cyrilzakka/clinical-trials huggingface dataset:
Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist

Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.

Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.

Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin\[9-39\], C) GIP-A + Exendin\[9-39\], or D) saline (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2
Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses

Ultrasound imaging provides useful information for the characterization of ovarian masses as benign or malignant. The most accurate mathematical model to categorize ovarian masses is the IOTA ADNEX model.This model estimates the risk of malignancy and performs similarly to subjective assessment by an experienced ultrasound examiner for discriminating between benign and malignant adnexal masses. The ability of IOTA ADNEX to discriminate between benign and malignant masses is very good (area under the receiver operator characteristic curve 0.937 (95% CI: 0.915-0.954). The ADNEX model maintains its accuracy even in the hands of operators with different experience and training.

According to IOTA terminology, 13% of ovarian masses detected on ultrasound examination are classified as solid. Solid ovarian masses have a risk of malignancy of 60%-75%2 and the discrimination between benign and malignant in this morphological category is challenging. Additionally, it has been estimated that 30% (25/84; 95% CI 18 to 44%) of solid malignant ovarian masses are metastases from non-ovarian tumors. The discrimination between primary ovarian cancer and metastatic tumors in the ovary is also clinically important for planning adequate therapeutic procedures. It is worth exploring the predictive performance of the diagnostic tools in identifying ovarian masses with ultrasound solid morphology.

Preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a monocentric retrospective study. However, no statistically significant differences have been observed between primary ovarian cancer and metastases to the ovary.

A new technology is emerging in engineering ultrasound field: the analysis of ultrasound summed RF data- raw data generated by the interface of ultrasound beams with human tissues. To date, raw data are not utilized for conventional imaging and their eventual role in clinical practice is unknown. Indeed, summed RF data could better correlate with biological parameters then parameters identifiable in B-mode images. Summed RF data could also improve radiomic analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a preoperative ultrasound diagnosis of a solid ovarian mass (solid according to IOTA terminology, i.e. 80% of the tumor consists of solid tissue).
2. Patients who will undergo surgery within 120 days after the ultrasound examination.
3. Patients at least 18 years old.
4. Informed consent signed.

Exclusion Criteria:

1. Patients under 18 years of age.
2. Patient refusal
EPO Deep Tank in Dialysis Subjects

Subject incidence of adverse events

To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have comparable safety profiles when administered to patients with CKD receiving dialysis.

Eligibility Criteria:
Inclusion Criteria: - ≥ 18 years of age - Receiving hemodialysis or peritoneal dialysis - Baseline Hb between 11.0 g/dL and 13.0 g/dL - Currently receiving Epoetin alfa RB ie. EPOGEN or PROCRIT - Transferrin saturation (Tsat) \>15.0% Exclusion Criteria: - Currently receiving or ever received treatment with any erythropoietic stimulating protein other than EPOGEN, Procrit and Aranesp. - Uncontrolled hypertension (defined as diastolic blood pressure \>110 mmHg or systolic BP \>180 mmHg during screening). - Grand mal seizure within the last 6 months prior to screening. - Acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment. - Stroke (hemorrhagic or ischemic) or transient ischemic attack within 12 weeks before enrollment. - Major surgery within 3 months prior to screening (excluding vascular access surgery). - Clinical evidence of systemic infection or inflammatory disease at the time of screening and up until enrollment.

For peritoneal dialysis subjects, an episode of peritonitis within 30 days before screening. - Known positivity for HIV antibody or Hepatitis B surface antigen.

Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin. - Blood transfusions within 8 weeks prior to screening or active bleeding. - Androgen therapy within 8 weeks prior to screening.

Systemic hematological disease (eg ,sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - Other investigational products are excluded. - Subject is currently enrolled in, or has not yet completed, a period of at least 30 days since ending other investigational device or drug trial(s).

Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - Pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - Anticipating or scheduled for a living-related kidney transplant. - Known history of severe hyperparathyroidism (PTH \>1500pg/ml) within 3 months prior top enrollment. - Currently receiving home hemodialysis treatment. - Currently receiving immunosuppressive therapy.
Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars

Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.

Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.

Eligibility Criteria:
Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent
The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.

Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources.

While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children.

Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery .

Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting.

A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study.

Exclusion Criteria:

1. hypersensitivity to gabapentin
2. patient refusal
3. epilepsy
4. neurological or psychological conditions that impair communication.
5. current use of gabapentin, psychotropic or opioids medications.
Treatment for Patients Suffering From Anemia Due to Chemotherapy

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection
Covered Stents Versus Bare-Metal Stents

To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.

Symptomatic chronic atherosclerotic gastrointestinal ischemia (CGI) is an uncommon, potentially underdiagnosed condition caused by fixed stenosis or occlusion of in most conditions at least one of the three gastrointestinal arteries. Atherosclerosis is a predisposing factor for CGI. Clinical symptoms can vary widely. Typical symptoms are postprandial abdominal pain, unintended weight loss and food avoidance. But atypical abdominal pain such as exercise related pain, diarrhoea and nausea can also indicate CGI. The use of endovascular techniques for revascularization of chronic stenosis and occlusions of the gastrointestinal arteries has rapidly increased and endovascular therapy with stenting has become the most common method chosen for revascularization, having replaced open surgery with its associated morbidity and mortality. Nowadays standard care in significant chronic gastrointestinal ischemia is the use of bare metal stents although the patency of these stents is not very high. According retrospective data the patency of covered stents is significantly higher compared to bare metal stents. One likely explanation for these lower restenosis and re-intervention rates observed with covered stents is the established barrier to tissue ingrowth. Only recent retrospective data about this topic is available but the expectancy in this prospective study is that the patency of covered stents is indeed higher compared to metal stents.

Eligibility Criteria:
Inclusion Criteria:

* Patients with consensus diagnostic of CGI based on a clinical meeting with a gastroenterologist, a vascular surgeon and an interventional radiologist.
* Diagnostic consensus of CGI is based on.
* Presence of postprandial pain
* Unexplained weight loss (\>5% of normal body weight).
* Significant stenosis of \>50% of at least one of the gastrointestinal arteries on a recent CTA (Computer Tomographic Angiography) not older than one year, with maximum slice thickness 1 mm and enhancement in aorta of 300HU (Hounsfields Units)
* Mucosal ischemia detected by VLS (Visible Light Spectroscopy) or tonometry
* Patients over the age of 18 years.
* Patients who gave informed consent.
* Patients have sustained atherosclerosis.

Exclusion Criteria:

* Patients who don't give informed consent.
* Age \< 18 years
* No stenosis detected during arteriography.
* Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when comorbidities relevant to kidney function present).
* Previous stent placement in the to be treated gastrointestinal artery.
* Pregnancy
* Celiac artery compression syndrome.
* Vasculitis
Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

The goal of this study is to learn if using a lay VA volunteer, who will assist patients with education regarding precision medicine, can improve care quality and outcomes for Veteran patients with lung cancer.

Participants in the intervention group will receive 1:1 communication with a lay VA volunteer in addition to their usual clinical care. The lay VA volunteer will provide patients with education about precision medicine and support in their care. Researchers will compare a control group who will receive their usual oncology care as provided by clinical teams at the VA. There will be no change in their care.

All participants will be asked to complete a survey at the time of enrollment in the study, and also at 1 month. This survey will measure patient participation in their cancer care, satisfaction with healthcare decisions, and overall questions about knowledge of precision medicine.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years old that have been newly diagnosed with any stage of lung cancer.
* Patients must have the ability to understand and willingness to provide verbal consent.
* Participants must speak English.

