cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers

Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or chemical stimulations.

This study has investigated various aspects of the physiology of the microcirculation in the past years and is still recruiting under parallel protocols of physiological investigations of the neurovascular control of the cutaneous microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with no clinical signs of, or risk factors for, vascular disease

Exclusion Criteria:

* Smokers, Pregnancy, Allergy,
The Effects Of Intravenous Ibuprofen on Pain, Oxidative Stress and Inflammation in Laparoscopic Hysterectomy Operations

Objective: The aim of this study is to evaluate whether the exposure of oxidative stres in the peroperative period and the postoperative 24th hour can be decreased with the thiol-disulfide homeostasis (TDH) method and C-Reactive Protein (CRP) with intravenous ibuprofen used for postoperative analgesia in patients undergoing total laparoscopic hysterectomy Material and Method: Sixty-nine patients with American Society of Anesthesiologists (ASA) scores I and II who scheduled for laparoscopic hysterectomy were included in the study. The patients were randomly divided into two groups as ibuprofen and paracetamol (Group IP) and paracetamol (Group P) with the sealed envelope method. When the vascular access was established from all patients (T0), after blood was drawn for TDH and CRP measurements, while 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% isotonic and iv infusion of 1 g paracetamol was started simultaneously, only 1g of paracetamol infusion was administered in Group P. In the IP group 800 mg ibuprofen and 1 g paracetamol, in the P group only paracetamol, the medicines specified for each group administered intravenously every 6 hours. The postoperative pain level in the patients was evaluated at the 1st, 2nd, 6th, 12th and 24th hours with the Visual Analogue Scale (VAS). Rescue analgesia with 1mg/kg tramadol as an iv bolus was applied to patients whose VAS score was 4 and above. Other blood samples for CRP and TDH were taken before insufflation (T1), after desufflation (T2) and at the postoperative 24th hour (T3). Demographic and hemodynamic data of the patients, duration of anesthesia and Trendelenburg position, need for additional analgesia, presence of nausea and vomiting, VAS scores, pathology results, CRP and TDH levels were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Elective Total Laparoscopic Hysterectomy, Aged between 30 and 65, Body Mass Index (BMI) below 35, ASA class I and II

Exclusion Criteria:

* trauma patients to be operated in emergent conditions, ASA risk classification III-IV and more, have a postoperative intensive care indication, Active and clinical symptoms of anemia, Platelet level lower than 30000 / mm3, History of gastrointestinal bleeding in the last 6 months, History of bleeding diathesis or increased Patients at risk of intracerebral hemorrhage, Oliguric and / or need dialysis in the last 1 month before surgery, or have received dialysis, Patients who used a combination of Warfarin, Lithium, Angiotensin Converting Enzyme (ACE) inhibitor and Furosemide medication or who needed to use any analgesic, muscle relaxant or sedative medication within the last 24 hours.

Patients who had a hypersensitivity reaction to any anesthetic or analgesic drug to be used in the study Patients did not want to participate in the study
Patient Satisfaction and Tear Osmolarity With the Use of Blink Tears, Blink Gel Tears and Systane Balance

This is a single center clinical study designed to determine patient satisfaction and the effect of the use of artificial tears on tear osmolarity with time after instillation of three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and Systane Balance).

Patient satisfaction and tear osmolarity with the use of Blink Tears, Blink Gel Tears and Systane Balance.

Eligibility Criteria:
Inclusion Criteria:

* male or femal subjects (aged 18 or older)
* diagnosed with mild to moderate dry eye syndrome
* provide written informed consent and sign/date a health information release
* women of childbreaing potential must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

