cyrilzakka/clinical-trials huggingface dataset:
18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors

To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging either for an initial assessment, recurrence detection or assessment of pathologic response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and tumor to background (TBR). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

Eligibility Criteria:
Inclusion Criteria:

patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
* Inform consent signed.

Exclusion Criteria:

* FEV1 \<40% of reference value.
* Respiratory insufficiency (pO2 \<60 mmHg or pCO2 \>45 mmHg).
* Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio \> 1.5).
* Bullous emphysema.
* Pulmonary arterial hypertension.
* Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).
* Psychiatric illness.
* Comorbidities that could increase the risk of the TBLB.
* Pregnancy.
Dental Implant Supported Removable Dental Prostheses

To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Extraction sockets should have healed at least 4 months
* Sufficient bone volume to place six implants in the maxilla
* No previous bone augmentation procedures
* The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
* Accepting to comply with study procedures

Exclusion Criteria:

* Physical or psychological disorders prohibiting implant treatment
* Heavy smoking (\>10 cigarettes/day)
* Present alcohol and/or drug abuse
* Physical handicap that may interfere with the ability to perform oral hygiene
Femoral Bone Metastases

Bone is a common site of metastasis for a range of malignancies. Bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. Previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function.

The goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. Patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease characteristics, ambulatory status and limb function will be documented before treatment. These Clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of malignancy other than lymphoma
* Presence of femoral metastases at high risk of pathologic fracture (Mirels' score 8 or more)
* At least 18 years of age
* Able to provide written informed consent
* Able to participate in follow-up

Exclusion Criteria:

* Surgical consultation for the purpose of obtaining a tissue/histological diagnosis only, not for treatment
* Histological diagnosis of lymphoma
Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients

Sodium-glucose co-transporter 2 inhibitors (Sglt2i) attenuate the incidence of cardiovascular events in individuals with preserved or mildly reduced kidney function. Whether this benefit is also observed among individuals with end-stage renal disease (ESRD), in whom cardiovascular disease is a leading cause of mortality, remains unexplored. To appraise the influence of dialysis on the pharmacokinetics of Sglt2i is a prerequisite to determining the treatment regimen that best fits this population.

In this study ESRD individuals, aged 18 years and older, on a regular dialysis regimen for a minimum of 3 months at the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp) will be enrolled in a pharmacokinetics study.

In the single-dose protocol, hemodialysis participants will take Dapagliflozin 10mg P.O. immediately before the dialysis session, and blood samples will be collected every 30min during dialysis and again 24h and 48h after termination. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis.

In the multiple-dose protocol, both hemodialysis and peritoneal dialysis participants will take Dapagliflozin 10mg P.O. daily in the morning for 7 days. Blood samples will be collected at baseline, and again after 48h and 7 days.

The plasma levels of dapagliflozin and its inactive metabolite, D3OG, will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry.

The primary outcome is the plasma concentration-time curve of dapagliflozin and its inactive metabolite D3OG during a regular hemodialysis session. Secondary outcomes are: (i) the steady-state plasma concentration of Dapa; (ii) the accumulation ratio of Dapa; (iii) the total mass of Dapa and D3OG extracted by the dialysate; (iv) the dialytic clearance of dapagliflozin.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis for 3 months or more prior to enrollment
* 18 years of age or older
* Signed the informed consent form

Exclusion Criteria:

* Liver dysfunction
* Allergy to dapagliflozin
* Currently receiving a Sglt2i
Nurse Delivered Cell Phone Adherence Intervention (Pick It UP)

Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.

This study is testing a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling only; (c) control counseling + regimen tailored text reminders; or (d) control counseling only. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 9 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Currently taking HIV treatment medication with non-adherence

Exclusion Criteria:

* Under age 18
* Not HIV positive
* Not taking HIV treatment medications
* Adherent to HIV Medications
Assesment of Two Different Modalities of Maxillary Canine Retraction Assisted With Injectable Platelet Rich Fibrin

The present prospective clinical study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with injectable platelet rich fibrin.


Eligibility Criteria:
Inclusion Criteria:

* An age range from 15-22 years.
* Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
* All permanent teeth present, 3rd molars are excluded.
* Good oral and general health.
* No systemic disease/medication that could interfere with OTM. No previous orthodontic treatment.

Exclusion Criteria:

* Patient diagnosed to have an indication for non-extraction approach.
* Poor oral hygiene or periodontally compromised patient.
* Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction

A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.

The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.

The local infiltration analgesia will be performed by the surgeon during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Statut ASA I-III.
* Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

Exclusion Criteria:

* Pregnancy.
* Contraindication to local anesthesia.
* Patient with chronic pain, opioid consumption or alcohol consumption.
* Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
* Patient with diabetic or femoral neuropathy.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK

This is a National, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital in the UK and to assess the level of adherence of subject receiving SAIZEN® via Easypod™.

Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

- To assess the level of adherence of subjects receiving SAIZEN via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN via easypod™
* To identify adherence subject profiling
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF-1) (i.e. above, below or within normal ranges)
* To assess the endocrinological profile including Triiodothyronine (T3), Thyroxine (T4), Thyroid-stimulating hormone (TSH), Insulin-like Growth Factor 1 (IGF-1) and Insulin-like Growth Factor-Binding Protein 3(IGFBP-3) levels
* Temporal profile of IGF-1 and IGFBP-3 levels

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod electromechanical injection device according to Summary of Product Characteristics (SmPC)
* Over the age of 2 years
* Under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the Investigator, where relevant)
* Appropriate Informed Consent/Assent provided

Exclusion Criteria:

* Patients taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to Saizen as defined in the SmPC or any other condition which precludes the use of SAIZEN in a given patient
* Use of an investigational drug or participation in an interventional clinical trial
Severe ARDS: Generating Evidence

An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.

Approximately one-quarter of ARDS patients develop severe hypoxemia, which has been associated with mortality rates approximating 40-50%. The majority have been described to present with severe disease at baseline, suggesting an opportunity for early intervention. In addition, use of evidence-based practices in severe ARDS is highly variable and inconsistent; use of unproven treatment modalities is also frequently seen. Given the variability in treatment practices in severe ARDS, an understanding of the patient-level and institutional-level factors contributing to differences in therapeutic approach is needed in order to improve the quality and consistency of care given to these high-risk patients. SAGE is a multicenter, observational cohort study examining the patient-level and institutional characteristics associated with variability in management of patients with moderate to severe ARDS, factors associated with survival or need for adjuvant therapy, and variability in ventilator management of patients on extracorporeal membrane oxygenation. Findings from this observational study can subsequently be used to inform future interventional trial development.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU
3. Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours:

   1. Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules
   2. Respiratory failure not fully explained by cardiac failure or fluid overload
   3. PaO2/FiO2 ratio \< 150 with a minimum of 5 cmH20 PEEP

Exclusion Criteria:

There are no exclusion criteria.
Imipenem and Sulbactam in the Treatment of Imipenem-resistant Acinetobacter Baumannii Bacteremia

Infections caused by imipenem-resistant Acinetobacter baumannii are associated with high mortality and morbidity. The treatment choices for this resistant pathogen are limited.

The objective of the present proposal is to evaluate the effectiveness of combination therapy of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the clinical effect with the in vitro synergistic results.

Acinetobacter baumannii has been increasingly reported in the outbreak of nosocomial infections in the intensive care units, which not only prolong the length of hospital stay but result in high attributable mortality. With its intrinsic resistance to many antimicrobial agents and rapid acquirement of resistance mechanism, resistance to carbapenems, which is often accompanied with resistance to multiple drugs, has emerged worldwide. The limited treatment choice included tigecycline, colistin, and sulbactam. However, the low serum level and bacteriostatic nature of tigecycline hamper its application in blood stream infection, one of the most common presentations of A. baumannii infections. The nephrotoxicity and neurotoxicity of intravenous colistin have caused great concerns in critically ill patients whereas immediate bronchospasm after inhalation and significant clinical consequences have been reported. Sulbactam has been used for decades in combination of ampicillin and well tolerated. However, the emergence of resistance strains and discourage of monotherapy in severely ill patients make combination an attractive choice. Combination of sulbactam and carbapenems has good synergism against A. baumannii with elevated minimal inhibitory concentration (MIC) of sulbactam and/or carbapenems while in an animal model using A. baumannii with higher MIC of both sulbactam and meropenem, survival rate was higher in combination group than sulbactam or meropenem-treated alone group. The similar in vivo bactericidal effect was also observed in combination of imipenem and sulbactam. Despite plenty of in vivo and in vitro studies mentioned above, the clinical studies were limited. Besides, the information regarding the correlation of in vitro synergistic effect of carbapenem and sulbactam with the clinical effect is rarely mentioned. Therefore, our study is aimed to evaluate the effectiveness of combination therapy of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the clinical effect with the in vitro synergistic results

Eligibility Criteria:
Inclusion Criteria:

* elder than 18 years old are included if they have bloodstream infections due to A. baumannii regardless of primary infection sites

Exclusion Criteria:

* pregnancy or lactation in women
* history of serious allergy or intolerance to study drug therapy
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)

The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, release of medical information, and HIPAA forms
* Age greater than or equal to 18 years
* Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test
* Implanted with an FDA-approved LVAD (for BTT or DT indication, e.g. HeartMate® XVE) within 72 hours prior to randomization, and able to receive the first dose of study drug by 72 hours (+6 hours) post LVAD implantation
* Post-op hemostasis adequate for starting low level anticoagulation (as assessed by surgeon)
* Extubated and able to take oral medication

Exclusion Criteria:

* Evidence of active bleeding within 24 hours prior to randomization
* History of a platelet disorder, including but not limited to thrombocytopenia and thrombasthenia
* Thrombocytopenia with platelets \<80,000/ml within 48 hours prior to randomization
* History of an inherited or acquired coagulation disorder
* Hemoglobin \<8 g/dL (4.85 mmol/L) or hematocrit \<26% within 24 hours prior to randomization
* Clinical indication for (or the intention to use) standard anticoagulation therapy at time of randomization (e.g., atrial fibrillation or DVT)
* Intention to treat with more than 325 mg aspirin daily
* Any clinical requirement or intention to treat with phenytoin, tolbutamide or warfarin post randomization
* RVAD support at the time of randomization
* Estimated glomerular filtration rate (GFR) ≤30 ml/min (by Cockcroft-Gault formula), or any form of dialysis within 48 hours prior to randomization
* Evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or liver enzyme values (AST or ALT) that are \>3 times the upper limit of normal; or Total Bilirubin \>1.5 times the upper limit of normal (with the exception of Gilbert's Syndrome) within 3 days prior to randomization
* Active systemic infection, in the judgment of the investigator, within 3 days prior to randomization
* Stroke or transient ischemic attack (TIA) within 6 months prior to randomization
* History of intracranial hemorrhage or gastrointestinal bleed within 3 months prior to randomization
* Alzheimer's disease, or any other form of irreversible dementia
* History of psychiatric disease (including drug or alcohol abuse) that may impair compliance with the study protocol
* Pregnant or breastfeeding at time of randomization
* Received investigational intervention within 30 days prior to randomization
* Body weight \< 45 Kg
Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury

Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes.

Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.


Eligibility Criteria:
Inclusion Criteria:

all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021

Exclusion Criteria:

the patients who did not received debridement or flap reconstruction surgery for Pressure injury