cyrilzakka/clinical-trials huggingface dataset:
The BRIDGES Project: Bridging Resources to Engage Women in Integrated HIV Care and Support Services

The BRIDGES Project seeks to test a program intended to help women living with HIV who face specific barriers due to culture, gender, violence, trauma, adverse mental health, and substance use to be able to better access HIV care. This program was created and tried with women living with HIV, as previously studies have indicated that women with these experiences are less likely to have stable HIV care. The BRIDGES Project will use Peer Navigators, who are other women living with HIV who have had similar experiences and have been successful in accessing care, to help other women living with HIV to access HIV care and stay in HIV care. The BRIDGES Project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and Peer Navigator. Through participation in BRIDGES, women will: (1) build skills to cope with HIV care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to HIV treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.

The BRIDGES Project intervention is culturally-tailored intervention for syndemic-affected cis- and transgender women living with HIV/AIDS (WLHA) that aims to: 1) build skills to cope with syndemic-related affective distress, 2) facilitate linkages to both HIV treatment and relevant ancillary service providers (e.g., domestic violence, mental health, substance use), and 3) teach women interpersonal skills to activate social support networks (e.g., service providers, friends, family) when faced with new or ongoing barriers. Participants in the The BRIDGES Project are estimated to demonstrate improvements in HIV care outcomes (i.e., linkage to HIV care, self-efficacy in ART adherence, retention in HIV care) and syndemic-support outcomes (i.e., coping skills, activated social support networks, linkage to and receipt of ancillary support services) compared to HIV-infected women assigned to standard of care (self-guided access and use of Ryan White case management).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Identify as female, including cis-gender female or transgender female
* Living with HIV/AIDS
* Ability to speak and understand English
* Self-report one or more syndemic factor(s) \[lifetime history of or current: trauma, physical violence and/or sexual violence, PTSD symptoms, substance use, adverse mental health\]
* identification as one of the following: out-of-care or unstable in care, newly diagnosed, never in care, or linked to care but have fallen out of care\]
Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.

Primary Objective:

To assess whether there is a higher incidence of uninformative ultrasound in black vs white women

Retrospective cohort study

Study Subjects:

Women 45 years or over seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022. Only people with documented ethnicity will be included.

Study Procedures:

Cases will be identified by searching our two-week referral and ultrasound records . Clinical data collected includes age, BMI, previous abdominal uterine surgery (Caesarean section or open myomectomy) and parity. Symptoms will be categorised into postmenopausal bleeding with no hormone use, unscheduled bleeding on hormone replacement therapy (HRT) or abnormal perimenopausal bleeding (in women over 45 years of age).

Ultrasound data recorded will be the presence or absence of fibroids, whether transabdominal ultrasound was needed in addition to transvaginal or transrectal ultrasound, whether the endometrium could be seen clearly (i.e whether the ultrasound examination was informative) and the endometrial thickness in those where it was. Clinical outcomes recorded will be the need for endometrial sampling, mode of sampling and histology results. The local cancer registry will be checked for the year following the study to check for any subsequent cancers in women discharged without endometrial sampling.

Eligibility Criteria:
Inclusion Criteria:

* Women seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022

  * 45 years of age or older
  * Ethnicity documented in their clinical notes

Exclusion Criteria:

* Ethnicity data not available
Effects of VR-based Respiratory Training on Motor Reaction Time and Correctness, Stress Levels, Attention, Motor Skills, Postural Stability and Sleep Quality in Shift Healthcare Workers

This study investigates the effects of virtual reality (VR)-based respiratory training on various physiological and cognitive functions in shift-working healthcare professionals, including paramedics and nurses. The research will evaluate how VR-guided breathing exercises influence: stress levels, motor reaction time and accuracy, attention and cognitive performance, motor skills and postural stability, sleep quality

Participants will be divided into three groups:

VR-based respiratory training group - performing guided breathing exercises in a VR environment.

Music-based relaxation group - listening to relaxing music without structured breathing instructions.

Control group - no intervention.

The findings will help determine whether VR-based respiratory training is an effective method for improving stress resilience, cognitive function, and physical performance in shift-working healthcare professionals.


Eligibility Criteria:
The study will be conducted in a group of paramedics and nurses of both sexes, aged 23-45. It is expected that 60 people will be examined. The study will include hospital emergency department employees, working shifts, with a minimum of two years of work experience. Those who receive a doctor's consent to participate in the study and give informed consent will be admitted to the study.
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.

