cyrilzakka/clinical-trials huggingface dataset:
Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as triamcinolone acetonide as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity inarthroscopic knee surgery or total knee arthroplasty. However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I ,II or III;
* Participates with an anticipated fully recovery within 2 hours postoperatively;

Exclusion Criteria:

* History of craniotomy;
* Expected delayed extubation or no plan to extubate;
* Participants who cannot use a patient-controlled analgesia (PCA) device;
* Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Allergy to opioids, triamcinolone acetonide or ropivacaine;
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
* Preoperative Glasgow Coma Scale\< 15;
* Suspicion of intracranial hypertension;
* Peri-incisional infection;
* Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD

This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and characterize malignancy score of pulmonary nodules on LDCT chest scans taken as part of a lung cancer screening program.

LDCT DICOM images of patients who underwent routine lung cancer screening will be selected and enrolled into the study. Enrolled scans analyzed by radiologists with the assistance of the Median LCS (formerly iBiopsy) device are compared to the analysis by radiologists without the assistance of the Median LCS device.

Figures of merit for patient level and lesion level detection and diagnostic efficacy will be calculated and compared, sub-class analysis will be performed to ensure device generalizability.


Eligibility Criteria:
Inclusion Criteria:

* ≥50-80 Years of age;
* Current or ex-smoker (\>=20 pack years);
* Patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to United States Preventive Services Task Force (USPSTF) 2021 Criteria);
* Received LDCT due to inclusion in high-risk category for lung cancer.

Exclusion Criteria:

* Prior lung resection;
* Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition;
* Patients/images used during AI model development;
* Patients with only hilar and/or mediastinal cancer(s);
* Patients with only ground glass cancer(s);
* Patients with nodules, solid or part-solid \>30mm (masses);
* Patients that are not accompanied with the required clinical information;
* Patients with imaging with any of the following: missing slices, slice thickness \>3mm;
* Partial cover of the lung.
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.

Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended.

Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.

Objectives. To examine whether early enteral iron supplementation (EI) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (ID) in infants with a birth weight of \<1301 g. Methods. Infants were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as enteral feedings of \>100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral iron supplementation \[LI\]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of \<.25. ID was defined by any one of the following criteria: ferritin, \<12 mg/L; transferrin saturation, \<17%; or increase of absolute reticulocyte counts by \>50% one week after the onset of enteral iron supplementation. Restrictive red cell transfusion guidelines were followed and all transfusions were documented. Erythropoietin was not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with ID. Results. Ferritin at 61 days was not different between the groups. Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI is feasible and probably safe in infants with birth weight \<1301 g. EI may reduce the incidence of ID and the number of late blood transfusions. ID may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. Pediatrics 2000; 106:700 -706; preterm infant, iron supplementation, iron deficiency, blood transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Inborn infant
* Birth weight of \<1301 g
* Admitted between June 1996 and June 1999

Exclusion Criteria:

* Major anomalies
* Hemolytic disease
* Twin-to-twin transfusion syndrome
* Missing parental consent
Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease

This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).

Participants who complete the 48 weeks of treatment in Period 1 will have the option to receive ALXN1840 for 24 weeks in Period 2 (open-label extension).

Safety will be monitored throughout the study.

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of Wilson Disease by Leipzig Score ≥ 4.
2. Adequate venous access to allow collection of required blood samples.
3. Able to swallow intact ALXN1840 tablets or mini-tablets.
4. Willing to avoid intake of foods and drinks with high contents of copper.
5. Willing and able to follow protocol-specified contraception requirements.

Key Exclusion Criteria:

1. Decompensated hepatic cirrhosis or MELD score \> 13 (ages 12 to \<18) or PELD score \> 13 (ages 3 to \< 12).
2. Modified Nazer score \> 7.
3. Clinically significant gastrointestinal bleed within past 3 months.
4. Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN) for participants treated for \> 28 days with WD therapy or ALT \> 5 × ULN for treatment-naïve participants or participants who have been treated for ≤ 28 days.
5. Marked neurological disease requiring either nasogastric feeding tube or intensive inpatient medical care.
6. Hemoglobin less than lower limit of the reference range for age and sex.
7. History of seizure activity within 6 months prior to informed consent/assent.
8. Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or estimated glomerular filtration rate \< 30 milliliters/minute/1.73 meter squared.
Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders

The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.


Eligibility Criteria:
Inclusion Criteria: - Active RA - Documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - Able to self-inject study drug Exclusion Criteria: - Previous use of anti-tumor necrosis factor (TNF) monoclonal antibody - Receipt of anti-CD4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count - Receipt of intra-articular corticosteroids within 2 weeks before screening - Receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - Significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction \[MI\] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or HIV positive)
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Diagnosis of persistent bronchial asthma (with reference to the Global Initiative for Asthma Guidelines 2002)
* Baseline FEV1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, DSCG, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
* Baseline FEV1 60 - 90% in patients receiving not more than 500 mcg BDP-CFC (or equivalent) and/or in combination with any other asthma medication mentioned above
* No change in the asthma treatment 4 weeks prior to baseline period
* Patients who, with the exception of asthma, are in good health

Main Exclusion Criteria:

* Poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
* Patient using regularly \>8 puffs/day rescue medication prior to baseline
* History of lower airway infection in the last 4 weeks prior to baseline period
* Diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
* Heavy smoker: currently: \>20 cigarettes/day and/or \>10 pack years, ex-smoker: with a smoking history of ≥10 pack years
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Liver insufficiency (Child Pugh A or worse)
* Active hepatitis
* Known infection with HIV
* Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
* Alcohol and/or drug abuse
* Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
* Pregnancy or patient of childbearing potential who is not using reliable method of contraception
* Patients not able to follow study procedures, e.g. due to language problems, psychological disorders
* Suspected inability or unwillingness to comply with the study procedures
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and at least 18 years of age.
* Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
* Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
* To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or at least 4 on the 11 point NPRS scale).

