cyrilzakka/clinical-trials huggingface dataset:
Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
3. Body weight ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
4. HbA1c\<6.0%;
5. The subjects have no plans to have children and voluntarily take effective contraceptive measures from the time of signing the informed consent to 2 months after the last medication, and have no plans to donate eggs/sperm; the pregnancy test of female subjects with fertility must be negative.

Exclusion Criteria:

1. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
2. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
3. History of disease that increases the risk of bleeding;
4. Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
8. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
9. History of hypoglycaemia;
10. History of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture;
11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes

This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.

Study Objectives

1. To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and optical coherence tomography (OCT).
2. To assess duodenal layer thickness differences between patients with type 2 diabetes.
3. To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum.
4. To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus.
* Patient is willing to sign an informed consent form.

Exclusion Criteria:

* Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures, inflammatory disease or previous anastomosis of the esophagus or duodenum.
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or hereditary medullary thyroid cancer
* Signed informed consent
* One or more measurable lesions

Exclusion Criteria:

* Brain metastases or spinal cord compression
* Specific laboratory ranges
* Specific heart problems
* Prior chemotherapy and/or radiation therapy
* Participation in other trials within 30 days
Comparative Study of TetraGraph and Mechanomiograph Neuromuscular Monitors in Clinical Settings

Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings.

Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over.
* ASA (American Society of Anesthesiology) physical status I-III.
* Informed written consent.
* Surgery requires the use of a moderate-duration muscle relaxant.

Exclusion Criteria:

* History of neuromuscular disease (e.g. stroke with hemi symptoms, myasthenia gravis, severe polyneuropathy).
* Medication affecting neuromuscular transmission.
* Open wound or rash due to electrode position
* Expected difficult intubation.
* Pregnancy, breast-feeding.
* Implanted pacemaker
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects

Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions.

The investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.


Eligibility Criteria:
Inclusion Criteria (for matching controls):

* Adult male and female subjects (18--\>85 years old)

Exclusion Criteria (for matching controls):

* Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;
* Persons injured at the time of the experiments (fractures,...);
* Persons having reported repetitive spatial troubles/disorders;
* Persons with eye disorders and non-corrected vision problems;
* Pregnant women.
Molecular Basis of Pediatric Liver Cancer

The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

Pediatric liver cancers are rare, affecting at times no more than 1 in one million population. Understanding the molecular basis of these cancers is important in order to develop more accurate diagnoses and more effective treatments. Current classifications of these cancers are based on how these cancers look on diagnostic studies such as radiologic imaging or under the microscope. Such a classification system does not explain why a particular cancer has a different outcome from what is considered "usual" for that particular cancer. Nor does such a classification system explain why two different classes of cancers behave the same way. Understanding the genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

To achieve these goals, large numbers of such cancer patients or affected tissue must be collected. This is not possible in any single institution, or any single country. The current project will collect biological samples such as residual tumor tissue, saliva, or blood from affected patients and their biological parents and families, along with clinical information about the cancer. These biological samples will be used to study the genes and how these genes work in tumor tissue and in non-tumor tissue. The results of this study will permit childhood liver cancers to be categorized on the basis of common defects in genes and their function.

Eligibility Criteria:
Inclusion Criteria:

* Prior or current treatment for a childhood liver tumor, malignant or benign, at age \<21 years.
* Biological parents and siblings of eligible children.

Exclusion Criteria:

* No prior or current treatment for a childhood liver tumor.
* Non-biological parents, legal guardians, or non-biological siblings of eligible children.
The Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients in a Primary Medical Center in Jordan

This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic patients outcomes in a primary health care center.

About 103 patients with type 2 diabetes were randomized to control or intervention group, the control group received a standard care, while the intervention group received the collaborative care between the clinical pharmacist and physicians. Fasting blood glucose, HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three months of follow-up. Treatment related problems (TRPs), quality of life, adherence, and patients knowledge about their medications were assessed. Cost avoidance and clinical significance of implemented clinical pharmacist interventions were assessed too.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more at the time of diagnosis

Exclusion Criteria:

* pregnant patients
* breastfeeding patients
* patients with urgent or emergent cases
* patients with cognitive impairment
* if the patient is unable to provide informed written consent
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Eligibility Criteria:
Inclusion Criteria:

* 6-14 year old children with a history of asthma for at least 12 months
* must demonstrate airway constriction brought on by exercise

Exclusion Criteria:

* is taking any medications that are not allowed in the study
Non-Invasive Assessment of Wound Healing With Optical Methods

The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.


Eligibility Criteria:
Healthy Subject inclusion criteria

* Subjects must be 18-65 years of age
* Subjects must have no history of diabetes
* Subjects must have no history of vascular disease
* Subjects must have no findings of vascular disease on physical examination
* Subjects who are not allergic to Tegaderm

Patient Subject inclusion criteria:

* Subjects must be 18-65 years of age
* Subjects must have documented diabetes mellitus for at least 6 months.
* Subjects must have at least one documented chronic wound for a minimum 8 weeks.
* A chronic wound is defined as any wound that has not healed after 8 weeks and has a minimum surface area of 1cm2. There is no maximum wound size.
* Wound(s) must be secondary to the complications of diabetes, including vascular disease neuropathy, or both.
* Wounds must be on the ankles or feet
* Subjects who are not allergic to Tegaderm

EXCLUSION CRITERIA

* Subject must not be \<18 or \>65 years of age
* Subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated.
* Subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows:
* Subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index \<0.75 or toe-brachial index \<0.5)
* Subjects who are unable to return for weekly follow-up appointments will not be included.
* Pregnant or lactating people will not be invited to participate.
* Subjects who are allergic to Tegaderm
The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients

Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.

