cyrilzakka/clinical-trials huggingface dataset:
Contrast-enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Diabetic Gastroparesis

The objective of the proposed study is to assess gastric emptying time (GET) based on contrast-enhanced multispectral optoacoustic imaging (CE-MSOT) in a collective of patients with type 1 diabetes mellitus (T1DM). The results will be correlated with disease duration and severity.

T1DM is a chronic autoimmune disease in which autoantibodies destroy the pancreas's insulin-producing cells. In Germany, it is estimated that 32,000 children and adolescents and approximately 335,000 adults suffer from T1DM. The trend has been increasing in recent years.

A complication of T1DM is diabetic gastroparesis (DGP), in which gastric emptying is delayed without mechanical obstruction. Symptoms of DGP include nausea, vomiting, and abdominal pain. Many patients\* are asymptomatic.

DGP is associated with higher HbA1c, autonomic neuropathy, nephropathy, retinopathy, and increased gastrointestinal symptoms.

In this study, gastric emptying will be imaged noninvasively and without radiation based on MSOT. MSOT, in addition to imaging endogenous chromophores, allows visualization of exogenous chromophores. If the dye indocyanine green (ICG) is ingested orally, the signal of the dye in the lumen of the gastrointestinal tract can be visualized noninvasively by MSOT over different intestinal segments. If food is labeled with ICG and ingested by subjects\*, the passage of chyme through the gastrointestinal tract can be tracked by measuring the signal with MSOT, and transit times can be measured.

This study will investigate gastric emptying times of patients\* with T1DM.

Eligibility Criteria:
nclusion criteria Group 1

* Written informed consent
* T1DM diagnosis
* Duration of disease at least 5, preferably 10 years with diagnosed neuropathy Group 2
* Written informed consent
* T1DM diagnosis
* Duration of disease at least 5, preferably 10 years without diagnosed neuropathy Group 3
* Written informed consent from parent or guardian
* T1DM diagnosis
* Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value \> 8.5 mmol/l) Group 4
* Written informed consent of parent or guardian
* T1DM diagnosis
* Duration of disease at least 5, preferably 10 years with good medication control (HbA1c value \< 7.5 mmol/l) Exclusion criteria

Generality:

* Pregnancy
* Breastfeeding mothers
* Tattoo in the area of the examination
* Subcutaneous fat tissue over 3 cm
* Known hypersensitivity to ICG, sodium iodide or iodine
* Hyperthyroidism, focal or diffuse thyroid autonomy
* Timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study)
* Impaired renal function
* Taking the following medications: Beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite
A Study of LY3541105 in Healthy and Overweight Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
* Have a body mass index (BMI) in the range of greater than or equal to (\>/=) 18.5 to less than (\<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of \>/=27 to \<40 kg/m², both inclusive (in Part B and C)
* Have had a stable weight for the last 3 months

Exclusion Criteria:

* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
* Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
* Have history or current evidence of a clinically significant cardiovascular condition
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's disease).

Weight loss is a common and severe symptom of amyotrophic lateral sclerosis (ALS), caused both from inadequate calorie intake and an increased metabolic rate. People with ALS are generally instructed to increase their calorie intake; however, the ideal amount and type of calories has not been studied. Several studies in an animal model of motor neuron disease have shown that a high fat/high calorie diet can increase survival by as much as 38%. Mice on a high fat diet also live longer than mice fed diets consisting of high protein or high sugar. We are therefore conducting a phase II safety, tolerability, and preliminary efficacy trial in ALS of high fat versus high calorie versus normal diet. The normal diet will be calculated based on the number of calories needed to replace each participant's measured daily calorie requirement.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of ALS
2. Male or female subjects aged 18 years or older
3. Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or PEG) or jejunostomy tube (J-tube)
4. Must require non-invasive ventilation (BIPAP) for less than 10 hours/day
5. Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.

