cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

The classical method for spinal anesthesia relies on the use of bony landmarks to identify the level and point of entry of the spinal needle. Over the years, in experienced hands, this method consistently proved to be successful and safe.

The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was relatively slow compared to peripheral nerve blocks or central venous catheterization. This could be due to the technical difficulties posed by the bony structures surrounding the spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are reluctant to change their conventional landmark technique, particularly with most studies showing no change in the success rate between ultrasound guided and the landmark techniques.

Several studies however showed that the ultrasound guided approach reduces the number of attempts to achieve a successful block and reduces the procedure time particularly in obese patients and those with technical difficulties.

In this study the investigators are trying to answer the following question : Is there any advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients with easily palpable bony landmarks?

Patients will be randomized using a web based randomization program into two groups: Ultrasound guided spinal anesthesia (US) \& conventional spinal anesthesia (C). In both groups, the level of the third or fourth lumbar inter-space (L3/4 or L4/5) will be identified using either ultrasound (transverse and longitudinal approach) or palpation method using anatomical landmarks.

All ultrasound examinations and spinal anesthesia will be performed by 3 anesthetists with experience in ultrasound guided neuraxial block (between 100 and 200 cases). The ultrasound examination will be done using Logiq e TM ultrasound machine (GE Solingen Germany) with 4C RS 2 - 5.5MHz Broadband multi-frequency probe.

The predetermined point of entry for the introducer needle will be marked on the patient's back. The spinal anaesthesia will be administered with the patient in the sitting position, using a 26 gauge pencil point needle (PortexTM) with 15 mg of heavy Bupivacaine and 20 micrograms of Fentanyl. An independent observer, who is blinded to the method used to identify the point of entry of the introducer needle, will be collecting the data.The spinal anesthesia will be labeled as successful if a bilateral block to the sixth thoracic dermatome (T6) , judged by loss of cold and touch discrimination, is established 5 minutes after the spinal injection.

Eligibility Criteria:
Inclusion Criteria:

* All mothers with body mass index (BMI) equal to or less than 35 who has normal singleton pregnancy
* At 37 weeks gestation or more
* Admitted to Corniche Hospital for elective caesarean section under spinal anaesthesia

Exclusion Criteria:

* Patients with BMI \>35
* Patieints with difficult anatomical landmarks
* Patients with neurological disease or coagulation defects
* Patients receiving anticoagulants
* Patients refusing spinal anaesthesia
Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers

The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers

The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro testing, and all legally required biological safety tests have been conducted and CE-mark was granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of dialyzers which has been available commercially globally for approximately three years. Clinical evaluations have been completed with the Polynephron membrane within the last three years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.

The aim of the dialyzer evaluation is to compare performance characteristics and hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients 18 years or older
* Stable on hemodialysis for more than 3 months
* An average haematocrit value of 30 % or higher in the last three 3 months
* Stable vascular access of either a fistula or graft
* Stable anticoagulation and regimen
* Stable erythropoiesis-stimulating agent (ESA) regimen for the last three 3 months
* No active infection
* Able to sign informed consent and able to participate in the study
* Medically stable

Exclusion Criteria:

* Participation in another study which may interfere with the planned study
* Active infection
* Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
* Female(s) who are pregnant or planning to be pregnant
* Problem with or allergy to anticoagulation
* Central venous catheters
Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients

To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:

* A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital
* PaO2/FiO2 ≤ 300 (corrected for altitude)
* RR ≤ 30/min during early use of oxygen
* Adults of 18 years and older
* Provision of written informed consent to participate in study by subject or legal representative.

Exclusion Criteria:

Patients who meet one or more of the following exclusion criteria will not be eligible for the study:

* Patients under the age of 18
* Patients who are not diagnosed or suspected of having an acute COVID-19 illness
* Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 \> 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.
* Patients who require immediate IMV upon admission or have a RR \> 30/min on early oxygen intervention.
* Thoracoabdominal desynchrony and paradoxical breathing at admission
* Patients in immediate need of or on vasopressors upon ICU admission
* Patients or legal representatives who are unwilling or unable to provide written consent.
Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis

This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading.

Prior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Participants will train for up to three sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. An exploratory third session may be conducted to investigate changes in knee loading while using the new walking strategy during over-ground walking.

The movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.


