cyrilzakka/clinical-trials huggingface dataset:
Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation.

Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission.

Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU with the diagnosis of septic shock as defined according to the Sepsis-3 criteria (suspected or confirmed infection AND vasopressor/inotrope ongoing to maintain MAP ≥ 65 mmHg AND Lactate ≥ 2 mmol/l in the last 6 hours

Exclusion Criteria:

* Age \<18 years
* Septic shock for more than 12 hours at the time of screening
* Acute burn injury \>/= 10% of the body surface area
* Known pregnancy or lactating women
* Consent not obtainable due to national legislation
* Patients on chronic dialysis
* Patients that are known to be allergic to furosemide or metolazone
Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR).

This is a prospective, monocentric, non-randomized study.

Colorectal surgery accounts for 60,000 acts per year in France. One of the feared complications after colorectal resection surgery is anastomotic leak (5-20% of cases), associated with significant morbidity and mortality. Ischemia of the colorectal or colo-anal anastomosis would be one of the main risk factors for the occurrence of a fistula (REF 1). During the operation, the inferior mesenteric artery is ligated and the remaining colon is vascularized only by Riolan's arch, the link between the networks of the inferior mesenteric artery and the superior mesenteric artery. Arterial ligation by operation is responsible for a transient drop in flow at the level of the anastomosis, while the arch develops.

Preoperative ischemic conditioning by arterial embolization is a technique already used in esophageal surgery (REF 2). The objective is to embolize the arterial branches that will be ligated during surgery a few weeks before the resection procedure, in order to allow hypertrophy of the remaining branches to allow better vascularization of the anastomosis on the day of the intervention. The CHUGA is one of the motor centers of this technique. In our experience, embolization performed 3 to 4 weeks before esophageal surgery allows a reduction in the rate of fistulas (p=0.02). These results made it possible to aggregate other centers towards this technique, and a request for PHRC-K is in progress.

In the context of ischemic conditioning before colorectal surgery, a proof of concept on 5 patients has just been completed by the University Hospital of Nîmes (REF 3) of which Dr Ghelfi (Radiologist) and Dr Trilling (Colorectal Surgeon) are investigators. The preliminary results seem suggested.

The responsibility and safety of preoperative embolization of the inferior mesenteric artery have already been validated by meta-analyses of data from patients who received AMI embolization before placement of a covered aortic stent (REF 4).

The objective of this study is to show that ischemic conditioning improves the vascular supply of the colon for risky procedures in colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patient to benefit from left colonic surgery or rectal surgery with upper ligation of the inferior mesenteric artery and colorectal or colo anastomosis
* Person affiliated to or benefiting from social security
* Person who has given written informed consent

Exclusion Criteria:

* History of digestive resection or abdominal aorta surgery
* Renal failure with GFR \< 30 ml/min (MDRD)
* History of severe allergy to iodine contrast medium
* Pregnant, parturient, lactating women
* Patient subject to a legal protection measure or unable to express his non-opposition (guardianship, curatorship)
* Patient deprived of liberty by judicial or administrative decision
Longitudinal Cognitive Assessment by BoCA

The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not- repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance.

After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.

The BoCA evaluation can help doctors figure out if an underlying condition is causing a patient's cognitive decline. Many treatable conditions such as sleep disorders, mood problems, heavy metal accumulation, as well as lack of movement and social interactions can affect memory and thinking.

Our goal is to reduce barriers for patients to receive the testing that may benefit their treatment and health through the use of digital technology.

Eligibility Criteria:
Inclusion Criteria:

age 50 or older

Exclusion Criteria:

younger than 50 years
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
* Subject is willing to follow a weight-maintaining diet and exercise program during the study
* Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
* Subject has a history of type 1 diabetes
* Subject has used contact lenses within the last 6 months
* Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
* Subject has more than 3 alcoholic beverages per day
* Subject has more than 6 servings of caffeine a day
* Subject has participated in a previous MK8245 study
Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds

82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.

The study of predictors of pain chronicity in patients with gunshot and mine-explosive wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. Since pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries
Vascular Response to Brachytherapy Using Functional OCT

The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.

Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.

In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
* Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.
Advanced Visuohaptic Surgical Planning for Trauma Surgery

This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.

The proposed tool will allow surgeons from different specialties to simulate, plan and iterate on complex procedures based on individual patient data in 3-D from a CT scan. The software will allow surgeons to both see and feel the results of their interventions - for example, the quality of the bite or bone alignment of a reconstructed jaw following severe trauma - before the actual surgery, leading to better planning, fewer errors, shortened surgery time and improved outcomes for the patients. The purpose of this study is the evaluation of a visuohaptic planning system for mandibular trauma surgery that is based on interactive manipulation of CT data.

Eligibility Criteria:
Inclusion Criteria:

* Craniofacial deformity, including post-traumatic, congenital or acquired deformity
* Patients who have already have surgery because there was a clinical indication for surgical correction

Exclusion Criteria:

* No craniofacial deformity
* No clinical indication for surgical correction
* Contraindication for surgical correction
Improving Medication Therapy Through a Digital Interdisciplinary Medicine Therapy Optimisation Model

This study investigates if a digital interdisciplinary medicine therapy optimisation (MTO) model in primary care can improve medication therapy, quality of life, medication adherence, and beliefs about medicines, among patients \>65 years living in sparsely populated areas. The intervention includes digital medication interviews, comprehensive medication reviews, interdisciplinary patient-centred discussions, and follow-ups.