Exclusion Criteria:

1. History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy, prior biliary disease such as gallstones
2. History of diabetes
3. History of prior myocardial infarction or stroke
4. Laboratory values: Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal
5. Allergy to soy, fish, or milk products
Effect of Rational Drug Education on the Attitudes of Parents of Hospitalized Children

In this project, it was aimed to determine the effect of the rational drug management training program on parents' attitudes towards rational drug use. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program on rational drug use will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the education program on rational drug use applied to parents whose children are hospitalized. Although studies on rational drug use in parents have increased in recent years, most of them consist of descriptive studies aimed at evaluating knowledge and attitudes towards rational drug use. It seems that the number of intervention studies on rational drug use in parents is limited. No intervention studies aimed at the rational drug use attitudes of parents whose children are hospitalized have been found. This study has the feature of revealing the effectiveness of the rational drug use education program to be applied to parents in cases of illness and hospitalization where the importance of rational drug use becomes evident.

The aim of the research will be carried out using a parallel group (experiment-control) randomized controlled design, which is one of the experimental methods, to determine the effect of the rational drug management training program on parents' attitudes towards rational drug use.

Goals:

* To examine the effect of the rational drug management training program on parents' attitudes towards rational drug use,
* To compare the average scores of the attitude scale towards rational drug use between the parents in the experimental group and the control group in the project.

Eligibility Criteria:
Inclusion Criteria:

* Having a child between the ages of 0-12,
* admitted to the pediatric ward,
* who have not previously received training on rational drug use
* Parents who volunteered to participate in the study

Exclusion Criteria:

* illiterate
* parents with mental retardation, vision and hearing impairment
Does an Abdominal Wall Nerve Block During Surgery Help Reduce Pain From Kidney Transplantation?

This is a randomized, placebo controlled, double blind study to determine the effectiveness of a Transversus Abdominis Plane (TAP) block for reducing postoperative pain and opioid use in kidney transplant recipients.

The management of post-operative analgesia in kidney transplant recipients is complex secondary to labile fluid shifts and limitations in the use of NSAIDs secondary to their potential nephrotoxicity. A majority of transplant centers rely on the use of intravenous patient-controlled opioid analgesia as the predominant method of post-operative pain control, however this practice is at odds with the worldwide initiatives to reduce post-operative opioid use and dependence.

This study is a single center prospective randomized double blinded study which will compare the post-operative benefits of TAP block with liposomal bupivacaine plus free bupivacaine versus placebo (normal saline) TAP block in participants receiving both the ARS and the Gibson incisions for kidney transplantation . Approximately 200 participants will be enrolled at the Cleveland Clinic.

The operative approach (i.e. Gibson or ARS) is at the discretion of the operating surgeon and will proceed in the standard fashion. At the completion of the dissection of the external iliac vessels and prior to bringing the transplant kidney into the field, an intraoperative TAP block will be performed by inserting a 22 gauge spinal needle from inside the abdomen into the transversus abdominus plane of the abdominal wall at the lateral superior and inferior border of the surgical dissection and injecting the pre-determined analgesic or placebo.

The remainder of the procedure, including the vascular and urinary anastomosis, will proceed identically between the two groups. All participants will receive the same post-operative abdominal surgical dressing.

Post-operative pain control will follow standard clinical guidelines. All participants will be prescribed on-demand oral Oxycodone 5 or 10 mg tablets plus IV Morphine or IV Dilaudid if needed for severe breakthrough pain. On discharge, all participants will receive ten 5 or 10 mg Oxycodone tablets.

Eligibility Criteria:
Inclusion Criteria:

- Recipients of a single, living or deceased renal transplantation

Exclusion Criteria:

* Previous renal transplantation on the same side of the body
* Requiring a native or graft nephrectomy or other additional procedures
* Urine diversion or augmentation
* Bowel diversion
* Recipients of an enbloc pediatric kidney
* Recipients of a dual kidney transplantation
Efficacy and Saffety of Oral Immunotherapy to Pistachio

The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
* Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022

Exclusion Criteria:

* Patients who have received oral immunotherapy to pistachio for less than 18 months.
* Patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier
Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed by the participant him/herself
* Males and females of age 18 or older
* Infected with S. stercoralis (positive by at least two Baermann assays on two different days and infection intensities of at least 0.75 LPG in the two stool samples.
* Agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up).
* Female participants of childbearing potential to ensure adequate contraception during the study period.

Exclusion Criteria:

* No written informed consent by individual.
* Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
* Recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: Type 1 and/or 2 diabetes; Psychiatric disorders; Chronic heart, liver, or renal disease
* Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration.
* Actively participating in other clinical trials during the study.
* Positive pregnancy test or breastfeeding women and planning to become pregnant within three months of study drug administration.
* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin within 4 weeks before planned study drug administration.
* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
* Known allergy to study drugs or any of the ingredients
Courses Emergency Psychiatric Strasbourg

Describe and analyze routes and modes of care for patients in emergency consultant in various emergency care and public psychiatric outpatient devices to provide useful information to optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and downstream of where they viewed urgently.


Eligibility Criteria:
Inclusion Criteria:

* All patients, men and women, adults and minors of 11 years and more, seen for psychiatric consultation request emergency (unscheduled and requiring specialized psychiatric consultation within 72 hours)

Exclusion Criteria:

* Will not be included in the study psychiatric consultations requested by internal hospital services other than emergency services, patients with psychiatric emergencies revised for post-emergency consultations
Evaluation of the Safety of the Medical Device Simeox®

The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18, male or female.
* Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis.
* Hospitalization for a minimum of five days or a maximum of 8 days.
* Bronchial clearance is usually productive.
* FVC and / or FEV \<85% predicted, with stable lung function.
* Agreement to participate to the study and signature of the informed consent form
* Social security coverage.

Exclusion Criteria:

* Patient infected with bacteria resistant to antibiotics.
* Bronchial clearance is not usually productive.
* Patient with contra-indication for physiotherapy bronchial clearance.
* Patient who received a lung transplant.
* Care requires more than 2 sessions of chest physiotherapy daily.
* Duration of mechanical ventilation \> 8h/day.
* Patient with an episode of hemoptysis during the month before inclusion.
* Patient with an episode of pneumothorax during the last month.
* Pregnant or lactating women.
* Patient with a disability and/or unwillingness to follow protocol requirements.
* Patient participating in another clinical study or having tested an experimental drug within 30 days prior to his inclusion in the study.
* Patient ( s) with another condition which, according to the investigator , may interfere with the result or conduct of the trial and thus justify their non- inclusion in the study.
Take Off Pounds After Stroke Trial (TOPS)

The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.

The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, in achieving clinically significant weight loss without impairment of physical function when initiated within 90 days following ischemic stroke in patients with BMI 27-to-49.9 kg/m2.

Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet intervention) or enhanced standard care (control) with randomization stratified by recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a stratification factor because it is expected that patients with difficulty swallowing (dysphagia) after stroke that results in need for modifications to food/liquids will have a different weight loss trajectory than patients who are able to safely consume a regular diet. The follow-up duration will be 12 weeks for all subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke within 90 days of randomization
2. Age \>=18
3. BMI 27-49.9 mg/kg2
4. Able to meet all nutritional and fluid needs by oral intake.
5. Ready to undergo behavioral change
6. Able and willing to provide written informed consent
7. Maximum weight \<=350 lbs

Exclusion Criteria:

1. Medical contraindication to weight loss or diet, including the following: renal disease requiring dialysis, taking lithium, or end stage liver or renal disease considered incompatible with diet intervention by patient's personal healthcare provider or the study PI
2. Enrollment in a conflicting clinical trial (defined as a trial with an intervention known to affect weight or with an exclusion for participation in another trial)
3. Pregnancy or desire to become pregnant, or currently breastfeeding
4. High-risk of malnutrition using a standard screen
5. Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months preceding screening)
6. Allergy to soy based food products
7. Require thickening of liquids due to dysphagia
8. Inability to communicate with study team
9. Inability to speak English
10. Irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.


Eligibility Criteria:
Inclusion criteria

* Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion
* No treatment with bisphosphonates within 6 months prior to inclusion into the study
* Good health status (ECOG Performance status 0-2)

Exclusion criteria

* Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening
* Abnormal renal function
* History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
* Pregnancy and lactation
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)
Berberine and Cinnamon in Management of Diabetes

In this randomized clinical trial, patients with diabetes will be randomly assigned to receive either Berberine, and Cinnamon supplements or placebo for 12 weeks. Then the glycemic characteristics will be compared in two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-70 years
* Diagnosed type-2 diabetes mellitus (based on American Diabetes Association criteria)

Exclusion Criteria:

* Patients with an allergy to berberine /cinamon

  * Lactation, pregnancy
  * Patients with any malignancy
  * Patients with unrelated chronic illness
  * Patients with cardiac, liver or respiratory failure