cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration


Eligibility Criteria:
Inclusion Criteria:

* Legal at the time of signing the agreement
* Subject affiliated to the french social protection
* Ileostomy has achieved since 10 days minimum at day 0 (D0: start of study treatment)
* Ileostomy output \> 1.5 liters / 24h for at least 24 hours at day 0
* accept to use an effective method of contraception during the study: (during the 6 months following injection of lanreotide for the experimental group and for the control group: 4 days after the last dose of chlorhydrate of loperamide
* People able to understand the objectives, modalities and risks related to the study and give written informed consent

Exclusion Criteria:

* people with guardianship or with judicial protection
* simultaneous participation in another biomedical research protocol involving a drug or topic exclusion period
* pregnancy or breastfeeding
* administration of lanreotide or related peptide between surgery and D0
* hypersensitivities to lanreotide or related peptides and / or diosmectite and / or loperamide and / or one of their excipients
* acute hemorrhagic colitis
* bloody diarrhea and / or high fever
* Clostridium Difficile Infection at the inclusion
* uncontrolled diabetis defined by HbA1c\> 7% at D0
A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017)

The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to:

* Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
* Has a body mass index (BMI) 18.0 to 32.0 kg/m\^2 (inclusive)

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)
Novel Antineuronal Antibodies in Gastrointestinal Motility Disorders

Gastrointestinal motility disorders represent a heterogeneous group of neuromuscular diseases of the enteric nervous systems. While autoimmune neuromuscular diseases of the central nervous system (CNS) are well described, the role of autoimmunity in enteric nervous system (ENS) has been less studied. Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system proteins, suggesting an autoimmune mechanism targeting the enteric nervous system. The investigator's aim is to identify novel anti neuronal antibodies that contribute to autoimmune gastrointestinal motility disorders by analyzing the serum of patients with abnormal gastrointestinal motility.

Autoimmune gastrointestinal dysmotility (AGID) represents a subset of autoimmune disorders that affect the motor function of the gastrointestinal tract. It will often result in refractory gastrointestinal symptoms and poor quality of life. Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins, which may be suggestive of an autoimmune mechanism targeting the enteric nervous system. The diagnosis is often made clinically in patients with gastrointestinal dysmotility in the context of primary autoimmune disease or a paraneoplastic syndrome. To date, specific diagnostic tests for AGID disorders do not exist. This study will aim to find whether patients with symptomatic autoimmune gastrointestinal dysmotility (AGID) will have a specific antigen and/or antibody causing the symptoms. The study will also aim to find whether patients with positive autoantibody titers will frequently have positive tilt-table testing (autonomic dysfunction).

The goal of this study is to determine the prevalence of autoimmune antibodies in patients presenting with unexplained GI dysmotility and refractory symptoms, and to examine the outcome (safety, tolerability, and clinical improvement) in a pilot cohort of such patients with a serum screening for antigens, antibodies, and validated questionnaires. This will be a prospective pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>13 years old.
* Patient referred to the GI Motility clinic for suspected enteric dysmotility based on chronic refractory gastrointestinal symptoms
* English proficiency and literacy sufficient to sign consent.

Exclusion Criteria:

* Pregnancy documented with a serum or urine pregnancy test. If participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine test for pregnancy and remove them from the study if the test results come back positive.
A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess and compare how risperidone and olanzapine, two antipsychotic medications, affect the regulation of glucose (sugar) in the body.

The newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders, and they may cause fewer side effects than the older antipsychotic drugs do. However, some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose (sugar) in the body. This negative effect could make the patient gain weight and even develop diabetes mellitus. This randomized, double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder. Patients will be randomly assigned to receive risperidone (target oral dose of 6 milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months. Repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs. The primary laboratory test used to assess the patient's regulation of blood glucose will be the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test. Risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram tablets taken orally once a day for 6 months

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or related disorder
* stable with respect to disease symptoms and other medical conditions
* would benefit from this type of antipsychotic drug
* if female, using birth control.