Eligibility Criteria:
Inclusion Criteria:

* Medial and/or lateral compartment knee osteoarthritis
* Diagnosed with knee osteoarthritis of at least six months duration
* Ambulatory without aids
* Able to walk for at least 60 minutes
* Typical pain rating less than or equal to 4 on scale of 0-10
* Able to reduce gastrocnemius muscle activation by 10% from baseline

Exclusion Criteria:

* History of symptomatic arthritis in lower limb joints other than the knees
* Replacement of any lower extremity joint
* Symptoms originating from the patellofemoral joint
* Body mass index equal to or greater than 35
* Nerve or muscle disease associated with walking difficulty
* History of rheumatoid arthritis, gout, or autoimmune disease
* History of lower limb fracture or surgery requiring hospitalization
* Pregnant
* Severe knee malalignment, defined as a hip-knee-ankle angle of more than 5 degrees from neutral
* Recurrent giving way of the knee
Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients

The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom

Exclusion Criteria:

* anticipated operating time \< 1 hour
* body surface area that exposured by drape \< 30% of total body surface area
* BMI \> 30
* corrected age \< 40 weeks
* preoperative body temperature is higher than 37℃ or less than 35.5℃
* patients with skin disease
* history of malignant hyperthermia
* patients who cannot use esophageal stethoscope
Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain

Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in the management of patients with neck pain. However the mechanisms for pain relief associated with this intervention remain largely unexplained. Recent evidence suggests structures within the brain may have a role in creating responses of pain relief. This study aims to use functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow to structures within the brain following TSM in patients with neck pain. All patients will undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of the index finger and the great toe. Subjects will then receive either TSM or sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful stimuli. The primary outcome of interest is the shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology. This study will be the first to examine this type of response to manual therapy within the brain in patients with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Primary complaint of mechanical neck pain of less than 6 weeks in duration as identified in the patient's initial physical examination. Mechanical neck pain is defined as generalized neck and/or shoulder, peri-scapular pain with symptoms provoked by neck postures, neck movements, or palpation of the cervical musculature

Exclusion Criteria:

* Any medical red flags suggestive of non-musculoskeletal origin of pain, such as metabolic disorders, osteoporosis, tumor, and/or rheumatoid arthritis
* No contraindications to spinal mobilization
* No contraindications to MRI (claustrophobia, presence of cardiac pacemakers, cochlear implants, metal implants, implanted hearing aids, and previous injuries caused by bullets or shrapnel, pregnancy or thought to be pregnant
PPI for Prevention of Post-sphincterotomy Bleeding

Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.

Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy.

Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing ERCP who will require sphincterotomy

Exclusion Criteria:

* Previous sphincterotomy/papillotomy
* Previous Polya gastrectomy
* Patients on maintenance PPI
* Pregnant and lactating women
* Age \<18 years
* Previous liver transplant
* unable to consent for study
Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.
2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

Eligibility Criteria:
Inclusion criteria:

1. Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
2. Patients must have evaluable disease evidence;
3. Age ≥ 18 years old;
4. The expected life span is more than 3 months;
5. ECOG score 0-2 points (see Attachment 2);
6. Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up;
7. Those who voluntarily participate in the trial and sign the informed consent.

Exclusion criteria:

1. Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
2. Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
3. Use chemotherapy or radiotherapy within 3 days before the blood collection period;
4. Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
5. Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
6. Those who have previously used any gene therapy products;
7. History of epilepsy or other diseases of the central nervous system;
8. New York Heart Association (NYHA) class III or above (see Annex 3);
9. creatinine\> 1.5 times the upper limit of normal or ALT / AST\> 3 times the upper limit of normal or bilirubin\> 2 times the normal upper limit;
10. active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
11. pregnant or lactating women;
12. suffer from other uncontrolled diseases that the researcher considers inappropriate;
13. Any condition that the investigator believes may increase the subject's risk or interfere with the test results.
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients

This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).


Eligibility Criteria:
Inclusion Criteria:

1. Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
2. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
3. Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)

Exclusion Criteria:

1. Unable to obtain consent
2. Weight \>250 kg (weight limitation of scanners)
3. Unable to lie flat for 30 minutes to complete the PET or MRI imaging
4. Severe claustrophobia precluding image acquisition
5. Lack of intravenous access
6. Non-MRI compatible pacemaker or hardware
7. eGFR \< 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
8. Prior androgen deprivation therapy
eFHS Messaging Trial

In this research the investigators will develop and test an innovative scalable mobile health and digital cardiovascular monitoring system within a longitudinal deeply characterized cohort with three components: 1) smartphone application (app) designed to promote adherence, integrate digital and mHealth information, and facilitate communication with participants and researchers; 2) smartwatch activity monitoring using the Apple iWatch; and 3) home blood pressure (BP) monitoring using the Withings blood pressure device.

