cyrilzakka/clinical-trials huggingface dataset:
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).

Eligibility Criteria:
Inclusion Criteria:

* physician-diagnosed asthma
* age 6 or older
* pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
* beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
* Juniper Asthma Control Score of 1.5 or greater if not on daily controller
* good current health

Exclusion Criteria:

* current or past smoking (greater than 20 pack-years)
* chronic or current oral steroid therapy
* pregnancy, lack of effective contraception (when appropriate), lactation
Evaluation of Corrected Carotid Artery Flow Time as a Predictor of Fluid Responsiveness in Spontaneous Breathing Patients

It is still challenging to assess intravascular volume status in spontaneously breathing patients. Recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume change. The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously breathing patients before induction of general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (19-80 years of age) who were scheduled to undergo elective neurosurgery for brain tumor

Exclusion Criteria:

* BMI \> 35 or \< 15 kg/m2
* the presence of carotid artery stenosis \> 50%
* systolic blood pressure \> 160 mmHg
* cardiac rhythm other than sinus
* intracardiac shunt 6. valvular heart disease
* a left ventricular ejection fraction of \< 50%
* right ventricular dysfunction 9
* chronic obstructive pulmonary disease
* pulmonary hypertension
* chronic kidney disease (eGFR \< 60 mL/min/1.73m2)
* pregnancy
Combination of ATG-based Conditioning Regimen and PTCy for GVHD Prevention in Allo-HSCT After PD-1 Blockade

The aim of this study is to evaluate the efficacy and safety of anti-thymocyte globulin combined with PTCy (post-HSCT cyclophosphamide, PTCy) in preventing graft-versus-host disease (GVHD) in allo-HSCT patients after anti-PD-1(anti-programmed cell death protein 1) antibody treatment. In this study, patients with hematological malignancies who needed to receive allo-HSCT after PD-1 antibody treatment were selected as the research subjects. Fludarabine and Busulfan was used as the conditioning regimen, and the dose of ATG (anti-thymocyte globulin, ATG) combined with PTCy was used as the GVHD prevention regimen. The aim of this study is to reduce the incidence of Regimen-Related Toxicity and GVHD without affecting engraftment and relapse, thereby reducing non-relapse mortality and further improving the survival of patients.

ATG (anti-thymocyte globulin, rabbit; 5 mg/kg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg/kg, day -5; 2.5 mg/kg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and unrelated donor-HSCT. Reduced-dose PTCy regimen: two doses of 14.5 mg/kg Cy were given on days +3 and +4 post-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* (1) age ≥ 18 years old, regardless of gender;
* (2) patients with hematological malignancies (including lymphoma, leukemia, myelodysplastic syndrome, etc.) who had received at least one course of PD-1 antibody treatment;
* (3) patients with indications for allo-HSCT, available donors (including matched sibling donors, haploidentical donors and unrelated donors), and no contraindications for transplantation;
* (4) patients suitable for conventional Bu/Flu conditioning regimen;
* (5) no serious heart, liver, kidney, lung and other important organ diseases;
* (6) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
* (7) Hematopoietic stem cell transplantation comorbidity index (HCT-CI) score was 0-3;
* (8) expected survival time of at least 12 weeks;
* (9) women who are not pregnant or breastfeeding;
* (10) voluntary participation in clinical research; They or their legal guardians were fully aware of the study and signed informed consent. Willing to follow and complete all trial procedures;

Exclusion Criteria:

* (1) pregnant or lactating women;
* (2) other serious conditions that may limit enrollment (e.g., advanced infection, etc.);
* (3) unable to understand and follow the study protocol or sign the informed consent form.
Temperature Manipulating Gloves for the Treatment of Insomnia

The investigators plan to test the effectiveness of warm gel gloves in reducing the time it takes individuals to fall asleep (sleep latency). The investigators will have subjects track their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called an actigraph to measure the degree of the persons' difficulty falling asleep. It must take at least 30-minutes to fall asleep 3-days per week to qualify for the study. If a subject qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. The baseline sleep latency data will be compared to the treatment period using a independent t-test. The investigators believe that wearing the warm gel gloves will reduce sleep latency.

Insomnia affects anywhere from six percent to 33% of the U.S. population depending on the precision of the definition being used. Therefore, represents one of the most prevalent health concerns for Americans. Individuals with insomnia frequently report problems such as (but not limited to) difficulty focusing and concentrating, memory difficulties, impaired motor coordination, irritability and impaired social interactions. Moreover, chronic insomnia has also been associated with reduced quality of life, higher absenteeism, impaired job performance, and higher healthcare utilization.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for each participant are as follows: Must be between 18 and 65 years old
* Have difficulty initiating sleep for at least two-weeks, including a sleep latency of at least 30-minutes, three days per week (as measured by wrist actigraphy and/or sleep logs)
* No history of a dermatological disorders or chronic pain conditions
* Not currently using narcotics, psychotropic or hypnotic medications and willing to refrain from using these medications during the course of the study
* Limits caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day
* Limits alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night, must adjust alcohol consumption to 7-drinks per week and less than or equal to 1 drink on any one night for at least two weeks before study begins, and must not consume alcohol later than 8pm
* Naps less than or equal to 1-hour per week according to subjective report
* Must have a body mass index less than 30
* Shift workers will not be accepted.

Exclusion Criteria:

* History of a dermatological disorder
* Using narcotics, psychotropic or hypnotic medications
* Caffeine consumption greater than 2 coffee servings, or equivalent per day
* Alcohol intake greater than 7 drinks per week and greater than 1 drink on any one night, consume alcohol later than 8pm
* Naps greater than 1-hour per week according to subjective report
* Body mass index greater than 30; Shift worker.
Cardiovascular Complications of Carfilzomib

Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.


Eligibility Criteria:
Inclusion Criteria:

* Intention to treat by Carfilzomib

Exclusion Criteria:

* History of carfilzomib treatment
Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer

The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer surgery (invasive or in situ) by conservative surgery
* Age ≥ 18 years
* Indication of adjuvant radiotherapy
* Adjuvant chemotherapy allowed
* Agreeing to participate in a clinical study
* Able to participate in a clinical trial

Exclusion Criteria:

* Metastatic Breast Cancer
* Personal history of breast cancer
Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema

To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy and evaluate the clinical outcomes regarding safety, efficacy, and pharmacodynamics parameters.


Eligibility Criteria:
Inclusion Criteria:

Confirmed Diagnosis of Empyema: Patients with a clinical and radiological diagnosis of

Exclusion Criteria:

1 - Hypersensitivity or Allergy to the selected antibiotic: Patients with a known history of hypersensitivity or allergic reactions to used antibiotics.

2- Pregnancy and Lactation
Melatonin for Pediatric Emergence Agitation

efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

Eligibility Criteria:
Inclusion Criteria:

* ASA I
* scheduled for unilateral inguinal herniorrhaphy
* parents conscent

Exclusion Criteria:

* allergy to this study drug
* Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction
A Phase 2b Diabetic Kidney Disease Study

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.

Eligibility Criteria:
Key Inclusion Criteria

1. Adult men or women ≥ 18 years of age.
2. Diabetic kidney disease DKD defined as:

   1. diagnosis of T2DM
   2. eGFR 25-75 mL/min/1.73 m2
   3. UACR 100-3000 mg albumin/g creatinine
3. BP ≤ 150/100 mmHg
4. Stable dose of ACEi or ARB Key Exclusion Criteria

1. Serum potassium \> 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c \> 10.5 % 4. B-type natriuretic peptide level \> 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning

This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. These conclusions may guide us on how to correctly perform Extracorporeal Membrane Oxygenation, including whether or when should this treatment enabled, the mode of Extracorporeal Membrane Oxygenation, whether to combine blood purification, treatment schedule and disembarkation time.

This study will be conducted in the Affiliated Hospital of Nantong University, the Sixth People's Hospital of Nantong University, the Branch of Affiliated Hospital of Nantong University, the People's Hospital of Qidong City, the People's Hospital of Rudong County, the People's Hospital of Rugao City, and the People's Hospital of Hai 'an City. It is expected that 60 patients with poisoning will be included, and the blood and urine samples of 60 patients will be collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record will be established.

