cyrilzakka/clinical-trials huggingface dataset:
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)

Primary Objectives:

* Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
* Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR

Secondary Objectives:

* To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
* To characterize the safety and tolerability of BIVV020 in kidney transplant participants
* To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
* To evaluate the immunogenicity of BIVV020

Up to approximately 2 years

Eligibility Criteria:
Inclusion Criteria:

-Participant intended to receive SOC therapy per Investigator's judgment and local practice.

Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor.

Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.

* BMI ≤ 40 kg/m2.
* Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
* Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).

Exclusion Criteria:

* Participants who are ABO incompatible with their donors.
* Participants with known active ongoing infection as per below:

  1. Positive HIV.
  2. Positive HBV.
  3. HCV with detectable HCV RNA.
  4. Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention.
* History of active tuberculosis (TB) regardless of treatment.
* Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
* Prior treatment with complement system inhibitor within 5 times the half-life.
* Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comfort and Quality of Life of Older Cardiac Patients

The aims of the study were to determine the comfort and quality of life, to examine the relationship between them, and to identify factors that affect the comfort and quality of life in older cardiac patients. The cross-sectional study was conducted in the inpatient cardiology clinic of a university hospital in Bolu. Overall, 209 patients, who met the inclusion criteria, consisted of the sample. A descriptive characteristics form, the General Comfort Scale and Quality of Life Index Cardiac Version-IV was used to collect data. The study was reported in The Strengthening the Reporting of Observational Studies in Epidemiology Statement. Mean of the General Comfort Scale scores was 16.18±0.82, and the mean of the Turkish Quality of Life Index (QLI) Cardiac Version-IV scores was 2.97±0.39. Physical, psycho-spiritual, environmental, and sociocultural comfort levels associated with both the general QLI Cardiac Version-IV scale and sub-dimensions of its (p\<0.05). The location of residence, perception of income status, frequency of hospitalization, dietary adherence, routine health control, and dizziness were the independent variables associated with the General Comfort and Quality of Life scale (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* were to be 65 years and older,
* have a diagnosis of CVDs,
* speak and understand Turkish,
* can communicate verbally.

Exclusion Criteria:

* hearing impairments and cognitive limitations
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female 3 months of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
* Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
* Major congenital defects or serious chronic illness.
* History of seizures or of any neurological disease at study entry.
* Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
* Acute disease at time of enrolment
Addition of Acetaminophen in Standard PDA Management

Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.


Eligibility Criteria:
Inclusion Criteria:

* Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight \< 1000 grams
* Hemodynamically significant PDA as defined by any of the following:

  1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
  2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
  3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
* Echocardiographic criteria:

  1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5

Exclusion Criteria:

* No enteral feedings
* PDA-dependent congenital heart disease
* Prior treatment with prophylactic indomethacin
* Prior PDA treatment with any medications
* Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
* Abnormal liver enzymes (ALT \> 60 IU/L and AST \> 60 IU/L)
* Platelets count \< 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
* Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
* Prior enrollment to other interventional clinical study where PDA is an outcome variable
Low Glycemic Index and Load Diet for the Treatment of Acne

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.

Eligibility Criteria:
Inclusion Criteria:

* Having moderate inflammatory acne
* 18 to 25 years old
* Male
* Stable weight during the last 3 months

Exclusion Criteria:

* Previous or actual isotretinoin therapy
* Antibiotic therapy or during the last 3 months
* Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
* Endocrine disorders
* Drug and alcohol consumption during the last 6 months
* Tabacco use during the last 6 months
* Lactose intolerance
* Have eating disorders or gastrointestinal disorders
* Actual nutrition therapy
* Have chronic diseases that requires pharmacologic therapy
* Severe acne that requires isotretinoin therapy
Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder

This study aims to determine whether referral to the Bridge Clinic reduces overall index hospital length of stay when compared to direct referral to a long-term outpatient addiction provider for patients with active opioid use disorder (OUD) being considered for medications-for-addiction treatment (MAT).


Eligibility Criteria:
Inclusion Criteria:

* Inpatients at VUH with active OUD being considered for MAT.
* Patient accepting a transitional prescription for buprenorphine-naloxone or IM naltrexone whose outpatient plans are not fixed

Exclusion Criteria:

* Deemed ineligible for referral to outpatient Bridge Clinic by the Addiction Consult Team (examples include but are not limited to patients with severe, active co-occurring psychiatric disorders requiring a higher level of psychiatric care or patients for whom methadone maintenance is deemed the best choice of MAT).
* Patients previously randomized in this study.
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes

In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.


Eligibility Criteria:
Inclusion Criteria:

* Healthy overweight (BMI \>-95th) youth between 12 and 18 years of age
* Waist circumference \>-75th percentile
* Sedentary (no structured exercise \>2 times/week for past 6 months)
* Non-smokers, non-diabetic, no medical conditions
* Weight stable for past 3 months

Exclusion Criteria:

* Smokers
* Diabetes
* Psychiatric disorders
* Syndromic obesity
* Pregnancy
* Taking medications known to affect study outcomes
Falls From Sitting to Standing

Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called "pan-scan." Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls.

Study Design: We performed a retrospective review of consecutive patients from the trauma registry of a large, urban Level 1 trauma center. Inclusion criteria were registration during the 2019 calendar year, age ≥ 65, mechanism of fall from either sitting or standing, and performance of "pan-scan" at time of assessment. Patient demographics, physical exam findings, CT results, injuries, and patient disposition were recorded. The sensitivity, specificity, positive and negative predictive values of the physical exam for significant injuries were calculated.


Eligibility Criteria:
Inclusion criteria

* age \>65
* presented with fall from sitting or standing from 01/01/2019-12/31/2019

Exclusion criteria included

* age \<65 years,
* falls from height,
* GCS less than 14,
* patients who did not undergo the complete pan-scan.
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 657 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.


Eligibility Criteria:
Inclusion Criteria:

* Between 8 and 24 weeks gestation at enrollment
* Eligible for Medi-Cal (at or below 213% of the federal poverty level)
* Speak English or Spanish

Exclusion Criteria:

* Unavailable to attend group prenatal care sessions
* Not planning to continue prenatal care with site provider
* Cannot legally consent to participate in the study
Master Framework For Relapse or Refractory Acute Myeloid Leukemia

This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites

Treatment outcome for acute myeloid leukemia (AML) has improved over the last few decades. With intensive multidrug induction regimens, a complete remission is expected. Despite such advances, therapy resistance or relapse remains the main causes of death in adult patients and in children. Relapsed or refractory (R/R) AML is a hard-to-treat disease, with a 5-year overall survival (OS) estimate below 20% in adults and 30%-35% in children, and no standard of care exists. HSCT (allogeneic hematopoietic stem cell transplantation) remains the only curative strategy for R/R AML patients, including pediatric and elderly ones. Some new personalized therapies have recently been integrated into the treatment options of R/R AML. However, there is a need to collect consistent data on the efficacy of these new strategies in real-world settings. Lack of data from clinical trials can be a barrier in most countries, limiting patient accessibility to some very effective drugs. The STREAM study is part of the Horizon Europe Mission Cancer 2022 IMPACT-AML project, that proposes to create an inclusive master framework for relapsed or refractory acute myeloid leukemia. In STREAM we will collect data and monitor outcomes of patients with R/R AML across Europe. In close collaboration with the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, GA101157011), STREAM is developed under ERN-EuroBloodNet central registry, the European Rare Blood Disorders Platform (ENROL), incorporating EU standards for interoperability and the GPDR-compliant SPIDER pseudonymization tool offered by the EU-RD Platform in the context of rare disease registries will be implemented, to allow cross-hospital and cross-country participation. The STREAM study will allow to collect high-quality data from patients at any stage of the disease, for any cancer subtype, in any age group, including pediatric and elderly population, unfit patients, patients with rare mutations, patients with high-impact end-organ damage, patients from rural regions, post-transplant relapse. Data collected in STREAM will foster the production of novel knowledge on rare populations in a pragmatic setting and will form the basis for building international trials to be conducted worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AML diagnosis according to WHO2022 or ICC2022
* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria
* Participant or his/her legal representative is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.
ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder

BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied.

METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months).

HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.


Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV-TR criteria for panic disorder and/or social anxiety disorder as assessed by the SCID.
* Daily access to the Internet via computer and smartphone
* Residing in Sweden and speaking sufficient Swedish to communicate with the research team

Exclusion Criteria:

* Parallel psychological treatment
* Non-stable dosage of psychoactive medication during last 3 months
* Participants deemed to suffer from suicidal tendencies or another condition requiring specialized treatment
Anesthesia-induced Hypotension and Fluid Responsiveness

The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index \[PI\], pleth variability index \[PVI\], pulse oximetry plethysmographic variance \[ΔPOP\]) can best predict hypotension during induction of anesthesia.

Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. A well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. However, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. Since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs.

Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. In this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-6 years
* Scheduled to undergo elective surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification III or more
* Contraindication of laryngeal mask airway (LMA) insertion:

  (1) Esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index \[BMI\] \> 30, expected anesthesia time \> 2 hours)
* Arrhythmia
* Left ventricular failure (ejection fraction \< 40%)
* Congenital syndromes which are known to affect cardiopulmonary function
* Use of inotropics/vasopressors before anesthesia
* History of allergic reaction to drugs used in general anesthesia
Full Versus Partial Repairing of Soft Tissue Surrounding the Hip in Arthroplasty for Femoral Neck Fractures

A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ \<7, pathological fractures, non-walkers were excluded.

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.

Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Walker
* Hemiarthroplasty or Total Hip Arthroplasty
* Preiffer test \>7/10

Exclusion Criteria:

* Pathological fracture
* Non-walker
* Pfeiffer test \<7/10 indicating mental alteration