cyrilzakka/clinical-trials huggingface dataset:
Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial

A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

This was a randomized, single-blind controlled trial of women who underwent cesarean section at Healthpartners Regions Hospital. Potential participants were identified during routine obstetrical care of singleton pregnancies at Regions Hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. Patients were excluded if the cesarean section was performed emergently. Randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. Patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. Patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section

Exclusion Criteria:

* Severe immunocompromise (AIDS) or emergent nature of cesarean section
Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

Dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (CS). Although alterations in respiratory-swallow coordination is a known underlying pathophysiologic mechanism of dysphagia in multiple patient populations, no group has examined respiratory-swallow physiology in CS patients. The proposed study will examine respiratory-swallow physiology in CS patients and determine its association with unsafe swallowing and inferior health-related outcomes.

The proposed study will examine respiratory-swallow physiology in cardiothoracic surgical patients and determine its association with unsafe swallowing and inferior health-related outcomes. Participation will involve a single postoperative research exam of approximately 60-90 minute duration. Participants will be seated upright and positioned for simultaneous instrumental imaging of swallow physiology, nasal airflow monitoring, and respiratory inductance plethysmography testing.

Eligibility Criteria:
Inclusion criteria:

* Adults over 18 years of age who have undergone cardiothoracic surgery at UF Health
* No allergies to barium
* Not pregnant
* Willing to participate in study

Exclusion criteria:

* Individuals 18 years of age or younger
* Allergies to barium
* Pregnant
* Not willing to participate in study
Study of the Effects of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent Provirus

The Farnesoid X receptor (FXR) is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism. A recent study opens the hypothesis that Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes. This hypothesis implied that modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus replication. The results of in vitro studies with Human Immunodeficiency Virus-infected cell lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death; the overall effect is therefore antiviral. Farnesoid X receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies. This last data raises the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus.

It is therefore crucial to confirm on quiescent CD4 + T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models.

Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome. The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains. It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 + T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART. Human Immunodeficiency Virus-positive patients will be any patients, irrespective of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of antiretrovirals, away from primary infection, when they already had a complete western blot, indicating an evolution of the infection without treatment and constitution of an already evolved reservoir. Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 + T lymphocytes / mm3.


Eligibility Criteria:
Inclusion Criteria:

* human immunodeficiency virus infected patients
* T CD4 \> 500/mm3. Viral load undetectable for more than a year under stable treatment. No history of virological failure.
* under first line cART treatment
* Indetectable viral load

Exclusion Criteria:

* Acute or chronic anemias.-
* Acute infections, fever
* Vaccination in the two months preceding inclusion.
Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.

Intravitreal injections of erythropoietin for off-label use have been shown to be beneficial in eyes with diabetic macular edema.However, the pharmacokinetic profile of erythropoietin after intravitreal injection in humans has not yet been determined clearly. The purpose of this study was to determine the intraocular pharmacokinetics of erythropoietin after a single intravitreal injection in a prospective investigation.

Eligibility Criteria:
Inclusion Criteria:

* diabetic macular edema that failed to respond to or recurred after the previous macular focal laser photocoagulation or intravitreal therapy, or both.
* visual acuity worse than 40/200 snellen bisual acuity

Exclusion Criteria:

* Eyes with vitreomacular traction, active proliferative diabetic retinopathy, intraocular inflammation, uncontrolled intraocular pressure , cataract surgery within the past six months, or a prior history of vitreoretinal surgery
Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain

Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes. Our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic LBP participating in a multi-station full-body supervised exercise program. The results obtained may permit generation of potential treatment effect modifiers that will eventually have to be validated before being recommended for clinical practice.

All participants took part in the 6-week exercise program, as well as in the two evaluation sessions (pre- and post- exercise program). At the initial evaluation, subjects completed forms and questionnaires on sociodemographics, symptomatology, comorbidities, work restrictions, pain and functional limitations and fear-avoidance beliefs. A physiotherapist measured their lumbar and hip mobility, conducted diagnostic and pain provocation tests and assessed endurance of the trunk muscles. Following the initial evaluation, subjects took part in the 6-week multi-station full-body supervised exercise program (2 to 3 sessions per week). The Oswestry disability questionnaire (ODI) was completed at the initial and at the final evaluations. The change in ODI score following the program was considered the principal measure reflecting favorable or unfavorable outcome.

An improvement of 50% in the initial ODI score was considered the reference standard to determine a favorable outcome. Univariate associations with favorable outcome were tested using chi-square or paired t-tests. Variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. Finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable.

Eligibility Criteria:
Inclusion Criteria:

* episode of subacute or chronic LBP with or without radiation to the lower limbs
* minimal score of 17% on the Modified Oswestry Disability Index

Exclusion Criteria:

* previous surgery to the spinal column,
* lumber spine injection in the past two weeks
* signs of upper motor neuron lesions
* serious medical conditions (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis)
* unavailability to participate in the 6-week exercise program
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.

Eligibility Criteria:
Inclusion Criteria:

* overall healthy subjects;
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug;
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
* history of gastrointestinal issues or procedures;
* history of seizures, diabetes or cancer (except basal cell carcinoma);
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
* abnormal screening laboratory results that are considered clinically significant by the investigator;
* current enrollment in another clinical study;
* previous enrollment in this study;
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
* pregnant or breastfeeding female;
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Improving Post-discharge Antimicrobial Use

One in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. The investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving antimicrobial selection and duration.

Antimicrobial stewardship programs (ASPs) work to improve antibiotic prescribing within hospitals. ASPs often restrict their activities to inpatient antimicrobial-prescribing. However, at least 40% of all antimicrobial exposure associated with an acute-care hospital stay is prescribed at the time of hospital discharge (i.e., post-discharge). Post-discharge antimicrobials mediate clinical outcomes after discharge and may facilitate the spread of antimicrobial resistance.

