cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

Despite advancements in technology and improved surgical techniques, the occurrence of anastomotic leakage (AL) after colorectal surgery remains between 4% and 30%. AL is a feared complication associated with significant morbidity and mortality in colorectal surgery, with its causes being multifaceted. Inadequate blood supply to the intestines is believed to be a major contributor to its development. Various methods have been proposed to objectively assess intestinal perfusion beyond the subjective evaluation done by surgeons during surgery. However, these methods face challenges such as poor reproducibility and high costs, limiting their routine use. In recent years, indocyanine green (ICG) angiography has emerged as a tool for assessing organ perfusion in various medical scenarios. However, only one randomized clinical trial has been conducted regarding its use in evaluating colorectal surgery outcomes, which found that while ICG angiography sometimes led to additional bowel resection, it didn't significantly reduce the rate of anastomotic leaks compared to conventional methods. This could be due to the trial's small sample size, potentially reducing its statistical power. This study aims to investigate whether ICG angiography can lower the rate of anastomotic leaks during laparoscopic colorectal cancer surgery, while also examining its impact on resection margins, perioperative morbidity, and mortality rates.

A total of 561 subjects undergoing laparoscopic colorectal surgery for malignancy, will be randomized in 2 arms: A Study Group undergoing ICG angiography (i.e. colonic perfusion is intraoperatively assessed by ICG angiography and level of resection is selected based on the fluorescence) and a Control Group (i.e. resection is performed based on subjective judgment).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-85 years
* Malignant colorectal tumors
* Elective surgery

Exclusion Criteria:

* Abdomino-perineal resection
* Emergency procedures
* Conversion to open surgery
* No anastomosis
* Multifocal tumors
* Locally advanced cancer (T4)
* Distant metastases (M+)
* Major vasculopathies (previous PE, DVT, abdominal aorta surgery)
* ICG allergy
Sevoflurane, Propofol, Postoperative Pain

The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-69 years
* Gender: female
* ASA status 1-3
* Laparoscopic hysterectomy

Exclusion Criteria:

* Body Mass Index over 35
* Diabetes mellitus
* Liver disease
* Allergies to pharmaceuticals used in the Study
* Present use of opioids
A Novel Mechanics-based Intervention to Improve Post-stroke Stability

The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.

Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Experience of a stroke 6 months prior to participation
* Preferred overground gait speed of at least 0.2 m/s
* Ability to walk at self-selected speed for 3 minutes without a cane or walker
* Provision of informed consent.

Exclusion Criteria:

* Resting heart rate above 110 beats/min
* Resting blood pressure higher than 200/110 mm Hg
* History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
* Preexisting neurological disorders or dementia
* History of major head trauma
* Legal blindness or severe visual impairment
* Life expectancy \<1 yr; 8)
* History of deep vein thrombosis or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
* Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.
Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

To discover if the adding of a coxib increases the efficacy of the Aromasine.


Eligibility Criteria:
Inclusion Criteria:

* Femal patient aged \> 18 years
* Histologically proven breast cancer
* Menopausal patient according to the following definition:

  * amenorrhoea \> 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
  * surgical ovariectomy
  * treatment by LHRH analog
  * ovarian suppression by radiotherapy
  * amenorrhoea induced by chemotherapy \> 1 year
* Oestradiol and/or progesterone positive receptors
* Presence of one or several metastatic lesion:

  * mesurable lesion
  * bone metastase were detected by bone scintigraphy
* Patient who can have received:

  * Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
  * Metastatic Treatment by chemotherapy
* PS \< 2
* Adequate biological values
* Patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* Patient previously treated with hormonotherapy in metastatic phase
* Antecedent of treatment with aromatase inhibitors
* local relapse (with the exception of cutaneous thoracic nodes)
* Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa
The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients

The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.

The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards:

1. We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached.
2. We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children undergoing general anesthesia using a supraglottic airway device
* 6 months to 36 months of age
* 10 to 15 kilograms in weight

Exclusion Criteria:

* Active respiratory infection
* History of difficult mask ventilation
* Features or history of a difficult airway
* Gastrointestinal reflux disease
* Clinically significant pulmonary disease
The Effect of Social Media Use on Eating Behaviours

This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method. This registration describes the correlational experience sampling method.

This project aims to explore how social media use, in particular food photography, influences eating behaviours.

