cyrilzakka/clinical-trials huggingface dataset:
Modulation of Painful Perception

The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.

It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.

In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.

The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.


Eligibility Criteria:
Inclusion Criteria:

* Right handed

Exclusion Criteria:

* Pregnant or lactating women,
* Against-indications to MRI
* Drug intake of less than 12 hours,
* Neurological history or deficits, psychiatric, auditory or visual.
* Decline to participate
Improving Implementation of Lung Cancer Screening in Diverse Populations II

This project assesses the feasibility, appropriateness, and acceptability of a "Commonly Asked Questions after Lung Cancer Screening" (CAQ) informational document that the investigators created, resulting from patient and provider discussion in focus groups and interviews. If effective, the CAQ may be a new tool to help improve patient understanding of LCS results and adherence to follow-up recommendations.

Barriers to optimal implementation of lung cancer screening (LCS) include low levels of patient knowledge. Patient understanding of LCS results may alleviate distress and improve understanding of recommendations. The investigators developed a "Commonly Asked Questions after LCS" (CAQ) information sheet based on gaps in knowledge identified by patient focus groups and provider interviews. The study objective was to assess CAQ appropriateness and acceptability, and preliminary impact on patient understanding and distress after receiving LCS results.

The investigators conducted a pilot alternating intervention controlled trial of the CAQ. All patients in the University of Washington/Seattle Cancer Care Alliance LCS program who underwent baseline or annual LCS were received a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus the CAQ (intervention). The mailing assignment was alternated weekly. Mailed follow-up surveys assessed appropriateness and acceptability of CAQ as well as LCS knowledge in the intervention group.

Primary outcomes include: 1) Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale; 2) Correct self-report of next step based on Lung-RADS standardized follow-up; 3) symptoms of distress (measured by IES); as well as 4) measures of acceptability and appropriateness. Secondary outcomes include responses to 6 questions regarding lung cancer screening knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone LCS or is referred for LCS
* Able to give informed consent

Exclusion Criteria:

* Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
* Known malignancy other than non-melanoma skin cancer
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes

To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.

Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.

Trial population A total of 30 subjects with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
2. Insulin pump and CGM initiated at least 3 months prior to the recruitment.
3. Estimated HbA1c based on the 14-days CGM report above 8.5%.
4. Daily insulin dose of more than 0.5 international units per kilogram.

Exclusion Criteria:

1. Subjects with known diabetes complications.
2. Elevated tissue transglutaminase IgA antibodies in the last two years.
3. Children who developed an acute viral infections during the week preceding the recruitment.

Exclusion criteria after the Run-in period

1. Basal insulin proportion \> 55% of daily insulin dose.
2. Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
3. Estimated HbA1c \> 8.5% based on the 14-days CGM report.
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on at least one glaucoma medication
* Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Angle closure glaucoma
Effects of an Air Bolus on Primary Peristalsis

Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

Study Procedures and Analyses

1. All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study
2. After application of local lidocaine, the high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure.
3. Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
4. Following completion of the study, the manometry catheter and the single lumen tube will be removed.
5. The participant will also be instructed to resume their regular diet and activity.
6. All the pressure recordings will be analyzed by two individuals in a blinded fashion.

The investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere.

Statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
* Age 21 to 90 years

Exclusion Criteria:

* Under the age of 21
* Over the age of 90
* Presence of pharyngo-esophageal disease or motility disorders
* Pregnancy
* Lidocaine allergy
The Wellness Transformation Network Pilot Study

The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.

The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:

1. To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.
2. To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).

The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).

Eligibility Criteria:
Inclusion Criteria:

* Adults (males and females)18 years of age or older.
* Able to understand and communicate in English.
* Willing to answer a questionnaire on lifestyle and health status.
* Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.
* Willing to fast for 12 hours prior to two in-person study visits.
* Willing to consume a standardized test meal containing food ingredients.
* Willing to provide a urine sample.
* Willing to take a pregnancy test (female participants of childbearing potential).
* Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs).
* Willing to complete an online eDiary, including a 3-day food record.
* Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter)

Exclusion Criteria:

* Individuals diagnosed with diabetes.
* Women with confirmed pregnancy or who are breastfeeding.
* Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).
* Individuals with a fasting blood glucose of 7.0 mmol/L or higher.
* Individuals with abnormal glucose in their urine.
* Individuals who are related to or working for the clinic site, research staff, and study sponsor.
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers

To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Past medical history of epididymitis, orchitis, sexually transmitted diseases (chlamydia, gonorrhea, etc.) or urinary tract infection.
* History of prostatitis or prostate surgery.
* Urinary catheterization or instrumentation within 12 months of screening. Inguinal or scrotal hernia.
* Current or history of congenital genital abnormalities.
* Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception of small epididymal cysts and spermatoceles.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to spironolactone, eplerenone, or related compounds.
* Serum potassium \>5.5 mEq/L at screening or Day 0.
A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma

Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Phase I data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies.

Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Therapies for hepatocarcinoma are limited. Resection of the primary tumor is the therapeutic approach of first choice when possible. Although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis.

Phase I data suggest that low levels of amplitude-modulated electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of HCC-specific frequencies.

The patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.

Eligibility Criteria:
Inclusion Criteria:

* The patients must have a diagnosis of inoperable hepatocellular carcinoma.
* The patients who have an AFP level higher than 400 ng/ml and an appearance characteristic of cancer of the liver do not need histological confirmation. These patients must however have a negative serology for the antigen of surface of hepatitis B If serology for this antigen is positive, they must have a rate of AFP higher than 4000 ng/ml.
* Presence of one or more lesions measurable(s) according to criteria's RECIST.

Exclusion Criteria:

* Other anti-cancer treatments are not authorized during this study.
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. Diagnosed with type 2 diabetes mellitus
3. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the Specialist based on local label before and independently from the decision to include the patient in this study
4. Male or female, age above or equal to 18 years at the time of signing informed consent
5. Available HbA1c value below or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of below 14 days

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Treatment with any investigational drug within 30 days prior to enrolment into the study
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Cardiopulmonary Outcomes and Household Air Pollution Trial

The purpose of this randomized controlled field trial is to determine whether a liquefied petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen exposure to household air pollutants and improves cardiopulmonary health outcomes when compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged 25-64 years.

Randomized, controlled field trial of an LPG stove and fuel distribution intervention compared to standard cooking practices with open-fire biomass-burning stoves in the homes of participating adult women aged 25-64 years. The aim is to determine whether provision of cleaner fuels will result in important reductions in household air pollutants and consequently in an improvement in cardiopulmonary health outcomes over a one-year period. Participants randomly assigned to the intervention arm will receive a free LPG stove and fuel delivered to their homes during the one-year intervention period. Participants randomly assigned to the control arm will receive a free LPG stove and vouchers that can be used to obtain free fuel for an entire year at LPG fuel distribution centers at the end of the one-year intervention period. All participants will be followed for a second year to assess patterns and impacts of sustained use (intervention arm) and initial adoption (control arm).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Full-time resident ≥6 months in current location
* Capable of understanding procedures
* Capable of providing informed consent and responding to a questionnaire
* Primary household cook
* Currently using a traditional stove as primary stove for cooking
* Cooking room/area separate from sleeping room/area to minimize probability of use of biomass fuel stoves for heating living space.

Exclusion Criteria:

* Plans to move from the area within one year
* Uncontrolled hypertension
* Diagnosis of chronic obstructive pulmonary disease (COPD)
* Pregnant or planning pregnancy in the next year
The Effect of GIP(3-30)NH2

Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.

Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.

Six study hyperglycemic clamps (10 mmol/l) pr. participant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI 19-28 kg/m\*m
* Stable body weight

Exclusion Criteria:

* Diabetes
* Anemia
* First-degree relatives with diabetes
Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome

The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.

This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. Statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian ethnicity
* Age 18- 75
* Diagnosis of metabolic syndrome
* Presence of at least 12 teeth

Exclusion Criteria:

* Pregnancy
* Presence of infectious diseases such as hepatitis and HIV
* Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit
* Use of systemic antibiotics within three months prior to the baseline visit
* Antibiotic pre-medication required for the performance of periodontal examination
Sensory Augmentation Methods in Stroke

Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of foot placement, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during \~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Experience of a stroke 6 months prior to participation
* Gait speed of at least 0.2 m/s
* Ability to walk on a treadmill without a cane or walker
* Provision of informed consent

Exclusion Criteria:

* Evidence of cerebellar damage
* Resting blood pressure higher than 220/110 mm Hg
* History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
* Preexisting neurological disorders or dementia
* Legal blindness or severe visual impairment
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
* Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern