cyrilzakka/clinical-trials huggingface dataset:
A Study of Sterile Saline Infusion in Healthy Volunteers

The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than (\>)18 and less than (\<) 36
* Able to understand the English language
* Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention

Exclusion Criteria:

* Age \< 18 years and \> 60 years
* BMI \< 18 or \> 36
* Unable to understand the English language
* Currently pregnant or lactating
* History of skin sensitivity or allergy to steel needle or adhesive tape
* History of abnormal blood coagulation or bleeding
* History of abnormal immune function or frequent skin infections
* Active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease
* Has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery

Buprenorphine intravenous, sublingual, and transdermal patches have been researched for their antihyperalgesic effects, although peripherally mediated effects have not been examined in Egypt surprisingly

This prospective, randomized, double-blind controlled trial involved 88 patients who were scheduled for inguinal hernia surgery followed by a TAP block. Patients were allocated into group B (n= 44) received 20 ml of 0.25% Ropivacaine for TAP block; group BR (n= 44) received 20 ml of 0.25% Ropivacaine containing 300 μg of buprenorphine for TAP Block. The primary outcome of the study was the analgesic and antihyperalgesic effect of buprenorphine compared to the control group. The duration of analgesia, analgesic consumption, postoperative pain scores at rest and sitting up to 48 hrs, and effect on wound hyperalgesia at 24 and 48 hrs were evaluated. Secondary outcomes of the study include incidence of side effects and TAP block-related complications were recorded. Effect of buprenorphine on patients with predicted high pain scores and incidence of persistent postoperative pain were also determined.

A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Inguinal Hernia
2. Medically free

Exclusion Criteria:

1. participants with a history of heart, renal and liver cell failure.
2. allergic reaction to studied drugs, and history of epilepsy,
3. hydrodynamic instability,
4. chronic pain.
5. mental illness.
Prevention of Narcotic-Induced Nausea

We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.

Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine will be given through this IV per the doctor's order. With this medicine, patients will be given 10 milliliters (2 teaspoons) of either Sodium Chloride (salt water) or Phenergan mixed with Sodium Chloride (salt water). Phenergan is a medication typically used to help with nausea and is a common ingredient in prescription cough medicine.

After this is finished, patients will be asked to rate their pain and nausea in 30 minutes, and again 1, 2, and 4 hours later. If the doctor decides the patient is able to be discharged from the emergency room before the 4 hours are up, they will be asked to rate your pain and nausea again before going home, and the study will be stopped at that time.

Eligibility Criteria:
Inclusion Criteria:

1. Patient in Christian Care Emergency Department
2. Require intravenous narcotics for painful condition
3. ≥18 years of age
4. Able to visually rate amount of pain and nausea

Exclusion Criteria:

1. Hypersensitivity to promethazine or opioids
2. Patient requesting anti-emetic at enrollment
3. Narcotic administration in last 6 hours
4. Pregnancy or currently breast-feeding
5. Known seizure disorder
6. Medical Instability
Effectiveness of Celecoxib After Surgical Sperm Retrieval

While narcotic medication are commonly used for pain control near the time of surgery, there are significant side effects including constipation, nausea, risk of overdose leading to decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have designed a prospective randomized clinical trial to evaluate how effective the anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of surgery. Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.

Patients will be divided into two groups: the first group receives a celecoxib pill and the second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly which pills are given. The patient will complete questionnaires for pain level. By comparing the pain levels we can better understand whether celecoxib (Celebrex©) significantly decreases perioperative pain.

All consecutive patients scheduled to undergo elective, outpatient microsurgical testicular sperm extraction (TESE) beginning in 9/2011 will be invited for participation. Microdissection TESE will be performed unilaterally or bilaterally, through a midline scrotal incision, under general anesthesia.

Participants will be prospectively randomized in a 1:1 ratio to receive 200 mg of celecoxib or placebo b.i.d. in a double-blind fashion, initiated the night prior to surgery, and continued for six days thereafter. The randomization sequence will be generated and implemented by the institutional investigational pharmacy. Placebo medication, identical to the study medication, will also be provided by the institutional pharmacy.