Exclusion Criteria:

* Patients who are delirious, bipolar, severely mentally retarded, or suicidal
* psychiatric diagnosis of disease unrelated to schizophrenia
* presence of stroke, brain tumor, Parkinson's Disease, or diseases that affect blood glucose control
* history of diabetes
* long or recent history of taking risperidone, olanzapine, quetiapine, clozapine, or investigational drugs
* recent history of unstable thyroid function
* if female, not using birth control
* abusing drugs or alcohol.
Mesenchymal Stem Cells in Central Nervous System injury2017

Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.


Eligibility Criteria:
Inclusion Criteria:

* CNS injury \> 3 months
* age \> 18 years
* willing to give consent
* stable vital signs
* absence of active infectcion

Exclusion Criteria:

* any contradiction to intrathecal infusion
* age \< 18 years
* CNS injury \< 3 months
* CNS injury \> 3 years
The Prognostic Value of PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer

Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. The inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information; (2) patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment. The exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to PET/CT; (2) patients with other malignancies; (3) patients received hormone therapy without NHT; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information
* patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment

Exclusion Criteria:

* patients who received novel hormone therapy or a prostate biopsy prior to PET/CT
* patients with other malignancies
* patients received hormone therapy without novel hormone therapy
* patients received chemotherapy or radiotherapy prior to or during novel hormone therapy
* absence of follow-up data at our institution
Functional Respiratory Imaging After Neostigmine or Sugammadex

The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral nerve/muscle to assess the patients' breathing capability at the end of surgery. It is possible that respiratory complications after surgery (e.g. desaturation and atelectasis) are related to the lack of diaphragm activity.

A previous trial by our study group links the use of sugammadex, a novel selective relaxant binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular junctions, instead of increasing the amount of acetylcholine (like neostigmine does), sugammadex will result in a better neuromuscular coupling. This may have its subsequent effects on the central control of breathing, influencing the balance between intercostal and diaphragm activity.

The investigators now propose a study in rats, where the investigators will use Functional Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The images obtained through micro-CT scans allow us to accurately reconstruct airway morphology in the free-breathing rat. It will provide us with new insights into breathing physiology after reversal of neuromuscular blockade.

This study is designed to assess the effect of sugammadex, neostigmine/glycopyrrolate and spontaneous reversal of a moderate rocuronium-induced neuromuscular blockade on regional lung ventilation. This is a randomized, controlled, parallel-group double blind trial in rats. A total of 18 adult male Sprague-Dawley rats will be used, 6 in each treatment group. The animals will be randomized in one of three groups, in a 1:1:1 ratio. This randomization will be performed according to a computer-generated randomization list. The first group will receive neostigmine/glycopyrrolate. The second group will receive sugammadex. The third group will receive water for injection. Reversal agents will be administered at a train-of-four (TOF) of 0.5, as measured with AMG.

The investigators will assess regional ventilation by means of micro-CT scanning during spontaneous breathing after the TOF ratio has reached ≥ 0.9. This way, the investigators can accurately reconstruct airway morphology. The different airway sections can then be linked to the corresponding lung tissue, and a full anatomical picture is thus rendered. A comparison of morphological scans at different breathing levels (e.g. end-inspiratory and end-expiratory) will allow us to model breath-by-breath regional airway and alveolar recruitment.

Eligibility Criteria:
Inclusion Criteria:

* male Sprague-Dawley rats

Exclusion Criteria:

* N/A
Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort

This study evaluates the use of exhaled air analysis as tool to monitor the disease activity in Crohn's Disease (CD). This study is a validation of the previous findings. In this study the participant will be asked to donate exhaled air, blood samples and fecal samples. The breath samples will be used to measure various volatile metabolites in breath. The breath air will be next used to validate the previous findings. The blood samples will be used to define the origin of volatile metabolites in breath. Finally, the potential of exhaled breath analysis as non-invasive marker of diseases activity will be compared to established fecal calprotectin.

