cyrilzakka/clinical-trials huggingface dataset:
Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate

This study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. In accordance with our clinical practice, thermal indicator injections are synchronized with respiration. The impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.

Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. Recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision.

This study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. The reliability of the thermodilution measurements are tested A) in sedated, artificially ventilated cardiac surgical patients and B) in the same patients when postoperatively awake and spontaneously breathing. We further compare the use of room temperature and iced thermal indicator injections.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients.

Only patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria -

Exclusion Criteria:

* Acute cardiac surgery
* Preoperative arrythmias
Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy

The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.

The main questions it aims to answer are:

Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?

Participants will be randomly divided into 3 groups：

1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
2. Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.
3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training.


Eligibility Criteria:
Inclusion Criteria:

* The pathological diagnosis is lung cancer, and the diagnostic criteria refer to the 2023 edition of the Clinical Diagnosis and Treatment Guidelines for Lung Cancer of the Chinese Medical Association.
* Diagnosed as sarcopenia, the diagnostic criteria refer to the 2023 version of the Expert Consensus on the Diagnosis and Treatment of sarcopenia in the Elderly in China.
* Chemotherapy has been carried out and the remaining chemotherapy frequency is ≥ 4 times.
* Physical disability free, Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 points
* No language communication barriers, able to cooperate in completing scale assessments
* Expected life\>6 months
* Previous irregular exercise habits
* Patients and their families have informed consent and voluntarily join
* A person who has a smartphone and can complete WeChat check-in

Exclusion Criteria:

* Merge with other malignant tumors
* There are contraindications or symptoms or diseases that affect exercise, such as uncontrolled hypertension, venous thrombosis, infection, platelet count\<50 × 109/L, white blood cell count\<3.0 × 109/L, hemoglobin\<10 mg/dL, bleeding tendency, arrhythmia, heart failure, unstable angina, heart valve disease, chronic obstructive pulmonary disease, asthma, limb dysfunction, severe muscle, bone and joint diseases, etc
* The risk factor score table for blood flow restriction training scores\>2
* During rest, blood oxygen saturation ≤ 90%
* Cannot conduct human body composition analyzer testing, such as for patients with cardiovascular stent implantation, pacemaker equipped, artificial joint replacement, or amputation
* Patients carrying PICC
* Patients with cognitive impairment and mental illness
* Patients with planned weight loss
Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement

The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
* Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
* No history of previous orthodontic treatment.
* Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).

Exclusion Criteria:

* Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
* Pregnant women.
Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting

This prospective observational study will investigate the correlation of a surrogate marker of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department (ED), in-hospital Length of Stay and revisits to the ED.

The exposure, frailty, will be assessed according to Loss of Independence (LOI) a possible low-cost quick tool to identify frailty in patients. The study population will be ED patients, \>65 years of age in a Swedish regional health care system (Region Östergötland, Sweden), comprising three EDs in Linköping, Norrköping and Motala. The outcomes will be compared according to the degree of frailty and censored over 7, 30 and 90 days.

Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization and mortality.

The Loss of Independence (LOI) defined as inability to rise from a chair with or without existing aids, is a possible low cost surrogate marker to measure frailty. Several studies on triage scores for predicting mortality and need of hospital admission have identified LOI as one of the most important variables. LOI was prognostic in ED populations regarding mortality within 1-30 days in Denmark, Ireland and Tanzania. Data from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Geriatric Surgery Pilot Project showed that LOI was associated with higher rates of readmission and death after discharge in geriatric patients undergoing surgical procedures6.

The aim of this study will be to investigate if the frailty, as assessed with LOI, is associated with increased 30-day mortality in a Swedish ED context. Secondary outcomes include 7- and 90-day mortality, ED-length of stay, hospital admission, in-hospital length of stay, subsequent falls and medication changes. Additionally, we collect data on morbidity and comorbidities to assess the association with the level of frailty. Since this is a multicentre study, possible geographic differences will be studied as well. Based on the results of this study, possible interventions could be identified to improve the care of the frail geriatric patients presenting at the ED.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years
* able to answer questions to estimate frailty
* or have a proxy to answer questions

Exclusion Criteria:

* \<65 years
* unable to answer questions to estimate frailty
Use of Loteprednol for Contact Lens Intolerance and Dryness

Study of the effects of Loteprednol on CL dryness


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Any race or ethnic background
4. CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
5. Patient is in generally good \& stable overall health.
6. Patient likely to comply with study guidelines \& study visits.
7. Informed consent signed.
8. OSDI score 18 or higher while wearing lenses
9. Unsatisfactory wearing time with contact lenses

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis
5. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
6. Pregnant or lactating women.
7. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.
Diagnosis and Natural History Study of Patients With Neurological Conditions

The purpose of this study is to improve understanding of neurological conditions. Patients participating in this study will continue receiving medical care, routine laboratory tests, and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care physician. Doctors at the NIH plan to follow these patients and offer advice and assistance to their primary care physicians.

The objective of this protocol is to provide diagnosis and follow Experimental Therapeutics Branch (ETB) patients not currently entered on another research protocol. No investigational treatments will be administered on this protocol, and the NIH physicians will be playing largely a consultative role to the patient's primary physician.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients may be included on this protocol if they have an identifiable neurological disorder or represent a diagnostic puzzle. These disorders would include patients with Parkinson's disease, Alzheimer's disease, multiple system atrophy, progressive supranuclear palsy, restless legs syndrome, other cognitive and movement disorders, and diagnostic puzzles.

