cyrilzakka/clinical-trials huggingface dataset:
Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital scoliosis
* 6-16 years old at the time of assessment

Exclusion Criteria:

* Cognitive impairment caused by congenital, traumatic or other reasons;
* Existence of mental or psychological disorders;
* There are factors that may affect neurological development, including any known central nervous system disease, neurological injury, or history of neonatal asphyxia;
* Unable to cooperate with cognitive function tests;
* The child is unable to communicate in Chinese.
HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia

This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 2023/2024 and 2024/2025 seasons.

The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial using the infrastructure of the Regional Vaccination Program of Galicia for patient recruitment, inclusion, randomization, and vaccine administration and the Galician health registries for data collection including baseline information, follow-up data and safety monitoring. Participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment. Informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration. The participation in the study is voluntary, and only individuals who accept signing the informed consent will be recruited. Participants may withdraw from the study at any point.

The study aims to randomize at least 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care)
* 2. Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study
A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram \[mg\]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in healthy participants under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, urinalysis or breathing alcohol test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* Have no history of psychiatric disorder within the 5 years prior to the screening
* Have no history of gastrointestinal resection that may affect drug absorption

Exclusion Criteria:

* Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
* Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug
* Use of any prescription or nonprescription medication (including oriental medicines) within 30 days before the first dose of the study drug is scheduled
Intranasal Oxytocin for Infants With Prader-Willi Syndrome

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (OT) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding.

Study Hypothesis 2: The Study team hypothesize that replacing OT in infants and children with PWS will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI
2. Physical exam and laboratory results that are within the normal range.
3. Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.
2. Prior chronic treatment with oxytocin.
3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.
Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

The purpose of this study is to determine the response rate and response duration with the combination of low-dose rituximab, romiplostim and high-dose dexamethasone.

Immune thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.

Corticosteroids increase the platelet count in about 80 percent of patients. However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Romiplostim, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin, has been shown to be effectively raise the platelet count in adult patients (aged 18 years and over) who have had their spleen removed or where splenectomy is not an option and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work (refractory ITP). There are a few case reports where romiplostim an option as first line treatment for IT.

The purpose of this study is to determine the response rate and response duration with the combination of rituximab (100 mg weekly four weeks), romiplostim (2mcg/Kg four weekly) and high-dose dexamethasone (40mg PO days 1-4) in untreated adult patients with \<30\*109/L platelet count diagnosed with immune thrombocytopenia.

A complete response is defined as an increase in platelet counts to \>150×109/L on two consecutive occasions. A clinical response is defined as an increase in the platelet count between \>30×109/L on two consecutive measures and no bleeding. Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count \<30×109/L) or to time of analysis Patients will be evaluated each week during 4 weeks and then every month for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed immune thrombocytopenia (IT) Platelet count less than 30,000/mm3 on two occasions.
* Subject ≥ 16 years
* Subject has signed and dated written informed consent.

Exclusion Criteria:

* Previous treatment (only corticosteroids at dose or prednisone equivalent of 300 mg)
* Performance status above or equal to 2.
* Pregnancy and lactation
* Previous splenectomy
* Connective tissue disease
* Autoimmune hemolytic anemia
* Relapse
* Active infection, sepsis or fever
* Positive for hepatitis B virus or hepatitis C virus or human immunodeficiency virus.
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Be able and willing to provide written informed consent.
* 18 to 75 years old.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
* Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\])
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Has adequate organ function.

Exclusion Criteria:

* Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has undergone major surgery within 30 days of Study Day 1.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method

This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. The other scales will be performed after 1 hour the patients learned their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame count method.


Eligibility Criteria:
Inclusion Criteria:

* Patients whom planned elective coronary angiography and accept to be included in the study as a participant

Exclusion Criteria:

* \< 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases
Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures

This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.

Interventional thoracic ultrasonography (TUS) includes both diagnostic and therapeutic procedures. Fine-needle aspiration biopsy , Tru-cut Pleural or lung parenchymal biopsy and Cope or Abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures.

Thoracic ultrasound guided procedures are safe and tolerable. Pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of TUS guided procedures. Lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia.

To reduce pain, analgesia should be considered as premedication. Despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders.
* Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention

Exclusion Criteria:

* Children and patients less than 18 years old.
* Pregnant and lactating ladies.
* Patients with disturbed level of consciousness.
* Patients with known bleeding disorders.
* Patients with advanced liver and kidney disorders.
* Patients with known hypersensitivity to NSAIDS.
* Patients with chronic chest diseases.
* Patients who refuse to participate in the trial
Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia
* 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment
* 60 APS pregnant patients diagnosed by clinical department

Exclusion Criteria:

1. Thrombosis history
2. Rheumatic immune disease
3. Use oral contraception or biological inhibitors
4. History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes
Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients

Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)

Clinical Assessment and Comparison of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients in the mandibular posterior region.
* Patients with healthy systemic condition.
* Insufficient ridge width (\< 5mm).
* Presence of proper inter-arch space for placement of the implant prosthetic part.
* Adequate soft tissue biotype (≥ 2 mm).

Exclusion Criteria:

* Patients with systemic conditions that may interfere with the results of the study.
* Patients with local pathological defects related to the area of interest.
* Unmotivated, uncooperative patients with poor oral hygiene.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.

The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)

EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.

The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR

Exclusion Criteria:

* Patients that don't want te receive any repair for their disease
Fosamprenavir in Pts With Hepatic Impairment

APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV 700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV 100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal Products for Human Use (CHMP) has requested longer-term safety data among this hepatically impaired HIV-infected population who have received the recently updated FPV/RTV dosing regimens.

An observational cohort study will be conducted using routinely collected data in three European HIV patient cohorts with a high proportion of hepatitis co-infected individuals. Patients who received FPV/RTV will be followed to address the following objectives.

Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment.

Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV) or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in subjects with mild to moderate hepatic impairment.

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients with or without hepatic impairment coinfected with HBV or HCV who started FPV/RTV-based therapy on or after January 1, 2008. The FPV/RTV exposed patients will be stratified into four groups for analysis (see interventions A-D for label/description above), according to their degree of baseline hepatic impairment, which will be defined according to FPV/RTV dose received (and APRI score for interventions A and D). The LPV/RTV intervention group must have started this therapy at approved standard doses on or after January 1, 2008.

Exclusion Criteria:

* Receipt of FPV/RTV or LPV/RTV within the year preceding the baseline visit.
Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic breast cancer (any site) age 21 or older
* Patients willing and able to provide informed consent \& perform study procedures
* Patients may enroll with recently (with 2 months) progressive tumor burden
* Performance status of 0,1 or 2

Exclusion Criteria:

* Patients unable or unwilling to provide informed consent and or perform study procedures
* Patients with active, uncontrolled coagulopathy
* Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin
* Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacement. Both genders. No age limits.

Exclusion Criteria:

* Allergy to erythromycin or colistin. Previous infection in the knee.