cyrilzakka/clinical-trials huggingface dataset:
Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly

The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.

This is a safety clinical trial. This trial is monocentric, open label, non-randomized.

Sixty elderly patients will be enrolled in this study, 30 with bedsore cares and 30 with rehabilitation sessions.

Six bedsore cares or rehabilitation sessions will be assessed for each subject. For each session, patient pain will be evaluated using a visual analogic scale VAS at different times, before session, 5 minutes then 20 minutes after the beginning of the session, and a last VAS 1 hour after the end of the session. During the two first sessions, patients do not receive Pecfent® to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care.

An evaluation of respiratory rate and of the level of sedation will occur at different time : after 5 minutes then 20 minutes of care, at the end of the care session,at half an hour then one hour after the care session.

At the end of sessions,

* The nurse or physiotherapist will assess their satisfaction regarding the objectives achieved during the session with a four points verbal descriptor scale (very satisfied, satisfied, not much satisfied, not satisfied). They will also evaluate at the end of the four last session their satisfaction regarding the convenience of the use of pecfent® and its contribution towards care.
* Patients will assess their satisfaction regarding the course of the session with a verbal descriptor scale (VDS) and their level of anxiety felt during the session with a VAS.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized geriatric patient requiring care or rehabilitation
* Patient with pain during treatment or mobilization. (VAS ≥ 4)
* Written Informed consent

Exclusion Criteria:

* All unstable fractures
* Confusion: unable to assess their level of pain using a VAS.
* Contraindications to PecFent ® (. Hypersensitivity to the active substance or to any of the excipients listed in section Composition Use in patients who had never received treatment for opioid severe respiratory depression or severe obstructive pulmonary disease.)
* Person under legal protection
Feasibility Assessment of the Blood Pressure Imager, a Continuous Blood Pressure Monitor

The investigators are developing Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals in underserved, low-resource environments at their own homes or regional care settings. Over the last one-year the investigators have developed the BPI prototype, which is ready for testing. BPI is a wrist device that includes a camera, color lights and soft membrane with a reflective coating. In this device feasibility study, the BPI will be placed over the radial artery at the wrist with the help of a wrist strap. The primary purpose of this feasibility study is to compare the BPI with a commercially available cuff-based blood pressure measuring devices.

If the participant volunteers to participate in this study, after signing the informed consent, responses to background data - age, gender, height, weight, wrist circumference of dominant arm, history of high blood pressure, diabetes, high cholesterol and cardiovascular disease - will be collected; The BPI will be strapped to the right or left wrist making sure it is comfortable to the participant and the readings from the BPI will be recorded in a computer. The continuous BPI readings will be recorded for 2 minutes. Simultaneously, blood pressure readings will be obtained from a cuff-based, commercially available blood pressure measuring device placed in the same arm. The research team will take a minimum 3 and maximum 6 sets of readings. At the end of the BPI readings, we will place an ultrasound probe of the wrist at the level of the wrist to assess the size of the radial artery and depth of the artery from the skin.

Participant Timeline: The collection of the background data will take 5 to 10 mins. The placement of the BPI and cuff-blood pressure device and the data collection will take about 15 to 20 mins. The ultrasound image collection will 10 to 15 mins. Overall, the study procedures will be less than an hour.

Eligibility Criteria:
Inclusion Criteria:

* Tests will be performed with any adult volunteer who is physically and mentally able to perform the experimental tasks.

Exclusion Criteria:

* We will restrict the experiments to adult volunteers who are physically and mentally able to consent.
Implementation of the Robson Classification of Cesearn Section in Sohag University Hospital

Aim Of The Work find out the frequency and indications for CS in sohag university hospitals and to analyze them according to Robson' ten group classification. This would be helping in adopting suitable measures to reduce the CS rate and identifying various challenges in our setting.

