cyrilzakka/clinical-trials huggingface dataset:
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve -B

The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Subjects will also complete health history questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers with no GI symptoms
* Ages 18-80
* Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
* Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach

Exclusion Criteria:

* Unable to provide consent
* Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
* Taking medications affecting gastric motility
* Pregnant females
* Prisoners
Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question\[s\] it aims to answer are:

1. Health-related quality of life (HRQoL)
2. VAS score
3. Beta estradiol
4. TNF Alpha
5. Adnexal mass recurrence

Participants will be randomized into 4 groups, each group will receive:

1. Leuprolide Acetate injection/month
2. Dienogest 2 mg/day
3. COC (mycrogynon)/day
4. DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

1. Beta estradiol level is measured in the serum, before and after treatment
2. TNF alpha is measured in the serum, before and after treatment
3. Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30)
4. VAS score will be recorded before and after treatment
5. Adnexal massa recurrence evaluation using USG

Eligibility Criteria:
Inclusion Criteria:

Patient post surgical removal of endometriosis cyst Willing to participate

Exclusion Criteria:

1. Use of any hormonal therapy for endometriosis within the previous 16 weeks.
2. History of severe adverse drug reactions or hypersensitivity to steroid hormones.
3. Failure of previous treatment with COC, DMPA used in this study.
4. There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
5. Smoker.
Knowledge, Attitude and Practice Among Undergraduate Dental Students, Cairo University Towards Ergonomics

this study will evaluate knowledge, attitude, and practice of fifth-year dental students Cairo university toward ergonomics

Ergonomic is the study of people and their working environment. Ergonomic consequently is the science concerned with designing products and procedures to maximize efficiency and safety.

The world health organization defines Musculoskeletal disorder (MSD) as "a disorder of the muscles Tendons, joints, intervertebral discs, Peripheral nerves, and vascular system''.

The musculoskeletal disorders are common among medical professionals, and especially dentists and dental hygienists, because of the prevalence of different postures in dental procedures, prolonged stature, unsupported sitting, griping smaller and thin instruments for a longer time and limited access during dental procedures.

Musculoskeletal disorder (MSD) affect muscle, joints, tendons, ligaments, and nerves and caused by work itself or by working environment. It has been reported that back pain is the most common followed by neck pain and shoulder pain. If early signs and symptoms are noted, with the understanding of mechanisms of progression of the disease, MSDs can be prevented at earlier stage.

(Gupta et al., 2014), state some signs and symptoms of MSD on dentists:

Signs of MSDs:

* Decreased range of motion.
* Loss of normal sensation.
* Decreased grip strength.
* Loss of normal movement.
* Loss of coordination.

Symptoms of MSDs:

* Excessive fatigue in the shoulders and neck.
* Tingling, burning or other pain in arms.
* Weak grip, cramping of hands.
* Numbness in fingers and hands.
* Clumsiness and dropping of objects.
* Hypersensitivity in hands and fingers.

Goals of Ergonomics according to (Pendyala and Karunakar, 2014) :

* Prevention of work-related musculoskeletal disorders and conditions which might lead to it.
* Increasing safety and productivity.
* Enhanced performance by eliminating unnecessary effort.
* Improving the standard of care to the patient.

So this study is conducted to assess the knowledge, attitude, and practice (KAP) among fifth-year undergraduate dental students, Cairo University towards Ergonomics

Eligibility Criteria:
Inclusion Criteria:

* Fifth-year undergraduate dental students, Cairo University at the time of the study

Exclusion Criteria:

* Refusal to participate
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）

This study is an exploratory clinical study to observe the safety and efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in the heart failure patients with reduced ejection fraction. The study was a 12 months single center, randomized, double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of follow-up.

The study was a 12-month single center, randomized, double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of follow-up.We plan to recruit 40 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously infusion a dose of 1.0\*10\^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) respectively at 0,6,12 week. The control group will be given the same dose of 1 percent human serum albumin injection. Then centralization visit was conducted at 0,7 day, 6,12 week, 6 and 12 month. The primary safety end point is the incidence of any treatment emergent serious adverse events within12 months after intravenous MSC infusion, including death, nonfatal MI, stroke, sustained ventricular arrhythmias (\>15 seconds or causing hemodynamic compromise), and other adverse events such as infection, tumor formation and clinical abnormal, which will be evaluated by monitoring for serial troponin, hematology, chemistry, urinalysis, 24-hour Holter, CTscans and ultrasound of abdomen.There are independent data and safety monitoring committees to monitor patient safety throughout the duration the trial.The primary efficacy endpoint is a change in Left Ventricular Ejection Fractions (LVEF) measured by left ventricular opacification (LVO) with contrast echocardiography and magnetic resonance imaging (MRI) at 12th month.