The research question will be approached using a combination of methods. The first is the experience sampling method, where data is gathered from participants as they are going about their day-to-day lives. This method comprises two sub-sections - a correlational study, and an experimental study. This registration describes the correlational experience sampling method.

The study will measure participants' regular phone use and eating behaviours. Participants will be recruited via online platforms and participate in the study for one week. At the beginning of the week, they will be required to fill in some online questionnaires (e.g. demographic information). For the rest of the week, they will be prompted at specific time points in the day via smartphone to answer some questions about their phone use and eating behaviours.

The expected outcome of the project is to collectively evaluate the data from the various methods to conclude how social media use, and in particular the act of food photography, influences the various aspects of eating behaviours.

Eligibility Criteria:
Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program
Evaluation of the SafeSpace App Intervention

The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health.

The investigators will ask participants to:

* Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks.
* Provide contact information.
* Receive and open app push notifications for 10 weeks (up to 3 per week).
* Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up).
* Receive occasional text messages from the study team.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be assigned female or intersex at birth
* Participants must be youth in the U.S. (14-18 years old)
* Participants must have daily access to an iPhone

Exclusion Criteria:

- Participants must not be currently pregnant or currently trying to become pregnant

Other Criteria:

- The study's priority/preference population is for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas.
In Vitro Fertilization Impact on Metabolic Parameters

A quantitative prospective cohort study will be conducted, where blood samples will be collected at different timings during the IVF protocol, to assess the impact of fertility medications on metabolic parameters of patients undergoing IVF treatment.

Numerous factors predispose women to develop pregnancy-related complications, these include gestational diabetes (GDM), pre-pregnancy obesity, advanced maternal age (\> 35 years) and gestational age, abnormal weight gain during pregnancy, family history of diabetes, PCOS and low parity. Evidenced-based studies reported that women with PCOS have a significantly higher risk of developing GDM compared with women without PCOS, independently of the obesity factor; this risk is higher when both factors coexist.

Given the known effect of reproductive hormones on weight-gain, controversies still exist on whether ART predispose women to more adverse obstetric outcomes compared to normal pregnancy. ART describes different procedures to help women become pregnant, with In Vitro Fertilization (IVF) being the most commonly performed. It has been demonstrated that IVF is associated with glucose intolerance in mice and it will be interesting to determine whether this physiologic phenomenon is also altered by IVF medication (such as estrogen and progesterone) in humans. While some studies reported that singleton pregnancies conceived by ART (IVF or ovulation induction) were strongly associated with GDM compared to spontaneous conceptions, other studies did not find significant differences in the risk of GDM. Increased GDM risk presented with IVF can be associated with prenatal obesity or secondary to maternal PCOS condition. The former studies did not specify the body mass index (BMI) and the medical history of participants undergoing IVF, such as the presence of PCOS. Due to limited available data, we still cannot distinguish whether these adverse pregnancy outcomes are due to the pre-existing conditions such as PCOS, or are secondary to the IVF therapy itself.

Eligibility Criteria:
Any patient presenting to us for fresh IVF with the following:

Inclusion Criteria:

* Presenting with or without PCOS
* Presenting with structural or mechanical infertility, such as fallopian tube obstruction, endometriosis, fibroids
* Presenting with male factor
* Presenting with or without insulin resistance
* Combination of more than one of the listed above criteria

Exclusion Criteria:

* Pre-diabetes or diabetes patients (confirmed by impaired or abnormal OGTT)
* Age above 39 years of age
* Taking glucose-lowering meds, such as metformin or janumet.
* Taking corticosteroids
The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

* The primary aim is to document the incidence and short-term outcome of the elderly ICU patient (≥ 80 years) using a multicentre, multi national approach
* The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group
* To create hypothesis for further studies, in particular on various outcome prediction

The investigators have chosen to use a prospective registration of routinely collected data in this ICU population. The study is mainly European based, but will also allow for ICUs outside Europe to participate.

20 consecutive ICU admission in patients ≥ 80 years of age will be collected OR all patients ≥ 80 years in a three months' period (whatever comes first).

Data are collected electronically through an e-CRF and with baseline documentation of the ICU. The database is located in Denmark, at the Department of Epidemiology, University of Aarhus (http://vip1study.com/) . Each ICU will only have access through the database of their own patients, and patient ID is not registered (Names, birth-date or social security numbers) so it is in that sense anonymous.

Even with de-identified data, most countries must seek necessary consent from the authorities to collect such data, and hence there will be a period between ICU recruitment (starting April 2016) and patient recruitment (October 1. 2016) to allow for this to be done prior to study start.

