cyrilzakka/clinical-trials huggingface dataset:
Ventilation and Esophageal Pressure Changes

A study to observe the effect of variations in ventilator settings including tidal volume and PEEP on transpulmonary pressure monitored with an esophageal balloon catheter and to correlate intraoperative transpulmonary pressure variations and intraoperative stroke volume variation changes.

This study seeks to observe the effects of variations in ventilator settings on transpulmonary and intrathoracic pressures. More specifically, to observe the impact of variations in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm of water (H2O) to 5 cm H2O on transpulmonary and intrathoracic pressures monitored with an esophageal balloon catheter. The impact of this recommended decrease in tidal volume on the clinical utility of stroke volume variation (SVV) as a guide for fluid administration has not been previously examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
* Age ≥ 18

Exclusion Criteria:

* Patients undergoing planned esophageal surgery
* Patients with significant nasal or esophageal pathology
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients

This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription.

Exclusion Criteria:

* ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period.
Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part III

The purpose of the present study is to evaluate the effect of Hyaluronic acid application in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.

Although it has been demonstrated the role of HA in many different biological process related with tissue repair and regeneration, specific mechanisms involved in the early wound healing process in the oral soft tissues remains unclear.

A recent in vitro study evaluated the effects of two HA formulations on human oral fibroblasts involved in soft tissue wound healing/regeneration. The authors demonstrated that the investigated HA formulations maintained the viability of oral fibroblasts and increased their proliferative and migratory abilities. Moreover, enhanced expression of genes encoding type III collagen and transforming growth factor-β3, characteristic of scarless wound healing. Interestingly, TGFB1 remains unchanged. Moreover, compared to untreated control cells, either HA preparation upregulated the expression levels of COL3A1 in both HPFs and HGFs at 24 hour, whereas no effect on COL1A1 mRNA levels was detected The HAs upregulated the expression of genes encoding pro-proliferative, pro-migratory, and pro-inflammatory factors, with only a moderate effect on the latter in gingival fibroblasts. However, in vitro experiments have certain limitations. HA would undergo degradation to lower MW molecules following hyaluronidase activity during the post-operative period and will thus exert additional or even opposing effects on the wound repair process.28

To highlight, is the fact that in the latest years, the translational medicine focuses in research concerning scar-free wound healing tissues repair mechanisms and regarding this, it has been proposed that HA plays an important role in the fast and scarless fetal wound healing seeing during the first and second trimester.

Therefore, the aim of the present pilot study will be to evaluate the effect of hyaluronic acid application on gene expression and cellular behavior in the early wound healing process of gingival tissues. The second aim of the present work will be to evaluate the effect of HA in the wound healing clinical response.

Our hypothesis is that HA modifies the expression of genes related with the early wound healing response and the behavior of the main cells involved in this biological process: fibroblasts; stimulating and accelerating their wound healing potential.

Eligibility Criteria:
Inclusion Criteria:

* patients that required periodontal surgery;
* patients age between 30-60 years;
* patients with full mouth plaque score and full mouth bleeding score \< 15%;
* patients with a good general healthy status;
* patients without any medicaments or drug consumption that can affect the healing process;
* non-smoking patients.

Exclusion Criteria:

* patients in pregnancy;
* patients in lactation period;
* patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
* patients with systemic diseases.
Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD

This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD

This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.

Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
* Patients with COPD: able to understand the instructions; FEV1\<80% predicted value, naive to the SIMEOX device.

Exclusion Criteria:

* Healthy subjects: obesity (BMI \> 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
* Patients with COPD: obesity (BMI \> 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.
Effects of Using Customized Insoles With Anterior or Posterior Plantar Support in Cross-pelvis Syndrome and Perception of Body Alignment in Young Adults: a Randomized Clinical Trial

INTRODUCTION: Custom insoles with anterior or posterior support are described in the literature mainly for the treatment of foot and knee dysfunctions and this therapeutic effect extends to the promotion of biomechanical alignment between pelvis and trunk, by an ascending propceptive response. In this perspective, it can be hypothesized that the use of these insoles may favor individuals with anterior and posterior cross pelvis syndrome, who have biomechanical imbalance in the pelvis segment. To date, there is no literature data on the effect of continuous, noninvasive and inexpensive therapy on this individual profile.

