cyrilzakka/clinical-trials huggingface dataset:
Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study
2. Subjects between 18 to 85 years old
3. Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale
4. Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel sensation by Von-Frey fiber on the forearm

Exclusion Criteria:

1. Subject is pregnant
2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self reported
4. Use of carbamazepine within the past 6 months as self reported
5. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
6. History of neurological disorders as self reported
7. History of unexplained fainting spells as self reported
8. History of severe head injury resulting in more than a momentary loss of consciousness as self reported
9. History of neurosurgery as self reported
10. Unstable pain
11. Large placebo responder
12. Low adherence during the run-in period
13. Low baseline pain
Cytokine Profiling Post-Heart Transplant

Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.


Eligibility Criteria:
Inclusion Criteria:

Group 1

* 18 years and older
* Cardiac Transplant recipient with graft dysfunction of unknown etiology

Group 2

* 18 years or older
* No history of heart failure or cardiac transplantation Group 3
* 18 years or older
* Class II-IV heart failure Group 4
* 18 years or older
* Heart Transplant 6 months or greater prior to blood draw
* No graft dysfunction

Exclusion Criteria:

Group 1 Heart Transplant with Unexplained Graft Dysfunction

* Cellular or antibody-mediated cardiac allograft dysfunction

Group 2 Normal Control group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 3 Heart Failure Group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 4 Heart Transplant with Normal Graft Function Group

* Active infection within 1 month of blood draw
* Known graft dysfunction
* Known Inflammatory Disease
Use of Empagliflozin to Treat Prediabetes

The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).

The overall study design is a 13-week, double-blind, placebo-controlled intervention trial, testing the ability of empagliflozin to improve glucose metabolism among overweight and obese individuals at risk for diabetes (compared with a multivitamin-placebo). The study involves metabolic testing before and during the intervention to identify changes in outcomes as a function of the intervention and to ensure participant safety. The study involves 9 visits to the Samaritan Athletic Medicine Center on the campus of Oregon State University in Corvallis, Oregon. Full completion of the study is anticipated to take \~4 months. The project is being completed in collaboration with physicians at Samaritan Health Services.

Eligibility Criteria:
Inclusion Criteria:

* BMI 26-45 kg/m2
* Weight stable (± 10 lbs in previous 3 months)
* Fasting blood glucose \<126 mg/dL or HbA1c \<6.5% (\<48mmol/mol)

Exclusion Criteria:

* Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week)
* Pregnancy, planning to become pregnant or nursing
* Lidocaine allergy
* Current or recent smoking or nicotine use (≤ 1-year abstention)
* Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
* Major metabolic or cardiovascular conditions (e.g., type 1 diabetes, Crohn's disease, untreated hypo- or hyperthyroid, cancer, coronary artery disease, tachycardia, prior bariatric surgery, peripheral vascular disease, liver diseases (e.g., cirrhosis)
* Diagnosed type 2 diabetes. In absence of diagnosis, two separate samples with test results of fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5% (48 mmol/mol).
* Contraindications/precautions for empagliflozin (impaired renal function (EGR\<60), history of: empagliflozin hypersensitivity, ketoacidosis, hypotension, recurring urinary tract or genital mycotic infections, amputation)
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)


Eligibility Criteria:
Inclusion Criteria:

* Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit
* Histologically and/or cytologically confirmed cancer with ECOG ≤2
* Life expectancy of ≥ 3 months
* Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days

Exclusion Criteria:

* Hypersensitivity to adhesive plasters
* Contraindications to 5-HT3 receptor antagonists
* Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator
* Any cause for nausea and vomiting other than CINV
* Clinically relevant abnormal ECG parameters
* Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
* A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder
Intravenous Fluids in Benign Headaches Trial

Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.

This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10 to 65 years
2. Temperature less than 100.4 F
3. Normal neurologic exam and normal mental status

Exclusion Criteria:

1. Pregnant
2. Meningeal signs are present
3. Acute angle closure glaucoma is suspected
4. Head trauma within the previous two weeks
5. Lumbar puncture within the previous two weeks
6. Thunderclap onset of the headache
7. Known allergy to one of the study drugs
8. History of intracranial hypertension
9. Is a prisoner
10. Patient declined informed consent
11. Non-English speaking patient or parent/guardian for pediatric patients
12. Attending provider excludes patient
13. Severe Dehydration
Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock

The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)

The investigators will perform a prospective observational study of patients in haemorrhagic shock with suspected life threatening bleeding from trauma, treated by the prehospital emergency doctor response team of the Medical University of Graz and the HEMS (Helicopter Emergency Medical Service) of Graz according to their SOPs. Only patients that are being transported to the resuscitation room of the Medical University of Graz after prehospital transfusion will be included.