* have any active ocular disease other than mild to moderate dry eye sundrome that would interfere with study interpretation
* active ocular allergy in any eye
* history of or active ocular infection/inflammation
* concomitant use of contact lenses (unilateral or bilateral)
* history of any corneal refractive laser surgery (e.g., LASIK, LASEK, RK,PRK) in the study eye (s);
* corneal disorder or abnormality that affects cornea sensitivity or normal spreading of the tear film in any eye.
* history of any intaocular surgery or glaucoma laser surgery (e.g., ALT, SLT) in the study eye (s)
* known sensitivity or allergy to any of the study medications or their components;
* uncontrolled systemic disease;
* contraindication to pupil dilation;
* Schirmer's Test- Standard Test (with anesthesia) result of less than or equal to 3 MM
* use of artifical tears prior to Baseline Visit (Visit 2, Day 0);
* Current use, use within 2 weeks prior to Baseline Visit ( Visit 2,Day 0) or likely use during the study period of any topical ophthalmic medications (e.g., antibotics, glaucoma medications) other than ophthalmic medications used in the study.
* use of any omega 3 supplement, artificial tear product (s), vasoconstrictor and/or redness reliever ocular drops 30 days prior to or during the study perior;
* use of cyclosporine ocular drops 12 months prior to or will require ocular surgery during the study period.
* females who are pregnany, nursing or planning a pregnancy or who are of childbearing potenital and not using a reliable method of contraception;
* any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
* concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit (Visit 1)
Integrating Malaria Vaccine with Seasonal Malaria Chemoprevention in West Africa

This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the eﬀectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Eﬀectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-eﬀectiveness.

Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.


Eligibility Criteria:
Inclusion criteria:

Control arms :

* Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;
* Resident in the catchment area of a health centre assigned to the control arm;
* Willingness to comply with the study procedures;
* Written informed consent from Parent/Guardian.

Intervention arms :

* Children aged 3-59 months at the time of first study vaccination;
* Resident in the catchment area of a health centre assigned to the intervention arm;
* Willingness to comply with the study procedures;
* Written informed consent from Parent/Guardian.

Exclusion Criteria:

1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
2. Any history of anaphylaxis in relation to vaccination;
3. Known chronic illness;
4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
5. History of vaccination with another malaria vaccine. -
DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC

Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.

All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU settings
* in defined time interval of the study

Exclusion Criteria:

* duration of ICU stay shorter than 24 hours
Geriatric Telemanagement of HEALTH Conditions in Nursing Home Residents Recently Discharged From the Hospital- GET HEALTH-I

Get-HEALTH-I Study is a prospective interventional study to evaluate the impact of a geriatric telemanagement program on cost-effectiveness and clinical outcomes in nursing home residents post-hospital discharge.

The primary objective of the study is to develop a geriatric co-management governance model using telemedicine for elderly patients with multimorbidity discharged from the hospital to nursing homes.The model will integrate geriatric specialists with nursing home staff and general practitioners. This model will be implemented in selected nursing homes in the Marche Region (Italy).

A secondary objective of the study is to measure the performance of the model in terms of effectiveness and cost-effectiveness. In particular, an evaluation will be conducted on the effects of implementing the geriatric telemanagement governance model on the risk of hospitalization, geriatric syndromes (falls, delirium, pressure ulcers), number of medications, and inappropriate prescriptions. Adherence to the intervention by GPs and nursing home staff, satisfaction and perception of utility, costs, healthcare resource utilization, and cost-effectiveness will be evaluated."

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents discharged from the hospital within one week of admission to the nursing home

Exclusion Criteria:

* Residents admitted for a short-term stay
Voclosporin in Adolescents With Lupus Nephritis

The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).

This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods, in which period 1 is double-blind, placebo controlled, and period 2 and period 3 are open-label, with increasing doses of voclosporin in a pediatric population.

Eligibility Criteria:
Key Inclusion Criteria:

* Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
* Subjects with kidney biopsy confirmed active lupus nephritis.

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening.
* Current or medical history of:

  * Congenital or acquired immunodeficiency.
  * Clinically significant drug or alcohol abuse prior to screening.
  * Malignant neoplasm.
  * Lymphoproliferative disease or previous total lymphoid irradiation.
  * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
  * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
* Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
* Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
* Currently taking or known need for any of the following medications:

  * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix

The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.

Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.