Patients 18-90 years of age, inclusive, are eligible.
Urinary Incontinence After Endoscopic Prostatectomy

This is a prospective cohort study aiming to identify the preoperative and intraoperative predictors of urinary incontinence after endoscopic transurethral bipolar prostatectomy

Benign prostatic hyperplasia (BPH) represents a progressive, age-related proliferation of prostatic stromal and epithelial cells, with histopathological changes typically manifesting after the fourth decade of life. Epidemiological studies demonstrate a prevalence increasing from approximately 50% in men aged 60 years to 90% by age 85 years. The condition frequently results in bladder outlet obstruction, clinically presenting as lower urinary tract symptoms (LUTS) that are conventionally categorized into obstructive (voiding) and storage (irritative) subtypes. Among contemporary surgical interventions, transurethral bipolar prostatectomy techniques - including bipolar transurethral resection of the prostate (B-TURP) and bipolar laser enucleation of the prostate (BipoLEP) - have established efficacy in the management of BPH-induced LUTS, as demonstrated in randomized controlled trials and meta-analyses.

Postoperative urinary incontinence (UI) remains among the most clinically significant complications following surgical management of benign prostatic hyperplasia (BPH). Early transient UI represents a frequently observed postoperative sequela, serving as both a primary source of patient anxiety regarding surgical intervention and a substantial determinant of postoperative dissatisfaction. While the majority of transient UI cases demonstrate spontaneous resolution within 1-6 months postoperatively, persistent UI develops in a clinically relevant subset of patients. This chronic manifestation constitutes a serious long-term complication which decrease the quality of life of the patients.

Reported rates of urinary incontinence following BPH surgery exhibit considerable variability, which may be attributed to differences in surgical techniques, inconsistent definitions of incontinence, and heterogeneity in assessment methods. Moreover, the majority of studies fail to specify the type or duration of incontinence.

Predictors of postoperative urinary incontinence (UI) following endoscopic surgery for BPH require systematic evaluation to optimize preoperative counseling and identify high-risk patients. A thorough discussion of UI risk should be incorporated into the shared decision-making process. This prospective study aims to identify and characterize preoperative and intraoperative risk factors for stress (SUI) and urge (UUI) urinary incontinence in patients undergoing endoscopic BPH surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Males ≥50 years undergoing primary B-TURP/BipolEP for BPH
* Preoperative IPSS ≥8, Qmax ≤15 mL/s, prostate volume ≥30mL
* No prior incontinence/neurological bladder dysfunction

Exclusion Criteria:

* Prostate cancer history
* Concurrent anti-incontinence procedures
Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position

This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years
* American Society of Anesthesiologists(ASA) Classification I-II-III
* Minor and major spinal surgery
* Prone position
* Sinus rhythm
* Absence of atrial fibrillation. or severe arrhythmia
* Informed consent

Exclusion Criteria:

* Absence of informed consent
* Age less than 18 or older than 80 years
* Cardiac rhythm abnormalities: atrial fibrillation and / or severe arrhythmia
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.

METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* All participants will be 60 years of age or older.

Exclusion Criteria:

1. systolic dysfunction
2. patients with evidence of significant ischemic or valvular heart disease
3. chronic pulmonary disease.

Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.

Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.
Follow-up of Symptomless Inguinal and Ventral Hernias

The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.

This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (\> 1 cm) was also obtained before laparoscopy.

The patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.

Eligibility Criteria:
Inclusion Criteria:

* occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria:

* clinically diagnosed inguinal or ventral hernia
Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares

The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.


Eligibility Criteria:
Inclusion Criteria:

* From 1 year old
* anxious or phobic patients
* very young children requiring selective dental cares
* mental deficient patients
* ASA 1 or ASA 2 patients

Exclusion Criteria:

* ASA 3 or ASA 4 patients
* contraindication linked to the experimental product
* patients with mental disorder incompatible with the motory test
* patients that have received anxiolytic treatment less than 2 hours before the dental care
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 6 months old and weighing at least 15 kg.
* Infestation with head lice and viable nits.
* Are otherwise in a normal state of health.
* Willing and able to attend all study visits as scheduled.
* Agree not to cut or chemically treat their hair in the period between treatment and the final visit.
* The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
* Females of childbearing potential must have a negative urine pregnancy test at screening and agree to take reasonable precautions against becoming pregnant during the study period.

Exclusion Criteria:

* Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks.
* Subjects unable to comply with the study obligations and all study visits.
* Subjects with eczema or other chronic conditions of the scalp and skin.
* Subjects in a household with more than 5 infested members.
* Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
* Subjects with neurologic conditions including a seizure disorder or history of seizures.
* Subjects with an infestation of body lice or pubic lice (determined by questioning).
* Subjects suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study.
* Subjects with other diagnoses which, in the opinion of the Investigator, would interfere with efficacy or safety assessments or would preclude study participation.
* Subjects with very short (shaved) hair.
* Subjects who have been treated with a systemic antibiotic within the previous 2 weeks before screening.
* Subjects who have been previously enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
* Pregnant and/or nursing females.
Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* Previous history of tuberculosis
* Allergy to any of the study drugs
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks