cyrilzakka/clinical-trials huggingface dataset:
Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes.

Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus (type 1 or 2)
* Age 18 years or older
* No changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes
* Painful diabetic neuropathy \> 3 months, but not more than 5 years
* Pain level ≥ 4 on an 11 point Numerical Pain Rating Scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment)
* Loss of protective sensation by the 5.07 Semmes-Weinstein Monofilament (SWM, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot)

Exclusion Criteria:

* Known or suspected radiculopathy (based on patient's record and anamnesis)
* Any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive
* Severe cardiac disease or surgery within last 3 months, e.g., Acute Myocardial Infarction, Congestive Heart Failure grade 3 or higher
* Any major infectious, malignant or other severe systemic disease, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis, Creutzfeldt-Jakob disease
* Patient is incompetent to comply with study requirements (in the investigator's opinion)
Multicomponent Strategy to Implement a Clinical Practice Guideline and Improve Health Outcomes in People With SLE

Principal objective: To produce scientific knowledge on the effectiveness and cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a Clinical Practice Guideline (CPG) for Systemic Lupus Erythematosus (SLE), formed by an educative intervention, an computerized clinical decision support system (SADC), complemented by an automated feedback built into the electronic clinical record.

Secondary objectives will be previously developed: 1) the analysis of medical practice variations along the care of SLE patients in the Canary Islands Health Service (SCS); 2) the best available scientific evidence to support the optimal development of the SADC; 3) the context and the barriers to innovation implementation in the SCS; and 4) the development of the contents for the implementation strategy, including the SADC and the automated feedback.

Methods for the main objective: The main objective will be assessed under an open, multicentric and randomized (by clusters) clinical trial, in the SCS. The multicomponent intervention will be compared to the usual procedures for CPG dissemination. The main measure will be the self-perceived activity of SLE rated by the SLAQ scale. Self-perceived health related quality of life (HRQoL) data will be obtained by means of the questionnaire EQ-5D-5L , to estimate a cost-effectiveness ratio.

Methods for secondary objectives: The rest of the objectives will be developed by a mix of quantitative and qualitative research methods to allow adapting the design, development and execution of the intervention to the characteristics of the context.


Eligibility Criteria:
Inclusion Criteria:

* Patients:

Adults (older than 18 years) diagnosed with SLE of any seriousness and situation (active, remission or clinically quiescent and serologically active), who agree to participate and sign informed consent.

* Health professionals:

Physicians specialized in rheumatology or internal medicine that include in their quotas a minimum of 30 patients with eligible SLE.

Exclusion Criteria:

* Patients:

SLE limited to the skin, advanced chronic kidney disease (dialysis or renal transplant); Mental illnesses and / or sensory or cognitive deficits; or participating in extension or follow-up studies of another RCT (possible change in follow-up guidelines). Participants in observational studies may be included as they do not change usual practice.
Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)

The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence.

The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.


Eligibility Criteria:
Inclusion Criteria:

* Perceptible radial artery pulse
* Diagnostic or interventional procedure feasible to be performed with radial access.

Exclusion Criteria:

* Myocardial infarction with ST segment elevation in time for primary angioplasty.
* Cardiogenic shock or hemodynamic instability.
* Clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery
* Prior recent radial artery access (1 month)
One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block

the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture \&amp;#34;O\&amp;#34; group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.

In the Multipoint \&amp;#34;M \&amp;#34; group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.

In the Control \&amp;#34;C \&amp;#34; group (n=34 ): The patient will receive patient controlled analgesia\&amp;;PCA\&amp;

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years old.
* Sex: both sexes.
* Physical status: ASA I to III.
* Body mass index (BMI): 18- 30 kg/m2.
* Type of operations: elective laparoscopic cholecystectomy.
* Written informed consent from the patient.

Exclusion Criteria:

* Known hypersensitivity to lidocaine or bupivacaine.
* Opioid-dependent patients.
* Coagulation disorders or taking drugs affect surgical hemostasis.
* Patients with pre-existing neurological deficits.
* Uncooperative patient or with altered mental status.
Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .


Eligibility Criteria:
Inclusion Criteria:

* Children
* ASA I or II
* tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* Allergy to dexmedetomidine
* Allergy to anesthetic drugs
* History of neurological disease
* History of neuromuscular disease
* History of renal disease
* History of hepatic disease
* craniofacial anomalies
* History of cardiac disease
* History of respiratory disease
High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.

Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.

The investigators will conduct a prospective multicenter randomized non-inferiority study. Eligible patients will be those with Lynch syndrome (known germline mutation in mismatch repair genes) who undergo surveillance colonoscopies. Patients will be sequentially assigned in a 1:1 ratio to HD-WLE or HD-CE. The method of stratified randomization based on partial colectomy history will be used to avoid proportion imbalance between groups. Participant centers must have an organized high-risk of CRC clinic and endoscopic unit provided with HD technology. Endoscopists must have a documented high adenoma detection rate and experience in performing CE in patients with high-risk conditions of CRC.

The principal aim is to compare the adenoma detection rate with WLE vs CE. Principal outcome measures will be: 1) adenoma detection rate, defined as the proportion of patients with at least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number of detected adenomas in each arm (HD-WLE or HD-CE) divided by the number of colonoscopies in each arm.

The sample size calculation was determined for a non-inferiority study. Assuming an ADR of 28% with conventional chromoendoscopy in patients with Lynch syndrome, a 15% non-inferiority margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. Based on these assumptions, it was determined that 122 patients were required for each arm (a total of 244).