Cesarean Section Is A Surgical Procedure Used to Deliver A Baby Through Incisions In The Abdomen And Uterus . The incidence of Caesarean deliveries is increasing every day passing faraway beyond WHO recommended rate of 15% for all deliveries(1).

The rates of maternal morbidity and mortality are higher after CS compared to vaginal birth. CS is associated with an increased risk of abnormal placentation, uterine rupture, ectopic pregnancy, stillbirth, and preterm birth.

therefor Increase rate of unnecessary caesarean sections has been a growing concern in most parts of the world,Worldwide Caesarean section rates have risen from around 7% in 1990 to 21% in 2021 and are projected to continue over current decade if this trend continuees,by 2030 the highest rates are likely to be in Eastern Asia(63),Latin America and the Caribbean (54),Western Asia (50), Northen Africa (48),Southern Europe (47) and Australia and New Zealand(45) . According to the latest survey , one in five women in the world now deliver by caesarean section .Egypt has the highest rate of Caesarean section of 54 % in the Eastern Mediterranean Region , with no furthermore improvement to maternal and child mortality rates(2).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women more than 28 wks who will be admitted for labour

Exclusion Criteria:

* pregnant women less than 28wks
* pregnant women presented with rupture uterus
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report

in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age, 18-70
* Pain localized to the pelvic and perineal region
* The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
* The intensity of pain assessed by VAS (visual analogue pain scale) \> 7
* Importantly, the included participants should gain \> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root

Exclusion Criteria:

* Coagulopathy
* Infection at site of maneuver
* Abnormal Psychological behavior that interfere with integrity of obtained data
Fistula-associated Anal Adenocarcinoma

The fistula-associated anal adenocarcinoma is rare in patients suffering from anal fistulas. There is only little data available for this patient collective making characterization and management of this disease difficult. Late diagnosis and advanced tumor stage at diagnosis result in poor clinical outcome. It is the purpose of this study to evaluate patients clinically diagnosed with a FAAC and to further perform a histopathological characterization of the available tumor specimen.

All patients receiving surgery for an anal fistula in the years 1999 to 2019 at a tertiary university referral hospital were included in the analysis. A retrospective review of patients' charts was performed. Patients suffering from FAAC were eligible for histopathological analysis including immunohistochemistry and molecular profiling.

Eligibility Criteria:
Inclusion Criteria:

* anal fistula

Exclusion Criteria:

* previous cancer of the anal canal
Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.

The investigators primarily aim to observe the number of attacks from initiation of belimumab treatment.

The secondary outcomes are to determine: The safety profile of belimumab in participants with NMO and whether belimumab improves Expanded Disability Status Scale (EDSS), et al.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years old
2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria
3. Clinical evidence of either at least one attack requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a combination of these therapies) in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening.
4. EDSS \<= 6.0
5. Patients were seropositive for AQP4-IgG
6. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc)
2. Participation in another interventional trial within the last 3 months
3. Tumor disease currently or within last 5 years
4. Pregnant, breastfeeding, or child-bearing potential during the course of the study
5. Clinically relevant heart, liver, kidney or bone marrow function disorder
Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements

Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension theoretically changes pulse wave velocity.

Diabetes mellitus related vascular alterations are associated with an increased risk of hypertonia, atherosclerosis, neuropathy, diabetic retinopathy, and further more.

Increased vascular rigidity, which is based on the increased stiffness of vessels caused by vascular damage leads to an increase of pulse wave velocity. This assumption is based on the Moens-Korteweg-equation which is calculated using the modus of arterial vessel elasticity, arterial vessel wall thickness, the arterial radius and blood viscosity.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years

Exclusion Criteria:

* Diabetic foot gangrene
* No possibility of pulse wave velocitiy measurement on the finger or toe
Evaluation of Resuscitation Markers in Trauma Patients

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.

This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.