OBJECTIVE: To evaluate the effects of using customized insoles with anterior or posterior plantar support in cross pelvis syndrome and in perception of body alignment in young adults.

METHODS: This is a blinded randomized controlled trial in individuals of both sexes aged 18-25 years and functionally diagnosed with posterior or anterior pelvic syndrome. Excluding thoracic deformities, lower limb differences, diabetic neuropathy, previous reports of some specific surgeries and treatment of ongoing physiotherapy. A pilot study will be carried out with 20 individuals divided into two groups for sample calculation (Personalized Insole Group and Placebo Group). After the pilot study, an initial screening will be carried out to verify the eligibility criteria. For the eligible, the pre-intervention evaluation will be carried out, which will be contemplated by personal data; scale of presence and intensity of pain; foot health status; foot posture index; by ely and thomas hamstring tests associated with an inclinometer and by photogrammetry. Individuals will be randomized into blocks of 10 individuals. A day will be marked to make the insole, in which the researcher will make the adaptations based on the biomechanical evaluation of the volunteer. To the invidious with the posterior cross pelvis syndrome an anterior support will be made in the insole and for those with anterior cross pelvis syndrome a posterior support will be made in the insole. For the placebo group, the insole will be made of the same material as that of the custom insoles, although, without support.


Eligibility Criteria:
Inclusion Criteria:

* Crossed pelvis syndrome (anterior or posterior)
* Difference in length leg ≤ 1cm
* Don't show: scoliotic or kyphotic deformity; chirurgie or fracture in spine in last 12 months; thoracic chirurgie; diabetic neuropathy; cesarean surgery; mixed crossed pelvis syndrome
* Not participating in any physical activity or physiotherapy

Exclusion Criteria:

* Join in other physical activity during the study
* Refuse to wear the insoles
Quality of Care of Oncological Patients With HPN

Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other aspects, the transition from the inpatient to the outpatient setting (discharge management), the organization of HPN at home or in a care facility (care management), the expertise required to care for patients with HPN and consistent compliance with standards are key to the quality of care for patients requiring HPN.

Hospital patients on parenteral nutrition (PN) to be continued at home are often discharged at very short notice. A good interlocking of all players is required to collect and distribute the relevant information, to secure proper training for those involved and to have all utilities and equipment at hand when the patient arrives.

This study collects nutritional and clinical parameters (including patient-reported parameters) along the continuum of care of HPN patients to evaluate the impact of the quality of care of HPN patients on their quality of life.

The HPN management will be evaluated by using a self-developed patient and a standardized quality of life questionnaire.

Patients will be recruited at the participating hospital by their treating physician before discharge and will continue their study participation after discharge.

The documentation period for the individual patients will be 3 months.

The questions of the patient´s questionnaire cover areas of interest like: satisfaction with discharge management, nutrition, satisfaction with HPN.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with an initial prescription for HPN during the current hospital stay
* Planned PN must at least contain the macronutrients glucose and amino acids.
* Solid, malignant tumor
* Anticipated duration of the HPN is at least 28 days
* Age ≥18 years
* Full legal capacity or legal guardian available
* Fluent in German language
* Able to read and write in German language
* Signed patient informed consent form
* Indication for PN

Exclusion Criteria:

* Contraindication for PN
* ECOG performance status \>3
* Pregnant and breast-feeding women
* Concurrent participation in another clinical study that requires deviations from the hospital's routine PN, nutrition and/or nursing procedures
Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

This study aims at estimating the proportion of patients diagnosed with locoregional renal cell carcinoma who are at high risk for recurrence following nephrectomy, describe referral patterns, and characterize treatment in this population. Outcomes including estimation of the incidence of recurrence and disease-free interval following nephrectomy will be reported overall and among the subgroup off patients receiving adjuvant systemic therapy with sunitinib following nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for data abstraction:

  * Diagnosed with locoregional RCC (no distant metastasis at the time of diagnosis)
  * Underwent a nephrectomy at Duke between 01 April 2014, and 31 December 2019 (final dates determined based on results from part 2 data collection)
  * Aged 18 years or older at nephrectomy

Exclusion Criteria:

* none
Core Temperature in Open Water Wetsuited Swimming.