The goal is to recruit at least 100 ICUs which will give data from approximately 2000 elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* All admissions in the group

Exclusion Criteria:

* None
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients

This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.


Eligibility Criteria:
Inclusion Criteria:

* is ≥18 years of age
* has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days
* the subject or their legally authorized representative is able to provide informed consent
* has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)

Exclusion Criteria:

* is moribund, or in the opinion of the investigator is not expected to survive
* has sustained an electrical burn
Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses.

Methods: The present prospective randomized clinical trial was performed on 44 patients. The experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and clinical examinations. The results were statistically analyzed. The following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.

The aim of the present prospective, randomized, triple-blind controlled clinical trial was to evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of oral mucosae due to removable prostheses. The tested preparation contained two active molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5% chlorobutanol).

Eligibility Criteria:
Inclusion Criteria:

* Use of removable partial or complete dentures;
* Presence of lesions of oral mucosae due to dentures;
* Absence of any concomitant local or systemic pathology;
* Absence of pregnancy or breastfeeding;
* Negative allergic anamnesis;
* Negative anamnesis for recurrent aphthous stomatitis;
* No taking medicines with potential pharmacologic interactions with molecules to be tested;
* No taking antibiotics and/or painkillers for at least 6 months before entering the experimentation;
* Good oral hygiene with a full-mouth plaque score ≤25%;
* Non smoking or light smoking (≤10 cigarettes/day) status.

Exclusion Criteria:

Missing one or more of the above described conditions automatically excluded a subject from the study.
A Comparison of Tracheal Intubation Using the Totaltrack vs the Airtraq Laryngoscope in Routine Airway Management

Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed specifically for the airway management. However, despite their use in clinical practice, there are no comparative studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general anesthesia requiring OTI.
* Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
* Age ≥18 years.
* ASA I-III.
* Sufficient intellectual capacity to understand the procedure and equipment used.
* Do not submit predictors of difficult airway (Mallampati class III or IV; thyromental distance \<6 cm, sternomental distance \<12.5 cm, interincisal distance\<4.0 cm, bite test II or III, cervical mobility \<90 ° or history of difficult intubation).
* Do not undergo thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
* BMI \<30kg / m2
* Not presenting risk factors for aspiration
* Not presenting respiratory disease, coronary or cerebral vascular.
* Do not have a sore throat preoperative

Exclusion Criteria:

* Failure to meet the above criteria
* Pregnancy
* Allergy to any drug included in the protocol.
CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation for T and B Cell Depletion

This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD) in patients receiving unrelated or partially matched related donor peripheral stem cells using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility will be tested, focusing on engraftment, treatment-related mortality (with a specific focus on interstitial pneumonitis) and severe GVHD.

PRIMARY HYPOTHESIS: T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft vs. host disease (GVHD).

SECONDARY HYPOTHESIS: Use of the CliniMACS device will allow defined levels of T cell depletion to reflect the risk of severe GVHD in the donor/recipient pair.

Thus, patients with a relatively lower risk of severe GVHD will be assigned to Stratum 1 and receive a graft with lesser T cell depletion and a defined level of reinfused T cells. Patients with higher risk of severe GVHD or for whom there is no perceived clinical benefit of GVHD will be assigned to Stratum 2 and receive a more T cell-depleted graft.

Conditioning of the patient (except immunodeficiencies) includes :

* Thiotepa 5 mg/kg days for 2 days
* Cyclophosphamide 60 mg/kg days for 2 days
* Total body irradiation 200 cGy given twice a day for 3 days

Following conditioning patient's will receive stem cells that have been processed using the CliniMACS device. This processing is done in the stem cell laboratory at The Children's Hospital of Philadelphia. The Stem Cell Lab is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) and maintain complete standard operating procedures (SOP's) and procedure records.

Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory SOPs and using aseptic technique. The CHOP Stem Cell Lab has extensive prior experience with automated cell processing technologies, including the CellPro Ceprate device and the Isolex 300i.

Eligibility Criteria:
Inclusion Criteria:

As of October 2014 this study closed enrollment to malignant diseases. This study remains open to:

Non-malignant diseases:

1. Bone marrow failure, including severe aplastic anemia
2. Immunodeficiencies

Exclusion Criteria:

1. Patients who have had prior stem cell transplant (SCT) and bone marrow transplant (BMT) are excluded for study enrollment.