Eligibility Criteria:
Inclusion Criteria: The inclusion criteria were;

1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
2. at least 18 years of age
3. must sign the informed consent -

Exclusion Criteria: The exclusion criteria included:

1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
2. previous head and neck radiation
3. oral bisphosphonates for \> 3 years or any IV bisphosphonates
4. smoking \> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
5. requirement for prophylactic antibiotics
6. allergies to any medication or material used in the study, or that would adversely affect study procedures
7. chemotherapy in the previous 12 months
8. psychological problems that would interfere with treatment
9. patients unable or unwilling to sign the informed consent
10. pregnancy -
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI 18-30 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions

Self-reported history of:

* hepatic, renal, pulmonary, cardiovascular, or neurological disease;
* stroke or neurovascular disease;
* bleeding/clotting disorders;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse, excessive alcohol consumption;
* hypertension;
* active cancer;
* autoimmune disease;
* immunosuppressant therapy
Effects of Glucagon-like-Peptide-1 Analogues on Sexuality

This study is to investigate the effects of GLP-1 analogues (combined with lifestyle interventions in comparison to lifestyle interventions only) on sexual desire, mood, quality of life, the reproductive axis, retinal vessel diameters, physical fitness (and semen, for men only) in overweight or obese men and women.

Glucagon-like peptide-1 (GLP-1) analogues are widely used for the treatment of type 2 diabetes mellitus due to its well-known insulinotropic effects as well as for the treatment of obesity due to its satiation-promoting and appetite- suppressant effects. The GLP-1 analogues are approved in patients with obesity (BMI ≥ 30 kg/m2) or who are overweight (BMI ≥ 27 kg/m2) with additional comorbidities, such as prediabetes, diabetes mellitus type 2, arterial hypertension or dyslipidemia. Beside its influence on the reward for palatable food, several studies have shown that GLP-1 analogues modulate the rewarding effects of addictive drugs such as alcohol, nicotine and cocaine. As a further natural reward, sexual desire could be affected by GLP-1 analogues likewise.

This study investigates the influence of GLP-1 analogues on sexuality in a population of overweight and obese participants. A treatment with a GLP-1 analogue combined with lifestyle modifications for weight reduction will be compared to weight reduction with conventional lifestyle modifications only. In the context of the increasing use of GLP-1 analogues, particularly in young people with reproductive desire, laboratory analyzes of the reproductive axis (hormones and sperm cells) will be part of this study to document a possible influence. Mood changes, physical activity and fitness and effects on microvascular endothelial functioning by measuring diameters of retinal vessels will be further investigated.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27 kg/m2
* Willingness to lose weight by lifestyle changes only or by lifestyle changes plus GLP-1 analogue treatment as agreed in a routine clinical appointment
* Active sex life (sex with partner or masturbation ≥2x/month)
* Eugonadism:

  * Men: morning total testosterone ≥12mmol/l or free testosterone ≥ 0.198 nmol/l if\< 50 years old and ≥ 0.163 if \> 50 years old
  * Women: no primary or secondary amenorrhea (inclusive menopause) \*Secondary amenorrhea is defined as "absence of menses for more than three months in women who previously had regular menstrual cycles or six months in women who had irregular menses".

Exclusion Criteria:

* Diabetes mellitus, HbA1c ≥ 6,5 %
* Previous use of GLP-1 analogues during last 2 months.
* Exogenous testosterone substitution
* Current illicit drug abuse
* Pregnancy
Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).


Eligibility Criteria:
Inclusion Criteria:

* unilateral total hip arthroplasty with a direct anterior minimal invasive technique
* ASA score I or II
* signed written informed consent form
* 3 days hospitalization
* 45-80 years old
* primary Total hip arthroplasty

Exclusion Criteria:

* allergy to any given drugs
* contraindications for spinal anesthesia
* active bleeding
* renal failure ( gfr\< 90ml/h)
* hepatic failure ( abnormal sgot,sgpt,γgt)
* heart failure
* history of gastrointestinal bleeding
SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers

This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:

  * Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.

    * Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
  * Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
* Eastern Cooperative Oncology Group (ECOG) 0-1.
* Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.