Exclusion Criteria:

* Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization.
* Patients who anticipate moving care outside the Veterans Affairs Palo Alto Health Care System within 6 months.
Evaluation of LLLT/Music for Smoking Cessation

The purpose of this research is to study the preliminary effectiveness of a light therapy and music device for at-home use to aid the seasoned cigarette smoker in his/her attempt to stop smoking. This device, called the FQS system, is a type of cold, or non-heat producing laser and tranquil music system that will emit light and music onto the ear surface, through commonly found music earphones, available in most electronic stores. The theory behind this treatment technique is that the light and music will stimulate the part of the brain responsible for producing chemicals that satisfy the desire for nicotine. If this is correct, then the user will replace the need for nicotine with the pleasant treatment experience of light and music therapy.

This study aims to define the safety and physiologic effects that occur when low level light and music, configured in a wearable binaural head set are employed by seasoned smokers of cigarettes, with the end result of reducing the desire to smoke. This device use does not require any complementary or adjunctive drug use. A review of unregulated products that are marketed for smoking cessation, have as common mechanism of action, the administration and withdrawal of nicotine in a controlled dosing format. The proposed study device does not consider the use of the culprit drug, the best pathway to achieve rapid and long-lasting cessation results. The theoretical principle at work is the competition for absorption by nicotinic cholinergic receptors located in the brain by nicotine or by the LLLT and music therapy. If this competition for absorption by two competing elements (cigarettes and the proposed device) can result in the device "winning the race", then the neurotransmitters will respond to the LLLT and music stimulus instead of the serum nicotine and yield a reduced desire to consume nicotine. As with any new technology, it is essential to learn the variance between true efficacy and the placebo level of efficacy. This study seeks to define that variance.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects who have been smoking cigarettes for at least 5 years without any intervention therapy within the past 12 months.
* Apparent good health.
* Must admit to possessing the desire to stop smoking.
* Willing to use the proposed device at home, every day, for 15 minutes, for up to 6 weeks.
* Willing to participate in weekly monitoring program conducted through brief phone survey not to exceed 5 minutes per week.

Exclusion Criteria:

* Previous involvement in other smoking cessation studies.
* Use of any product, drug or device, designated as smoking cessation or reduction aid during the trial period or within the preceding last 12 months.
* Active and chronic consumption of any psychotropic or illicit drugs
* Evidence of any current viral, fungal or bacterial infection.
* Diagnosed mental disorders or habits that indicate self-destructive behavior, such as nail biting, morbid obesity, compulsive gambling or alcoholism.
* History of having been arrested for a criminal act or repeated non-criminal violations related to motor vehicle use.
Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
2. T≥3 or N≥1, and more than 15 lymph nodes were dissected.
3. Age ≥18 years and ≤75 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
5. Adequate hematological function:

   absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.
6. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
7. Adequate renal function:

   serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.
8. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent

Exclusion Criteria:

1. Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
2. Serious postoperative complications that will affect progress of chemotherapy.
3. Patients with chemotherapy contraindications.
4. Women who are pregnant or breast-feeding or who are planning for pregnancy.
5. Unable to complete the follow-up as planned.
6. Without informed consent due to psychological, family, social and other factors.
To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM

Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.

1. Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables.
2. Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.

Eligibility Criteria:
Inclusion Criteria:

* 48h preoperative biochemical indicators, blood general indicators, coagulation test complete

Exclusion Criteria:

* 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed
Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital

This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age
* Intubated and sedated man or woman
* Extubation within 48 hours
* Intubation of more than 48 hours in total
* Patient in intensive care at Niort hospital
* The trusted person or referent accepting the patient's participation
* Patient affiliated to the social security system

Exclusion Criteria:

* Known pregnancy
* Patient who refused to participate in the study after the fact
* Patients under long-term antidepressant treatment (treatment longer than 3 months)
* Patients under guardianship or curatorship
* Patient deprived of liberty
* Skin lesions on the hands/feet/head (wounds, erythema, burns, bedsores, phlyctenes)
* Inclusion in another clinical study