cyrilzakka/clinical-trials huggingface dataset:
Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

We will be investigating the use of ketamine in sedation for endoscopic procedures, specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy. Participants will be randomized to one of two arms including conventional moderate sedation with midazolam and fentanyl or the ketamine arm. They will then undergo the planned procedure. Physicians preforming the procedure will be surveyed following the procedure and patients will be surveyed twice, once after meeting criteria for discharge on day of the procedure and a second time 48 hours following the procedure.

In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Gastroenterology Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting to the endoscopy lab for esophagogastroduodenoscopy (EGD) and/or colonoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either a ketamine loading dose and then subsequent doses IV ketamine and midazolam 1mg IV prior to administration of ketamine or standard fentanyl/midazolam moderate sedation during their procedure. Participants will then undergo the planned procedure. The primary outcome will be patient satisfaction, which will be measured using the validated "Patient Satisfaction with Sedation" instrument (PSSI). A number of secondary outcomes will include the following: (1) provider satisfaction (measured using and the "Clinician Satisfaction with Sedation" instrument (CSSI), (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to recovery (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (4) time to cecum (for colonoscopy) total doses of medications given (midazolam, fentanyl, and ketamine), (5) overall time of the procedure, (6) adverse events, (7) changes in vital signs, (8) and the need for additional medications, in particular reversal agents.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy

Exclusion Criteria:

* Poor vital sign stability
* Hypoxia: O2 \< 92%,
* Hypotension, hypertension, heart rate and respiratory rates greater than 20% above or below normal as dictated by normal ranges in SAMMC protocol
* Any allergy to ketamine, fentanyl, or midazolam
* Patient is pregnant or refuses pregnancy test, in women of child-bearing potential.\*
* American Society of Anesthesiologists (ASA) score\>3
* Presence of a history of psychosis, hallucinations, and/or a psychotic disorder
* History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
* Active pulmonary infection or disease.
* History of airway instability, tracheal surgery, or tracheal stenosis.

  * \* Not applicable if patient is a female over 50 years old or has had a hysterectomy and/or oophorectomy
Improvement of Motor Tasks: Effects of Verbal Encouragement and Music

This study employed a randomized crossover design to assess the impacts of three different experimental conditions-standard environment, music, and verbal encouragement-on performance in an isometric endurance task, with comparisons made between untrained and trained individuals. Interventions were spaced seven days apart. Measurements included muscle activity and fatigue, assessed via surface electromyography, and the duration of the task.

The isometric endurance task required participants to maintain a 90° elbow flexion while holding a dumbbell in a supine grip, weighted to 80% of their one-repetition maximum, on the dominant side. During the task, participants were to keep their back and head against a vertical wall, stand with feet shoulder-width apart, and firmly on the ground. The dumbbell was held with the dominant arm, and the other arm was kept neutral by the side. It was crucial to avoid any rocking or movements that would ease maintaining the position. The test began when the bar was handed to the participant in the correct stance and concluded once the arm's angle deviated by more than five degrees from the start.


Eligibility Criteria:
Inclusion Criteria:

* Good general health,
* No medical conditions that could interfere with their ability to perform the test safely and effectively.
* To be considered exercised, participants had to have performed 150 minutes per week of vigorous intensity aerobic physical activity, in addition to muscle strengthening activities, for at least two days per week. Those who did not meet this standard were considered untrained.

Exclusion Criteria:

* History of surgery on the arm, shoulder or adjacent areas that could limit the ability to perform the test.
* Use of medication that affects muscle function or pain perception
Role Of Transthoracic Ultrasound in Predicting Post-extubation Distress During Successful Weaning

-To Assess Value of Transthoracic Ultrasound In Predicting Post-extubation Distress in Respiratory ICU Using Ultrasound Parameters As Diaphragmatic Excursion ,Diaphragmatic,Diaphragmatic Thickness Fraction,Diaphragmatic Thickness.

Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of post-extubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation or a trial of totally unsupported respiration are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU.

The Investigators hypothesized that the use of an integrative thoracic ultrasound assessment, encompassing bedside respiratory, and diaphragm sonographic data, could accurately predict post-extubation distress in patients who succeeded in a pressure support ventilation trial. In addition, The Investigators suggest that the use of appropriate analytical methods, that is, machine-learning methods, could permit the evaluation of the specific impact of respiratory and diaphragm sonographic data on the final estimation of a likelihood of post-extubation distress .

