cyrilzakka/clinical-trials huggingface dataset:
CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China.

A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.

Hospitals nationwide which have willingness to participate this study in CURES group will be selected. Each selected hospital will be regarded as a cluster and randomized into interventional or control group.

During the study period, eligible patients enrolled in hospitals assigned to interventional group will receive a variety of the multifaceted quality improvement(QI) interventions, including mandatory risk assessment, a computer alert(computer-based clinical decision support system and computerized reminders), strengthened education, and audit. Patients in hospitals assigned to control group will receive common recommended care only, or an existing policy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥14 years
2. Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
3. Written informed consent

Exclusion Criteria:

1. Inability to be followed-up at until 3 months after randomization
2. Have participated in similar trials or are undergoing other clinical trials
3. Refuse or are unable to give informed consent
4. VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment
5. Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).
An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas

Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
2. Age ≥ 18 years.
3. Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.73 m²).
4. Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
5. Negative for sulfonylurea drugs and insulin autoantibodies.
6. ECOG performance status ≤ 2, able to tolerate the examination.
7. All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.

Exclusion Criteria:

1. History of allergy or hypersensitivity to the components or excipients of the investigational drug.
2. Claustrophobia or inability to tolerate imaging procedures for other reasons.
3. Clinically significant active infection as determined by the investigator.
4. History or current presence of uncontrolled primary or metastatic brain tumors.
5. Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:

   1. Poorly controlled diabetes.
   2. Congestive heart failure.
   3. Myocardial infarction within the past 12 months.
   4. Uncontrolled and unstable hypertension.
   5. Chronic kidney disease or liver disease.
   6. Severe pulmonary diseases.
6. Poor compliance and inability to complete study procedures as expected.
7. Any other conditions that the investigator considers unsuitable for participation in the clinical study.
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy

To explore the correlation between gastric ultrasound evaluation and gastroscopic direct vision evaluation of gastric contents, so as to more accurately use gastric ultrasound to evaluate the gastric contents of patients undergoing painless electronic gastroscopy in the outpatient department, so as to develop an individual painless diagnosis and treatment strategy to reduce the risk of lung aspiration.


Eligibility Criteria:
Inclusion Criteria:

* ≥18years
* Patients undergoing painless electronic gastroscopy.
* Voluntarily participate and sign informed consent.

Exclusion Criteria:

* Patients undergoing general electronic gastroscopy.
* Patients who refused to undergo gastric ultrasound.
* Patients with postural difficulties during gastric ultrasonography.
* with fresh wounds or infections at the site of Gastric ultrasound
* Patients whose ultrsound image quality is too poor to properly display the relevant anatomical structures.
Comparisonof Extended Myoectomy and Myoectomy by Morrow in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)

The purpose of this study is to determine whether the application of the extended myoectomy in patients with obstruction of the left ventricular output more efficient than standard myoectomy by Morrow.

Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. Use of extended myomectomy eliminates mitral insufficiency due to SAM syndrome. The question remains whether it is possible at hypertrophic cardiomyopathy basal part and mediated mitral insufficiency use only myoectomy by Morrow is achieved regression SAM syndrome and release output of the left ventricle. Planned to create two equal groups of 30 people that will use two methods of surgical treatment of obstructive hypertrophic cardiomyopathy. The study will be terminated in the event of complete AV block more than 2% and unsatisfactory results of a myoectomy requiring perform mitral valve replacement in more than 15% of the patients studied. The study assumed crossover: in case of failure elimination SAM syndrome and mediated mitral insufficiency myoectomy by Morrow for patients will perform extended myoectomy in the case of a good result in patients are moved to the second group.

Planned studies the long-term and immediate results of operations:

* Quantitative determination of enzymes of myocardial injury: creatine phosphokinase MB and troponin I.
* Determination of atrial natriuretic peptide (ANP) and brain natriuretic peptide (VNP).
* MRI with contrast heart to assess remodeling of the heart chambers and heart weight measurements.
* TEE evaluation function and mitral valve gradient at the output of the left ventricle.

Eligibility Criteria:
Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* obstructive hypertrophic cardiomyopathy
* mediated mitral insufficiency by SAM syndrome
* II-IV (NYHA),
* average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
* basal or medium ventricular obstruction

Exclusion Criteria:

* Related defect of the aortic valve;
* Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
* Surgically significant coronary artery lesions;
* Patients requiring implantation of a cardioverter-defibrillator
Collaborative Care for Anxiety and Depression in Epilepsy

This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.