Following surgery, all participants will be asked to complete a take-home post-operative questionnaire recording their maximum pain level on an 11-point visual analog scale (0-10), at specific time intervals over the course of the day, ranging from every six hours on post-operative day (POD) #1 to every 8 hours on POD #2, every 12 hours on POD #3, and every 24 hours on POD #4 to POD #7. Patients will also record the number of 5/500 mg tablets of acetaminophen/hydrocodone used for supplemental pain control from POD #1 to POD #7. Thirdly, patients will record whether or not their pain was adequately controlled at each of the above-mentioned time intervals.

Eligibility Criteria:
Inclusion Criteria:

1. \>/= 18 years old
2. Male
3. Scheduled to undergo microdissection testicular sperm extraction

Exclusion Criteria:

1. History of allergies to celecoxib (Celecoxib)
2. Renal failure
3. History of ulcer disease
4. Any history of myocardial infarction
5. Any history of stroke
6. History of bleeding diathesis
7. Use of aspirin
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ankylosing spondylitis
* Active ankylosing spondylitis

Exclusion Criteria:

* Complete ankylosis of spine
* Previous treatment with etanercept
Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices

Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.

Eligibility Criteria:
Inclusion Criteria:

* implantable pacemaker or defibrillator in situ

Exclusion Criteria:

* malfunction of implantable pacemaker or defibrillator
* low battery voltage of implanted cardiac electronic device
Stem Cells for Bronchopulmonary Dysplasia

Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants

Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.

transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with BPD

Exclusion Criteria:

* parents' rejection
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device

The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients who received a Arcadius XP L® interbody fusion device between 2016 until approx. January 2021 (minimum Follow-up is one year) in the study center
* all indications as given by the instructions for use: degenerative disc disease (DDD), Instability, Spondylolisthesis up to grade 1, Post-discectomy syndrome, Post-traumatic instability
* Written informed consent for the documentation of clinical and radiological results

Exclusion Criteria:

* Patient is not willing or able to participate at the follow-up examination
* Patients living outside a radius of 100 km around the study center
* all contraindications as given by the instructions for use:
Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder

Objective: The purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder compared to normal subjects. Furthermore, it studied the relationship between their balance and the total percentile scores of the ADHD Rating Scale IV.

Objective: The purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder contrasted to normal subjects. Furthermore, it studied the relationship between their balance and the total percentile scores of ADHD Rating Scale-IV.

Design: The study was a cross-sectional design. Methods: Sixty children were involved in this research from both sexes (42 boys and 18 girls) with age ranged from 60 to 84 months. They were subdivided into two groups based on the ADHD Rating Scale-IV. The control group included 30 normally developed children from both sexes (20 boys and 10 girls) with a mean age of 67.53 ± 1.41 months, and the total percentile scores of ADHD Rating Scale-IV ≤ 50. The study group comprised of 30 children from both sexes (22 boys and 8 girls) with attention deficit hyperactivity disorder (ADHD) with a mean age of 68.60 ± 4.62 months. The total percentile scores of ADHD Rating ScaleIV were ≥ 93. Both groups were investigated for their balance by Pediatric Balance Scale (PBS).

Eligibility Criteria:
Sixty children were involved in the present research from both sexes (42 boys and 18 girls) which were subdivided into two equal groups (control and study groups). They were recruited from different kindergartens at Cairo, Egypt, based on the following criteria:

inclusive criteria:

* age ranged from 60 to 84 months.
* selected from both sex.
* Children in the study group with attention deficit hyperactivity disorder (ADHD) based on the ADHD Rating Scale-I with total percentile scores ≥ 93, Children in control group normally developed with total percentile scores of ADHD Rating Scale-IV ≤ 50.

exclusive criteria:

- no history of cerebral palsy, epilepsy or head trauma.
An Innovational Model to Manage Patient Expectations and Improve Patient Satisfaction: An Intervention Study

This new model to manage patient expectations was developed based on our international study conducted in four countries. The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and needs and thereby, improve patient satisfaction.