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 yrs. old who admitted to respiratory ICU and mechanically ventilated due to chest diseases and passed weaning trials

Exclusion Criteria:

* Pregnancy.
* Neuromuscular disorders.
* Psychiatric instability.
* Uncontrolled cardiovascular disease.
* Tracheostomy.
* patints with failed weaning trials.
* Inability to provide informed consent.
Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in combination with intraarterial treatment in patients with Acute Ischemic Stroke.


Eligibility Criteria:
Inclusion Criteria:

1.18-80 years old 2. NIHSS score\>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours

Exclusion Criteria:

1. Patients receiving Alteplase thrombolysis
2. Other diseases of the central nervous system
3. There has been a neurological disability in the past (mRS score\>2)
4. Difficulty swallowing
5. Arrhythmia, atrioventricular block
6. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
7. Macular edema
8. Magnetic resonance angiography shows vertebra-basilar artery obstruction
9. Hemorrhagic stroke
10. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
11. Pregnant and lactating women
An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)

An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged more than18
* HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
* Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
* Serum ALT no more than 2 x ULN (including normal ALT)
* Life expectancy 6 months
* A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
* Informed consent

Exclusion Criteria:

* Other subtype of lymphoma except DLBCL
* DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
* patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
* evidence of hepatocellular carcinoma.
* evidence of decompensated liver disease
Telerehabilitation and Conventional Physiotherapy Program for Caregivers of Individuals With Special Needs

The study was planned to investigate the effectiveness of home therapy method due to the difficulties experienced by caregivers of individuals with special needs in accessing physiotherapy and rehabilitation services for chronic neck and back pain.

Caring for a disabled child is a very difficult and long process for parents. In this process, mothers and fathers exert a lot of effort while caring for the child, carrying the child and playing an active role in its rehabilitation. For these reasons, it is reported that the physical health of mothers and fathers is negatively affected and they often experience waist and back pain. Telerehabilitation allows patients who cannot access rehabilitation due to geographical, economic or physical disabilities to benefit from rehabilitation services. The distance problem is especially valid in cases where people live far from the rehabilitation center, there are no rehabilitation professionals specialized in the relevant disease in the place of residence, when transfers are difficult due to mobility problems, and in cases where it is not possible or risky to go to the rehabilitation center due to epidemics, as is the case today. Telerehabilitation has the potential to overcome all these problems. The study was planned to investigate the effectiveness of home therapy method due to the difficulties experienced by caregivers of individuals with special needs in accessing physiotherapy and rehabilitation services for chronic neck and back pain.

Eligibility Criteria:
Inclusion Criteria:

* Being between 20-60 years old,
* Being a special needs child caregiver,
* Mechanical neck and back pain lasting 3 months or longer

Exclusion Criteria:

* Those who are caregivers of hearing and visually impaired children,
* Having previously undergone surgery in the cervical region,
* Patients with a history of inflammatory or infective arthritis in the cervical spine,
* Congenital spinal cord anomaly,
* history of malignancy,
* Having neuropathic pain
* Radiculopathy, myelopathy or other neurological disorders
* Those with chronic lung disease
* Vestibular disorders,
* Those with a history of continuous drug use,
* Individuals who have been involved in an exercise or physiotherapy program in the last 3 months,
* He will not be able to read the scales and the evaluation parameters will be excluded from the study.
Vascular Reactivity in Kidney Disease Patients

Dialysis patients suffer from many problems with blood vessels and this is even more so for patients with the added complication of diabetes. Diabetics have a number of reasons for vascular disease and one of the new areas of research is looking at the cells that line the blood vessels, called endothelial cells. It is thought that the number of red blood cells in the blood (haemoglobin concentration) affects the function of these cells. There is very little information available on what haemoglobin level is best for dialysis patients. As diabetics account for almost 40% of dialysis patients worldwide it is important to understand the effect different haemoglobin levels will have on the blood vessels.

Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations \[Hb\] in dialysis patients.

