cyrilzakka/clinical-trials huggingface dataset:
Sonar Guided vs Surgeon Delivered Parasternal Block

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.

Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block).

1. group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance
2. Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.

Eligibility Criteria:
Inclusion Criteria:

* Age: from 18 to 75 years.
* Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) via median sternotomy and under CPB (cardiopulmonary bypass)
* Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation).

Exclusion Criteria:

* • Previous, urgent, or emergent cardiac surgery.

  * Patients undergoing coronary artery bypass grafting (CABG)
  * local infection of the skin at the site of needle puncture,
  * Allergy to bupivacaine,
  * Coagulation disorders,
  * Clinically significant liver or kidney disease,
  * Heart failure or severe pulmonary hypertension.
  * severe renal, pulmonary, liver, or endocrine systemic disease,
Pentastarch Use in Cardiac Surgery

Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit

Exclusion Criteria:

* Emergency surgery
* Regurgitant valve pathology
* Redo surgery
* Significant left ventricular (LV) dysfunction
* Significant renal insufficiency
* Anticipation of associated procedure - eg carotid endarterectomy
* Ongoing sepsis or endocarditis
* Received aspirin (ASA) or Plavix within 96 hours of surgery
Accuracy of Commercially Available Heart Rate Monitors III

The objective of this study is to evaluate the accuracy of four heart rate monitors in cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving exercise on a treadmill and/or stationary bicycle.

This study will assess the accuracy of four of the best-selling optical heart rate monitors when worn by cardiac rehabilitation patients.

During testing, each subject will wear:

1. Two different optical heart rate monitors (one on each wrist)
2. A Polar chest-strap based monitor
3. ECG leads

The types of wrist-worn heart rate monitors assigned to each subject will be randomly assigned.

The location (left or right wrist) will also be randomly assigned.

Heart rate will be assessed using each of the 4 monitors with the subject on the exercise machines under each of the following conditions:

1. Pre-exercise
2. Treadmill: at 3, 5 and 7 min.
3. Stationary Cycle: at 3, 5 and 7 min.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus

Exclusion Criteria:

* Presence of a cardiac pacemaker
* Known chronic and persistent heart rhythm disorders
* Tattoos around the wrist or forearm area
* Use of a radial artery graft for coronary artery bypass grafting
Efficacy of Yoga Based Self-Management Program for Chronic Pain

Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app.

Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain for at least 3 months
* Having access to internet and video calls

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Patients not willing to give written consent
* Patients with severe psychiatric or personality disorder
* Malignancy
Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study

Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL) in PCD and healthy counterparts retrospectively at the first stage of the study and the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength, and exercise capacity in PCD patients with decreased inspiratory muscle strength from the database recorded between 10 July 2015 and 10 January 2015 retrospectively at the second stage of the study.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable
* Being able to cooperate with the assessments
* Not having any orthopedic, or neurological problems

Exclusion Criteria:

* Not being clinically stable
* Not being able to cooperate with the assessments
* Having any orthopedic, or neurological problems
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥ 18 years and ≤ 85 years.
* Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
* Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.

Exclusion Criteria:

* Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
* Active intermediate or posterior uveitis in the study eye(s).
* Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
* Have participated in another investigational device or drug study within 30 days prior to screening.
* Participation in a prior ADX-102 study.
Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment.

Pelvic chemoradiotherapy (CRT) is an effective treatment for Locally Advanced Cervical Cancer (LACC). However, CRT induces premature ovarian failure ceasing the production of ovarian hormones. This may lead to severe consequences to the patient's life quality, sexuality and overall healthy. An acceptable treatment to minimize the adverse effects caused by the lack of ovarian hormones is hormonal replacement but less than 40% of the patients younger than 50 years have access to this treatment. A second alternative treatment is ovarian transposing which is a surgical technique with variable success rate depending on how far the ovaries are from the radiotherapy field. A third, more promising, alternative is involves using autologous ovarian tissue as a graft in tissues far from the radiotherapy field. This treatment has the potential of maintaining the natural ovarian hormones production at a lower-cost and requiring a simpler procedure. The primary objective of this randomized phase 1-2 clinical trial is to validate the feasibility of ovarian tissue engraft into fatty tissue and its endocrine functionality.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix.
* FIGO 2018 staging IB3 to IVA.
* Absence of ovarian involvement.
* Age ≤35 Years.
* Absence of metastatic disease.
* Written consent.

