cyrilzakka/clinical-trials huggingface dataset:
The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.

The goal of this clinical trail is to compare the differences in carotid plaque Treg cells' gene signature for activation, proliferation, and suppressive function using scRNA-seq in patients treated with IL-2 compared to control.

Up till now our Lab has looked at Tregs and immune cells in the blood. The question remains whether low dose IL-2 can have the desired effect on Tregs in atherosclerotic plaques where they could alter the pathophysiology and potentially clinical outcomes for patients.

Up until recently, the cellular composition and cell-specific expression patterns of human atherosclerotic plaques remained elusive. However, recent breakthroughs studies using scRNA-seq, CITE-seq, and single-cell ATAC-seq on human carotid plaques have offered important insight into plaque composition, cell heterogeneity, and cell-cell interactions giving new perspectives on mechanisms of disease. The next logical stage is to use this new insight and powerful biological tool to assist in drug development for patients.

Therefore, the aims of the study are:

1. To assess if low dose IL-2, given systemically to patients at our proposed dose, can alter Tregs in atherosclerotic plaques (the disease tissue) to exhibit a proliferating, activated, and immunosuppressive phenotype
2. To assess if modulating plaque Tregs can cause a shift in the plaque immune landscape to a less inflammatory phenotype
3. To study the relationship between plaque and circulating immune cells after systemic immune modulation

Eligibility Criteria:
Inclusion Criteria:

* Presence of carotid stenosis on either ultrasound or CT scan.
* Planned to undergo carotid endarterectomy.

Exclusion Criteria:

* Autoimmune disease
* Any regular immunosuppressive treatment \[Inhaled or topical steroids are permissible\]
* Modified Rankin Scale score of ≥4 at screening
* Known active hepatic disease or alanine aminotransferase (ALT) \> 2xULN
* Severe chronic kidney disease (defined as eGFR \< 30 ml/min/1.73m2)
* Allergy or intolerance to aldesleukin
* Signs or symptoms of active infection
* History of human immunodeficiency virus (HIV), hepatitis B or C
* Current malignancy requiring active treatment
* Vaccine within 4 weeks prior to screening or plans for vaccination during study period
* Women of child-bearing potential and pregnancy
* Women who are breast-feeding
* Clinically relevant medical or surgical conditions that, in the opinion of the
The Effect of Hemodialysis on Hearing

The inner ear contains transporters that are responsible for maintaining a strict homeostatic environment, necessary for transmission and transduction of sound waves. Hemodialysis affects the body's composition including the aspects regulated by these transporters (pH, osmolarity, Na, K). We wish to observe if hemodialysis affects hearing, and if so, by which parameters.


Eligibility Criteria:
Inclusion Criteria:

* patients on hemodialysis

Exclusion Criteria:

* known hearing defect
Yoga on Posttraumatic Growth and Quality of Life

The objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life.

This is a experimental model with pretest-posttest control group study. Two hundred and fifty-two women who met the criteria for inclusion in the study made up the research population. Three instruments were used to obtain the research data: Personal Information Form, Posttraumatic Growth Inventory (PTGI) and SF-36 Quality of Life Questionnaire (SF-36).

Failure in modern medicine approaches or side effects of treatments and drugs, as well as the woman's anxiety to hurt herself and her baby direct her and her relatives to try complementary therapies. Women should prefer natural ways in coping with these postpartum problems rather than seeking medical advice.

When yoga and meditation, which are included in the group of mind-body-based complementary therapies, are performed in the postpartum period, they will help to relieve tensions and distresses that accumulate during birth, strengthen the pelvic floor, heal perineum, bring reproductive organs back to their prepregnancy condition healthily, provide the mother and the infant a sleep pattern, and have an easier transition to sleep.

Eligibility Criteria:
Inclusion Criteria:

* Having a baby between 2 and 6 months
* First time mom
* No tissue deformity in extremities

Exclusion Criteria:

* Any gynecological disease
* Any psychiatric illness
* Using any psychiatric medication
DMT310-009 Topical in the Treatment of Acne Vulgaris

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Patient sex at birth, male or non-pregnant female at least 9 years of age
* Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face

* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy on the face which may affect the patient's acne
Mindfulness-based Cognitive Coping for ADRD Caregivers

This project will evaluate the effectiveness of the Mindfulness-based Cognitive Coping (MCC) intervention to alleviate stress and depressive symptoms of caregivers of Individuals with Alzheimer's Disease and Related Dementia.


Eligibility Criteria:
Inclusion Criteria:

* Care for an individual with Alzheimer's Disease or Related Dementia (ADRD).
* Own a smartphone or tablet and have Internet access.
* Minimum age of 18 years old.
* Able to read and speak English.
* Spend at least 8 hours/week caring for a person with dementia.
* Plan to stay in the area for six months.

Exclusion Criteria:

* Severe psychological or physical illness.
* Cognitive impairment or any serious medical problem that interferes with caregiving role.
* Caring for ADRD patient with a life expectancy less than six months.
* Unwillingness to participate in all aspects of the study.
Trapezius Muscle Activities in the Natural Head Posture and Corrected Head Posture During Wall-Slide Exercise

The goal of this observational study is to investigate the effect of head posture on trapezius muscle activity and ratios during wall slide exercise. The main question the study aims to answer is:

•How does the trapezius muscle activity change during wall slide exercise when performed with a natural head posture and the corrected head posture? The participants performed wall slide exercise with their natural head posture and the corrected posture. For both interventions, muscle activity of the lower, middle and upper trapezius was measured with surface electromyography(EMG) Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) in the ascending, stationary and descending phases of the exercise.

Healthy individuals between the ages of 18 and 35 who have not had any pain in the upper extremity for the last 6 weeks, have musculoskeletal system pathologies of the upper extremity and/or any surgery were included in the study. Individuals who have had pain in the shoulder area for the last 6 weeks, had shoulder injury and/or shoulder surgery, have neurological, rheumatological or systemic diseases and body mass index (BMI) greater than 30 kg/m2 were excluded. Participants were asked to perform wall-slide exercise with both natural head posture and corrected head posture, separately. During the wall-slide exercise, muscle activations of upper trapezius (UT), middle trapezius (MT) and lower trapezius (LT) were measured with surface EMG Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) in the ascending, stationary and descending phases of the exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18 and 35
* Individuals who have not had any pain in the upper extremity for the last 6 weeks
* Individuals who do not have musculoskeletal system pathologies of the upper extremity and/or any surgery

Exclusion Criteria:

* Individuals who have had pain in the shoulder area for the last 6 weeks
* Individuals who had shoulder injury and/or shoulder surgery
* Individuals who have neurological, rheumatological or systemic diseases
* Individuals with body mass index (BMI) greater than 30 kg/m2
The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.


Eligibility Criteria:
Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects:

* Subjects who have undergone RYGB

Inclusion Criteria Healthy Subjects:

* Must match RYGB subjects in age, weight, and gender
* Subjects will be without active systemic illness

Exclusion Criteria all Subjects:

* Subjects \<20 years old and \>70 years old
* For Female Subjects: positive pregnancy text at the time of enrollment or study
* Subjects with functional or organic bowel symptoms.
Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis.

Subjects will undertake a \<2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo.

Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26.

Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted.

Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card.

Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology.

In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed.

Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. Male or female subjects, 18 years of age who have undergone an IPAA for UC
3. History of pouchitis
4. Overall PDAI score \> 7
5. Must have Chronic Antibiotic Refractory Pouchitis

Exclusion Criteria:

1. Lack of effective contraception
2. Women who are pregnant or breastfeeding;
3. Strong analgesia NSAID use
4. Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy.
5. Rectal products
6. Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
7. All other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the Screening Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer)
8. Anal sphincter dysfunction
9. Infections to cytomegalovirus or Clostridium Difficile
10. Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses
11. Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial
Trans-abdominal Fetal Pulse Oximetry

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Raydiant Oximetry, Inc. is developing a novel and non-invasive fetal pulse oximetry device to fundamentally improve how fetuses are monitored during labor. The Raydiant Oximetry Sensing System (Lumerah) is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah performs its measurements without the requirement for transvaginal placement and its associated risks. Lumerah is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation which is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The severe consequences associated with newborn metabolic acidosis and the lack of availability of an effective tool to support its early diagnosis led to the development of Lumerah.

In this study, women in labor will be simultaneously monitored with proven (previously FDA-approved) technology as a "ground truth". These women will be simultaneously monitored with both an external and internal oxygen sensor. Obstetric health-care providers are blinded to oximetry data presented by both devices; therefore, clinical decisions regarding interventions are made based on the standard factors, including cardiotocography. The primary efficacy analysis will be performed retrospectively by comparing data of fetal oxygenation displayed and recorded by both devices. Results of either the Lumerah external sensor or the internal sensor will not be used to guide or alter patient management.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and capable to provide informed consent
2. Age \> 18 years
3. BMI \< 50 (with no more than 4 cm between maternal skin and fetal skin)
4. Gestational age \> 36 weeks
5. Singleton pregnancy
6. Vertex presentation
7. Active labor
8. Category I or Category II tracings
9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower

Exclusion Criteria:

1. Age \<18 years
2. BMI \> 50 third trimester
3. Gestational age \< 36 weeks
4. Multiple gestation
5. Nonvertex fetal presentation
6. Suspected vasa previa
7. Latent labor
8. Category III CTG tracing (i.e., need for immediate delivery)
9. Fetal anomalies and/or chromosomal disorders
10. Chorioamnionitis
11. Placenta Previa
12. History of HIV, Genital Herpes, or other infection precluding internal monitoring
13. Unable to provide informed consent (e.g., cognitively impaired)
Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients

Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.

This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 year-old
* Expected duration of ICU stay ≥ 48 hours
* Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.

Exclusion Criteria:

* Patient with history of allergy to any of the antiseptic agent studied
* Expected survival \< 48 hours
* Catheter inserted outside the ICU or in emergency without respect of preventive measures.
* Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
* Pregnant woman or breast-feeding mother
Lumbosciatic Syndrome: Vojta Therapy vs. TENS

This pilot "pre-post" quasi-experimental study evaluates for the first time the effectiveness of Vojta Therapy in treating lumbosciatic and compares it with the transcutaneous electrical nerve stimulation (TENS) procedure. Patients who agree will be distributed alternately in order of arrival to a Physiotherapy Unit, in such a way that half of the sample will be treated using TENS and the other half with Vojta.

Lumbago/lumbosciatic (with or without radicular implication) is the second most frequent cause of primary medical care and the highest cause of disability in the entire world. This pathology is normally slight to moderate in the majority of cases, meaning that the therapeutical treatment tends to be conservative and thus the interest in increasing the range of non-invasive therapeutic possibilities is available.

Reflex Locomotion or Vojta Therapy began being used in 1959 for the rehabilitation of children with motor alterations and infants with a risk of cerebral palsy. Years later it was successfully applied to adults with neurological and motor alteration problems. Until now, there have been no studies on its use in pathologies of the spine and, in particular at a lumbar level.

A pre-/ post-intervention examination will be performed to obtain an objective clinical analysis (measurements of pain, disability, functionality and joint movement), by means of simple questionnaires completed by the patient (VAS scale, Oswestry and Roland-Morris questionnaires) and exploration techniques (Lasègue manoeuvre, Schöber test, fingertips to floor test and walking on heels and toes).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute, sub-acute or chronic lumbosciatic by a rehabilitation doctor were referred by said doctor to the Physiotherapy Unit, as candidates for either of the therapeutical procedures.

Exclusion Criteria:

* Patients with lumbosciatic resulting from a specific pathology (infection, metastasis, neoplasia, osteoporosis, fracture or inflammatory arthropathy).
HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders

This study is being done to determine if healthcare workers who have previously failed to respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant (hepB-CpG) (Heplisav-B)

Study Intervention Each individual who has completed at least 5 doses hepB vaccine with aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited to receive the hepB-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface antigen will be measured after the first dose during the visit for the administration of the second dose. One month after completion of the series, each immunized individual will have another anti-HBs measured.

Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs \< 10mIU/ml.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs \< 10mIU/ml
* Females of childbearing potential will be asked about the possibility of pregnancy as is the standard of care for immunization services. If a female indicates that she may be pregnant, study participation will be postponed until pregnancy is completed or the female reports that she is not pregnant.

Exclusion Criteria:

* Women who are pregnant or planning on becoming pregnant during the study
* Allergy to the vaccine or a component of the vaccine
* Not suitable for study participation due to other reasons, such as inability or unwillingness to comply with the study procedures, at the discretion of the investigators
Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Young Adult Smokers

This clinical trial evaluates the impact of Quitting Using Executive Function Strategy Training (QUEST) on quitting smoking (cessation) in homeless young adult smokers with an acquired brain injury (ABI). Over 70% of youth and young adults experiencing homelessness (YYEH) smoke tobacco. More than half of YYEH who smoke have made at least one attempt to quit smoking but few use evidence-based methods to increase success. In addition, 9 out of 10 of these have an acquired brain injury which may have a negative impact on successful smoking cessation. QUEST may help homeless young adult smokers with an ABI quit smoking.

PRIMARY OBJECTIVES:

I. Gather data needed to build QUEST (Quitting Using Executive function Strategy Training), an intervention to help youth and young adults (YYEH) with executive function dysregulation better 1) access evidence-based cessation; 2) adhere to processes of evidence-based treatment; and 3) address stress to prevent relapse.

II. Establish the feasibility of collecting acquired brain injury (ABI) status, and impact data sensitive to change over time (clinical and epigenetic), from YYEH tobacco users in community settings.

EXPLORATORY OBJECTIVE:

I. Determine if 1) executive functioning 2) mild cognitive impairment and 3) epigenetic age \& other biomarkers of health risk measures are sensitive to difference by ABI status among YYEH past week combustible tobacco users.

OUTLINE:

Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.

Eligibility Criteria:
Inclusion Criteria:

* 18-24 years old
* Utilizing STAR House ( a drop-in center for youth and young adults experiencing homelessness) services
* Use of combustible tobacco product in the last week
* Willing to quit smoking in the next 30 days
* Acquired Brain Injury (ABI) (15 youth with and 15 without)

  * CHATS will be used to determine ABI. Ask "C", "H" and "A" of the CHATS tool. If yes to C OR H and yes to A, that will be considered positive for ABI
* Have access to a phone
* Willing to use phone for QuitLine (QL) services
* Willing to enroll in Ohio Tobacco Quit Line
* Willing to share Ohio Tobacco Quit Line portal data with researchers
* Willing to provide biospecimens (exhaled air and nasal samples)
* Conversational English skills