Initially, a pilot study will be conducted to evaluate the feasibility of the method and to make appropriate adjustments to the study design before starting the main study. Patients that meet the inclusion criteria will be invited to participate in the study via letter. The patients will also receive three validated questionnaires; Medication Adherence Report Scale-5 (MARS-5), EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L) and The Beliefs about Medicines Questionnaire (BMQ) to fill in prior to initiation of the study, to collect baseline data. The intervention consists of several steps and all meetings are digital. At first, the patient will have a medication interview with a clinical pharmacist, Next, the clinical pharmacist conducts a comprehensive medication review based on information from the interview and the participant's medical records and laboratory values. The clinical pharmacist and the participant's primary care physician will then have a joint discussion regarding preliminary medication management proposals and therapy management plans. The patient will be informed by their physician if any medication changes have been made. Digital follow-up meetings with the patient and the clinical pharmacist will take place 1-2, 4 and 12 weeks after the baseline consultation, and additionally if requested by the patient or if the pharmacist consider it necessary. The clinical pharmacist will also conduct repeated medical record reviews every second week during the 12-week intervention period. After the last follow-up at 12 weeks, the patient will be asked to fill in the three questionnaires: MARS-5, EQ-5D-5L and BMQ one more time.

Eligibility Criteria:
Inclusion Criteria:

* Using 5 or more medications or recommended by the primary care physician (e.g. according to the use of certain medicines or conditions such as chronic kidney disease)
* Living at home (i.e not in a nursing home)
* Registered at certain primary healthcare centres in the rural areas of Västerbotten

Exclusion Criteria:

* Do not speak Swedish or unable to communicate
* Has home care services
* Has a confirmed major neurocognitive disorder
* Receives palliative care
Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients

To investigate the effect of cervical manual mobilization on head repositioning accuracy and postural balance in patients with chronic mechanical neck pain in a randomized controlled trial. Hypothesis: There is no difference between the intervention group (manual mobilization) and control group head repositioning accuracy and postural balance.

The aim of the study is to investigate the effectiveness of manual therapy to standing balance and head-neck proprioception sense in patients with chronic neck pain. The study will recruit 120 chronic neck pain patients and randomize the into 2 groups of 60. Group 1 will receive a course of manual therapy and infrared radiation for 15 minutes (twice weekly for 12 sessions). The other group (control) will receive infrared radiation therapy only. Manual therapy will be provided by experienced physiotherapists and assessed by a separate assessor. All outcome measures will be assessed at the beginning of study, upon completion of intervention, 3-month and 6-month after the completion of study. All measurements collected will be analysed by computerized statistical software in order to calculate the effectiveness of manual therapy and relationship among those outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Presented with a complaint of neck pain (defined as pain in the region from the upper thoracic spine to the occiput and the surrounding musculature) for more than 7 weeks.
* Had not received neck pain treatment in the past 1 month

Exclusion Criteria:

* Onset of presenting neck pain episode after trauma (eg, whiplash)
* History of cervical injury of trauma since the onset of presenting neck pain episode
* History of cervical injury or trauma
* Neck pain due to fracture, tumor, infection, severe spondyloarthropathy, or other non-mechanical cause such as inflammatory arthritis;
* Progressive neurological deficit, myelopathy, herniated nucleus pulpous, or severe incapacitating pain;
* Being treated by electrical devices;
* Blood coagulation disorder or were using corticosteroids or anticoagulant medications;
* History of stroke or transient ischemic attacks;
* Vertebrobasilar artery insufficiency;
* Neurologic disease (eg, multiple sclerosis, Parkinson's disease, syringomyelia);
* Congenital anomalies involving the C-spine;
* Systemic disease (eg, diabetes mellitus);
* Pain involving third-party liability or Workers' Compensation.
Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients

Although several clinical predictive models have been developed to predict postoperative pulmonary complications, few predictive models have been developed for elderly patients. In this study, the researchers aimed to develop a new, simplified model to assess the risk of postoperative pulmonary complications in elderly patients using perioperative database information.

Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has always been an significant predictor of postoperative pulmonary complications. With an aging population worldwide, more and more elderly people are undergoing surgery due to the expansion of surgical indications. As a result of this phenomenon, the elderly are also an important group for the prediction and intervention of postoperative pulmonary complications. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we constructed a model using database information.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

* preoperative mechanical ventilation
* operations related to previous postoperative complications
* a second operation after surgery
* organ transplantation
* discharged within 24 hours after surgery
* cardiac and thoracic surgery
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis

The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.

Lumoral treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss
* Age of 18-85 years
* Presence of \> 20 teeth
* Agreement to participate in the study and to sign a written consent form

Exclusion Criteria:

* Untreated/uncontrollable diabetes mellitus (DM) with HbA1c \>7%, and HbA1c \> 8 if insulin treated DM
* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
* Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
* Periodontal treatment during the previous 3 months
* Allergic to the photosensitizer
* Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
* Removable major prosthesis or major orthodontic appliance
* Active smoking, or habitual use of smokeless tobacco products
* Pregnancy or lactation
* A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Inflammation Markers in Hyperemesis Gravidarum

In this study, the relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated.

A total of 215 pregnant women, 102 with hyperemesis gravidarum and 113 healthy pregnant women, were included in the study. HEG patients were divided into three groups according to the modified PUQE classification: mild (n=38), moderate (n=32) and severe (n=32).

In our study, we proposed using a new prognostic marker for HEG patients. We think that our study will be a source for future studies on HEG.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women over 18 years of age
* 5-16 weeks of gestation.

Exclusion Criteria:

Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.