In the recent study(doi: 10.1097/Mib.0000000000000436) it was shown the potential of analysis of exhaled air to differentiate active and inactive state of Crohn's Disease (CD). Although, the molecules found in this cohort have shown potential to differentiate between CD patients in remission or with active disease, the validation of the outcomes has to be performed in new population. One crucial pathophysiologic factor in CD is excessive lipid peroxidation during oxidative stress, i.e. during overproduction of oxidants compared to the protective antioxidants. Oxidative stress is a potential aetiological factor and/or a triggering factor in CD. Many volatile compounds including hydrocarbons and aldehydes are produced during oxidative stress and they can be non-invasively measured in exhaled air 5, 6. However, exhaled breath contains volatile metabolites originating from previous or current uptake of environmental contaminants, and more interestingly from metabolism of foreign organisms (bacteria, viruses, fungi or yeasts). Therefore, it is important to study not only exhaled air but also blood in which blood borne volatile molecules can be measured. Since the current study also aims for validating the use of volatile molecules in exhaled air as non-invasive markers for disease activity in CD patients, the investigators will compare the outcome of exhaled air analysis with currently established non-invasive measure of disease activity, i.e. fecal calprotectin.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* BMI: 19-30
* scheduled colonoscopy

Exclusion Criteria:

* disease compromising immune system (such as HIV positive status or patients after organ transplantation
* liver disease
* active and untreated tuberculosis
* chemotherapy agents
Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers

The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects aged 18 to 50 years
* Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
* Able and willing to provide written informed consent.
* Able and willing to comply with all study procedures and restrictions.

Exclusion Criteria:

* History or evidence of clinically significant illness or surgery
* Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies.
* History of significant drug or alcohol abuse
* Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
* Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1.
* Pregnant or nursing females
* Shaving or waxing the planned study treatment application area within 7 days prior Day 1.
* Laser hair removal of the planned study treatment application area within 2 months prior to Day 1.

  * other criteria apply, please contact the investigator for more information
Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes.
* Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

1. metformin (stable dose for 6 weeks)
2. pioglitazone (stable dose for 6 weeks)
3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

   * Have HbA1C between 7.1% and 10.5%, inclusive.
   * Have a body mass index (BMI) ≤45 kg/m2.
   * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).

Exclusion Criteria:

* Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
* Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
* Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
* Women who are breastfeeding.
* Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
* Have had a kidney transplant or are currently on kidney dialysis.
* Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
* Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
* Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
* Are currently on a weight-loss program or have been on one within 3 months of entering the study.
* Have had a blood transfusion or severe blood loss within 3 months of entering the study.
* Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
* Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
* Have a history of pancreatitis.
* Have received treatment with an experimental drug within 30 days of entering the study.
* If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
* If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
* If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting

Although the long saphenous vein remains the most commonly used conduit in coronary revascularization, traditional open vein harvest may lead to significantly impaired wound healing and post-operative pain. To this end, endoscopic saphenous vein harvesting techniques have been shown to reduce post-operative morbidity. Studies have shown that endothelial integrity and luminal nitric oxide synthase (NOS) are better preserved with novel "no-touch" techniques; however, the effect and the associated mechanism of endoscopic vein harvest on endothelial integrity and function remain unknown. Therefore, in the present proposal, we will collect the saphenous vein segements immediately after harvesting, reperfusion, and grafting, and then use enzyme-linked immunosorbant assay (ELISA), immunohistochemical staining (IHC), and real-time polymerase chain reaction (RT-PCR) to detect the expression and distribution of endothelial NOS (eNOS), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), and platelet endothelial cell adhesion molecule-1(PECAM-1) at protein and RNA levels in the endothelium of saphenous veins. The major aim of this study is to elucidate the effect and mechanism of endoscopic saphenous vein harvesting on endothelial properties as compare to conventional open vein harvest technique.


Eligibility Criteria:
Inclusion Criteria:

* patient with coronary artery disease underwent coronary artery bypass grafting in our hospital

Exclusion Criteria:

* no