cyrilzakka/clinical-trials huggingface dataset:
A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.

The study will last up to approximately 8 weeks including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG)
* Have a hemoglobin level of:

  * at least 11.4 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB), and
  * at least 12.5 g/dL for individuals assigned male at birth (AMAB)
* Have a body weight equal to or greater than 45 kilograms (kg), and a body mass index within the range of 18.5 to 35.0 kilogram per square meter (kg/m²) at screening

Exclusion Criteria:

* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting risk when taking orforglipron, midazolam, or quinidine; or interfering with the interpretation of data
* Have a 12 lead electrocardiogram (ECG) abnormality, including known prolongation of QT/QTc interval, significant bradycardia, significant heart blocks or a history of any risk factors for ventricular arrhythmia, heart failure, hypokalemia or hypomagnesemia, or other factors that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure or pulse rate, deemed to be clinically significant by the investigator
* Have a history of benign ethnic neutropenia
* Have a GI disease or disorder, such as relevant esophageal reflux or gall bladder disease, which could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or impacts gastric emptying, for example gastric bypass surgery or pyloric stenosis, except for appendectomy
* Have a history or presence of pancreatitis, including chronic pancreatitis or idiopathic acute pancreatitis
* Have known allergies to:

  * quinidine
  * midazolam
  * orforglipron
  * related compounds, or
  * any components of the formulation
Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics

Patients with suspected breast cancer undergoing PET/CT at our hospital. The PET/CT center's chief physician and senior attending physician reviewed the films together and disagreement, if any, was resolved by consensus. The lesion was visually identified. A 3D region of interest(ROI) of the lesion was automatically outlined using the 40% threshold method, and PET metabolic parameters were measured . Breast lesions with radionuclide concentrations greater than those in normal breast tissue are considered to be breast cancer lesions, while lymph nodes with radionuclide concentrations greater than those in muscle tissue are considered to be metastatic lymph nodes.

Image segmentation: Image segmentation was performed using ITK-SNAP software (4) (version 3.6.0, http://www.itksnap.org/), Brush Style: circular, Brush Size: 10, Brush Options: 3D. The entire tumor volume was outlined on the PET image as ROI for segmentation.

An open source Python package (PyRadiomics version 3.0.1(5)) was used to extract the radiomics features from the ROI.

Univariate and multivariate binary logistic regressions were used to construct model for predicting lymph node metastasis in breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1) 18F-FDG PET/CT for breast occupancy; 2) adult female patients with pathologically confirmed breast cancer (age ≥18 years); 3) no history of surgery, radiotherapy, or chemotherapy before 18F-FDG PET/CT; and 4) interval between 18F-FDG PET/CT and puncture/surgery ≤2 weeks.

Exclusion Criteria:

* 1) multifocal, bilateral, or occult breast cancer; 2) incomplete clinical or pathological data; 3) poor PET/CT image quality, when metabolic tumor volume(MTV) cannot be automatically segmented; and 4) concomitant malignant tumors.
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite

Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.

Now, maxillary posterior dento-alveolar intrusion has been validated as a conservative treatment modality for treatment of skeletal open bite in adult patients. However, it was proved that mandibular posterior teeth extrusion take place during the treatment which results in reduction in the amount of open. bite closure. Therefore, the aim of our study is to compare in a randomized clinical trial methodology between maxillary posterior dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar intrusion in terms of anterior open bite closure.

Eligibility Criteria:
Inclusion Criteria:

* Skeletal open bite with a dental open bite ranging from 3-8 mm.
* Adequate incisal show at rest and on smiling
* Full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant).

Exclusion Criteria:

* Dental open bites without skeletal components
* Previous orthodontic treatment
* Medically compromised patients
Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients

The purpose of this study is to investigate the effect of beginning a renal replacement therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

The prevalence of obstructive sleep apnea increases with progressing renal insufficiency. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. We suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure.

The beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population.

The purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift.

The severity of obstructive sleep apnea is measured by two attended polysomnographies (PSG), a baseline PSG performed before and a follow-up PSG performed 6 month after beginning of a renal replacement therapy. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who have not yet begun a renal replacement therapy 6 months after the baseline PSG will be re-assessed and will be analyzed as control group

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI) ≥ 15/h
* age ≥ 18 years
* patient with end stage renal disease without renal replacement therapy.

Exclusion Criteria:

* unstable congestive heart failure
* active psychiatric disease
* amputation of the lower limbs, proximal to the ankle
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.
3. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. The result of rapid antigen test is positive.
6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
7. Abnormality hematology and biochemical test results.
8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
13. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.
14. Subjects plan to move from the study area before the end of study period.
Investigation of Effectiveness of Local Antibiotic With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo

The aim of this study was investigate the effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 3 randomly separated groups. For the first and second group, Platelets Rich Fibrin+ local antibiotics were applied into the tooth socket. For the first group, amoxicillin was applied and for the second group, clindamycin was applied. There was a control group which only Platelets Rich Fibrin was applied into the socket. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation.