Exclusion Criteria:

* In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
* Used opiates continuously (including tramadol) for more than ten days in the past year.
* Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
* Currently receiving any medications that are not at a stable dose (the same dose for \> 4 weeks prior to date of surgery).
* Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
* Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
* Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
Effect of VR VS Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients

Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises. Studies have indicated that VR can lead to significant improvements in motor function, coordination, and strength of the affected upper limb.

These advancements are often attributed to the ability of VR to provide real-time feedback, varied and repetitive tasks, and the stimulation of neuroplasticity. In contrast, conservative treatments, such as traditional physical and occupational therapy, though beneficial, may not offer the same level of stimulation and engagement. Overall, VR therapy can be a valuable adjunct to traditional rehabilitation, potentially accelerating recovery and improving functional outcomes for chronic stroke patients by providing a more dynamic and engaging approach to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
* Adults aged 18 years and older.
* Demonstrable sensorimotor impairment of the upper extremity due to stroke, as assessed by clinical evaluation.
* Sufficient cognitive ability to follow instructions and participate in VR therapy, as determined by a Mini-Mental State Examination (MMSE) score of 24 or higher.
* Medically stable and able to participate in physical rehabilitation sessions, as cleared by a healthcare professional.

Exclusion Criteria:

* Severe communication difficulties that would impede the ability to follow instructions during therapy.
* Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher)
A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

Major Objective Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

Secondary objective

1) If Fluorouracil implants application in clinical surgery could lead to the incidence of complications increased in biliary-enteric anastomosis.

2）Assess drug safety according to drug-related clinical and / or laboratory adverse events.

3）Observe the postoperative complication rate of Fluorouracil implants. 4）Observe the quality of life of patients used Fluorouracil implants.

Eligibility Criteria:
Inclusion Criteria:

* The patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (Annex 2).
* Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 3 months.
* Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:

Blood: WBC count \> 3.0 × 109 / L, Platelet count\> 100 × 109 / L, Hb \> 8.0g/dl. Liver function：serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal.

Renal function: creatinine less than 1.5 times the upper limit of normal.

* Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test.
* Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past.
* Patients who can understand the circumstances of this study and signed informed consent.

Exclusion Criteria:

* Currently is receiving effective treatment；
* Pregnancy, breast-feeding patients；
* Primary brain tumors or central nervous system metastatic tumor is not controlled;
* Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment.
* Patients with purulent and chronic infected wounds which delayed healing.
* Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
* Patients has a history of mental illness and difficult to control;
* Patients who was considered inappropriate to participate in the trials by the researchers.
Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients

The goal of this double-blind crossover randomized clinical trial is to evaluate the impact of a phenolic natural compound called hydroxytyrosol (HT) on patients at cardiovascular risk (CVR). The main questions it aims to answer are:

* Evaluating the effect of HT caramels on CVR biomarkers.
* Assessing the impact of HT caramels on cellular phenotype.

Participants will take 4 caramels/day, each containing 15 mg of HT, consuming a daily intake of 60 mg for 28 days. One group will begin with HT caramel consumption for 28 days, while the other group will start with a placebo treatment. Following a 2-week washout period, the treatments will be switched between the groups. Those who initially consumed HT will then switch to the placebo treatment, and vice-versa, each for a duration of 28 days.

A 10-week randomized, crossover, double-blind controlled clinical trial was conducted between April 2022 and March 2023 in the Catholic University of Murcia Randomization divided the participants in two groups, depending on whether they started consuming the caramels supplemented with HT, or the group that started consuming the placebo caramels.

The patients totally consumed 60 mg of HT per day distributed into 4 caramels/day with 15 mg of HT per caramel. The caramels in treatment group contained encapsulated HT in cyclodextrins, xylitol sweetened. On the other hand, the caramels in placebo group contained cyclodextrins and they were xylitol sweetened too. Patients were segregated into 2 groups: the ones who started as HT-group and the ones who started as C-group.

HT-group consumed HT caramels for 28 days, while C-group consumed placebo caramels followed by a 2-week washout period. Suddenly, groups were switched for 28 days, the ones who started as HT-group became C-group and vice-versa. The patients completely performed 4 visits during the study. In every appointment, they had blood and faeces extraction with body composition measurement. In addition, a Food Frequency Questionnaire (FFQ) based on Mediterranean Diet Serving Score (MDSS) was given to the patients in order to assess diet variability during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Elevated cholesterol level: \>200 mg/dL
* Elevated glucose level: \>100 mg/dL

Exclusion Criteria:

* Not been under antihypertensive, antidiabetic and/or hypoglycaemic agents
Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program

The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care plan in improving compliance among elderly polypharmacy users at community pharmacy settings. The specific objective of the project is to determine effects of pharmaceutical care program on medication adherence and persistence among elderly polypharmacy users.


Eligibility Criteria:
Inclusion Criteria:

* Both men and woman aged more than 65 years and taking more than 2 drugs

Exclusion Criteria:

* Inhabitants of nursing homes
* People receiving unit dose dispensing of medicine