cyrilzakka/clinical-trials huggingface dataset:
Lymph Node Mapping in Patients With Endometrial Cancer

This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

PRIMARY OBJECTIVE:

I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.

SECONDARY OBJECTIVE:

II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.

OUTLINE:

Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be willing and able to provide informed consent
* The patient is willing and able to comply with the study protocol
* The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
* The patient agrees to follow-up examinations out to 5-years post-treatment

Exclusion Criteria:

* The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy
* The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
* The patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity

Both the endocannabinoid system and the microbiome are highly conditioned by nutrition and physical activity, and have an interdependent, bidirectional relationship. We suggest studying the interleaving between the endocannabinoidome-microbiome axis and host metabolism under the combined effect of a diet and physical activity. More specificly, we will study the link between the impact of the diet on the intestinal microbiome and the endocannabinoid reaction after intense exercise.

Aims of the study are to compare the impacts of two short 7-day contrasted nutritional interventions (the Mediterranean diet (MED) and the Canadian diet (CAN)) on blood metabolites (endocannabinoids) after a maximal aerobic test. A 3 weeks washout between the two diets is planned. Gut microbiome at each test will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* women
* 20-30 years old
* healthy
* jogging \>1h/week and \>3h/week of physical activity
* bmi 18.5-25

Exclusion Criteria:

* postmenopausal, pregnancy or lactation
* pathology or medication
* smoking
* more than 7 alcohol consumption/week
* food allergy, food intolerance or food aversion
* important weight change in the last 6 months
* antibiotics in the last 3 months
* night worker
* pathologies
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or discontinue their PPIs to determine whether these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic encephalopathy (HE). Patients will be assessed for symptoms of minimal HE (MHE), using the established psychometric hepatic encephalopathy score (PHES) battery of tests. MHE assessment will be conducted at two timepoints: at baseline prior to randomization and TIPS creation and approximately 4 weeks after randomization and TIPS creation. Stool samples will also be collected at both timepoints to allow characterization of the gastrointestinal (GI) tract microbiome using 16S rRNA sequencing. The pre to post-TIPS change in PHES scores will be compared between patients randomized to continue versus discontinue their PPIs. Quality of life (QOL) will also be assessed. Changes in the GI tract microbiome will be analyzed to determine whether this represents a potential biological mechanism linking PPI use with post-TIPS HE.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing TIPS creation as part of routine clinical care
* On PPIs therapy (at least 20 mg omeprazole equivalent daily)
* Provision of signed and dated informed consent form by participant or legal representative
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, age greater or equal to 18

Exclusion Criteria:

* Grade IV esophagitis or gastric or duodenal ulcer
* Recent endoscopic esophageal variceal band ligation necessitating PPI therapy for prevention of banding ulcer
* Zollinger-Ellison syndrome
* Active Helicobacter pylori infection
* Pregnancy
Retrospective Collection of PillCam SB Movies

Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated.

Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected from 2 clinical sites, Sourasky and Sheba medical centers during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated by internal readers.

Eligibility Criteria:
Inclusion Criteria:

Videos collected from any PillCam SB procedure

Exclusion Criteria:

None
Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People

According to the French National Health Agency, the use of manual therapy techniques is "possible" \[grade B\] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.

In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes


Eligibility Criteria:
Inclusion Criteria:

Subjects aged 30 years or older and less than 65 years;

* Subjects considered naive to neurodynamic mobilisation techniques;
* Volunteers who have read and understood the information letter and have given their written consent to participate in the study;
* Fluent in spoken and read French;
* Effective contraception in women of childbearing age (progestin-only or intrauterine device or tubal ligation) for at least 12 months;
* For postmenopausal women, a confirmatory diagnosis must be obtained (non-drug-induced amenorrhoea for at least 12 months prior to the enrolment visit);
* Subject affiliated to a social security scheme.

Exclusion Criteria:

* Positive slump test on the day of the selection visit (production of asymmetric lumbar symptoms or painful radiations in at least one lower limb or unilateral reduction in physiological knee extension range of motion compared with the contralateral side);
* Neurological and neuropathic pain assessment score (DN4) greater than 4;
* Increase or decrease in sensory function in the lower limb compared with the contralateral side, as measured by Clinical Sensory Testing (CST);
* Any physical exertion of perceived intensity greater than 17 on the Borg 6-20 scale in the 72 hours prior to the trial and during the trial;
* Injury, complaint or symptom affecting the spine (cervical, thoracic, lumbar) and/or lower limb(s) requiring absence from work, school or leisure activities in the 12 months prior to enrolment;
* History of major surgery, injury to the trunk, spine and/or lower limb(s), or history of progressive rheumatic, neurological or oncological pathology;
Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia

There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.

While sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. The surgical pleth index (SPI) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. A more detailed investigation on the SPI and its behaviour under a posture maneuver shows the limitation of the device.

Another device developed calculates the "analgesia nociception index" (ANI) by heart rate variability and was launched into the market in 2010. However, the effect of posture - to our knowledge - has not yet been studied. The change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. These alterations in positioning are known to be accompanied by changes in haemodynamic parameters.

