cyrilzakka/clinical-trials huggingface dataset:
Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

A comparison of skin closure techniques (standard skin closure with staples versus a continuous (subcuticular) absorbable suture), to determine if this changes the rate of post operative wound infections in elective colorectal surgery patients.

In colorectal surgery, there has been a growing interest in the study of Surgical Site Infections (SSI), with an outstanding variability of reported incidence, ranging from 3% up to 30% depending on the series. Although general risk factors for infection have been identified, there is still a need to identify specific risk factors for colorectal surgery patients, to try to reduce these numbers. The technique and materials used for wound closure have been considered as interesting variables for study.

Main question of our study: is subcuticular (reabsorbable, continuous) suture better than skin staples for reducing wound SSIs in colorectal surgery? The study is sponsored by the Surgical Infection Society Europe, and was awarded the SIS-E Fellowship for young investigators (2013)

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>18), both genders.
* Elective colorectal surgery interventions
* Open surgery incisions and laparoscopic extraction incisions
* Incisions \>5cm, any location
* Intervention performed by a specialist colorectal surgeon
* Patient suitable for surgery in preoperative assessment
* Informed consent

Exclusion Criteria:

* Emergency colorectal surgery
* Scheduled multiple surgical procedures
* Unsuitable preoperative assessment
* Other infections present/being treated.
* Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.)
* Inability to understand the study/sign informed consent
Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma
* Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity

Exclusion Criteria:

* Females who are currently pregnant or planning to become pregnant, as determined by history during the study period
* Diagnosis of any other form of glaucoma other than open-angle
* Schaffer angle grade \< 2 in either eye by gonioscopy
* Chronic, recurrent, or severe inflammatory eye disease
* Intraocular surgery within 6 months or laser within 3 months
* History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus
* History of cystoid macular edema
* Inability to safely discontinue all ocular medications for 4 weeks
* Patients who smoke or have irregular daily sleep patterns
* Patients who have started or changed glucocorticoids therapy in the last 3 months
* Patients who are currently undergoing medical marijuana therapy
* Any use of a non-FDA approved medication for glaucoma in the last 3 months
Hypo-hydration Mood and Cognition

Recently changes in mood and cognition have been reported following minor reductions in hydration status. The aim is to explore that such changes in part at least reflect placebo response; therefore the consumption of plain or coloured water will be compared in drinks designed to differ in their ability to rehydrate.

162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored. Randomly on two occasions they will consume no drink or 300ml of plain or red colored water. In addition they will take a capsule containing sodium chloride or a placebo. Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times. Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded. Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.

Eligibility Criteria:
Inclusion criteria:

* 18 to 30 years
* Non-smokers
* BMI \< 30
* By self-report in good health
* Not taking medication for any psychological or other health disorder.

Exclusion Criteria:

* Do not meet inclusion criteria
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.

Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity, promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical use is still experimental especially in preoperative setting, where there are still no data of antioxidant and antiinflammatory beneficial roles. This study is a prospective observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1, M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with personalized nutritional and psychoeducational support. This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

An open-label, single center, phase 2 prospective observational clinical study

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
* absence of distant metastasis
* signed informed consent.

Exclusion Criteria:

* Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
* Breast cancer recurrence
* Metastatic breast cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Living distant from center and unable to attend for check-ups and meetings
Mobilization With Movement for Shoulder Impingement

Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.


Eligibility Criteria:
Inclusion Criteria:

* history of shoulder pain of \> 3months duration
* pain localized at the proximal anterolateral shoulder region
* medical diagnosis of shoulder impingement syndrome
* at least 2 positive impingement tests including Neer, Hawking, or Jobe test

Exclusion Criteria:

* diagnosis of fibromyalgia
* pregnancy
* a history of traumatic onset of shoulder pain
* other histories of shoulder injury
* ligamentous laxity based on a positive Sulcus test and apprehension test
* numbness or tingling in the upper extremity
* previous shoulder or cervical spine surgery
* corticosteroid injection on the shoulder within 1 year of the study
* physical therapy 6 months prior to the study
Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator

People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

Data pending

Eligibility Criteria:
Inclusion Criteria:

* Breathing difficulties from vocal cord paralyses
* Tracheostomy tube
* Ability to understand the purpose of the research
* Appropriate hand motor coordination

Exclusion Criteria:

* Lack of understanding the research
* Poor hand motor coordination
* Non-acceptance of tracheostomy
* Inability to passively move the paralyzed vocal cords
Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial

The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure.

