cyrilzakka/clinical-trials huggingface dataset:
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

Regional anesthesia decreases postoperative pain scores and opioid consumption, and may prevent chronic pain after surgery in patients undergoing surgery. However, some patients experience an increase of pain into the severe range when the nerve block wears off, also known as rebound pain. The investigators are studying if a nerve block (numbing injection) in the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.

This is a prospective, randomized study in healthy volunteers who will undergo sensory testing using quantitative sensory testing (QST), complete psychosocial and pain questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve block) in a supervised, monitored setting (BWH Clinical Investigation Center). The investigators plan to assess the association between different QST modalities at different time points pre- and post-nerve block resolution. Semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, ≤ 65 years old
* BMI \>18, \< 35
* Able to speak and understand English
* Willingness to undergo psychophysical testing (e.g., QST, pain questionnaires)
* Willingness to have nerve block performed

Exclusion Criteria:

* Ongoing acute or chronic pain in upper extremities
* Skin or tissue infection affecting upper extremities
* Previous hypersensitivity to mepivacaine or lidocaine
* Previous neuropathy (numbness, paresthesia, or motor weakness) in either upper extremity
* Loss of any limb
* Bleeding issues or bleeding disorder
* History of alcohol or drug abuse
* Currently pregnant or breastfeeding
* History of seizure or epilepsy
Targeting Inflammation for Endometrial Cancer Prevention

This study examines risk assessment and identifies prevention strategies for endometrial cancer. Collecting samples of blood and urine and risk assessments from patients with benign conditions or endometrial cancer may help doctors learn if there is a relationship between chronic inflammation and increase in risk for endometrial cancer.

PRIMARY OBJECTIVE:

I. To develop a model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations.

OUTLINE: This is an observational study.

Patients complete a risk factor questionnaire over 15 minutes. Patients also undergo collection of blood and urine during pre-operative visit and collection of tissue samples at the time of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 years old undergoing hysterectomy for any benign indication or endometrial cancer

Exclusion Criteria:

* Men
* Women under the age of 18 years
* Women with a history of cancer, except for endometrial cancer or non-melanoma skin cancer
* Women with type 1 diabetes
* Women that have received radiation or chemotherapy for cancer
Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults

The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.

All the patients will be clearly informed and will be included in the present study after their informed consent. The autonomic nervous system (ANS) will be evaluated using bio-sensors such as Photoplethysmography (PPG) and Galvanic skin response (GSR). The measurements will take place once for an individual. There will be three groups consisted of manual therapy, deep-slow breathing, and control groups. Non-invasive cranial and visceral techniques will be applied on the manual therapy group. The deep-slow breathing group will get an intervention consisting of deep-paced breathing to increase cardiac harmony. The control group will rest for the same amount of time as other interventions to distinguish whether the changes are related to intervention. After given consent, the participant will be assigned randomly to one of three groups. All the participants will be subjected to baseline measurement of the abovementioned metrics prior to intervention. All the interventions will take place in a controlled setting. After baseline measurement, the participant will take one of the three interventions which will take 30 minutes. After the data for each person is captured via sensors, it will be stored on a personal computer for further analysis and interpretation.

According to investigator's hypothesis, deep-slow breathing group will show signs of sympathetic withdrawal and parasympathetic dominance and that manual therapy group will also show same autonomic shift too.

Eligibility Criteria:
Inclusion Criteria:

* To be between 18- 30 years old.
* To volunteer to participate in the study
* Not engaging in regular exercise.
* Not to have a chronical disease or history of chronical disease.
* Not to take any medication that affects heart rate variability.

Exclusion Criteria:

* Being outside of the range of 18- 30 years old.
* To have any kind of medical condition that disturbs the autonomic nervous system
* To have a chronical disease
* To have a regular medication
* To have/had head injury, intracranial bleeding or increased intracranial pressure.
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

The purpose of this study is to test the effects of reducing indoor environmental tobacco smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.

BACKGROUND:

Asthma, a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli, is emerging as the most prevalent and serious environmental health problem among children in the United States. Numerous studies, both prospective and cross-sectional, suggest that exposure to ETS is one of the predominate risk factors for childhood asthma, but this has not been confirmed in a controlled trial.