The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated Informed Consent Form
* Stated willingness to comply with all study procedures
* Males and Females; Age \>= 18 years
* \* Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings
* Anxiety or Depression symptoms
* Receiving clinical neurological care at Atrium Health

Exclusion Criteria:

* Current participation in another treatment of intervention study
* Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview
* Comorbid medical condition with life expectancy less than 6 months
* Not a good candidate for collaborative care due to:
* Active ongoing treatment by a psychiatrist
* Active suicidal ideation
* History of past suicide attempt and:
* receiving ongoing psychotherapy OR
* has seen a psychiatrist in the past year
* History of suicide attempt in the past year and:
* currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators
* Unstable drug or alcohol abuse

For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate

* individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or
* individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures
The Effect of Chest Physiotherapy After Bariatric Surgery

The aim of this study was to investigate the effect of chest physiotherapy applied to patients undergoing bariatric surgery on pulmonary functions, dyspnea levels, functional capacity and quality of life.

This randomized, controlled trial, was designed, conducted, and reported in accordance with the standards of The CONSORT (Consolidated Standards of Reporting Trials) Statement. The patients were randomised and divided into two groups each comprising 74 patients. Chest physiotherapy and mobilisation was applied to the patients in the first group, and only mobilisation was applied to the patients in the second group. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day. Chest physiotherapy and mobilization were applied twice a day, 8 times in total. The following parameters were evaluated preoperative and postoperative:arterial blood gas, oxygen saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for pulmonary hypertansion, Borg dyspnea score for severity of dyspnoea, 6-minute walk test for functional capacity, Nottingham health profile for quality of life.

Chest physiotherapy consisted of postural drainage (30-45 degree eleve), breathing exercises (deep breathing, diaphragm breathing, active breathing techniques cycle) and coughing techniques (huffing, controlled coughing, manual assisted coughing). In the chest physiotherapy program, diaphragmatic respiration, constrictive lip respiration, segmental respiration, incentive spirometry and coughing were performed on the 1st postoperative day. All respiratory exercises were repeated twice a day and percussion was added on the 2nd postoperative day. All respiratory exercises and percussion were repeated 2 times a day until the discharge of the post op day 4 until discharge, and the work with incentive spirometry was removed per hour. Patients were mobilized as early as possible by the physiotherapist. The patients in both groups were instructed to sit out of bed and stand up on the first postoperative day, walk 45 m in the corridor on the second day, walk freely (approximately 150-300 m) on the third and the fourth days.

All operations were laparoscopic, sleeve gastrectomy or Roux-en Y gastric bypass (21). Routine anesthesia was performed with desflurane and remifentanil. In all procedures, patients were treated with the split upward position (French position) and a semi-reclining position (anti-Trendelenburg position). All patients received prophylaxis against deep vein thrombosis for 2 weeks with pneumatic compression stocking and subcutaneous low molecular weight heparin. Perioperative antibiotics (cefazolin 2 g) were also routinely administered. The patients were discharged on the fourth postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* obese and morbidly obese patients
* aged between 30 and 50 years

Exclusion Criteria:

* previous obesity surgery
* presence of chronic respiratory disease
* renal / hepatic dysfunction
* malignant hyperthermia
* regular alcohol
* smoking and drug use
* pregnancy.
Anovaginal Distance, Interobserver Agreement

Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound

Aims: This study describes perineal ultrasound measurement of the AVD in regard to ease of learning and interobserver agreement, in order to establish if the method is reliable to use in further research about objective postpartum description of perineal tears.

Methods: To educate the examiners, the method was shown and described by an experienced examiner. The examiners then measured the anovaginal distance in one woman repeatedly with until similar results (+/- 5 mm ) were achieved. The woman was in the lithotomy position and a vaginal ultrasound probe was used. The AVD in another 40 women was then measured and documented by two examiners, right after the other, who were blinded to the other´s results. The distance was measured between the mucosal margin of the internal anal sphincter and the vaginal probe. Interobserver agreement was calculated using Kappa-score.

Eligibility Criteria:
Inclusion Criteria:

Examiners; the gynecologists authoring the study

Patients:

* any women visiting the gynaecological outpatient clinic of Linköping University Hospital where a vaginal ultrasound examination was performed

Exclusion Criteria:

Examiners: n/a

Patients:

* inability to understand spoken or written Swedish
XG005 for Pain Control in Subjects Undergoing Bunionectomy

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and all study staff performing study assessments will be blinded to treatment allocation. Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour treatment period.There will be a Follow-up Visit on Day 15.