Eligibility Criteria:
Inclusion Criteria:

* patient with no systemic diseases, no current infection, no smoke, no pregnancy

Exclusion Criteria:

* no inflammation
DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients' lives.

This study will examine both clinical and non-clinical reasons for pursuing surgery, taking into account previously unexplored areas in surgical decision-making including the comprehensive impact of this disease, as well as factors that impact a surgeon's willingness to recommend surgery. Ultimately, this patient-centered research approach will help us understand the impact of treatment decisions on a patient's quality of life, work, and clinical symptoms, and will ultimately help to inform our recommendations for the treatment of patients with diverticulitis.

The DEBUT study was developed from questions raised by our Washington State Surgical Collaborative, (SCOAP Colon and Rectal Surgery Work Group) and will be carried out in clinics and hospitals across Washington State, Oregon, and California. The investigators invite patients to participate in research activities designed to identify the impact of diverticulitis and treatment options, in order to better understand the outcomes that matter most to patients. Patients who are considering surgery or who have received treatment for their diverticulitis will be recruited for study participation. Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent quarterly for up to four years. These surveys will examine quality of life, overall health, and clinical symptoms to understand what drives patients and surgeons to an operation, as well as how that decision impacts quality of life and recurrent events in patients that choose to have surgery compared to those that do not have surgery. Participating surgeons will complete surveys that examine their indications for surgery and surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of diverticulitis
* Patients 18 years of age or older
* Patients who are able to consent to participate in research

Exclusion Criteria:

* Patients that have had prior colon resection surgery
* Patients that do not make their own medical decisions
Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation

COVALENT is a randomized, controlled, multi-center study that aims to evaluate the clinical routine practice of endotracheal intubation in an operative setting comparing video-assisted laryngoscopy to direct laryngoscopy.

Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small study populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (irrespective of the shape of the blade) is non-inferior to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adult, legally competent patients
* Scheduled for elective, non-cardiac surgical procedure
* Need for endotracheal intubation as determined during the premedication visit
* Informed consent
* Care providers performing the intubation have at least one year of training in anesthesiology and experience in the use of VAL

Exclusion Criteria:

* Lack of ability to give consent
* Previous participation in this study
* Pregnancy
* Need for fiberoptic intubation
* Patients scheduled for bariatric surgery
* Any circumstance that will lead the anesthesiologist(s) in charge to believe that random assignment of a laryngoscopy instrument may compromise patient safety during induction of anesthesia
Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Eligibility Criteria:
Inclusion Criteria:

* 6 months to \< 36 months of age

Exclusion Criteria:

* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
* Known or suspected impairment/alteration of immune function
* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function
China Structural Ventricular Arrhythmias Registry

This is an observational, prospective, multi-center registry ,aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 participants will be recruited from 10 centers in China,with clinical data to be abstracted from medical records ,and blood samples to be collected for finding promising risk indicators.The follow-up should be made every 6 mouths.

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition ,the mainstream treatment relies on implantable devices and medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as a efficient and economic strategy for early prevention and treatment.

Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained staffs .At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.

Exclusion Criteria:

* none
Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall

The purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the respiratory function.

All study protocol will be performing in three different days. In the first day, the participants will undergo to the initial assessment, which consisted of anamnesis and anthropometric measurements: weight, height and body mass index (BMI). Then, they will be submitting to spirometry and respiratory muscle pressure using a manovacuometer.

All patients will submit underwent two types of intervention: respiratory muscles stretching (RMS) and remain at rest (control group). The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will use for each stretching pattern with an interval of 30 seconds between series.

For the intervention in the control group, all volunteers will be position at rest in a comfortable in a chair during 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* patients post-stroke with right hemiparesis no more than 3 months, from both sexes, aged above 20 years, score between 1 and 3 according to Ashworth Scale for upper limbs, score above 85 according to Barthel Index and a minimum punctuation of 18 for Mini Mental State Examination.

Exclusion Criteria:

* Volunteers presenting facial paralysis; rheumatic or orthopedic diseases; spinal abnormalities or deformities that compromise the respiratory mechanics; spirometry with forced expired volume in the first second (FEV1) bellow 80% from predicted values and FEV1∕forced vital capacity (FVC) ≤ .7; presenting respiratory comorbidities; recent history of thoracic or abdominal surgery; hemodynamic instability or pregnancy.
Upper Limb Blood Flow Restriction in Handball Players

Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return.

Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players.

Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography).


Eligibility Criteria:
Inclusion Criteria:

* Athletes over 18 years of age.
* Federated in handball at the time of the study.
* No lower limb injuries in the three months prior to the study.
* Signing the informed consent document.

Exclusion Criteria:

* Athletes who have undergone surgery in the year prior to the study.
* People who do not attend at least 80% of the treatment sessions.
* Players who are receiving physiotherapy treatment in parallel to the physical preparation of the team they are playing for.