Exclusion Criteria:

* Previous treatment for cervical cancer or other malignant diseases.
* Rare histology tumors.
* Absence of one or both ovaries.
Study on the Effect of PRKCB1 Modulating Inflammatory Factors and the Role for Developing Major Depressive Disorder

Depressive disorder is known as being accompanied with the activation of immune system which could lead to a series of changes including the neuron apoptosis, synapses transmission inhibition and emotional symptoms. The activation of protein kinase C (PKC) can reverse the immune/inflammatory process and restore the neuroplasticity and neurotransmitters transmission. Based on our finding that patients with major depressive disorder (MDD) showed a significantly lower gene expression of PRKCB1, while the PKC activation mediated by PRKCB1, we hypothesize that PRKCB1 contribute to the development of MDD and treatment response by its specific expression in brain, regulating ERBB, Chemokine signaling pathways and PKC activation during the neuroinflammatory process. In the present study, we aim to evaluate and verify the regulation effect of PRKCB1 on the neuroimmune and inflammatory mechanism in depressive disorder by a serious of studies focus on PRKCB1 gene expression modulating process and different downstream biomarkers which associated with PRKCB1 effect, combined with the specified treatment (plus omega-3 poly unsaturated fat acids). This study may provide scientific evidences for using neuroinflammatory biomarkers to diagnose MDD, as well as personalized treatment.

(1）To find out the differences of expression of mRNA, lncRNA, miRNA and proteins of PRKCB1 between patients with depressive disorder and healthy subjects.

(2) Patients with depressive disorders will be randomized into two groups that they will be treated with escitalopram or escitalopram plus Omega-3 PUFAs. To observe the effects of Omega-3 PUFAs on PRKCB1 and related neuroimmune/neuroinflammatory pathway which may improve understanding the relationship between neuroinflammatory regulation and depressive disorder treatment.

Eligibility Criteria:
Inclusion Criteria for patients:

1. Drug-naive or medication free for no less than 4 weeks;
2. 18-60 years old, Han nationality;
3. Junior high school diploma or above;
4. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR;
5. Scored 17 or higher on the Hamilton's Depression Scale with 17 items (HAMD-17) and scored 2 or higher for the 2nd item (depressive mood);
6. Written informed consent has been obtained.

Exclusion Criteria for patients:

1. Concurring psychotic disorders;
2. Woman who is pregnant or breast feeding or is planning to get pregnant;
3. Scores 3 or higher on item 3 (suicidal) of HAMD-17;
4. serious allergy or disease of immune system;
5. had anti-inflammatory drug or immunosuppressant in the past 1 month;
6. serious medical or surgical illness or history;
7. had MECT in the past 1 month.

Eligibility Criteria for healthy volunteers:

1. match the patient group in age, gender, education and handedness;
2. no history of psychiatric disorders or debilitating general medical disorders.
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients

This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.

Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1 patients
* Matched control-subjects

Exclusion Criteria:

* Patients or subjects with anti-inflammatory drugs
Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Eligibility Criteria:
Inclusion Criteria:stroke patients in the 3-4.5 hour time window -

Exclusion Criteria:stroke patients in more than 4.5 hour time window

-
Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.

The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Newborn infants with birth weight \>500 gm.
2. Gestational age \>24 completed weeks.
3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
4. No known lethal congenital anomaly or genetic syndromes.
5. Signed parental informed consent.