The interventional model comprise teachable-learnable communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, Respond, Provide relevant information and Document the intervention.

The intervention includes all frontline care givers; however, most of the activities will be done by the nursing staff. The set of activities will be executed by the nurses at three separate periods of time during the patient's hospitalization: time of admission, intermediate time and at time of discharge.

The study is based on the hypothesis that a structured interventional model will significantly improve patient satisfaction during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* all patient older than 17 years who are able to express their expectations and needs to the clinicians and further have the ability to understand and fill in a questionnaire

Exclusion Criteria:

* Patients who are demented
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis

Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

To determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.

Eligibility Criteria:
Inclusion Criteria:

• Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)

Exclusion Criteria: None
Effects of Intravenous Lidocaine During Sedation for Colonoscopy.

This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.

Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)

The potential benefits of lidocaine infusion will be tested on:

* propofol consumption (primary outcome)
* intraoperative respiratory depression
* time for patient recovery
* postoperative fatigue
* postoperative pain
* postoperative cognitive dysfunction

Eligibility Criteria:
Inclusion Criteria:

* colonoscopy without gastroscopy

Exclusion Criteria:

* lidocaine allergy
* epilepsy
* severe heart rhythm disorders
* renal failure with creatinine clearance lower than 30ml/minute
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).


Eligibility Criteria:
Inclusion criteria:

* Age ≥18 years.
* Written informed consent prior to any study-related procedure
* Willing and able to comply with protocol-specified procedures and scheduled evaluations
* Pathological diagnosis of nasopharyngeal carcinoma (NPC)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1or 2
* Absolute neutrophil count (ANC) \> 0.5 x 109/L
* Haemoglobin \> 80 g/L
* Platelet count ≥ 50 x 109/L
* Total bilirubin ≤ 2 x the upper limit of normal (ULN)
* Alanine transaminase (ALT) ≤ 5 x ULN
* Serum creatinine ≤ 2 x ULN

Exclusion criteria:

* History or clinical evidence of neoplastic central nervous system (CNS) involvement. Note: Irradiated brain metastases that have been stable for \> 1 month and do not require systemic glucocorticoid administration are allowed
* Major surgery within 4 weeks of ARGX-110 first dose administration
* Unresolved grade 3 or 4 toxicity from prior therapy (except mucositis from local radiation therapy).
* Active, untreated viral, bacterial, or systemic fungal infection
* Childbearing potential unless using an adequate measure of contraception
* Pregnancy or lactation. History of hypersensitivity to recombinant proteins
* Any clinical finding, including psychiatric and behavioural problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study
Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha.

Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
* Within 48 hour diagnose sepsis
* Agree to participate

Exclusion Criteria:

* Pregnancy and lactation
* Severe thrombocytopenia, platelet less than 30.000/mm3
* Bleeding or high risk of major bleeding
* During anticoagulant treatment
* After thrombolytic treatment
* Decompensated chronic liver diseases
* Chronic kidney diseases on dialysis treatment
* During high dose corticosteroid treatment
* HIV with CD4 count below 50/mm3
* Indication for high dose heparin treatment
Cardiovascular Response to Orthostatic Fractional Gravity

There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 55
* Affiliated to a Social Security System
* Who accepted to take part in the study
* Who have given their written stated consent
* Who already participated in parabolic flights or performed a centrifuge run up to 4 G with head movements without occurrence of serious nausea or vomiting or cardiovascular discomfort.
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
* Medication with beta blockers, ACE inhibitors, calcium channel blockers or diuretics.
Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis

Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.The purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the Mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.

A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 81 eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory cytokines (Interleukine-6 \[IL-6\] and Tumor Necrosis Factor-a \[TNF-a\]).

Eligibility Criteria:
Inclusion Criteria:

1. coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent
2. willing to participation in the study

Exclusion Criteria:

1. cigarette Smoking
2. continuous consumption of any antioxidant supplement such as vitamin E, vitamin C and Selenium in last month
3. consumption of flaxseed or any omega-3 supplement at the beginning of the study
4. َadvanced renal disease
5. unwillingness to continuance
6. any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation