cyrilzakka/clinical-trials huggingface dataset:
The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain

This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity

All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively.

For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients

The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients admitted for laparoscopic sleeve gastrectomy
* Elective surgery
* BMI \> 40
* American Society of Anesthesiology Classification: 1-2

Exclusion Criteria:

* Patients' refusal to participate in the study
* Patients unable to give an informed consent
* Pregnancy
* Emergency surgery
* Patient with known allergy to paracetamol
* Patient with hepatic failure
* international normalized ratio \>1.7
* Albumin\<3.5g/Dl
* Bilirubin \>2mg/dL
* Patient with fever \> 37.5 ° C
* Patient with hemoglobin \< 8
* Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery.

Drug addict
Acromegaly Combination Treatment Study

In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.

Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms. The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from the start of the study. However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility.

After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start pegvisomant monotherapy at the same dose and schedule that they attained normalization in combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
* Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy
* Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
* Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
* Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.
* Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly
* Normal liver function tests before randomization to treatment
* The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.

Exclusion Criteria:

* The patient harbors a macroadenoma with visual field defects due to chiasmatic compression
* The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.
* The patient had pituitary surgery within 3 months prior to study entry
* The patient had radiotherapy within 12 months prior to study entry
* The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.
* The patient has a known hypersensitivity to any of the test materials or related compounds.
* The patient has a history of, or known current problems with alcohol or drug abuse.
* The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy

This study evaluates patient-reported experiences of radiation dermatitis in patients with breast cancer undergoing radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18
* Patients diagnosed with breast cancer
* Currently undergoing or recently completed radiotherapy
* Willing to provide verbal/oral consent

Exclusion Criteria:

* Persons \< 18
* Inability to provide verbal consent
* Non-English speakers (unless translations are available)
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis

Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.


Eligibility Criteria:
Inclusion Criteria:

* Painful osteoarthritis
* Hydarthrosis (synovial effusion)

Exclusion Criteria:

* large effusion
* severe pathologies
* anti-osteoarthritic treatments
Consumption of Dairy Yogurt Enhanced Immune Function

To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels.

A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG, 20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC) from each participant to Target cell (T) (K562 cells) as 10:1, 5:1, 2.5:1 or 1.25:1.

Eligibility Criteria:
Inclusion Criteria:

* The levels of white blood cells under 8x10\^3/μL
* males and females
* 30-69 years old
* nondiabetic and nonobese subjects
* able to give informed consent

Exclusion Criteria:

* consumption of any probiotic products within 1 month before screening
* unstable body weight (body-weight change \> 2 kg within 3 months before screening)
* diabetes
* history/presence of significant metabolic disease
* pregnancy or breast-feeding
* acute or chronic infection
* liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment
* subjects taking any drugs or supplements
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS

Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.


Eligibility Criteria:
Inclusion Criteria:

* age bwten 20 and 75
* peritoneal dialysis \> 4 weeks duration
* written consent
* daily urine output \> 500 ml

Exclusion Criteria:

* subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
* pregnant women
* subjects who are expected to discontinue peritoneal dialysis with one year
* mixed dialysis modality (peritoneal + hemodialysis)
* hypoalbuminemic subjects (serum albumin \< 3.3 g/dL)
* high blood pressure (\> 160/100 mmHg despite antihypertensive medications)
* severe heart failure (NYHA FC III, or IV)
The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy

BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy.

METHODS: One hundred and five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
* Scheduled for elective modified radical mastectomy

Exclusion Criteria:

* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Preoperative bradycardia
* Preoperative atrioventricular block
* Preoperative hypertension
* BMI\>30
Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.

Eligibility Criteria:
Key Inclusion Criteria:

1. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)

Key Exclusion Criteria:

1. Patients who, during the parent dupilumab study, R668-BP-1902 (NCT04206553), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to program drug and which led to discontinuation of investigational product
2. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
3. Treatment with BP-directed biologics, as defined in the protocol
4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
5. Planned or anticipated use of any prohibited medications or procedures during program treatment
6. Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

NOTE: Other protocol defined inclusion/exclusion criteria apply
Comparison of Intraoperative Warming Devices

The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.


Eligibility Criteria:
Inclusion Criteria:

* Initial total knee arthroplasty.
* Expected duration of surgery at least 2 hours.
* General anesthesia.
* American Society of Anesthesiologists (ASA) classification I-III.
* Age \>= 18 years.

Exclusion Criteria:

* Skin abrasion at the device application site.
* History of peripheral vascular disease.
* History of allergic skin conditions of the upper extremities.
* History of malignant hyperthermia.
Carotid Aneurysm Registry

To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The aim of this study is to collect data on ECAA and its treatment to assess the natural history of ECAA and the success and safety of different treatment strategies.

CAR is a prospective observational study, initiated by the Department of Vascular Surgery at University Medical Centre Utrecht (UMCU), The Netherlands. The study is descriptive in nature. The registry will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics committee of the UMCU has approved the study and all patients must give written informed consent before enrollment. Study enrolment is open to any patient diagnosed with an ECAA and ongoing.

Enrollment criteria: Participation in the CAR is intended for all subjects diagnosed with an ECAA irrespective of chosen treatment. Aneurysms are defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm. To be included, aneurysms must be located in the CCA, the external carotid artery or in the extracranial part of the ICA.To be included in the registry, patients need to be 18 years old. There are no additional exclusion criteria.

Intervention and follow-up:CAR does not interfere with the physician's treatment decision. Follow-up visits and imaging studies are scheduled as usual in their clinical practice, as this study does also not interfere with or influence the follow-up regimen.

Study endpoints:The primary endpoint of the CAR is freedom from aneurysm related symptoms at 30 days and at mid- and longterm follow-up. The secondary endpoint comprises treatment safety.

Endpoint monitoring:An endpoint adjudication committee, consisting of clinical experts, is set up to harmonize and standardize endpoint assessment and to determine whether the endpoints meet described criteria. This committee will review important subjective endpoints reported by trial investigators. The members of this committee are blinded to the treatment regime.

Data collection and monitoring: Data collected will be recorded through a web-based case report form (CRF). Data will be collected at baseline, at the moment of intervention, at the 30-day (or first postoperative) visit and during the follow-up phase. Data will remain at the UMCU in a secure environment.

This registry is a multicenter study. Statistical analysis: Statistical analyses will be performed using SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Individual has one or more aneurysms of the extracranial carotid artery. Defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm.
* Individual is ≥18 years of age.
* Individual has signed informed consent

Exclusion Criteria:

* none
Behavioral Treatments for Anxiety and Depression in Veterans With Parkinson's Disease

Behavioral Treatments for Anxiety and Depression (BehTA-D) is a research study for anxiety and depression in individuals with Parkinson's disease (PD). The research clinicians try to teach skills that may help participants cope with anxiety and depression in the context of Parkinson's disease. Research clinicians will also discuss ways improve management of Parkinson's symptoms. Other skills taught include how to relax, change thinking, add in meaningful pleasant activity.

Components of evidence-based cognitive behavioral therapy (CBT) treatments from current manuals developed for depression and anxiety will be used to construct the 8-week treatment program. The flexibility of modular based treatment allows patients and counselors to personalize interventions and skills for managing anxiety and depressive symptoms. The first treatment session will be in-person. All following sessions will be provided by telephone. Caregivers will have the option of being involved in 2 ways throughout treatment - as a "coach" to facilitate use of new skills by their loved one with PD and as a recipient of stress- management support. The scope of caregiver involvement will vary across patients, based on their preference. Involved caregivers will be given the opportunity to participate in 1 telephone-based stress-management session and 1 follow-up call scheduled individually during the first 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Have a confirmed diagnosis of idiopathic Parkinson's disease
2. Have significant anxiety and/or depressive symptoms as indicated by a score of greater than 4 on the Geriatric Depression Scale -15 or greater than 5 on the Hospital Anxiety and Depression anxiety subscale

Exclusion Criteria:

Patients will be excluded if they have cognitive impairment as indicated by the Montreal Cognitive Assessment (MoCA \< 23) or if they have a condition that threatens their safety or life including suicidal intent, current psychosis, bipolar, substance abuse or impulse control disorders within the past month.
Database of Interstitial Lung Diseases

The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs.

Protocol title: 'Registration of clinical data and DNA of patients with Interstitial Lung Disease (ILD)' Rationale: The etiopathogenesis of most Interstitial Lung Diseases (ILDs) is still unknown. Further research, e.g. to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the etiopathogenesis of ILDs.

Objective: Availability of relevant clinical data and DNA/serum samples of ILD patients in a database. Those data can be used for future research.

Study design: A prospective observational study

Study population: Patients diagnosed with ILD attending the pulmonology department in participating hospitals.

Intervention: a blood sample is taken from each patient. Furthermore, additional information is collected from the medical file.

Main study parameters/endpoints: DNA and serum sample, demographic variables, medical information, occupational history and hobbies.

Nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. The risks of drawing blood from a vein are minimal.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an ILD, as stated by the American Thoracic Society (ATS)
Study of Renal Blood Flow During Human Endotoxemia

The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.

Many septic patients develop acute renal failure and the risk is higher in patients with diabetes. The pathogenetic mechanisms behind the development of acute renal failure in connection with sepsis is not completely understood. One among many possible explanations is a change in renal hemodynamics. However, it is still largely unknown what happens to the renal plasma flow during human sepsis. In this study we give endotoxin injection (0,3 ng/kg) to type 2 diabetics and healthy controls as an experimental model of sepsis. Renal plasma flow and glomerular filtration rate are measured by DTPA-renography 1 day before before and 1,25 and 6,5 hours after injection of endotoxin. Furthermore WBC, plasma-cytokines,VCAM-1/ICAM-1, endothelin-1, Thromboxane B2, angiotensin 2, renin and PAI-1 are measured on an hourly basis up to 8 hours after endotoxin injection.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Type 2 diabetes

Exclusion Criteria:

* Renal failure
* Heart failure
* Lung disease
Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth

The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.

The essential oils have been presented as a realiable alternative to the "gold Standard" (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain. Some years ago, a new alternative without alcohol has been launched to the market. This formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy adults.
* Minimum of 24 permanent teeth.
* No gingivitis (Community Periodontal Index score = 0).
* No periodontitis (Community Periodontal Index score = 0).
* Absence of untreated caries.

Exclusion Criteria:

* Smoker or former smoker.
* Presence of dental prostheses.
* Presence of orthodontic devices
* Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
* Presence of any systemic disease that could alter the production or composition of saliva.
Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid

The purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.

Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Scheduled to see an internal medicine provider
* No recent colorectal cancer screening

Exclusion Criteria:

* Personal history of colorectal cancer
* Family history of colorectal cancer
* Blood seen in stools within last month
* Obvious cognitive or physical impairment that would prevent participation