Exclusion Criteria:

1. Considered non-viable by clinician (decision not to administer effective therapies)
2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
3. Infants known to require surgical treatment
4. Abnormalities of the upper and lower airways
5. Neuromuscular disorders
6. Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube
Identification of Neurological Prognostic Markers of Cardiac Arrest Patients Alive on 3rd Day

The aim of the study is to identify prognostication predictors of 6-months neurological outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia (TH).

Cardiac arrest (CA) management remains challenging. As fewer than 20% of patients survive to discharge, early prognostication of functional outcome needs accurate prediction.Survivors outcome depends on initial CA conditions (cause, duration and severity of ischemic injury) that may lead to the post-cardiac arrest syndrome, associated with high mortality. Hypoxic-ischemic encephalopathy is the second cause of poor outcome after CA. Indeed, most survivors remain comatose or in a vegetative state leading to decisions to withdraw life support. Thus, the American Academy of Neurology had proposed a decision algorithm for use in prognostication of comatose survivors published in 2006.Before the widespread use of therapeutic hypothermia (TH), predictor factors of neurological outcome were: serum neuron-specific enolase (NSE), N20 somatosensory-evoked potentials (SSEP), status epilepticus, pupil and corneal reflexes and Glasgow coma score motor response (GCS-M). Therapeutic hypothermia is recommended in the management of CA.It has been associated with improved outcome after ventricular fibrillation out-of-hospital cardiac arrest (OHCA). However, TH may interfere with clinical examination and electrophysiological predictors (EEG, SSEP) making prognostication of functional outcome hardiest.The use of sedative drugs and muscle paralysis during TH is another cause of delayed neurological assessment and prognostication.The NSE cutoff values to predict poor neurological outcome are not well defined and can be influenced by TH either.The present study aims at identifying clinical, electrophysiological and biological prognostication predictors of 6-month neurological outcome in survivors at day 3 after CA treated by TH. Neurological functional status was assessed using the 5-item scale Cerebral Performance Category (CPC). Neurological status was retrospectively assessed at 6 months: CPC of 1 or 2 was defined as good neurological outcome and CPC of 3 to 5 were defined as poor neurological outcome. Deaths in the first 3 days and decisions to withdraw or to withhold life support were also collected. The following prognostication factors were tested: neurological examination at day 3 and 7 including corneal and pupillary reflexes, GCS-M, status epilepticus, electro-encephalogram (EEG), SSEPs and NSE levels between day 2 and day 3.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* successfully resuscitated of out-of-hospital cardiac arrest (OHCA)
* patients admitted to ICU

Exclusion Criteria:

* in-hospital cardiac arrest patients
* death before ICU admission
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers

Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms.

This is e.g what happens when human tissue is cut of from blood supply for a time, and the blood supply is again restored. The damage following the restoration of blood is known as "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated blood to the deprived tissue can in it self contribute to cell death due to excessive amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize their damage.

The purpose of the investigators methodology study is to make an ischemia-reperfusion model on healthy volunteers (on the lower limb) to examine the expression of markers that are expressed in the muscle and the blood when blood supply is cut of to an area and later restored. The investigators wish to measure the product of the damage caused by free radicals and the levels of antioxidants.

If the investigators can produce elevation of oxidative and inflammatory markers, this model can be used to test antioxidative intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Between 18 and 40 years.
* Non smokers.
* No known history of familiar cardio/vascular diseases.
* No intake of prescription medicine.
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain

Objective: To determine the effectiveness of diaphragm biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

* Neural disorders
* Systemic disorders
* Cognitive disorders
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia

The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.


Eligibility Criteria:
Inclusion Criteria :

* persons who have provided written consent
* Patients with national health insurance cover
* Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN \< 500 / mm3) lasting more than 10 days.
* Patients with malignant hemopathy who have received an autologous bone marrow graft
* Patients with severe idiopathic medullar aplasia (PN \< 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)

Exclusion Criteria:

* Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).
* Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).
* Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.