DESIGN NARRATIVE:

The randomized, double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms. The intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive (placebo) units in the control group homes. The following hypotheses are tested. (1.0) Children assigned to the ETS reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group. (1.1) Children assigned to the ETS reduction group will have significant improvements in asthma symptoms compared with children in the control group. (1.2) Children assigned to the ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years at enrollment
* Doctor diagnosed asthma by ICD-9 billing codes (from billing records)
* Greater than 1 exacerbation(s) in the past year requiring an unscheduled asthma visit
* Exposed to the smoke of greater than or equal to 5 cigarettes in and around the house per day
* Lived within a 9-county area surrounding the city of Cincinnati

Exclusion Criteria:

* Already using a HEPA air cleaner
* Lacked electricity
* Had a coexisting medical problem
* Family planned to move in the next year
Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?

Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study.

Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia

After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Dementia of Alzheimer's or vascular type
* Early dementia defined by Clinical Dementia Rating of 1.

Exclusion Criteria:

* lives alone
* significant communication problems
* significant co-existing diseases
* blood tests:vitamin B12\< 150 pmol/l, serum creatinine\> 250 mol/l, hypothyroidism and syphilis
Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy

This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy

Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.
* Agree to participate and give a consent

Exclusion Criteria:

* Allergic reactions to anesthetics
* Hemodynamic instability
* Ruptured ectopic pregnancy
Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Borderline Personality Disorder
* Current Major Depression

Exclusion Criteria:

* Past 2 months SSRI use
* Past 6 months non-SSRI antidepressant use
* Past 2 months initiation of psychotherapy
* Lifetime bipolar disorder, organic disorder, psychotic disorder
* Current alcohol or drug dependence
* Current severe suicidal / homicidal ideation necessitating immediate medical intervention
* Currently pregnancy or nursing
* Unable or unwilling to cooperate with study protocol
Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Moderate to severe COPD (by ATS criteria)

1. FEV1/FVC \<0.70
2. FEV1 \< 60% Predicted

Exclusion Criteria:

1. Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc...)
2. Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc...)
3. Pregnancy
4. Age \<18
Modulation of Inflammation by Medium Cut Off Membranes

This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.

Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.

Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.

Eligibility Criteria:
Inclusion Criteria:

* time since initiation of dialysis \> 3 months
* age \> 18 years

Exclusion Criteria:

* time since initiation of dialysis \< 3 months
* age \< 18 years
* ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
* major surgery less than 2 weeks before inclusion in the study
* pregnancy
* mental illness
* lack of written and informed consent
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 60-80 years old.
* Complaints of memory loss in everyday life
* Non-smokers or very light smokers (no more than 10 cigarettes/day)
* Negative urine screen for drugs of abuse
* Ability to provide written informed consent

Exclusion Criteria:

* History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
* Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
* Clinically significant abnormality on electrocardiogram
* History of alcoholism or drug dependence
* Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
Effects of Adding Different Drugs for Preventing Cough Induced by Bronchoscopic Spraying of Local Anesthetics

Cough is the most unwanted response during bronchoscopic interventions for hemodynamic instability, hypoxemia, and interruption of interventions. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. In previous reports, there were many drugs and techniques investigated for preventing cough during broncoscopic spraying. As bronchoscopic interventions need more space and stability of airways to precisely operate on, few studies have focused on the effects of different drugs for preventing cough. In this study, Different intravenous drugs (lidocaine, alfentanil, compared to normal saline) is planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopicly spraying local anestheticsuch as cough intensity, BIS levels, ANI, Transdermal O2 and CO2, respiration were recorded and analyzed.

Cough is the most unwanted response during bronchoscopic interventions. Cough could lead to airway spasm, hemodynamic instability, desaturation, hypoventilation, and then interrupt the following interventions. In previous reports, lodicaine and other drugs given intravenously, inhalationally or trans-cricoidally have been investigated for preventing cough during conventional broncoscopic examinations. As bronchoscopic interventions were goaled to precise localization and operations with higher yield rate. Steady airways without endotracheal tubes are usually required. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. There are few studies focused on the effects of different drugs for preventing cough even bronchoscopic spary of local anesthetics has become the routine pratice before interventions. In this study, different intravenous drugs (lidocaine, alfentanil, compared to normal saline) are planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopic spraying local anesthetic were recorded and analyzed. Besdies cough scores, the following changes are recorded and compared: (1) status on visualization and the responses to spraying of vocal cords, (2) anesthetic depth (BIS levels), ANI scores (3) blood pressure and heart beats, (4) data of hemoglobin saturation (SPO2) and Transdermal O2 and CO2. We goaled to compare the effects of intravenous lidocaine and etomidate on cough intensity, hemodynamics, ventilation, and bronchoscopic withdrawl rate during bronchoscopic interventions with intravenous anethesia.

