cyrilzakka/clinical-trials huggingface dataset:
Hyperbaric Oxygenation in Diabetic Ulcer

Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for hours, instigating healing processes in wounds caused by disturbances in of perfusion in small vessels, a condition often found in patient with diabetes.

We plan a prospective, double-blind randomized clinical study in 80 patients with chronic diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number of monitoring and imaging procedures will be done, cells in the bloodstream indicating improved healing will be determined.

Hypothesis: HBO will instigate the healing process in the majority of patients with chronic diabetic leg ulcer, provided the patency of the large vessels is given.

We plan a prospective, double-blind randomized clinical study (phase III) in 80 patients with diabetes mellitus. All of them will receive the optimum metabolic treatment for their underlying disease. The treatment group will be administered HBO according to the problem wound schedule, the controls will have sham treatment in the hyperbaric chamber. Routine wound care (dressings, physiotherapy, antibiotics if necessary) will be identical in both groups and according to its clinical needs.

Before treatment, indocyanine green videoangiography (ICG), transcutaneous (partial) oxygen pressure (TcPO2) and LifeViz 3D (three-dimensional medical imaging and reconstruction) documentation will be done and endothelial progenitor cells (EPC) as well as markers of bone metabolism will be determined in all patients.

The measurements will be repeated according to the schedule during the treatment period and at controls after 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Age between 18 and 80 years
* Chronic foot ulcer (up to Wagner scale III)
* Patency of large vessels tributary to region of wound
* Good outpatient diabetes management as verified by a specialized centre (HbA1c\<8.5%; IFCC: 69mmol/mol).

Exclusion Criteria:

* Clinically relevant obstruction of large vessels tributary to region of wound
* Non-adherence to diabetes therapy
* Pregnancy
* Reactive airway disease
* Radiographic evidence of pulmonary blebs or bullae
* Untreated pneumothorax
* History of seizures except childhood febrile seizures
* Cardiovascular instability
* Mechanical ventilator support
* Treatment with Bleomycin or Anthracyclin in history
* Unable to perform the Valsalva-procedure
* Participation as a subject in any other medical or biomedical research project; if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent.
Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.

Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.

Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .

Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .

our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.

The aims of this project is to verify if our theory is corect by blinded comparision between two methods.

Eligibility Criteria:
Inclusion Criteria:

* children with obstructive symptoms
* the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)

Exclusion Criteria:

* without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
* tonsillectomy
* Non randomalization, not blinded
Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia

PURPOSE:

The current study aims to:

* Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.
* Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia.

BACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia

HYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP.

RESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?


Eligibility Criteria:
Inclusion Criteria:

* Their age will be ranged from 8-12 years.
* Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
* Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
* They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

* - Cardiovascular or respiratory disorders.
* Botulinium muscular injection in the last 6 months
* Surgical interference in lower limbs and/or spine.
* Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
* Seizures.
* Visual or hearing impairment
Endoscopic Bariatric Stapling Pilot Study

This study is a prospective single-arm, multicenter study to evaluate the safety and effectiveness of the TOGA® Procedure for the treatment of morbid obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years - 60 years
2. Eligible for bariatric surgery per US National Institute of Health (NIH) guidelines BMI ≥ 40 kg/m2 and \< 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more comorbidities. Comorbidities are defined as diabetes, pulmonary disease, cardiac disease, or hypertension \[systolic blood pressure of ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg (or both) or on treatment for hypertension\]
3. History of obesity for at least 2.5 years
4. History of failure with non-surgical weight loss methods.
5. Agree to comply with the substantial dietary restrictions required by the procedure.
6. Understands risks of procedures, agree to follow protocol requirements, including signing informed consent, returning for follow-up visits and completing all required testing, completing diet and behavior modification counseling.

Exclusion Criteria:

1. Patient history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis.
2. Significant known esophageal disease including grade 3-4 esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, nutcracker esophagus, achalasia, esophageal dysmotility.
3. Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia.
4. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
5. Hiatal hernia ≥2cm
6. Severe cardiopulmonary disease or other serious organic disease including HIV or cancer.
7. Currently pregnant or nursing. Potentially childbearing (i.e not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 12 months.
8. Current alcohol or drug addiction.
9. Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator or psychologist/psychiatrist, make the subject a poor candidate for this procedure.
10. Previous gastric, esophageal, pancreatic, or bariatric surgery.
11. Infection anywhere in the body at the time of the procedure.
12. Patient history of scleroderma.
13. Thyroid disease which is not controlled with medication.
14. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
15. Known active H-pylori infection.
Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell

All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.