Swimming in cold water is intrinsically unsafe. One of the threats is a fall in core body temperature (Tcore), which adversely affects all body systems and increases the risk of death. Wetsuits mitigate, but do not negate this threat. Environmental conditions may confound findings from laboratory studies or computer models, thus necessitating open water studies.

This study was designed to investigate the effects of open water wetsuited swimming on core body temperature at a range of different water temperatures between 8.4oC and 24.5oC.


Eligibility Criteria:
Inclusion Criteria:

* Trained and highly trained swimmers.

Exclusion Criteria:

* a history of cardiovascular disease, arrhythmias, or gastrointestinal abnormalities precluding the use of rectal temperature measurement.
Sleep Disorders in Patients With Multiple Sclerosis

Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple sclerosis
* Expanded Disability Status Scale score \< or = 5
* Fatigue (Modified Fatigue Impact Scale \> 45), with a disease duration \> 3 months

Exclusion Criteria:

* Depression
* Cognitive disorders
* EDSS \> 5
* Epilepsia
* Obesity
* Drug inducing sleep disorders
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years, male or female
* Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients
* Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy
* Liver function status Child-Pugh Class A or B (score≤7)
* ECOG Performance Status score 0 or 1
* Patients must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Known history or symptomatic metastatic brain
* Uncontrolled moderate and severe ascites
* With bleeding tendency and thrombosis history
* Known history of severe cardiovascular disease
* Uncontrollable active infections (≥CTCAE Grade 2)
* Pregnant or breastfeeding women
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥18 years of age
* CSU diagnosis for ≥ 6 months prior to screening
* Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period
* UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1)
* Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study

Exclusion Criteria:

* Hypersensitivity to any of the study treatments
* Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
* Other diseases with symptoms of urticaria or angioedema
* Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results,
* Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C.
* Pregnant or nursing (lactating) women
* Women of child-bearing potential not using highly effective methods of contraception
Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

A multicenter randomised double-arm clinical trial, to compare safety and efficacy of oral versus intralesional injection of steroid in a group of patients suffering from idiopathic orbital inflammation is designed. Outcome measures include number of recurrences, duration of remission, and side effects.

Expected to be finished in 3 years, patient enrollment includes 59 patient in each arm of the study. Inclusion criteria consist of clinical and/or imaging evidence of dacryoadenitis with or without adjacent rectus muscles (superior and inferior recti) myositis. Patients meeting following conditions will be excluded:

1. Age \< 15 years
2. Diabetes mellitus
3. Collagen Vascular Diseases
4. Vasculitides
5. Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
6. Glaucoma
7. Patients who have lost one eye
8. Bilateral disease
9. Abnormal thyroid-stimulating hormone

Outcome measures include number of recurrences, duration of remission, and side effects.

Patient allocation will be based on blocks of 4. Each patient will undergo lacrimal gland biopsy and subsequently will be allocated to one arm of the study according to a predetermined randomization sequence (balanced block of four). Outcome measures will be recorded in 0, 3 and 6 months after patient enrollment.

Patients in oral steroid group will receive 1 mg/kg/day of Prednisolone, tapered in 3 months (based on a detailed table).

Patients in injection group will receive 1 shot of 1 mL (20 mg Triamcinolone + 3 mg Betamethason) into the lacrimal gland.

Eligibility Criteria:
Inclusion Criteria:

* Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis

Exclusion Criteria:

* Abnormal thyroid-stimulating hormone
* Systemic Vasculitides
* Bilateral Orbital Inflammation
* Collagen Vascular Diseases
* One Seeing Eye
* Glaucoma
* Diabetes Mellitus
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype

This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* A male or female ≥ 15 years of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Known to be seronegative for anti-HBs-antibodies, anti-HBc-antibodies and/or HBsAg.
* Positive for the HLA-DQ2 genotype as determined in the previous sero-HBV-069 prevalence study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
* Previous vaccination against hepatitis B.
* History of non-response to previous hepatitis B vaccination.
* Known exposure to hepatitis B within 6 weeks.
* History of hepatitis B infection.
* Confirmed human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrollment.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
* Pregnant or lactating female
Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.

The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.

Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.

Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* Stage II-III pelvic organ prolapse
* Bilateral preservation of the ovaries
* Sexually active women

Exclusion Criteria:

* Smoking
* Body Mass Index \> 30
* Strenuous activity (frequent heavy lifting)
* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
* Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period