The aim of this study was to evaluate the ANI in patients undergoing elective surgery in lithotomy position.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Body mass index (BMI) \< 35 kg m2
* American Society of Anesthesiologists (ASA) status I-III
* Elective urology and gynaecology surgery in lithotomy position
* 15 healthy volunteers were included in the study as a control group

Exclusion Criteria:

* Age \< 18 years
* ASA status IV or higher
* BMI ≥ 35 kg m2
* Chronic heart rhythm disorders
* Implanted pacemakers
* Patients with a history of chronic pain and emergency surgery
Physical Activity Behavior of Rheumatoid Arthritis Patients and Healthy Controls

The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls.


Eligibility Criteria:
Inclusion Criteria (RA patients):

* Rheumatoid arthritis
* Functional classes I, II and III
* Age 40 to 80 years
* Stable disease activity
* Stable DMARDS last 3 months

Exclusion Criteria (RA patients):

* Functional classes IV
* Inflammatory flare
Bispectral Index to Guide Intubation in Pediatric Anesthesia

This prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children.

* Children will received intra-rectal premedication based on midazolam 0.4mg
* Children will be monitored according to standard guidelines
* One blinded anesthesiologist will be in charge of anesthesia induction and the other one will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane minimal alveolar concentration, bispectral index) and guidance of induction according to the predetermined bispectral index (up and down allocation)

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology physical status classification system :1 or 2
* scheduled ear, nose and throat surgery in a one day program
* oral intubation required

Exclusion Criteria:

* parents refusal
* recent respiratory infection
* epilepsy
* suspected difficult intubation
A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

The purposes of this study are to:

* Learn about the safety and tolerability of CK 4021586 after a single dose and multiple doses in healthy subjects.
* Find out how much CK-4021586 is in the blood after a single dose and multiple doses.
* Determine the effect different doses of CK-4021586 on the pumping function of the heart.
* Determine the effect of food in the stomach on how much CK-4021586 is in the blood after a single dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic, dermatologic, hepatic, renal, hematologic, respiratory, cardiovascular (including arrhythmia), gastrointestinal, gallbladder/biliary, musculoskeletal, neurologic, or psychiatric disorder in the opinion of the Investigator or designee.
* History of significant hypersensitivity or allergy to any drug compound or other substance, unless approved by the Investigator and the Sponsor's Medical Monitor.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
* Participants with breast implants that may impede echocardiography
* Clinically significant illness within 4 weeks prior to check in.
* Significant ECG abnormalities (heart block, prolonged QT interval, arrhythmia)
* History of, or current substance abuse (drug or alcohol), known drug or alcohol dependence within the last 2 years prior to Screening, or positive test for drugs of abuse during the screening period
* Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study, in the judgment of the Investigator
Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007.

Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS.

All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants.

The patient questionnaire will consist of the following items:

A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life.

The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician.

The physician fills out a second questionnaire, covering the following items:

Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending one of the participating primary care surgeries on a fixed day
* Male or female patients of any age

Exclusion Criteria:

* Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.
* Patients who are not able to understand the questionnaire due to mental impairment or language problems.
* Children and adolescents under the age of 18 years
Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.

Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not available.

HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it is not available in underdevelopment countries.

There are different articles about replacement clarithromycin with azithromycin as a method of eradication of HP that is decreases length of therapy and increases, effectiveness of drugs and decreases resistance of drugs.

The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.

Eligibility Criteria:
Inclusion Criteria:

* patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy

Exclusion Criteria:

* patients who got H-pylori eradication treatment previously
* patients who used study drugs during 3months before study
Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach

This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)

This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis

Exclusion Criteria:

* Patients with contraindications to undergoing CT coronary angiography
* coronary revascularization within the last six months
* renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up
Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH) during at least 3 months, but nowadays the duration of treatment is not accurately determined.

The D-Dimer determination has been used like recurrence predictors after LMWH treatment suspension, but in cancer patients the useful is limited. Phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of LMWH treatment for each patient.

We are carrying out a study in Cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn. Patients are being followed after LMWH withdrawal until 6 months. Blood samples are being taken at baseline (LMWH withdrawal), 3 weeks and 3 months after. We will look for association between several biomarkers and venous thromboembolism recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).
* Patients treated with LMWH since cancer diagnostic.
* Signed informed consent sheet

Exclusion Criteria:

* Patients with life expectancy lower than 6 months
* Pregnancy woman
* Patients with cerebral metastasis
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency

Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected.

Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization.

The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance.

The aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.


Eligibility Criteria:
Inclusion Criteria:

* All children \< 18 years of age with isolated or combined cleft palate that will undergo pharyngeal flap surgery due to velopharyngeal insufficiency, as well as their parents, in any of the 6 specialized cleft center in Sweden.

Exclusion Criteria:

* Cognitive impairment making it difficult to understand the study.
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion Criteria:

* Type 1 or Typ2 diabetes mellitus.
* Obesity induced by other endocrinologic disorders.
* Self-reported change in body weight \> 5 kg within 90 days before screening.
* Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
* History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
* History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
* Lifetime history of suicide attempt.