The objective of the messaging trial is to test the effect of messaging strategies on improving participants' long-term use of and engagement with our selected mobile health technologies and on increasing response rate of survey data collection.

The research design includes a cohort eFHS Study and an embedded randomized factorial trial on a subset of the cohort.

For the primary e-cohort, the investigators will build a custom mobile app for use within the Framingham Heart Study (FHS) to digitally collect data, compare it against research clinic-collected data, quantify risk factor burden, and perform CVD risk prediction. The app development will focus on 1) CVD risk factor data that would benefit from more frequent ascertainment than the every four to eight year FHS examination cycles; 2) circumstances where in vivo assessment may be superior to clinic-based assessment; 3) key endpoints of the FHS that are considered FHS landmarks. In addition to the eFHS App, participants will be offered wireless devices (Withings BP) to measure blood pressure and an Apple Watch to measure heart rate and steps per day.

For the messaging trial, the investigators will conduct a randomized factorial trial phase to test the effect of messaging strategies. Participants will be sent a weekly notification through the eFHS app. Participants will be randomly allocated to one of 8 groups defined according to the following: using personalized reminder messaging vs. standard neutral messaging; notification sent on a weekday vs. weekend; notification sent in the morning vs. the evening. The three main comparisons will be simultaneously evaluated according to a 2x2x2 factorial design.

Eligibility Criteria:
Inclusion Criteria for the eFHS study:

* Participants of the FHS Third Generation, Omni Group 2, and New Offspring Spouse Cohorts attending the in-person examination 3 with access to a smartphone or home internet access and English speaking/reading.

Specifically for the RCT substudy (re: engagement with select mobile health technologies):

* English-speaking individual
* Owns an iPhone with compatible iOS (version 9 or higher);
* Residence in the United States
* Provision of permissions for notifications and data sharing with the Research Center
* Provision of signed and dated informed consent

Exclusion Criteria:

* Participants who do not meet the inclusion criteria
Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study

To find out if lower levels of vitamin D is more prevalent in preeclamptic women


Eligibility Criteria:
Inclusion Criteria:

* Parity: primigravida.
* Age: 18 - 35 years.
* Singleton pregnancy.
* Gestational age: 36-40 weeks.
* No past history of any medical disorder and with no other medical complications during pregnancy

Exclusion Criteria:

* Women with preexisting medical conditions like rheumatoid arthritis, thyroid, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption and lupus.
* History of intake of medications influencing bone, vitamin D or calcium metabolism e.g. antiepileptic, theophylline, antitubercular drugs in the last 6 months.
* Women with multiple pregnancy.
* Women with congenital fetal malformation.
* Women with known thrombophilia
Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke

Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke


Eligibility Criteria:
Inclusion Criteria:

* First cerebro vascular accident (CVA) diagnosis
* Basic cognitive and communicative abilities

Exclusion Criteria:

* Traumatic brain injury (TBI)
* Confusion state and lack of cooperation due to brain lesion
* Unstable cardiovascular status
* Independently climbing stairs ability at entrance
Development of an AI Solution to Evaluate Clinical Activity of TAO Using Periocular Images Taken by Smartphones in Patients With Thyroid Dysfunction

This study was conducted to develop an AI solution to evaluate clinical activity score (CAS) of thyroid associated orbitopathy (TAO) using periocular selfie images taken by smartphones in patients with thyroid dysfunction.

An AI solution to evaluate CAS in TAO was developed in previous retrospective study using periorbital digital images taken by DSLR camera in the studio. This AI solution will be adjusted to show its best performance with periocular selfie images taken by smartphones.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid eye disease

Exclusion Criteria:

* Patients who have prior facial anomaly or surgery
* Patients who cannot use smartphone camera app
Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.

Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with large volumes of a solution which also contain local anesthetics. However local anesthetics, can also lead to a marked production of methemoglobin. New generation pulse oximeters are able to measure SpMetHb non-invasivly.

The aim of this study is:

1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia.
2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.


Eligibility Criteria:
Inclusion Criteria:

* planned liposuction in tumescent local anesthesia

Exclusion Criteria:

* hematologic disorders