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven pathologic germline mutation in one of the mismatch-repair (MMR) gene (MLH1, MSH2, MSH6, PMS2 or Epcam) who will undergo surveillance colonoscopy

Exclusion Criteria:

* Patients with total colectomy
* Concomitant inflammatory bowel disease
* Inadequate bowel preparation (Boston scale \<2 in any colonic segment)
* Incomplete procedure (without intubation of cecum or ileo-colonic anastomosis)
* Previous colonoscopy in less than one year
* Inability to sign informed consent
Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft

The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.

The purpose of this study is to compare the clinical effects of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>=18 years and periodontally and systemically healthy;
2. Presence of at least one site with \<=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
3. Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
4. Full mouth probing depths \<=5mm;
5. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<=15%;
6. Be able to comply with all procedures related to the study.

Exclusion Criteria:

1. Smoking;
2. Pregnant or lactating women;
3. Untreated periodontal disease;
4. Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
5. Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
6. Under radiotherapy;
7. Allergy to the collagen;
8. Previous mucogingival surgery in the area.
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats.

The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of OSA within the last 12 months
2. No previous diagnosis of atrial fibrillation
3. Able and willing to follow-up as an outpatient
4. Age 40-85 years

Exclusion Criteria:

1. Life expectancy \< 2 years
2. Dementia or other neurologic condition which would make outpatient follow-up difficult
3. CHADS score \<2
4. Alcohol or drug abuse which would interfere with outpatient follow-up
5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
6. Current dialysis treatment or planned treatment within 12 months
7. Known bleeding disorder or prothrombin time \>15 seconds
8. Mechanical heart valve requiring anticoagulation
9. Moderate to severe mitral stenosis or regurgitation
10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)
11. Chronic obstructive pulmonary disease with oxygen dependence
12. Pregnant patients or patients that plan to become pregnant within the course of the study\*.
13. Patients with anticipated need for a pacemaker during the course of the study \*If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed
Long-term Study of Cariprazine in Patients With Schizophrenia

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
* Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Predictors of 30-day Postoperative Outcome After Elective EVAR

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Exclusion Criteria:

* Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.
Under Water Seal Versus Negative Pleural Suction in Chest Trauma Patients

:The investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.

Traumas are the leading cause of death in the first four decades of life and are mostly caused by traffic accidents. Thoracic traumas might lead to severe consequences, even though less than 50% of them required a surgical revision. Thoracic traumas can be divided in blunt or penetrating, according to the presence of open wound in the chest. Blunt traumas are the most frequent type of chest trauma with or without rib fractures that might be associated with haemothorax, pneumothorax or haemopneumothorax that are the most typical lesions or laceration.

Pleural chest tubes are used to reestablish negative intrathoracic pressure after disruption of the pleural space. Chest tube positioning is considered necessary in case of a pleural disruption with pneumothorax; intrapleural bleeding causing haemothorax; or in case of pneumo-haemothorax .

The management of pleural chest tubes with primarily under water seal or added suction is the subject of debate, and the benefits of one versus the other in regards to duration of air leak, amount of time the chest tube is in place, length of hospital stay and incidence of complications are unclear.

All of the previous made us interesting to examine the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group, the investigators think that power of suction will give the patient better results with less complications and excellent immediate relief with good quality of life, rapid return to normal life .

Eligibility Criteria:
Inclusion Criteria:

* • 1-Pneumothorax after penetrating or blunt chest trauma

  * 2-Hemothorax after penetrating or blunt chest trauma
  * 3-Hemopneumothorax after penetrating or blunt chest trauma 4-All patients of all ages and genders are included

Exclusion Criteria:

* 1-Anyperson associating with body trauma outside chest.

  * 2-Invasive mechanical ventilation
  * 3-Emergent Surgery (thoracoscopy, open thoracotomy)
  * 4-Chronic pulmonary diseases (COPD, CRPD)
Evaluation of PKU Sphere in Maternal PKU

This observational study aims to recruit females, aged 16 years and over, with phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) following dietary management advice pre-conception and/or during pregnancy, who are willing to take PKU sphere as part of their dietarty management.

The aim of this study is to observe dietary management and metabolic control in women taking PKU sphere pre-conceptually and/or during pregnancy. To do this the following data points will be captured:

* Blood spot phenylalanine and tyrosine levels to measure metabolic control
* Changes to dietary management and any adaptations arising from incorporating PKU Sphere
* Compliance/adherence of patients to their recommended amount of protein substitute prescription.
* Tolerance of PKU sphere with respect to gastrointestinal (GI) symptoms and pregnancy associated nausea and vomiting.
* Acceptability of concurrent protein substitute(s) (if applicable).
* Nutritional status and weight management.
* Routine standard of care data on the final pregnancy outcome and postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) which requires dietary management during pre-conception and/or pregnancy.
* Aged 16 years and above.
* Following dietary management advice pre-conceptually and/or during pregnancy, aiming for phenylalanine levels of 120-250µmol/L.
* Prior positive PKU sphere taste test completed as part of routine care.
* Chosen to take part or full requirement of protein substitute as PKU sphere pre-conceptually and/or during pregnancy.
* Willingly given, written, informed consent from patient.
* Participant is, in the opinion of the investigator, able to participate and can comply with the study protocol.

Exclusion Criteria:

* Conception of pregnancy without commencement of phe-restricted diet and blood phenylalanine not maintained within target range by 10 weeks' gestation.
* Patients with known soya, milk or fish allergies / intolerance.
* Intake of pegvaliase or large neutral amino acids within 30 days prior to screening visit.
* Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.

Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years
2. Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:

   * Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
   * Recurrent SBP - One or more prior episode(s) of SBP in year.
   * Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
   * Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion Criteria:

1. \< 18 years.
2. Advanced HCC (HepatoCellular Carcinoma)
3. Post liver transplant
4. HIV + ve, Immunosuppressive therapy
5. Pregnancy
6. Domiciliary treatment
7. No consent