity of daily living. Korean version of Modified Barthel index (K-MBI)
4. Cognition function test. Korean-mini mental state examination (K-MMSE)
5. Depressive mood. Korean-Geriatric Depression Scale (K-GDS)
6. Quality of life. Short form-8(SF-8)
7. Neuroimaging tools. Motor evoked potentials (MEP), Functional Magnetic Resonance Imaging (fMRI), Functional near-infrared spectroscopy (fNIRS).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who hemiplegic due to stroke
* Subjects who have more than 22 points of Fugl-Meyer Assessment score in upper extremity
* 40 subjects who have diagnosed as stroke before 3weeks to 3 months(subacute)
* 40 subjects who have diagnosed as stroke more than 6 months ago(chronic)

Exclusion Criteria:

* Subjects who have spasticity and upper extremity dysfunction at unaffected side
* Subjects who have bilateral or multiple brain lesion
* Subjects who have non-controllable medial or surgical disease
* Subjects who is less than 20 years old
* Subjects who have pre-existing and active major neurological or psychiatric disease
* Subjects who have less than 10 degrees of active wrist range of motion
* Subjects who can not complete outcome measurement task
* Subjects who have limitation of communication due to aphasia
* Subjects who have less than 17 points of K-MMSE
* Subjects who is pregnant
* Subjects who have pain or other muscle wasting disease which may interrupt upper extremity exercise
DES Versus BiOSS LIM - POLBOS II Study

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

Eligibility Criteria:
Inclusion Criteria:

* stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
* age ≥ 18 years old,
* de novo coronary bifurcation lesion (including unprotected LMS),
* MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation.

Exclusion Criteria:

* ST-elevation myocardial infarction (STEMI),
* bifurcations with Medina type 0,0,1,
* serum creatinine level ≥ 2.0 mg/dl,
* inability to take dual antiplatelet therapy for 12 months,
* left ejection fraction ≤ 30%
* lack of an informed consent
The Safety and Efficacy of Psilocybin in Patients with Treatment-resistant Depression and Chronic Suicidal Ideation

This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age at Screening
* Diagnosis of Major Depressive Disorder (MDD)
* Significant level of suicidal thoughts with active ideation and without immediate intent
* Failure to respond to 2 medications in the current episode

Exclusion Criteria:

* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
* Current alcohol or substance use disorder
ACS Monitoring Charité Berlin

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.

In the diagnosis of acute compartment syndrome, clinical suspicion supplemented by careful, repeated clinical examination continues to be the clinician's greatest tool. The classic signs and symptoms of acute compartment pressure are often listed as the 5 or 6 "Ps": Pain, Pressure, Pulselessness, Paralysis, Paresthesia, and Pallor. The diagnosis is typically not made by using equipment and it is difficult in the awake and oriented patient, becoming even more problematic in the polytrauma patient.

An alternative diagnostic method for compartment syndrome is invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. However, literature shows that commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and that user errors are common.

Compared to the invasive modalities or just experience of the surgeon, the CPMX1 shows promising advantages for the clinical application. Not only is the technology used for the CPMX1 device safe and non-invasive for the patient with only initial training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and confirmed in clinical setting). Recently, two clinical studies ("SWISS_EVIDENCE" and "SWISS_CLEARANCE") were conducted using the CPMX1 in healthy volunteers in a real-world clinical environment. Results of these studies confirmed that the application of the CMPX1 in patient care is safe and validated the reliability of compressibility ratio measurement with the CPMX1 in healthy volunteers.

The use of the CPMX1 device therefore facilitates the measurements, as it is based on pre- existing ultrasound methods, and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.


Eligibility Criteria:
Inclusion Criteria:

* Patients able to give consent
* Informed consent documented by signature
* Potential acute compartment syndrome (ACS) of the extremities (excl. hands, feet)
* Male or female
* Age 18 to 95 years
* Intact skin at the measurement site
* Open fracture up to Grade I if not in the measurement area

Exclusion Criteria:

* Potential Acute Compartment Syndrome (ACS) of both extremities considered
* Limb anomalies that could hinder the measurement
* Individuals who are deprived of liberty pursuant to an administrative order or court order or approval.
Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.

Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.

Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
* Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
* Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.

Exclusion Criteria:

* - Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
* Inadequate mouth opening
* Heavy smokers, more than 10 cigarettes/day
* Patients with poor oral hygiene and motivation.
* Pregnancy or nursing.
* Drug abusers.
* Psychiatric problems or unrealistic expectations.
* Patients with infection and or inflammation in the area intended for implant placement.
Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.

After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.

The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation
* Expected stay of 5 days in PICU after surgery
* Expected need of invasive ventilation for 48h after surgery
* Expected need for enteral feeding during 5 days.
* Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study

Exclusion Criteria:

* Medical indications for specific diet
* ECMO
* Dialysis