Eligibility Criteria:
Inclusion Criteria:

* patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.

Exclusion Criteria:

* conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision
Seroprevalence of COVID-19

Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Around 70% to 90% of a population needs to be immune to protect the uninfected. In A Spanish study of more than 30,000 people estimates that around just 5% of the Spanish population has developed antibodies

Aims of work:

A cross-sectional study to detect the seroprevalence to COVID 19 in chronic hemodialysis patients and compare it with the COVID 19 seroprevalence in healthy control in Sohag governorate Egypt

Methods:

After taken informed consent according to Sohag University Ethical Committee A questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous COVID 19 infection and infection control measures to prevent it

5 ml of the blood sample will be taken for IgG antibodies testing with a chemiluminescent microparticle immunoassay.

Eligibility Criteria:
Inclusion Criteria:

* patient accept to participate

Exclusion Criteria:

* vaccinated people
Video-assisted Thoracoscopic Surgery - Exparel Study

Video-assisted thoracoscopic surgery (VATS) greatly decreased the number and types of surgery that required open thoracotomy. Initially it was thought that VATS would lead to a reduction of respiratory problems and less acute pain in patients when compared to patients receiving an open thoracic surgery. However, for reasons not clearly understood, a large number of patients who undergo VATS still experience moderate to severe post-surgical pain (1). Physicians are still faced with the challenge of providing care that will manage both the respiratory issues as well as manage acute pain. The goal of this study is to find the most suitable regimen to effectively manage post-VATS-related pain.

The "promise" was that video-assisted thoracoscopic surgery (VATS) would be associated with less severe pulmonary impairment and less acute post-operative pain compared to open thoracotomy. However, VATS can cause moderate to severe post-operative pain in a significant number of patients and the reason for this is not well understood. In addition it has been found that post-surgical pain can be a strong predictor for the development of chronic pain. Inadequate control of acute pain not only causes serious discomfort and significant respiratory problems, but it may place this population of patients at greater risk of chronic pain and prescription opioid dependence.

Current protocols to manage and/or reduce VATS associated pain include combining the use of regional anesthesia techniques with opioid and non-opioid analgesics. Recent studies have investigated the efficacy of intercostal blocks using liposomal bupivacaine after thoracic surgery. However, these studies lacked an active comparator population of patients.

The study is designed as a prospective randomized study evaluating intercostal blocks using liposomal bupivacaine. The control population of patients will be treated with a paravertebral block using plain bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years and less than 80 years
* Undergoing video-assisted thoracoscopic surgery (VATS) procedure
* BMI less than 40

Exclusion Criteria:

* Unable to provide informed consent
* Non-English speaking
* Pregnant
* BMI greater than 40
* Video-assisted thoracoscopic surgery pleurodesis subjects
* Patients with pre-existing chronic pain
* Opioid tolerance
* Pain syndromes including fibromyalgia, regional pain syndrome or post therapeutic neuralgia in a thoracic distribution
* Allergy to the study medication
* Patients with infectious disease
* Patients with impaired coagulation
* Severe hepatic disease
* Incarcerated
BioDulse: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Healthy Adults

Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a healthy population.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-67

Exclusion Criteria:

* Terminal disease
* Past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment;
* Exclusively receiving enteral or parenteral nutrition,
* Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and SOP.
Endometrial Cell Collection With the PadKit

All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium. After the kit is returned to the Preprogen laboratory, a brief survey will be completed. Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.


Eligibility Criteria:
Inclusion criteria

1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.

1. Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
2. Cohort 2: women with planned hysterectomy for benign clinical indications

Exclusion criteria

1. Unable to provide informed consent
2. Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).