Eligibility Criteria:
Inclusion Criteria:

* Pre-hospital Priority 0 protocol activation:
* Glasgow coma scale \< 14
* Systolic blood pressure \< 90 mmHg
* Respiratory rate \< 10 or \> 29 breaths per minute
* Absent peripheral pulses
* Pre-hospital Priority 1 protocol activation:
* All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
* Flail chest
* Two or more proximal long-bone fractures
* Crushed, degloved or mangled extremity
* Amputation proximal to wrist and ankle
* Pelvic fracture
* Open or depressed skull fracture
* Paralysis

Exclusion Criteria:

* Hospitalization \< 24 hours ( transport of the patient to an other trauma center)
* Patients transported from an other hospital (first hours of medical support done elsewhere)
Home Based Exercises With and Without Posture and Ergonomics Training Among Students During COVID-19

The aim of this study is to investigate the effect of exercises with and without postural and ergonomic training among the students returning to university after quarantine due to COVID-19.

Postural awareness and ergonomic trainings are approaches that can help to relive pain among patients with Musculoskeletal complaints. The purpose of this study was to investigate the effects of posture and ergonomics training for students receiving distance education during the Covid-19 pandemic on musculoskeletal pain and physical activity level

Eligibility Criteria:
Inclusion Criteria:

1. Participant's using gadget like computer, mobile or laptop for online education during quarantine.
2. Participant's having musculoskeletal pain during COVID-19 quarantine.
3. Prolonged sitting and low physical activity during quarantine.
4. Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine.

Exclusion Criteria:

1. Participant's having musculoskeletal pain before the quarantine.
2. Participant's doing any type of physical activity during quarantine.
3. Participant's taking online classes or any online educational program before quarantine.
4. Participant's with known congenital, inflammatory and infectious conditions of spine.
5. Participant's following any ergonomic recommendations or any postural awareness during and after quarantine.
Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma

Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is "watchful waiting". The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.

There are controversies on the benefits of elective neck dissection (END) for clinically negative neck in early stage oral squamous cell carcinoma. The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. We initiate this multi-institutional study, expecting 448 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: END and "watch and wait". The END group will undergo one stage surgery of END and primary tumor excision, and the "watch and wait"group will be treated with primary tumor excision transorally as initial treatment, with rigorous postoperation consultation. All patients will be followed up with at least 5 years after initial treatment, and the survival rate and the recurrence rate between groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age:20 to 70 years old, both male and female
2. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate
3. The maximum diameter of the primary tumor is less than 4cm
4. Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound)
5. With at least 1-year's expected survival time
6. Willing to join the protocol and is able to give written informed consent

Exclusion Criteria:

1. Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases
2. The patient is pregnant or lactating
3. Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study
4. Patient is currently participating in another investigational drug study
Comparing Mobilization Techniques for the Hemiplegic Shoulder

One of the main complications after stroke is hemiplegic shoulder pain. It is known that one of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in the shoulder joint. Therefore, it is necessary to preserve the passive range of motion by using the most optimal mobilization technique. The aim of this study is to compare 2 different techniques in order to document their influence on shoulder range of motion and shoulder pain in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Upper limb impairment

Exclusion Criteria:

* Shoulder pain on the hemiplegic side with onset before the stroke
* Surgery at the hemiplegic shoulder
* Active movement possible within the whole range of motion
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.

Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.


Eligibility Criteria:
Inclusion Criteria:

* Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
* Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).

Exclusion Criteria:

* Moderate to life threatening fetal anomalies
* Multiple live gestations at birth (e.g. twins, triplets, etc)
* Intrauterine fetal demise
* Previous participation
* Stem cell collection
R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL

The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (\>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
2. Patients were classified as "non frail" (fit) if they had

   * ADL (Activity of Daily Living) score of 6
   * less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities
   * absence of geriatric syndrome
3. Patients HIV negativity;
4. Concurrent malignancy;
5. Written Informed Consent.

Exclusion Criteria:

* All other patients were classified as "unfit", and were excluded from randomization