Infertility is a common health problem in the United States with approximately 15% of women of childbearing age receiving care for this disorder. One of the most successful and commonly utilized treatment options is in-vitro fertilization (IVF). Data collected by the Center for Disease Control (CDC) and the Society for Assisted Reproduction (SART) showed that in the year 2001, over 100,000 IVF treatment cycles were performed through the more than 400 IVF centers in the U.S. Despite many recent technological advances, pregnancy rates with IVF remain limited with the most recent CDC/SART data reporting that only 27% of treatment cycles result in a live birth. Acupuncture has been utilized in China for centuries to regulate the female reproductive system and has in recent years become a popular option for infertile couples in the States. Though acupuncture has been studied in other infertility settings, IVF is chosen because:

1. IVF is one of the most common infertility treatments as well as the most resource intensive treatment option. Therefore, an improvement in IVF success will provide the greatest benefit to patients and society.
2. IVF affords a unique opportunity to gather the most data regarding the reproductive process and to investigate putative acupuncture related physiological changes.

We propose a randomized, sham controlled feasibility study on the effect of acupuncture on IVF. Sixty IVF patients will be recruited into the study to accomplish the following aims:

1. To examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study,
2. To identify issues related to the multicenter approach that could alter study endpoints,
3. To examine the effect size of the treatment group as compared to the sham group,
4. To examine whether acupuncture is a safe procedure for women undergoing IVF,
5. To examine the effect of acupuncture on clinical IVF outcomes, and
6. To examine the physiological and psychological impact of acupuncture on IVF patients.

Results obtained from the study will provide necessary information for a larger, definitive study, as well as knowledge regarding the broad mechanism of acupuncture on female reproductive function.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing in-vitro fertilization protocol (both IVF and intracytoplasmic sperm injection - ICSI)
* Patient is acupuncture naïve.
* Patient has basal serum follicle-stimulating hormone (FSH) \< 10
* Patient has given informed consent to participate in study

Exclusion Criteria:

* Patient has had acupuncture performed previously or currently
* Patient has basal serum FSH of 10 or more
Social Support Aid For People With Dementia

The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.

This project develops a novel social support aid (SSA) to allow persons with memory concerns (PWMCs) to more fully engage in their social network and enhance their quality of life. The SSA will assist people in an early stage of dementia, e.g., Alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. It provides memory cuing by displaying the names and relationships of the people with whom PWMCs are engaged. The investigators anticipate that the SSA will offer robust support for care partners and PWMCs in various communities. The SSA is not intended to replace caregiver aids, but rather augment them to further improve quality of life. Millions of Americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. While some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. Hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. Assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial.

This phase II Small Business Innovation Research project will continue work started in phase I and complete a product. The aim of this human subjects research protocol is to evaluate whether the SSA exerts positive benefits for PWMCs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (RCT) design. The investigators hypothesize that the proposed SSA will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.

Eligibility Criteria:
Inclusion Criteria:

PWMCs must be:

* A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss.
* Able to complete surveys in English or Spanish
* SLUMS score of 20 or above

Care partners of PWMCs must be:

* 21 years of age and over;
* self-identify as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'');
* indicate a willingness to use the SSA

Exclusion Criteria:

* Indicates an unwillingness to use the SSA.
The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries

The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin. It's used in reconstruction of the mutilated hand as a reverse pedicled flap. The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein. Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves. The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts. Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance


Eligibility Criteria:
Inclusion Criteria:

* patients aging 5 to 80 years.
* Soft Tissue defects following MCA injuries.
* Defect size less than 30 cm

Exclusion Criteria:

* Peripheral vascular disease
* Underling bone osteomyelitis
* Unhealthy skin of volatile aspect of donor forearm
* Defect more than 30 cm
* Ulnar artery previous ligated
Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma

From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.

A review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases
* Availability of imaging and clinical data
* Availability of at least one follow-up during the last 12 months form diagnosis

Exclusion Criteria:

* At least one inclusion creteria not met
A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index\</= 33 kg/m2
* In good health based on medical history, physical examination, vital signs, and laboratory testing
* Normal electrocardiogram (ECG) and blood pressure
* Able to comply with clinic visits and study-related procedures
* Able to sign an informed consent

Exclusion Criteria:

* Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
* Current smoker or recent history (within 3 months)
* History of tuberculosis, HIV, or hepatic disease
* Known sensitivity to doxycycline or other ingredients of study drug
* History of multiple/severe allergies
* Pregnant or breastfeeding women, or not currently using adequate contraception
* Participation in another investigational drug study within 4 weeks