cyrilzakka/clinical-trials huggingface dataset:
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age

This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbactam etzadroxil or ceftibuten alone. BAL fluid samples and plasma samples will be collected at designated timepoints to determine the concentrations of ceftibuten, ledaborbactam, and urea.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-55 years
* Males or non-pregnant, non-lactating females
* Body Mass Index: ≥18 and ≤32 kg/m2
* Forced expiratory volume in 1 second of at least 80% of predicted value
* Laboratory values meeting defined entry criteria

Exclusion Criteria:

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug or to medications used during a bronchoscopy
* Conditions that potentially alter absorption and/or excretion of orally administered drugs
* History or presence of significant diseases, including any clinically relevant acute illness or surgery within the past 3 months
* Positive alcohol, drug, or tobacco use/test
A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child

The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.

Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.

The researchers will compare whether blood oxygen levels were lower in the ORI group.


Eligibility Criteria:
Inclusion Criteria:

* Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
* Children with American Society of Anesthesiology physical status I, II, III

Exclusion Criteria:

* Patient who have chronic respiratory failure
* Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
* Patient whose initial Oxygen Reserve Index value is zero
* Patient who need supplementary oxygen before surgery
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
* Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria:

* Any intraocular surgery within 3 months
* Glaucoma
* Cataract
* High eye pressure
* Uncontrolled systemic disease
Oral Ivermectin for Chikungunya Viral Infection

Chikungunya viral infection (CVI) is a mosquito-borne infection, caused by chikungunya virus (CHIKV), an alphavirus, belonging to the family Togaviridae. This infection causes febrile illness associated with high fever, rash, acute deliberating and persistent arthralgia. There is no licensed vaccine or specific treatment for this infection. Ivermectin (IVM), commonly-used antiparasitic, has been demonstrated to inhibit replication of CHIKV.


Eligibility Criteria:
Inclusion Criteria:

* patients with virologic confirmation of chikungunya infection who had symptoms less than 72 hours prior to visit

Exclusion Criteria:

* patients with virologic confirmation of chikungunya infection who had symptoms more than 72 hours prior to visit
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer

The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.

The main questions it aims to answer are:

* 7-year ipsilateral breast tumor recurrence
* 7-year disease-free survival
* 7-year locoregional recurrence
* 7-year overall survival
* Adverse events of radiation therapy

Participants will be assessed by multi-dimensional methods after radiation therapy:

* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0


Eligibility Criteria:
Inclusion Criteria:

* Female patients with age minimum 19
* Pathological confirmation of HER2+ invasive breast cancer
* Eastern Cooperative Oncology Group performance status 0-2
* Informed consent of the participant

Exclusion Criteria:

* Pathological confirmation of ductal carcinoma in situ of the breast
* Previous history of radiation therapy to ipsilateral breast
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).

The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.

Eligibility Criteria:
Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
2. Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count

2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent

Exclusion Criteria:

1. Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
2. congestive heart failure
3. severe arrhythmia
4. nursing or pregnant women
5. aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
6. creatinine or serum bilirubin levels each 1•5 times or more than the normal range
7. active or previous malignancy
8. Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
9. History of clotting disorder
Raloxifene Use for The Heart

The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with established coronary heart disease or at risk for a major coronary event.

Exclusion Criteria:

* Postmenopausal symptoms that required estrogen replacement therapy.
* Suspected or known history of breast or endometrial carcinoma.
* Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.
* New York Heart Association classes III or IV heart failure.
Comparison of Quadratus Lumborum Block Types

This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption.

This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients undergoing lumbar spinal fusion surgery.
* Patients from 40-80 years.

Exclusion Criteria:

* Recent drug abuse
* History of illicit drug use
* Chronic pain patients not related to the back lesions.
* Opioid tolerant patients.
* Patients with any lower extremity weaknesses or deficits.
* Patients with American Society of Anesthesiologists (ASA) classification more than 3.
* Coagulopathy.
* Infection near or in the area of the block.
* Pregnant patients.
* Uncooperative patients who refuse care which directly effects research participation or clinical care.
* If the surgeon reports performing non-typical fusion.
* The presence of intraoperative complications like nerve injury or abnormal results of neuromonitoring and extensive dissection.
* Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.)
* Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control)
Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).

Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity

Frontal sinus surgery is a challenging component of endoscopic sinus surgery due to the intricacy and variability of frontal recess and sinus anatomy. Before the introduction of endoscopy in sinus surgery, complex cases of the frontal sinus were managed through the anterior wall using an osteoplastic flap approach. This technique was relatively successful in treating frontal sinus pathologies, but was invasive with adverse effects and failure in 6-25 percent of patients.

Different endoscopic techniques have been introduced for performing frontal sinusotomy. Draf categorized them into four techniques (Draf I, Draf IIa, Draf IIb, Draf III). Draf II procedures widen the frontal sinus outflow tract from the lamina papyracea laterally to the middle turbinate (Draf IIa) or the nasal septum medially (Draf IIb).