In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to read, understand, and provide written Informed Consent;
* Age range of 18-90 years;
* Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable.

Exclusion Criteria:

* if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis
* If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis.
* If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.
The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women

The objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin C. The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin C.

Recently, much attention has been paid to evidence that abnormalities of the postprandial state (hyperglycemia) are important contributing factors to the development of chronic disease. This attention has increased interest in the role low glycemic index (GI) foods could potentially play in preventing postprandial oxidative burst/stress. GI is a means by which to categorize carbohydrate according to their postprandial glycemic response. Low GI foods promote slow intestinal absorption, prolonged and less pronounced postprandial glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to people living with glucose abnormalities as well as those with normal glucose. Few studies have been conducted looking at the potential relationship between GI and oxidation and are limited by dietary/lifestyle confounders. The proposed study has been developed to eliminate these confounders. Hypotheses (3): 1. Sipping glucose slowly over 3h will result in less oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. Sipping glucose will reduce oxidative stress to the same extent as 1g of oral vitamin C. 3. The effect of sipping glucose on oxidative stress will occur sooner than that of vitamin C.

Eligibility Criteria:
Inclusion Criteria:

* healthy males or females
* 18 to 75 years

Exclusion Criteria:

* diabetes
* recent hospitalization
Pulsed Dye Laser and Intense Pulsed Light Configured With Different Wavelength Bands in Improving Erythematotelangiectatic Rosacea

Pulsed dye laser(PDL) and intense pulsed light(IPL) has been widely used in improving rosacea. To compare the efficacy and safety of PDL and IPL configured with different wavelength bands(Delicate Pulsed Light, M22 590, M22 vascular filter) in the treatment of rosacea, we designed a prospective, randomized controlled trial. We hope to make a comparison between PDL and IPL,between broad-spectrum IPL and narrow-spectrum IPL, between single-band IPL and dual-band IPL, and also provide clinical basis for clinicians and patients to develop individualized treatment plans.

Rosacea is a chronic skin condition characterized by erythema, inflammatory papules, pustules and telangiectasias, which typically occur on the face of middle-aged adults, especially fair skinned. The disease can lead to social stigmatization and may significantly reduce the quality of life of patients. For erythematous lesions and telangiectasia, intense pulsed light (IPL) therapy and lasers are popular treatmen option. Lasers and non-coherent intense pulse light sources (IPL) are based on the principle of selective photothermolysis. The target chromophore in vascular lesions is the oxyhemoglobin present in the red blood corpuscles (RBCs) which circulates in the blood vessels. Pulsed dye lasers (PDL) use a wavelength of 595 nm and is the gold standard of vascular lesion treatment. A common complication is post treatment purpura which appears immediately and can last for 7-14 days, which may be cosmetically unacceptable. The intense pulsed light (IPL) produces a non-coherent light beam with a spectrum of wavelengths from 500 to 1200 nm. Cut-off filters at 515, 550, 570, 590 nm are used for vascular lesions. To compare the efficacy and safety of PDL and IPL configured with different wavelength bands(Delicate Pulsed Light, M22 590, M22 vascular filter) in the treatment of rosacea, we designed a prospective, randomized controlled trial. We hope to make a comparison between PDL and IPL,between broad-spectrum IPL and narrow-spectrum IPL, between single-band IPL and dual-band IPL, and also provide clinical basis for clinicians and patients to develop individualized treatment plans.

Eligibility Criteria:
Inclusion Criteria:

age of at least 18 years; according to the rosacea diagnostic criteria established by the NRSEC in 2002, be diagnosed as erythematotelangiectatic rosacea; Rosacea clinical score is between 9 and 12; Fitzpatrick skin type III and IV;

Exclusion Criteria:

there was infection in the treatment site sunburn history within 1 month; received oral isotretinoin or laser treatment in the past 3 months received chemical peeling 1 month before the study pregnancy or breast-feeding. those who are receiving other treatment for rosacea, such as topical and oral drugs;
Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class 4 and above
* Esophagectomy for other non-malignant conditions
Levels of Raltegravir in the Female Genital Tissue

This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug levels to prevent viral integration of HIV-1. The study will also assess whether drug levels change in the tissue across the different phases of the menstrual cycle.

* Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular concentrations that should be sufficient to suppress HIV-1 replication throughout the menstrual cycle.
* Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher compared to extracellular concentrations in the plasma and PMBCs (peripheral blood mononuclear cells).
* Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein, which are present in higher numbers during periods of high progesterone.

HIV-1 is shed in genital secretions which increase the risk of transmission between sexual partners and from mother to infant. Antiretroviral medication taken prior to exposure to HIV-1 can prevent viral transmission from a mother to her infant. Raltegravir (RAL), by blocking integration of viral cDNA into the host's genome, makes an excellent candidate for preventing HIV-1 infection. RAL is licensed for treatment with twice-daily dosing based on plasma trough concentrations; however, intracellular concentrations of RAL which are relevant to blocking infection of cells have not been previously studied. P-glycoprotein pumps, which are involved in regulating drug absorption and metabolism, can influence intracellular drug concentrations. P-glycoprotein concentrations appear to vary with menstrual cycle suggesting it may affect intracellular drug concentration of RAL in women.

Women will be enrolled in the study and followed during the course of a menstrual cycle while taking a dose of 400mg PO twice daily. An initial screening visit will be performed prior to enrollment and participation in the study. Review of medical history as well as blood and urine collection will occur during the screening visit. Once enrolled, participants will have blood and genital tract samples collected once a week for four weeks to assess intracellular concentrations of RAL in the blood and genital tract tissue.

Eligibility Criteria:
Inclusion Criteria

Volunteers must be:

* Over 18 years of age.
* Willing to abstain from sexual intercourse during course of study.
* Able to commit to follow-up visit schedule.
* Willing to abstain from use of vaginal medications or creams 48 hours prior to follow-up visits.
* Willing and able to provide informed consent.

Exclusion Criteria

Volunteers will not be eligible for the study if they:

* Are over 50 years of age.
* Are pregnant, attempting to become pregnant, or breast-feeding.
* Have irregular menstrual bleeding.
* Are using a hormonal form of birth control.
* Have abnormal liver/kidney function test results at screening visit.
* Have HIV-positive test result at screening visit.
Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

This is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed 13-18 year olds.

In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell, 2005) and appears to be quite safe.

Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven patients of the four that were depressed two showed improvement in their depression (Quintana, 2005). No sham-controlled studies have been conducted.

The investigators wish to assess this in a sham-controlled study of 30 adolescents. The investigators hypothesize that rTMS will have an antidepressant effect and produce no neuropsychological impairment.

The study has two phases: the sham-controlled phase and an open phase.

Sham-controlled Phase

Participants are randomly assigned to an active or sham TMS condition.

Open Phase

Following the sham controlled period participants participants in the sham rTMS condition will be offered active rTMS. Participants will have the opportunity to receive up to 6 weeks of active rTMS.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depressive Episode of no more then 3 years.
* Montgomery-Asberg Depression Rating Scale score of 20 or more.
* Aged between 13 and 18.
* May or may not be taking antidepressant medication.

Exclusion Criteria:

* Patient (or family is patient is under 18)not able to give informed consent.
* Failure to respond to ECT in current or past episodes of depression.
* Significant other Axis 1 psychiatric disorders e.g. schizophrenia.
* In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicide risk.
* Drug or alcohol abuse currently or in the last month.
* History of neurological illness e.g. epilepsy; neurosurgical procedure
* Mental in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
* Women of child-bearing age whom pregnancy cannot be ruled out.
Delirium Assessment in the Pediatric Intensive Care Unit

Objective: Studies documenting the prevalence of delirium among critically ill children are still rare. Emerging literature from psychiatric specialists reports the prevalence of delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely to be an underestimation of the true prevalence, as demonstrated in early adult delirium literature, especially given the absence of validated bedside tools to diagnose delirium in the PICU.

The primary aim of this study is to validate the German version of the Pediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence Delirium (PAED) Scale.


Eligibility Criteria:
Inclusion Criteria:

* pediatric ICU patients

Exclusion Criteria:

* non-German-speaking
* inability to communicate due to severe hearing loss or brain injury
* preexisting psychosis
* mental retardation due to a specific diseases (e.g. M. Crouzon, Kabuki Syndrome, Z.n. Battered Child, Atrogryposes multiplex congenita)