The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.

Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.

With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Diffuse Large B-Cell Lymphoma diagnosis
* Patient eligible to receive 6 cycles of R-CHOP or R-CHOP like chemotherapy at full doses
* Age ≥ 18
* Stage I-IV
* Written informed consent
* ECOG Performance Status 0-3
* Ventricular Ejection Fraction (VEF) ≥40%
* No previous treatment for lymphoma (except for RT-IF)
* Negative β-HCG pregnancy test result at diagnosis for female of childbearing potential
* Use of acceptable method of contraception during the study and for 3 months after receiving the last dose of study drug for patients with childbearing potential
* Availability of the patient to be followed for all the phases of the chemotherapy treatment and for the subsequent follow-up

Exclusion Criteria:

* Inability to schedule a treatment at full doses of chemoimmunotherapy R-CHOP or R-CHOP-like for different reasons
* Central nervous system involvement due to lymphoma
* HIV
* Active cardiac pathology including heart failure, left ventricular dysfunction documented by a LVEF \<40%, arrhythmias (rapid atrial fibrillation, frequent ventricular arrhythmias), valvular aortic or mitral disfunction \> moderate, ischemic heart disease (myocardial infarction or acute coronary syndrome for over 6 months, angina at rest or with mild efforts)
* Previous treatment for lymphoma
* Other malignancy in the 3 years prior to the diagnosis of lymphoma with exception of non-melanoma skin cancer or in situ carcinoma
* Any other co-existing medical condition that would preclude participation in the study (uncontrolled bacterial or viral or fungal infection)
* Pregnant, or lactating and breastfeeding female
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.

Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80
* Male and female of all races and ethnicities
* Cirrhosis of any cause
* Any grade of hepatic encephalopathy (1-4)
* Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf

Exclusion Criteria:

* Acute liver failure
* Prisoners
* Structural brain lesions (as indicated by CT and confirmed by neurological exam)
* Other causes of altered mental status
* Previous use of rifaximin or neomycin within last 7 days
* Pregnancy
* Serum Na \<125 MEq/liter
* Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
* Uncontrolled infection with hemodynamic instability requiring vasopressors.
Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity Lymphedema

Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.

designing the optimal incision sites and identifying functional lymphatic vessels imaging is crucial for success, primarily due to its efficacy in draining edematous lymphatic fluid and reducing swelling in patients with lymphedema. In this study, we conducted patients with LVA lymphedema to investigate the correlation between LVA incision design, intraoperative functional lymphatic vessel assessment, postoperative limb reduction, and patient satisfaction.

question 1：Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity lymphedema

Eligibility Criteria:
Inclusion Criteria: Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months

-

Exclusion Criteria:

* lipedema；myoedema
Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol

Mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; This requires promoting the positive perception of maternal self-efficacy and thus achieving the reinforcement of behaviors related to the demand for care in relation to motor development.

* Objective: Determine the effect of an interdisciplinary intervention program on maternal self-efficacy and motor development of premature children in the cities of Bogotá and Tunja in comparison with the traditional kangaroo program.
* Methodology: Experimental study, with pretest/posttest design, with experimental and control group, which determines the baseline. With initial evaluation of the groups, randomized assignment, and post-intervention evaluation at 4 weeks and flow-up at 8 weeks. The intervention will be developed in two scenarios, in the outpatient kangaroo plan consultation and at home. The experimental group will receive an intervention based on the promotion of maternal self-efficacy and the motor development of the premature baby. The control group will have traditional kangaroo program care. The sample calculation is 92 participants, 46 in the experimental group and 46 in the control group. The intervention, evaluations and data analysis will be developed by blinded professionals. An analysis of the data will be done by intention to treat.
* Type of results expected to be obtained: It is expected to obtain an intervention that promotes maternal self-efficacy for the adequate stimulation of the motor development of the premature baby. It is expected to enhance the confidence and empowerment of the maternal role, the motor development of children in accordance with the corrected age and the incorporation of ICT for monitoring at home.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of a child born prematurely who attend the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025.
* Premature children between 32 to 36.6 weeks who participate in the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025.