The SOPs for prehospital transfusion are being implemented for the treatment of patients in extremis because of suspected life-threatening traumatic bleeding in the above-mentioned emergency services, according to the manufacturer's requirements. These transfusion SOPs are already part of the standard of care in the resuscitation room of the Medical University of Graz.

This study seeks to gather information on the benefits and potential harms of this change of prehospital clinical routine.

The treatment bundle will include 2 units of Fibrinogen and Plasma in addition to 10-20 mg/kg Tranexamic Acid

Eligibility Criteria:
Inclusion Criteria:

* aged, or believed to be aged
* 18 years or above
* confirmed or suspected life-threatening bleeding from trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
* need for volume replacement therapy.

Exclusion Criteria:

* patient with known recent history of thromboembolic events within the last 6 months
* known or suspected pregnancy at presentation
* patient with known refusal of a participation in this clinical trial.
Feasibility Study of Deep Brain Recordings for Learning and Memory

Background:

- Some people with movement disorders are in another NIH protocol. They will have electrodes placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers want to learn more about how brain cells and networks work while people learn and remember. They want to use the data from the other NIH study to do this.

Objective:

- To share data from before and during deep brain stimulation surgery. The data will be used in a study of how the brain learns and remembers.

Eligibility:

- People at least 18 years old who are in protocol 11-N-0211 and have certain movement disorders.

Design:

* As part of protocol 11-N-0211, data on participants brainwave activity is collected. In this protocol, they will have that data stored and shared.
* Researchers will access imaging data from deep brain stimulation surgery.
* Researchers will access other medical records.

OBJECTIVES:

The purpose of this protocol is to share neural data collected before and during deep brain stimulation surgery with the University of Pennsylvania to identify biomarkers of successful learning and memory.

STUDY POPULATION:

Up to twenty (20) adult subjects who are participating in NIH protocol 11-N-0211 Deep Brain Stimulation Surgery for Movement Disorders who provide written informed consent for sharing and the additional use of their data.

STUDY DESIGN:

This protocol only involves providing consent to share learning and memory data collected under Protocol 11-N-0211. There are no separate or additional participant procedures involved in this protocol.

Eligibility Criteria:
* INCLUSION CRITERIA:

Adults at least age 18

Currently enrolled in 11-N-0211

EXCLUSION CRITERIA:

Unable to provide own informed consent
Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

Considering physical and psychological problems that threaten women during the menopausal period, it seems that therapies that can help women cope with these problems, especially psychological ones, will be useful. The community mental health nurse is usually the first health professional whom women rely on to relieve their menopause symptoms. It is essential for the primary health care nurse to know how to properly approach women at this stage of their life and how to provide them the best and safe treatment. Because only limited interventional studies have been done to manage insomnia and depression among menopausal women in Egypt, the present study focused on reducing and insomnia and depression of menopausal women by using group Cognitive behavioral therapy. The current study aimed to examine the efficiency of group Cognitive Behavioral Therapy for insomnia and depression among menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Women with depression (BDI-II score of 14-63)
* Women aged between 40 and 55 years old, menopausal (12 consecutive months without menses)
* Women are willing to provide written informed consent to participate in the study.
* Women who have the ability to read and write Arabic language.
* Women who report wake after sleep onset (wakefulness in the middle of the night after falling asleep) of an hour or more on ≥ 3 nights per week and met criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013) insomnia disorder with onset or exacerbation during the peri- or postmenopausal period per clinical interview with the researcher.
* Women who have a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI), which indicates poor sleep, and a total score of \>7 on the Insomnia Severity Index (ISI), which indicates insomnia.