The purpose of this prospective multicenter observational clinical study was to 1) investigate the value of Extracorporeal Membrane Oxygenation in the treatment of fatal poisoning; 2) To investigate the changes of patients' organ functions (heart, lung, liver, kidney, brain) during the Extracorporeal Membrane Oxygenation operation and the influence on the removal of toxins. In order to obtain a more powerful clinical basis to guide the rational use of the Extracorporeal Membrane Oxygenation technology in patients with fatal poisoning.

Eligibility Criteria:
Inclusion Criteria:

* Severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure.
* Denying other available methods.
* Indications for the use of the Extracorporeal membrane oxygenation exist.

Exclusion Criteria:

* Severely impaired state of consciousness prior to cardiac arrest;
* Multiple organ dysfunction;
* Uncontrolled traumatic bleeding, massive gastrointestinal bleeding, and active intracranial hemorrhage;
* Left ventricular thrombosis; Severe aortic insufficiency.
Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery

The concept of Enhanced Recovery After Surgery (ERAS) protocols has revolutionized perioperative care by promoting a series of evidence-based practices aimed at reducing surgical stress and improving patient outcomes. Among these practices, preoperative carbohydrate loading has emerged as a significant intervention designed to mitigate the adverse metabolic effects of surgery


Eligibility Criteria:
Inclusion Criteria:

- Cardiovascular disease

Exclusion Criteria:

Insulin dependent diabetes

-
PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents

The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.

The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.

Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.

Eligibility Criteria:
Inclusion Criteria:

* 1A. Male or female \> 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :
* advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
* Measurable lesions \> 1 cm in short axis.
* Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium
* FDG PET/CT available for masked reading on appropriate medium

  1B. Male or female \> 18year old with head and neck (H\&N) cancer meeting the following criteria:
* advanced H\&N cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
* Measurable lesions \> 1 cm in short axis.
* Pretherapeutic native and contrast enhanced CT or MRI of the head and neck available for masked reading on appropriate medium
* FDG PET/CT available for masked reading on appropriate medium
* Oto-rhino-laryngologic (ORL) examination including ORL fibroscopy and/or optionally panendoscopy.

  2. Capacity to remain without movement during the PET/CT examination 3. ECOG performance status ≤ 2 at inclusion 4. Patient with life expectancy ≥ 24 weeks after inclusion. 5. In fertile females, at inclusion the pregnancy must be ruled out 6. Volunteer and capable to follow necessary instructions during the trial 7. Informed consent signed by the patient 8. Affiliation to a social security system

Exclusion Criteria:

- 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.

2. Scheduled treatment which does not include an antiangiogenic agent 3. Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. Pregnancy or breastfeeding.
Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension

The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

Patients with pulmonary arterial hypertension and their caregivers will be asked to participate in the study. The study consists of a baseline in-person visit (week 1) where quality of life and physical performance will be assessed, and subjects will be shown low-resistance training exercises to perform at home. The exercises will then be performed at home, as instructed, for 12 weeks. At week 12, subjects return for a follow-up in-person visit, where quality of life and physical performance will be reassessed. Patients and caregivers will also be asked to participate in separate exit interviews, where investigators will ask how they felt about the resistance training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PAH: idiopathic, heritable, associated with connective tissue disease, congenital heart disease, human immunodeficiency virus, drug- or toxin, or portopulmonary hypertension
* On stable PAH therapy for 3 months

Exclusion Criteria:

* World Health Organization (WHO) functional class IV
* Left ventricular ejection fraction \< 40% (via transthoracic echocardiogram (TTE) within one year of screening)
* Moderate or severe concomitant lung disease: Chronic Obstructive Pulmonary Disease (COPD) or interstitial lung disease
* Enrollment in a clinical trial
* Recent hospitalization (within 4 weeks of screening)
* Inability to perform the Short Physical Performance Battery or wheelchair bound