cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System

The study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019 assessing for difference in anesthetic techniques and outcomes.

The study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019. The purpose of the study is to evaluate the effects of anesthetic techniques for primary total joint replacement in Northern California Kaiser Permanente. The primary objective is to determine if there are clinically and statistically significant differences between the outcomes of general anesthesia and neuraxial anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - IV patients
* Age \> 18
* Primary total hip/knee replacement

Exclusion Criteria:

* Total joint replacement for oncologic tumors
* Emergent surgery
* Age \< 17
* Pregnant Female
* Neuraxial anesthesia conversion to general anesthesia
* Revision total joint replacement
* Bilateral total joint replacement
Hydrolysed Rice Formula Study

This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 0-13 months
* Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA
* Will receive at least 30% of energy requirements from the study formula
* Written informed consent from parent/carer

Exclusion Criteria:

* Severe CMA (including anaphylaxis) and/or requiring an AAF
* Faltering growth (based on NICE guidelines36 - Appendix 1)
* Previous allergy to any study product ingredients (including whey hydrolysate and/or rice)
* Primary lactose intolerance
* Food Protein-Induced Enterocolitis Syndrome (FPIES)
* Exclusively breast fed
* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes
* Severe hepatic or renal insufficiency
* Premature infants (born \<37 weeks) with a corrected age of \<4 weeks
* Requirement for any parenteral nutrition
* Participation in other clinical intervention studies within 1 month of recruitment
* Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements
Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC

In China, primary hepatocellular carcinoma (HCC) has high morbidity and mortality, imposing a heavy burden on the public. Surgical resection is an effective treatment, but as HCC is often latent, less than 30% of patients are suitable for surgery at first diagnosis. So systemic anti-tumor therapy is crucial for advanced HCC. Small-molecule targeted drugs like lenvatinib and sorafenib are NCCN-recommended first-line drugs for advanced HCC. The combination of targeted drugs and immune checkpoint inhibitors can prolong overall survival with good safety. The "2024 Guidelines for HCC Diagnosis and Treatment" shows that platinum-containing chemotherapy is a preferred systemic treatment for advanced HCC. However, in real-world practice, the efficacy and safety of the combination of targeted-immunotherapy and chemotherapy regimen for advanced HCC remain unclear.

This study is a retrospective cohort study aimed at evaluating the efficacy and safety of TKI + PD-1 inhibitor + XELOX chemotherapy in the treatment of advanced HCC. The study included the clinical data of 68 patients with advanced HCC who could not undergo radical surgical resection and received first-line triple-drug therapy (lenvatinib as TKI + camrelizumab/ tislelizumab/ atezolizumab as PD-1 inhibitor + capecitabine and oxaliplatin as XELOX chemotherapy regimen) in the Hepatobiliary Surgery Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University from April 2022 to December 2024. Demographic information, imaging information, blood biochemistry, blood routine, alpha - fetoprotein and other information of patients were collected as baseline information. Subsequently, based on the RECIST v1.1 standard, the objective response rate (ORR) evaluated by the researchers was set as the primary endpoint, and the surgical conversion rate, overall survival (OS), progression - free survival (PFS), and the incidence of adverse events were analyzed as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Be aged 18 years or older and be diagnosed with HCC by histology, cytology, or imaging studies.
2. Have HCC with a clinical stage corresponding to Barcelona Clinic Liver Cancer (BCLC) stage C.
3. Have not undergone systemic treatment previously, and initially receive the targeted - immunotherapy combined with XELOX chemotherapy regimen (lenvatinib + Sintilimab or Camrelizumab or Tislelizumab + Capecitabine + Oxaliplatin) upon the diagnosis of HCC.
4. Have a liver function classified as Child - Pugh grade A or B.
5. Have an ECOG PS score of 0 or 1.