Eligibility Criteria:
Inclusion Criteria:

1. LVEF≤40％;
2. NYHA II-IV;
3. Received maximally tolerated guideline-directed medical therapy ( GDMT) for at least 3 months before enrollment;
4. Angiography or coronary CT within 6 months shows that there is no indication for PCI / CABG; Or PCI / CABG indications, but refused.

Exclusion Criteria:

1. Severe valvular heart disease, congenital heart disease, acute viral myocarditis and acute coronary syndrome.
2. PCI / CABG, ICD / permanent pacemaker / CRT implantation within 3 months.
3. Recent cerebrovascular disease (\<6 months).
4. eGFR\<30ml/min, or ALT/AST\>120U/L.
5. Hematologic disease: anemia (hemoglobin ≤9.0 g/dL); leukopenia (\<3500/μL); thrombocytopenia (\<70000/μL); myeloproliferative disorders, myelodysplastic syndrome, acute or chronic leukemia, and plasma cell dyscrasias (multiple myeloma, amyloidosis) .
6. Malignant tumor within 5 years.
7. Life expectancy \<1 year according any disease.
8. Uncontrolled acute infectious diseases.
9. Known or suspected of being sensitive to the study drugs or its ingredients.
10. Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
The Effect of Cycled Light on Premature Infants and Mothers

Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life. This study is to verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life.

It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.

Background Dim, irregular lighting and lack of periodic light in the care environment for premature babies in Taiwan are currently common conditions. Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life.

Purpose To verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life.

Methods The preliminary plan of this study is to carry out empirical evidence and expert advice to confirm precise lighting and develop care intervention strategies for preterm infants based on evidence. It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.

Eligibility Criteria:
Inclusion criteria: (1) Premature infants over 32 weeks old, (2) Stable physiological conditions.

Exclusion criteria: (1) taking drugs that may interfere with sleep, (2) suffering from retinopathy (ROP) stage 3 or higher, (3) suffering from intracranial hemorrhage, grade 3 or higher, (4) suffering from upper limb injury or movement disorders, (5) The family has alcohol and drug abuse problems, (6) currently using respirators.
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous (IV).


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
* Participants of Japanese descent must be between 20 and 55 years of age.

Exclusion Criteria:

* Current or recurrent disease
* Current or relevant history of physical or psychiatric illness.
* Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
* History of significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
* Female participants who are pregnant or breastfeeding.
* Major surgery or hospitalization within 90 days prior to dosing on Day1.
* History of exposure to asfotase alfa.
* History of allergy or hypersensitivity to excipients of asfotase alfa or ALXN1910 (eg,sodium phosphate, sodium chloride).
Study of Antidepressants in Parkinson's Disease

The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.

The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.

This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.

Eligibility Criteria:
Inclusion Criteria:

To be eligible you must be:

* 30 years old or older
* diagnosed with Parkinson's disease
* experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB

This clinical trial aims to compare two methods of administering polymyxin B for treating severe brain infections caused by carbapenem-resistant Gram-negative bacteria (CRGNB). The two methods are: 1) delivering polymyxin B directly into the brain (intracranial administration) and 2) combining this with an intravenous (IV) infusion. The goal is to determine which approach is more effective in clearing the infection, improving patient outcomes, and influencing the concentration of polymyxin B in the cerebrospinal fluid (CSF). Participants in this study will be monitored for both effectiveness and safety, with a focus on CSF polymyxin B levels, to find the best treatment strategy for these challenging infections.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender.
2. Patients with cerebrospinal fluid (CSF) cultures showing carbapenem-resistant Gram-negative bacteria (such as Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa) and polymyxin MIC ≤ 0.5 µg/ml.
3. Diagnosed with intracranial infection and have been receiving polymyxin B treatment for at least 5 days, with an external ventricular drain (EVD) in place for continuous drainage.

Exclusion Criteria:

1. Patients with known allergy to polymyxin B or other severe allergic histories that may affect the study.
2. Pregnant women or other conditions that the investigator deems unsuitable for participation in the study.
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better sedation induction, recovery profile and is preferred by patients/families. The study is a double blind, randomized, placebo controlled crossover study. Following the induction phase of chemotherapy, children will be randomized in a crossover manner to receive either fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied on two separate occasions, once with propofol-placebo (normal saline) and once with propofol-fentanyl. Children will be monitored continuously by pulse oximetry, electrocardiogram (ECG) and direct nursing and physician observation during the sedation in accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7 for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be recorded every 3 minutes by a study investigator during sedation.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 2 years to 18 years with acute leukemia/lymphoma cared for by physicians in the Division of Hematology/Oncology in the Department of Pediatrics and receiving sedation for diagnostic/therapeutic lumbar punctures (LPs) in the UW Pediatric Sedation Program
* Enrollment will occur after the induction phase of chemotherapy.