Exclusion Criteria:

* Women who are currently under any type of psychotherapy or have a previous experience of Cognitive Behavioral Therapy.
* Women who have a history of neuropsychiatric illness, cancer, chemotherapy, and sudden stress in the previous 6 months (due to unfortunate events in the family) or have a severe or uncontrolled physical illness.
* Women who are clearly diagnosed as having sleep disorders or obstructive sleep apnea and had taken sleeping medications.
* Women who are on hormonal replacement therapy or cancer therapy or drugs such as tricyclic antidepressants, selective serotonin reuptake inhibitors, sedatives, and other hormones; and those who had undergone hysterectomy with oophorectomy.
The Relationship Between Academic Burnout and Psychological Resilience

A cross sectional study of prevalence and correlates of burnout and resilience among indergraduate medical students

A questionnaire based cross sectional study of The relationship between academic burnout and psychological resilience among undergraduates medical students, Faculty of Medicine, Mansoura University

Eligibility Criteria:
Inclusion Criteria:

- undergarduate medical students at Mansoura Faculty of Medicine

Exclusion Criteria:

* graduate students and interns
Kinetics of Etheric Oils, Smart Textiles vs. Ointment

The purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. The second aim of the study is to determine differences in the subjective convenience of the application forms. We will test an commercial ointment application vs. smart textiles. Smart textiles are new high-tech products with the unique possibility to combine the textiles with functional products e.g. pharmaceutical agents.

On the first appointment recruitment investigations will take place. After the person is enrolled to the study, the first determination of substances concentration in exhaled air and the convenience grade of the application form being exposed to will be achieved (study day 1). After a 7 days lasting washout phase on study day 2 newly determination of substances concentration and convenience grade of the other application will be assessed. Each study day will have an approximate duration of 11 h. During this time 9 samples of the persons exhaled air will be collected.

Eligibility Criteria:
Inclusion Criteria:

* caucasian
* Broca-index: between -20 and +25%
* who are willing and capable to confirm written consent to enrolment after ample information has been provided
* who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study.

Exclusion Criteria:

* subjects with any major relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
* subjects with any major clinically relevant laboratory abnormality.
* subjects who participated in another trial with any investigational substance within the last 4 weeks
* subjects who smoke more than 15 cigarettes per day
* subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol during the active study phase
* subjects who adhere to a diet or lifestyle (incl. competitive sports and weight lifting) that might interfere with the investigation
* subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
* subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
Which is the Best Bedside Test to Detect Endobronchial Intubation?

Background: Endotracheal intubation has become a well established standard in protecting the airway during surgical procedures, and in emergency situations. Serious complications can occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the golden standard to verify the correct endotracheal tube placement is bilateral ausculation of the chest. However this is not always satisfactory, as breath sounds can be transmitted to the opposite side of the chest in spite of endobronchial intubation. Therefore other clinical tests to verify the correct endotracheal tube placement have become part of daily clinical practice, like observation of symmetric chest movements, and use of the cm markings printed on the endotracheal tube. However so far no study investigated which of these bedside clinical methods works best in detecting an inadvertently placed endobronchial tube in adults. We therefore designed a study to compare three different bedside methods to verify endotracheal or endobronchial tube placement.

Objective: To determine which of four commonly used bedside methods of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity.

Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital, department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery.

Interventions: Patients were randomly assigned to eight study groups. In four groups, an endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. First-year residents and experienced anaesthesiologists independently performed one of the following randomly assigned bedside tests in each patient in an effort to determine whether the tube was properly positioned in the trachea: 1) bilateral auscultation of the chest (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3) estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a combination of all three mentioned tests (All Three).

Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position as independently assessed by first-year anaesthesia residents and experienced anaesthesiologists with each of the four bedside tests.


Eligibility Criteria:
Inclusion Criteria:

ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery that needs endotracheal intubation.

Exclusion Criteria:

* Pre-existing lung disease, pleural effusion, anticipated difficult airway, known endobronchial or tracheal lesions, or patients at risk for aspiration of gastric contents.
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial

The purpose of this study is to compare functional status and quality of life of a group of patients with chronic venous insufficiency treated with manual lymphatic drainage with a group not treated with manual lymphatic drainage.

Investigators hypothesized that manual lymphatic drainage can improve:

* quality of life,
* functional status,
* calf muscle strength,
* ankle range of motion,
* edema,
* severity of disease,
* and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).

Exclusion Criteria:

* Severe cardiac insufficiency,
* Acute venous or arterial obstruction,
* Arterial insufficiency, renal insufficiency,
* Uncompensated thyroid dysfunction,
* Pregnancy, neoplastic pathology,
* Systemic or limb infection,
* Recent musculoskeletal injury in the lower limb,
* Peripheral neuropathy in the lower limb.