cyrilzakka/clinical-trials huggingface dataset:
Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy

The purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.

Objective: To determine whether women having day-case laparoscopic supracervical hysterectomy (LSH) are as satisfied with the length of stay in hospital as women who stay overnight following the procedure.

Design: randomised controlled trial (RCT).

Setting: Ulleval university hospital, Oslo, Norway.

Population: 49 women scheduled for LSH were enrolled and 45 patients completed the study (22 in the inpatient group and 23 in the day-case group).

Methods: Women were randomised to either day-case care or overnight hospital stay following a routine supracervical hysterectomy. The primary outcome measure was satisfaction with the length of stay in the hospital (measured on a 10-point visual analogue scale) and secondary measures were health-related quality of life (measured using the EuroQol EQ5D), anxiety (measured using the State-Trait Anxiety Inventory for Adults (STAI) and general questions about their experiences of having the operation. Readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded. Measures were taken on the day of surgery (postoperatively), and on days 1, 2, 4 and 7 following surgery. The data were analysed based on an intention to treat.

Eligibility Criteria:
Inclusion Criteria:.

* women requiring a hysterectomy for benign conditions

Exclusion Criteria:

* previous history of cervical dysplasia, an abnormal smear test within the last two to three years,
* abnormal histology or cytology at endometrial sampling,
* a history of endometriosis,
* advanced endometriosis diagnosed intra-operatively,
* previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible),
* a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder,
* psychosis, or American Society of Anaesthesiologists (ASA) rating 3 and 4 patients, and
* inability to understand and execute oral and written Norwegian language.
* women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge; or they were living or staying at a hotel more than an hour's drive from the hospital; and if they did not have access to a telephone.
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.

Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.

Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.


Eligibility Criteria:
Inclusion criteria:

* Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
* Age 35-75 years

Exclusion criteria:

* Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
* Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
* Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
* Excess ethanol consumption (regular intake \>4 drinks/d, or binges of \>8 drinks at once for men, half these levels for women)
* Poorly controlled diabetes mellitus (A1c \>9%)
* History of acute or chronic pancreatitis
* Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis
* History of significant unexplained or uncontrolled bleeding or bruising
* Poorly controlled blood pressure (\>140/90mmHg, with or without treatment)
* Poorly controlled thyroid disease (TSH outside of normal range)
* Hepatic disease (ALT \> 2.5x ULN, Dx of hepatitis or cirrhosis)
* Any contraindication or prior adverse reaction to Lovaza
* Active cancer (except basal cell or squamous cell skin cancer)
* Pregnancy, plan/desire to become pregnant, breast feeding
* Inability or unwillingness to provide informed consent
Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression.

The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
* Wound in granulation phase (granulation tissue ≥50%),
* Wound at least 3 cm away from any edge of another wound,
* VLU between 2 and 20 cm2 in surface area,
* VLU duration between 1 to 24 months.

Exclusion Criteria:

* Patient under guardianship or protection of vulnerable adult,
* Patient with known allergy to any components of the tested compression system,
* Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
* Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
* Patient with non-controlled systemic infection by a suitable antibiotic therapy,
* Patient who had a deep vein thrombosis within 3 months prior to the inclusion,
* Patient with a lymphedema due to lymphatic obstruction,
* Diabetic patient with advanced diagnosed microangiopathy,
* Bedridden patient, or those spending less than one hour per day on their feet,
* Wound covered partially or totally with necrotic tissue,
* Clinically infected wound,
* Wound requiring surgical treatment or for which a surgery is scheduled during the study period,
* Cancerous lesions.
Boosting COVID-19 Vaccination Uptake Using Wastewater Surveillance

Vaccinations are among the most successful and critical public health interventions. Despite the enormous protection that vaccines provide to public health, both delays and refusals of vaccines (vaccine hesitancy) are on the rise. Given that low vaccination rates present both an individual and community risk, it is critical that measures are taken to increase vaccination uptake in both rural and urban counties in New York. Wastewater surveillance of SARS-CoV-2 has been shown to be a leading indicator of pending surges. This study will examine whether a communications campaign based upon SARS-CoV-2 wastewater surveillance data can increase COVID-19 vaccine uptake.

Forty counties have been selected for the communication campaign (20 in the treatment group and 20 in the control group). A difference-in-differences method will be applied to assess the impact of the communications campaign on vaccine uptake, which observes the outcomes between a control and treatment group over pre- and post-intervention time periods. The communications campaign will be evaluated using the change in vaccination status of residents of the treatment and control counties. Outcomes will also be compared between demographic groups including race and ethnicity because of differences in vaccination rates that have been already observed.

We hypothesize that information regarding COVID-19 provided by wastewater surveillance that is geographically based and more local to communities will increase COVID-19 vaccine uptake. This theory of local information having an impact on health behavior is a novel application of the health belief model to increase vaccine uptake.