Eligibility Criteria:
Main inclusion criteria:

* Scheduled to undergo unilateral first metatarsal bunionectomy
* Have negative urine drug screen
* Non-pregnant, non-lactating

Main exclusion criteria:

* Medical condition or history that in the investigator's opinion could adversely impact the subject's participation or safety
* Use of disallowed medications (e.g. pain medication, CNS active drugs such as benzodiazepines, tricyclic antidepressants, Serotonin, and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), or any other serotonergic medications, parenteral or oral corticosteroids)
* Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days
* Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics
* Monoamine oxidase inhibitors (MAOIs)
* Positive HbsAg and/or anti-HBc but negative anti-HBs
* HIV infection
* History of illicit drug use
* History of opioid dependence
* History of NSAID-induced bronchospasm or presence of nasal polyps, history of asthma or chronic rhinitis
* Significant history of allergic reactions or known intolerance to naproxen, pregabalin or any gabapentinoid, or to any rescue medication used in the study, or any medication used in the surgical and anesthetic protocol.
* Presence of severe depression as indicated by Patient Health Questionnaire (PHQ 9) total score of ≥20 or item 9 score \>0
* Presence of severe anxiety as indicated by General Anxiety Disorder (GAD-7) score of ≥15
* Presence of history of suicidal behavior or ideation as indicated by the C-SSRS
Solace European Confirmatory Trial

The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.

All patients undergoing sham treatment are treated at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 years of age or older with stress urinary incontinence (SUI)
* Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
* Willing to undergo cystoscopic procedures required and 36 month follow-up
* On stable medication for a minimum of 3 months
* Free of local genital skin infection
* Positive Pad Weight Test
* Free of impassable urethral strictures, trauma or necrosis

Exclusion Criteria (must answer NO):

* Pregnant or planning to become pregnant during the study period
* Non-ambulatory or bedridden or physically unable to complete test exercises
* Morbidly obese (defined as BMI ≥ 40 kg/m2)
* Bladder infection (including bladder inflammation or edema) or UTI within 3 months
* History of recurrent urinary tract infections
* Prior surgical procedure for incontinence within the past 6 months
* Is taking medications for urinary incontinence other than anticholinergics
* History of kidney stones
* Has a prosthetic heart valve
* Unable to tolerate any form of antibiotic
* Taking anticoagulation therapy, other than aspirin
* Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
A Study of TL-925 as a Treatment for Dry Eye Disease

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older
* A diagnosis of dry eye disease for at least 6 months
* An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye
* A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye
* A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea
* A sum corneal fluorescein staining score of ≥ 4 in the study eye
* A total lissamine green conjunctival score of ≥ 2 in the study eye
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.

Exclusion Criteria:

* Any clinically significant slit lamp finding
* Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
* Any keratorefractive surgery within the last 12 months
* Any intraocular or extraocular surgery within 3 months
Pharmacogenomic Study in Patients of Lung, Colorectal and Head/Neck Cancers Receiving Chemotherapy

The purpose of this study is to look at several genes that might determine how the body processes the drugs used to treat lung, colorectal and head and neck cancers. The goal of this examination is to help investigators determine the proper dosage to give future cancer patients or to better predict which future patients will respond to particular drug therapies.

This study is to establish a pilot pharmacogenomic program in identifying genetic variation to predict the safety, toxicity and/or efficacy of drugs. DNA will be extracted from patients' peripheral blood to study SNPs in DPD, TS, MTHFR, UGT1A1, CYP3A4, CYP3A5, GSTM1, GSTT1, GSTP1, HO-1, ERCC1, XPD, XRCC1 and EGFR genes. The results of genetic study will be compared to treatment efficacy and toxicity. The ultimate goal is to use genotype profiles to provide individualized cancer treatment to improve outcome and decrease toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Lung, Colorectal and Head and Neck Cancer Patients that have received or plan to receive chemotherapy as part of their treatment

Exclusion Criteria:

* Colorectal cancer patients that have never received or will not receive chemotherapy as part of their therapy
* Head and Neck cancer patients that have never received or will not receive chemotherapy as part of their treatment
* Patients with cancer types other than colorectal or head and neck
* Unable to give informed consent