The thickness of the nasofrontal beak, and a limited anterior-posterior dimension of the frontal recess, make the Draf IIa frontal sinus surgery with angled endoscopy and instrumentation visually diffcult and requires skilled dexterity.

The direct access or Carolyn's window approach to the frontal recess replicates Draf's technique via the endoscopic approach. The approach utilizes only the 0° endoscope. In this approach, the entire frontal process of the maxilla, agger nasi and nasal process of the frontal bone, is removed with a high-speed drill.The goal of the approach is to visualize all walls of the frontal sinus via a ° endoscope. This postoperative view predicts better irrigation access and drainage of the frontal sinuses.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and CT scan.
2. Unilateral or bilateral cases.
3. Denovo or recurrent cases.

Exclusion Criteria:

1. Individuals younger than 18 year-old.
2. Neoplasms
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer


Eligibility Criteria:
Inclusion Criteria:

1. Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
3. Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
4. Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP).
5. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
6. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.

Exclusion Criteria:

1. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
2. Participant has any medical history of interstitial lung disease or pneumonitis.
3. Participant has cirrhosis or current unstable liver or biliary disease.
4. Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
5. Participant has a diagnosis of immunodeficiency.
6. Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
7. Participant has not recovered adequately from AEs.
8. Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter.
9. Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary.
10. Participant has HBsAg positive, or HCV RNA positive.
11. Participant is known HIV infection.
12. Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment.
13. Participant with contraindication to carboplatin and paclitaxel.
Driving Pressure and Postoperative Pulmonary Complications

This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to 19 years
* Patient who undergoes one-lung ventilation for thoracic surgery

Exclusion Criteria:

* The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
* Patient who is contraindicated with application of positive end expiratory pressure
* Patient who rejects being enrolled in the study
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.

Primary Objective:

--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.

Secondary Objective:

--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.

Exploratory Objective:

--To study correlation between SUVmax and ADCmean in the pelvic RRPC.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients who are 18 years and older
2. Histologically or cytologically proven prostate carcinoma s/p definitive radiation
3. Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
4. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

1. Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
2. Patients with contraindication to undergo MRI
3. Patients with prior allergy to MRI contrast agent.
4. Extreme Claustrophobia
The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture

The main questions it aims to answer are:

It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.

The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.

Participants will:

- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.

This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.


Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age or older
2. Acute proximal femur fracture surgery
3. A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
4. Independent prefracture indoor walking ability, indoor NMS ≥ 2
5. Ability to speak and understand Danish
6. Able to provide informed consent on the participants own behalf

Exclusion Criteria:

1. Known allergy to intravenous iron
2. Residing permanently at a nursing home
3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
6. Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
7. Renal replacement therapy
8. Severe dementia assessed by physician
9. Recent intravenous iron injection, 4 weeks prior to surgery
10. Patient declared terminally ill
11. Pathologic Fracture
Early Palliative Care in Metastatic Esophageal Squamous Carcinoma (ESCC) and Gastric Cancer

The majority of patients with newly diagnosed metastatic ESCC and gastric cancer patients experience a number of physical and psychosocial symptoms related to their cancer. Those patients endure the greatest level of distress from their disease relative to other cancer populations in China. Although new drugs have been applied in recent years, the median overall survival time of metastatic ESCC and GC patients are still around 12 months. Therefore, it is essential to maximize their quality of life (QOL) from the time of diagnosis. Multiple studies demonstrate that symptoms such as pain, fatigue, and anorexia are prevalent at diagnosis and worsen over time. As a result, suffering increases throughout the course of the illness. To be most effective, palliative care with intensive symptom management and psychosocial support should begin at the time of diagnosis, not once life-prolonging therapies have failed. And some studies have revealed that early palliative can even prolong the overall survival time in advanced lung cancer. The investigators then initiated a randomized phase III clinical trial with standard oncology care plus early palliative care or not in metastatic esophageal carcinoma and gastric cancer to observe whether the early palliative can improve the QOL and even prolong the overall survival time in those patients


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age ≥18 years old
* Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease.
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Karnofsky performance status ≥80
* Life expectancy of ≥ 3 month
* WBC \> 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.5 times ULN
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
* Normal ECG and heart function
* Fertile patients must use effective contraception
* Good compliance

Exclusion Criteria:

* Previous treatment of palliative chemotherapy
* Only with Brain or bone metastasis
* No measurable lesions, eg. pleural fluid and ascites
* Suffer from severe heart disease or disease with other important organs
* Chronic diarrhea or renal dysfunction
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA


Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants from 12 months of age to 15 months of age.
2. Consent form signed by both parents or by the legal representative(s), properly informed about the study,
3. Parent(s) able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
3. Any known recent (≤30 days) exposure to measles, mumps or rubella,
4. Any known recent (≤30 days) exposure to varicella or zoster involving:
5. Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
6. Active untreated tuberculosis,
7. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
8. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
9. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
10. Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3