Eligibility Criteria:
Inclusion Criteria:

* Counties in New York State

Exclusion Criteria:

* Counties outside of New York State
Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program

Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible.

The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks.

The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.


Eligibility Criteria:
Inclusion Criteria:

* Phone screening
* Approval to participate in a weight management program from the child's pediatrician
* Children between the ages of 12 and 18 years
* Children overweight (\>85th-\<95th BMI percentile) or obese (\>95th BMI percentile)

Exclusion Criteria:

* Children with evidence of significant cardiovascular disease or cardiac arrhythmias
* Children with liver disease
* Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
* Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
* Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse
Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. 25 to 75 years of age.
3. Subjects requiring revision total hip replacement.
4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria:

1. Subjects with limited life span.
2. Subjects with difficulty in comprehending study protocol for any reason.
3. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.
4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

   * A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.
TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-4
* ≤ 1 year of age
* undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Exclusion Criteria:

* Patients less than 28 days old
* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for TOF monitoring
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients
Food or Supplemental Lutein Absorption

The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.

The absorption the macular carotenoids has shown variability between different supplements, and food sources such as egg and spinach. Investigation of the absorption of different forms of food (e.g. cooked, raw, blended) is not as well studied. Investigating the absorption of lutein from different forms of food is important to be able to prescribe lutein from forms of food that will be optimally absorbed.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 to 40 years.
* Generally healthy.
* No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
* Non-smoker.
* English language proficiency

Exclusion Criteria:

* Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
* Participant reported diagnosis, or current treatment of age-related macular degeneration.
* Participant reported diagnosis of epilepsy.
* Participant aversion, intolerance or allergy to study foods to be consumed (spinach, ginger, lemon, apple, flaxseeds)
* A female currently pregnant or trying to fall pregnant.
* Current or past smoker (within last 12 months).
* Under 18 or over 40 years of age.
* Currently taking a lutein supplement or consuming large amounts of foods containing lutein on a regular basis (\>3 days per week).
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Sympathetic overactivity partly promotes the development of peripheral artery disease which mainly leads to ischemia of the lower limbs. Endovascular arterial denervation (ED) is a minimally invasive technique which could deliver Radiofrequency energy by a multi-electrode catheter to the Lower limb artery to restore Sympathetic activity. The purpose of this study is to evaluate the effects of multi-electrode radiofrequency ablation system on lower limb ischemia with PAD.

Peripheral arterial disease(PAD) show insufficient blood supply of diseased limbs, which causes intermittent claudication of lower limbs, reduced skin temperature, pain, and chronic progressive disease that still produces ulcer or necrosis. Some clinical studies have shown Sympathetic overactivity in the lower arterial ischemic disease. The multi-electrode radiofrequency ablation system can significantly reduce the excitability of sympathetic nerve, restore the normal response of sympathetic nerve, relieve the pain and discomfort of patients, effectively improve the symptoms of lower limb ischemia, and improve the quality of life of patients.

Eligibility Criteria:
Inclusion Criteria:

1. eligible subjects aged 18-75 years,
2. clinically confirmed PAD patients in Rutherford category II-VI.

Exclusion Criteria:

1. thrombolytic therapy performed within 30 days,
2. patients who had undergone vascular bypass surgery before this study,
3. allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
4. patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
5. serious liver and kidney diseases,
6. history of hemorrhagic stroke within the last 1 month or ischemic stroke or transient ischemic attack within 2 weeks,
7. pacemaker implants,
8. patients who are pregnant, breast-feeding or planning pregnancy,
9. expected survival \< 24 months.
Molecular Biomarkers for Sepsis

This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the ICU of one of the participating centers.
* Cases: severe community acquired pneumonia with requirement for ICU admission.
* Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever \>38°C, CRP \>100mg/L, no infection focus expected in ≥ 24h.
* All required sample types can most likely be collected within the first 24h visits.
* Expected ICU stay of more than 24h.

Exclusion Criteria:

* Admission to the hospital within the prior 14 days.
* Patients with psychosis
* Evidence of a hospital acquired pneumonia.
* One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.
* Patients with an acute respiratory distress Syndrome (ARDS).
* Patient which can be managed as outpatients and do not require an ICU.
* Patient where a transmission to another institution is likely within the next 24h.
* Documented rejection of the general consent or participation to research in general.
* Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.
Plenum® Osshp in Maxillary Sinus Elevation Surgery

The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p\<0.05 will be adopted for all tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
* Over 18 years old;
* And that they have signed the informed consent form.

Exclusion Criteria:

* Smokers;
* Patients with uncontrolled systemic diseases;
* Patients with blood dyscrasias;
* Patients with sinus pathologies;
* Patients who take or have used medications that interfere with bone turnover;
* Patients irradiated in the head and neck region;
* Pregnant patients;
* Patients with untreated periodontal disease.