Several studies have shown that post-discharge antimicrobial use is often inappropriate. For example, using national VA data, the investigators found that 61% of fluoroquinolone treatment days were prescribed at hospital discharge; manual chart reviews at 9 hospitals found that 40% of these post-discharge fluoroquinolone prescriptions were either unnecessary or sub-optimal. Other studies have found that 53-79% of all post-discharge antimicrobials are either unnecessary or sub-optimal.

Post-discharge antimicrobials are an important target for antimicrobial stewardship. However, inpatient stewardship metrics do not capture post-discharge antimicrobials and ASPs frequently do not evaluate these prescriptions. A 2016 VA survey found that less than 50% of hospitals routinely reviewed targeted antimicrobials at discharge. According to a 2016 survey in Michigan, only 17% of 48 hospitals had a process for reviewing outpatient antimicrobial orders at discharge.

It is unclear how inpatient stewardship resources can be effectively leveraged to improve post-discharge antimicrobial use. If the goal is to improve post-discharge antimicrobial use, a potentially effective strategy may be an audit-and-feedback process focused solely on prescriptions for patients who will soon be discharged. In this trial, the investigators will evaluate the feasibility and effectiveness of such a process.

Eligibility Criteria:
Inclusion Criteria:

--The local stewardship team agrees to implement the discharge stewardship intervention on at least one inpatient service or ward.

Exclusion Criteria:

--The hospital already has an audit-and-feedback process in place that focuses on antimicrobial prescribing at hospital discharge.
A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise).

The proposed study will involve 4 group sessions each week for a total of 13 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 26 sessions (2 per week).

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Over 60 years of age with unwanted loneliness
* Must live in the city of Valencia
* Must speak Spanish or Valencian (or have sufficient knowledge to be able to answer the questions in the study).

Exclusion Criteria:

+ Severe mental disorder or dementia.
Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors

This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.

This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies. The primary objective is to determine the maximum tolerated dose (MTD), safety profile, and the overall response rate (ORR) of CAR-T cells in these patients. Secondary objectives include assessing marrow remission rates and minimal residual disease (MRD) clearance at various time points (2 weeks, 1 month, 3 months, 6 months, and 1 year) in patients with bone marrow involvement, as well as evaluating the changes in multiple sites of involvement through PET-CT or PET-MRI before and one year after CAR-T therapy. The study will also track event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) rates at 1, 2, 3, and 5 years post-treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients with relapsed/refractory hematologic malignancies confirmed to express CD19, CD22, CD20, CD7, CD5, CD2, CD79b, BCMA, GPCR5D, CD38, CD33, CD123, CD133, CLL1, EBV (GP350, LMP1), CMV (Gb21, gB280...) or other validated targets (supported by domestic and international preclinical/clinical evidence) who meet the following criteria:

Male or female, aged ≥18 years and \<75 years; Newly diagnosed patients with refractory disease (as defined by respective diagnostic criteria) after chemotherapy; Newly diagnosed patients with disease progression during chemotherapy and poor anticipated response to further chemotherapy; Patients with relapsed disease (≥1 recurrence) and confirmed residual tumor evidence; Patients with relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Patients with relapse after CAR-T therapy; Patients with hematologic malignancies deemed incurable by current surgical, radiotherapy, or chemotherapy interventions.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

Life expectancy \<12 weeks; Genetic testing reveals mutations or structural variants associated with the target antigens; Severe graft-versus-host disease (GVHD) requiring immunosuppressive therapy in post-HSCT relapse patients; Post-HSCT relapse \<3 months with no available donor;

Organ dysfunction:

Serum creatinine \>2.5 mg/dL; ALT/AST \>5× upper limit of normal (ULN); Total bilirubin \>2 mg/dL; Uncontrolled active infection; Active hepatitis B/C or HIV infection; Anticipated early loss to follow-up (\<3 months post-treatment); Failure to provide signed informed consent or lack of ethics committee approval; Concurrent systemic conditions that may interfere with study participation; Other exclusion criteria deemed appropriate by the investigator.
BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c \>7.0% to 10% for patients on metformin only
4. HbA1c \>7.0% to 10.0% at Visit 2 (Start of Run-in)
5. Age \>=18 and \<80years
6. Body Mass Index (BMI) \<=40 kg/m2
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
9. Treatment with anti-obesity drugs within 3 months prior to informed consent
10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
11. Alcohol abuse or drug abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial
Strengthening in Functional Mobility of Active Elderly

Aging is characterized by functional losses among which, the related to mobility and balance may be highlighted. Regular physical activity, including muscle strengthening exercises, is beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8 weeks-program of lower limbs strengthening exercises in the balance and functional mobility of physically active elderly. The investigators evaluated 18 women, with ages between 61 and 80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of the lower limbs, the workload was determined by the strength reached in the eight-repetition maximum test (8RM), applying progressive load increments between training sessions conducted (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of training, with subsequent adjustment of the load for the subsequent training. The training took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and statistically significant increase in muscle strength were observed in all muscle groups trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not significantly different after training. Therefore, strength training proposed was efficient in improving muscle strength in the lower limbs of irregular physically active elderly, impacting positively on functional gain gait. However, the gain in muscle strength was not enough to generate significant results in static balance probably due to the type of exercise performed as well as due being limited to muscle groups of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* aged between 61 and 80
* irregularly active (IPAQ)

Exclusion Criteria:

* Presence of one or more of the following conditions: neurological diseases, impaired cognitive autonomy or limited self-determination capacity, limiting orthopedic injury, orthoses for lower limb, hip or knee prosthesis, the cardiorespiratory system diseases or any kind of commitment that prevented the permanence in the standing position.