This project is going to ask dialysis patients (both diabetic and non-diabetic) to undergo a series of tests at three different time points over a one year period: a baseline set of tests, tested when haemoglobin is maintained at 130-140g/L and repeat the tests when haemoglobin is maintained at 105-115g/L. The current recommendation for haemoglobin is 110-120g/L. Patients will not be required to take any study medication but a specialist kidney doctor, using their usual medications of iron and erythropoietin therapy, will change their haemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years
2. Patients receiving either conventional haemodialysis 3-4 x week, for a duration of \> 6 months or peritoneal dialysis for a duration \>6 months
3. Stable dialysis access for at least 3 months (Permcath / PTFE / AVF)
4. On erythropoietin and iron therapy, with stable \[Hb\] x 2 months (105 - 135g/L)

Exclusion Criteria:

1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study
2. Patients with dysrhythmias
3. Pre dialysis SBP\> 180 mmHg on \> 2 times within a 2 week period
4. Between dialysis weight gain \> 5% of body weight (if evident \> 2 times/ 2 week period)
5. Soft tissue ulcers
6. Non traumatic amputations
7. Unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion
8. Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery)
9. Dementia
10. Clinical inability to comply with testing
11. Malignancy (active / under treatment)
12. Known hypo-responsiveness to ERT (\>200U/kg/wk)
13. Evidence of chronic gastrointestinal bleeding
14. Inadequate dialysis (PRU \< 65% or KT/V \< 1.2)
15. Participation in investigational study within last 3 months
Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery.

This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.

Exclusion Criteria:

* Pregnant women
* Patients who will undergo open cholecystectomy
* Patients who will need conversion to conventional open cholecystectomy
* Patients with ASA III classification or higher
* Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Women treated by normo fractionated radiotherapy for breast cancer
* Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.

Exclusion criteria:

* Were male patients
* Radiation dermatitis already treated or caused by another treatment
* Subjects deprived of their freedom or under guardianship
* Subjects in whom medical follow-up was impossible
* A cancer wound or skin flap on the irradiated zone
* A history of allergic skin reaction
* Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.
The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial

The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke

The efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP)in acute ischemic stroke has been demonstrated in China recently. Its role in secondary prevention of ischemic stroke need to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic cerebral infarction or TIA within 90 days.
2. Aged above 40 years old.
3. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
4. Stable clinical and neurological conditions.
5. Informed consent is obtained.

Exclusion Criteria:

1. Intracranial hemorrhage
2. Stroke of other unkonwn causes, or other known causes, such as Takayasu arteritis, Moyamoya disease, dissecting aneurysm and hypercoagulable state, carotid endarterectomy, angiogram, or cardiac surgery
3. Cardio embolism
4. Patients with anticoagulants treament including heparin or warfarin
5. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
6. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
7. A Modified Rankin score is more than 4
8. Abnormal liver function: ALT or AST level \>1.5 times upper limit of normal; Abnormal renal function: serum creatinine level \>2.0mg/dl or 177umol/l:
9. Concurrent participation in another clinical trial
10. Uncontrolled hypertension : systolic blood pressure greater than 180mmHg, or diastolic blood pressure greater than 100mmHg
11. Haemostatic disorder or thrombocytopenia (i.e., PLT\<100×109/l).
12. Currently active peptic ulcer disease
13. Pregnant or breast feeding
14. Planned for major surgery, carotid endarterectomy, or carotid angioplasty
15. Unable to give informed consent.
Platelet Reactivity in Septic Shock

Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of septic shock
* platelet count \>150\*103/mcL.

Exclusion Criteria:

* age \<18 years
* history of any hematologic disorder
* chronic liver failure
* previous chemotherapy
* transfusion of platelet during the previous 4 weeks
* renal replacement therapy before ICU admission
* history of antiplatelet therapy during the 8 days before inclusion
* history of heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia
* occurrence of HIT (defined as HIT score over 3)
* active bleeding
Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery

This is a prospective randomized controlled trial. Investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis.

Patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. And we will compare the clinical outcomes in the three method.

Perioperative period is critical in determining the risk of postoperative metastatic disease. Surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. Increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery.

Also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. However, no comparison was conducted among these anesthetic adjuvants. Thus, Investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III

Exclusion Criteria:

* Atrioventricular conduction disorder
* Having Bradycardia (\<50 bpm)
* Severe pulmonary dysfunction in pulmonary function test
* High risk for cardiovascular complications(expected postoperative event \>5%)
* Allergy or hypersensitivity reaction to each adjuvant.
* History or risk factors for Malignant hyperthermia
* Body mass index \>40 kg/m2
Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530

The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.


Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;
2. be willing and able to provide written informed consent prior to any study procedures being performed;
3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;
2. have poor or eccentric fixation in either eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
4. have microphthalmos in either eye;
5. have buphthalmos in either eye;
6. be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in either eye;
10. have keratoconus in either eye;
11. have any other corneal or conjunctival pathology or infection in either eye;
12. have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.