Exclusion Criteria:

* Mothers who manifest any diagnosed mental limitation to participate in the study.
* Premature children with hemodynamic alterations, congenital malformations, chromosomal syndromes, esophageal atresia, ductus arteriovenosus, heart disease and neurological pathologies.
Anomalies of Dense Platelet Granules

The study aims to know the overall prevalence of granular deficits and their breakdown by type (anomaly of number, content or secretion) in a population of patients with hemorrhagic symptomatology after exclusion of other known causes.

This study consists also to evaluate the association between the presence of a deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...)

-Evaluate the association between the type of deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...)

Patients will be recruited during the exploration visit (v0) or the confirmation/typing visit (v1) according to their follow-up.

* Exploration visit (v0): inclusion of patients without prior platelet exploration, and study of their dense platelet granules.
* Confirmation/typing visit (v1): verification of the persistence of anomalies detected in patients with an abnormality identified during v0 (no later than 6 months after v0) and in patients for whom a dense granules anomaly has already been identified during their standard management prior to the start of the study. Completion of complementary examinations to complement the typing of the granular anomaly and molecular analysis for family cases

Eligibility Criteria:
Inclusion Criteria:

* Adult or child patient ≥ 2 years
* Having a hemorrhagic score ISTH \> 3 for men, \> 5 for women and \> 2 for children.
* With no abnormal coagulation (defined by normal TP and TCK or activity ≥ 50% of FII, FV, FVII, FX, FVIII, FIX, FXI)
* no deficiency of Willebrand factor (defined by a cofactor activity with Ristoctin (VWF: RCo \< 50%))
* no a known major thrombocytopenia/thrombopathy linked to a deficiency of one of the major platelet receptors
* Information of the patient and/or his legal representative present

Exclusion Criteria:

* Inability or refusal of compliance with research requirements
* Thrombocytopenia \< 100 G/L
* Treatments interfering with platelet functions within 10 days prior to inclusion
* Malignant hemopathy
Dexmedetomidine for Attenuation of Pressor Response

Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . The pressor response could be blunted by dexmedetomidine which is a selective alpha 2 agonist which might provide hemodynamic stability during tracheal intubation.

Various drugs include local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics have been tried to blunt the laryngoscopy and intubation response, with varied success. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its various effects have led to its increasing use for reducing anesthetic and analgesic requirements in the perioperative period. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation. Electrical cardiometry is recently introduced for assessment of many cardiovascular variables and continuously applicable method of cardiac output (CO), stroke volume (SV), and other hemodynamic parameters monitoring. Its use is growing because it is non-invasive, shows reliability in CO measurements and can be used as a continuous bedside monitor Although different doses of dexmedetomidine (0.5- 2.0 μg/kg) have been used in various studies which suggested its efficacy in blunting the hemodynamic pressor response , However, no studies to the best of our knowledge had incorporated CO monitoring for detection of minimal hemodynamic changes during laryngoscopy and endotracheal intubation which can be best achieved by using Cardiometry monitor.

In this study, we will compare two doses of dexmedetomidine for prophylaxis against pressor response of ETI using cardiometry.

Eligibility Criteria:
Inclusion Criteria:

1 - ASA physical status 1-2. 2. Age 18- 60 years old of both sexes. 3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

1. Age \&lt; 18 years and ≥ 60 years
2. Pregnancy
3. Emergency surgery or full stomach
4. Renal or Hepatic patients
5. Patients with suspected difficult airway {e.g., high neck circumference, high body mass index (above 30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
6. Total duration of laryngoscopy will be noted and in cases where duration exceeded 15 sec the case will be excluded from the study.
7. Any patient on regular intake of beta blockers or calcium channel blockers
8. Patients with any known hypersensitivity or contraindication to dexmedetomidine,
9. Patients with significant neurological, psychiatric, or neuromuscular disorders.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)

This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease, on dialysis for \> 3 months
* Treatment-naïve or previous treatment with ESA
* Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion Criteria:

* Participation in a clinical trial
* Anemia due to an associated malignant pathology