Exclusion Criteria:

* American Society of Anesthesiology score ≥ 3
* Cardiorespiratory instability
* Allergy to propofol or its components
* Age less than 2 years
* Patients receiving other sedative analgesics
* Patients with an oxygen requirement
Iron Deficiency in Acute Myocardial Infarction: Prevalence Pilot Study

Acute Myocardial Infarction (heart attacks) affect about 86000 people each year in the UK. Given this large number of people, it is important that health teams look at ways to ensure the best care to improve outcomes after a heart attack.

In related heart conditions, the role of iron is important, but there isn't much information about what effect iron levels have on patients following a heart attack.

We want to plan a large scale study to look at this, but need some early data to understand how many patients have low iron levels. This small study will take part at one NHS Trust and will test for iron levels in all patients who provide consent (we expect up to 70 patients will take part). We will also collect data from medical notes for these patients and use all of this information together to understand more about iron and to plan a larger study.


Eligibility Criteria:
Inclusion:

1. - Adults patients who sign an informed consent form.
2. - Type 1 myocardial infarction within the previous 10 days

Exclusion

1 - Not fulfilling inclusion criteria
Pressure Supporting Ventilation and EEG-guided Emergence for Free of Unwanted Complications

This study aims to assess whether pressure supporting ventilation and electroencephalogram (EEG)-guided emergence can reduce airway complications after thyroid surgery compared with conventional emergence. Patients will be randomly assigned to either pressure supporting ventilation and EEG-guided emergence group (intervention group) or conventional emergence group (control group). Co-primary outcomes are the incidence of emergence coughing and lowest percutaneous oxygen saturation (SpO2) after emergence. Secondary outcomes included severity of emergence cough, emergence time, blood pressure and heart rate during emergence, Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon post-anesthesia care unit (PACU) arrival, incidence of desaturation during PACU stay, hoarseness, sore throat during PACU stay, duration of PACU stay, surgeon satisfaction regarding emergence process, postoperative pain score, and patient satisfaction score regarding emergence process.

Adult patients aged \< 40 years scheduled to undergo thyroid surgery will be screened for eligibility. Patients will be randomly allocate to either the intervention group or control group.

* In the intervention group, pressure support ventilation will be applied from the start of subcutaneous suture until extubation. At the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the EEG spectrogram, indicating the patient's recovery of consciousness. For safety reason, extubation will also be guided by the following processed EEG indices thresholds:

  1. 95% spectral edge frequency (SEF) ≥ 23
  2. Patient state index (PSI) ≥ 64
* In the control group, conventional full-awake extubation will be performed based on the routine practice of our institution. At the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. Extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume \> 5 ml/kg, end-tidal carbon dioxide \< 45 mmHg, spontaneous respiratory rate 10 to 20 breaths/min.

In both groups, the Oxygen Reserve Index (ORi) will be monitored. Blinded investigator will assess the incidence of emergence coughing and the lowest SpO2 after emergence.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged under 40 years who are scheduled to undergo thyroid surgery.

Exclusion Criteria:

* Patients scheduled for radical neck dissection
* Patients scheduled for lymph node biopsy
* Patients with an anticipated difficult airway
* Patients experiencing difficulty during intubation
* Patients with a fasting time not meeting institutional policy
* Patients with a body mass index (BMI) greater than 30 kg/m²
* Patients with sleep apnea
* Pregnant or breastfeeding women
* Patients unable to communicate
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

This is an observational study to systematically investigate domestic patients with Alzheimer's disease to figure out the safety under a situation of the use of Donepezil HCl 23mg. Additionally, if the dose of Donepezil HCl increase, there is need to examine the safety of Donepezil HCl 23mg in depth for patients with Alzheimer's disease by comparing aspects of occurring adverse events by the type of Donepezil HCl increase.

Eligibility Criteria:
Inclusion Criteria

1. Patients who admitted the reading and using of his/her biographical and medical data by word
2. Patients who maintained Aricept dosage for at least 3 months before involved in the study

Exclusion Criteria

1. Hypersensitivity to the active substance or to any of the excipients
2. Breast feeding
3. Pregnancy