Exclusion Criteria:

1. Experienced rupture and bleeding of esophageal or gastric varices within the past six months.
2. Imaging findings indicate the presence of main portal vein invasion in hepatocellular carcinoma.
3. Imaging results show inferior vena cava involvement in hepatocellular carcinoma.
4. Imaging examinations reveal cardiac involvement in hepatocellular carcinoma.
5. Pregnancy and lactation.
Imaging of Pilosebaceous Units and Acne Lesions by RCM and OCT Confocal Microscopy and Optical Coherence Tomography

The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects, biodistribution and selective photothermolysis provided by gold microparticles and diode laser pulses, using RCM, OCT and histology.


Eligibility Criteria:
Inclusion Criteria:

All subjects

1. Healthy men and women
2. 18-45 years of age at baseline
3. Legally competent, able to give verbal and written consent
4. Communicate in Danish verbally as well as in writing
5. Women with negative pregnancy-test
6. Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
7. Fitzpatrick skin phototype I-III

Acne skin

1. Subject with previous or prior clinical diagnosis of acne vulgaris, IGA score 1-4
2. Subjects with 1 - 75 inflammatory facial lesions on the cheek, forehead, and/or chin, with no more than 2 nodulocystic lesions (see Appendix II, table 4)
3. Each included patient with acne should represent at least 3 of 5 acne lesions
4. Subject with in good general health, willing to participate and able to give informed consent, and able to comply with protocol requirements

Exclusion Criteria:

1. Pregnant and lactating women
2. Subject with a known allergy to gold, or any other ingredient in the microparticle suspension
3. Individuals with skin diseases or skin lesions in the area of research interest will be excluded
4. Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study
5. Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator
6. Subject with a history of keloids which is deemed clinically relevant in the opinion of the investigator
7. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or very severe acne requiring the continuation of systemic treatment during the study period.
8. Subject with active skin disease or excessive scarring that, in the opinion of the investigator, would impact the ability to administer the gold microparticles or use of OCT/RCM in the areas
9. Subject having used oral retionoid therapy such as isotretionoin within 3 months prior to baseline.
10. Subject having used topical retinoids, topical corticosteroids, topical antibiotics or combination therapy within 2 weeks of baseline
11. Subject having used over-the-counter topical products containing azelaic acid, benzoyl peroxide, and/or salicylic acid within 1 week of baseline
12. Subject having used light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area within 3 weeks of baseline.
13. Subject who has received an investigational drug or was treated with an investigational device within 30 days prior to baseline.
The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.

Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with osteoarthritis in need of a TKA

Exclusion Criteria:

* Inflammatory arthritis
* Post-traumatic arthritis
* A history of or current venous thromboembolic disease
* Any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
* Preoperative hemoglobin \<10 g/dL or a platelet count \< 140,000 /uL3
* Allergy to TXA
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes

The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.

After taking informed written consent, the recruited patients will be subjected to the following:

1. Detailed history

   * Personal History: Name, age ,residence ,special habits of medical importance
   * Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
   * Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
   * History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.
2. Examination of the patients General examination: blood pressure, pulse, temperature

   Abdominal examination:
   * Inspection: fundal level, scars, umbilicus.
   * Palpation: presence of contractions, fetal lie and presentation.
   * Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
   * Non stress test to ensure reassuring fetal well being
   * Ultrasound examination to:-

     * Assess fetal viability.
     * Amniotic fluid index.
     * Determine gestational age.
     * Exclude major anomalies.
     * Placental location.
3. Baseline laboratory investigations:

   * Complete blood count (CBC).
   * Prothrombin time (PT).
   * Activated partial thromboplastin time (aPTT).
   * Liver and kidney function.

The included patients were randomized using sealed opaque envelope method into one of two groups:

Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.

Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age between 24 and 34 weeks

Exclusion Criteria:

* Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as

  * Emergency Cesarean section.
  * Chorioamnionitis.
  * Placenta previa.
  * Multiple gestation.
  * Preeclampsia.
  * Macrosomia.
* Non reassuring fetal status or fetal distress
* Presence of fetal anomalies incompatable with life
* Woman with antepartum haemorrhage
* Diagnosis of Established preterm labor
Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of participants with moderate or severe psoriasis. The purpose of this study was to describe the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate adalimumab efficacy and safety profile.

Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
* Participant has indication of psoriasis systemic therapy
* If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
* Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
* Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
* A vasectomized partner
* Total abstinence from sexual intercourse
* Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

* Participants who have active infections
* Participants enrolled in another study or clinical trial
* Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
* History of active tuberculosis (TB), histoplasmosis or listeriosis
The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China

At present, the elderly population in China has reached 241 million, and there are more than 20 million elderly surgical patients every year, accounting for about 25% of the surgical population. However, there is no research report on the anesthesia related risk factors of death of elderly patients in hospital. The purpose of this study is to analyze the perioperative data of multicenter database, and to explore the anesthesia related death risk factors of elderly patients with noncardiac surgery in the investigator's country, especially within 24 hours after surgery, so as to help improve the anesthesia management technology of elderly patients during surgery, improve the medical quality of perioperative period, and improve the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* 1.patients larger than 65 years old at the time of surgery 2.Patients hospitalized for surgery between Jua 2008 to April 2020

Exclusion Criteria:

- 1.Critical demographic information and course records are inaccurate or missing.

2.The outcome could not be determined during the hospitalization. 3.Cardiac surgery patients 4.Patients undergoing surgery under local anesthesia
AIMN Multicenter Study: Staging of Lymphomas Using PET/CT

In recent years, the introduction of PET/CT tomographs (which have now almost completely replaced tomographs equipped with PET alone), has allowed a significant increase in diagnostic accuracy in the majority of tumors. However, in order to reduce the radiation doses, administering CT images are acquired for patients at a low dose (generally 60mA 120kV) without the use of contrast agents. This prudential attitude, however, makes it essential to carry out "diagnostic" CT investigations which, at the end of the diagnostic process It leads to an increase in the dose administered for the patient rather than to savings.

This study aims to evaluate the possible advantages in diagnostic, economic and quality of life terms of PET/CT performed with diagnostic CT with intravenous contrast medium, with the aim of benefiting the neoplastic patient in the diagnostic process by optimizing (from a temporal and dosimetric point of view ) the diagnostic procedures to which it is subjected.

It is expected that the integrated PET/CT procedure can facilitate the process of staging the neoplasm and that this procedure can have a positive impact on the patient's quality of life while also reducing the costs incurred in terms of time and money.


Eligibility Criteria:
Inclusion Criteria:

* Established lymphoma (non-Hodgkin's lymphoma and Hodgkin's disease) being staged;
* Performing the PET/CT examination within two weeks of diagnosis and before treatment;
* Signing of the Informed Consent.

Exclusion Criteria:

* patients \<18 years;
* Patients who have not signed the Informed Consent;
* Execution of previous anti-inflammatory or anti-inflammatory therapies in the 4 weeks preceding the PET exam.
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation.

In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.


Eligibility Criteria:
Inclusion Criteria:

* LVAD (HVAD, Heartware Inc., Framingham, MA, USA) implantation more than one month ago
* Stable renal function (clinical judgement)
* Age 18 years or older
* Ability to give informed consent

Exclusion Criteria:

* Severe chronic renal impairment (CL\<30)
* History of significant thromboembolic events
* Significant bleeding disorder
* HIV or Hepatitis C infection
* Heparin induced thrombocytopenia
* Known hypersensitivity to Dabigatran or Phenprocoumon
The INFLUENCE of Cytoreduction on PRO in EOC

Based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. This will be achieved through a translational biomedical research approach. Due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles \[+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of \>1 cm2 and stage IV)\]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).

Eligibility Criteria:
Inclusion Criteria:

* Epithelial ovarian cancer
* Stage \> II
* ECOG \< II
* Treated with primary surgery followed by chemotherapy
* Willing to participate and to sign the informed consent

Exclusion Criteria:

* \< 18 years old
* Borderline and non-epithelial ovarian tumors
* Stage \< II
* Advanced ovarian cancer submitted to neoadjuvant chemotherapy
* ECOG 3-4
* Pregnancy
* Severe cardiopulmonary disease
* Patients participating in QoL intervention studies