The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Between 18 and 75 years old
* American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion Criteria:

* ASA 4 or 5
* Revision knee arthroplasty
* Diagnosis of chronic pain
* Daily chronic opioid use (over 3 months of continuous opioid use)
* Inability to communicate pain scores or need for analgesia
* Acute knee dislocation/fracture
* Infection at the site of block placement
* Age under 18 years old or greater than 75 years old
* Pregnant women
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.

Patients with cystic fibrosis who have pulmonary exacerbations associated with the isolation of Methicillin-resistant Staphylococcus aureus (MRSA) in their sputum will be identified by their primary physicians and by laboratory record review. If they meet the inclusion criteria, they will be invited to participate in the study. The primary outcome variables include pharmacokinetic and pharmacodynamic indices. The study end points include completion of the sputum and blood sampling for pharmacokinetic studies of both intravenous and oral formulations of linezolid and collection of microbiologic specimen (sputum and anterior nares cultures) one month after discharge. Additionally, pharmacokinetic data will be analyzed for effects of age and cystic fibrosis transmembrane conductance regulator (CFTR) mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome

Eligibility Criteria:
Inclusion Criteria:

* Subjects \< 18 years of age inclusive, with a confirmed diagnosis of cystic fibrosis being admitted to the hospital for acute pulmonary exacerbation with MRSA isolated from sputum culture.
* Female subject of childbearing potential must have a negative pregnancy test prior to the first dose of study drug, and if sexually active agrees to use an acceptable method of birth control per investigator judgment for the duration of the study.
* Subjects who are receiving medications with serotonergic (such as certain types of antidepressants) and adrenergic activity that can not be discontinued based on clinical judgment of the primary physician may be enrolled. These subjects will be monitored closely for serotonin- and sympathomimetic-associated toxicity.
* Subject (when able) and subject's parent /legal guardian agree to comply with the study requirements.
* Subject has sufficient venous access to permit administration of the study medication, collection of pharmacokinetic samples and monitoring of safety variables.
* Duration of linezolid therapy is expected to exceed 7 days.
* English and Spanish-speaking subjects.

Exclusion Criteria:

* Subjects with clinical or laboratory evidence of severe hepatic (Child-Pugh class C) disease
* Subjects with severe renal impairment (estimated creatinine clearance \<30 mL/min)
* Subjects with a history of allergy to linezolid.
* Pregnant and breastfeeding subjects.
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease

The purpose of this study is to understand the treatment approach (i.e., targeting gait or targeting the postural adjustment prior to gait) that is most effective at improving gait initiation dynamics in people with Parkinson disease. Ten adults with idiopathic Parkinson disease who self-report difficulty initiating gait will complete the study. The investigators will be using a randomized crossover design, where the participants will participate in two series of training (i.e., postural training and steady-state gait training) with a one-week washout between trainings. Investigators will evaluate the changes induced in gait initiation postural adjustment size, first step length, and first step speed from each intervention. Due to the anticipated limitation of steady-state walking to directly address postural adjustment amplitude, it is hypothesized that training for larger amplitude weight shift during gait initiation will yield improved gait initiation dynamics compared to training with large amplitude movements during steady-state walking.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson disease characterized by asymmetrical onset of at least 2 of 3 cardinal signs (resting tremor, bradykinesia, or rigidity) with no atypical signs or exposure to dopamine-blocking drugs
* The presence of mild to moderate gait or balance impairment (a rating of 1-2 on MDS Unified Parkinson Disease Rating Scale (MDS-UPDRS) item 10 \[gait\] or rating 1-3 on item 12 \[postural stability\]
* Hoehn \& Yahr stages 1-3 ("on" for those who fluctuate)
* Self-report of difficulty with freezing of gait (i.e., a rating of 1-4 on question 3 of the Freezing of Gait Questionnaire)
* All participants must be able to walk \> 5 minutes at greater than or equal to 80% of comfortable gait speed (CGS) on the treadmill and \> 5 minutes over ground without assistance or an assistive device.

Exclusion Criteria:

* Uncontrolled cardiorespiratory/metabolic disease, vestibular dysfunction that may affect gait or balance
* Parkinson's related or unrelated dementia (i.e. Montreal Cognitive Assessment score \<21)
* Comfortable over ground walking speed of less than 0.5m/s
* History of traumatic brain injury
* self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment
* other neurological disorders or orthopedic injury that may affect gait
* recent orthopedic surgery (in the last 6 months)
* Participants will also be excluded if they have severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
* Participants who are currently receiving supervised physical therapy services
Preconditioning Volatile Anesthesia in Liver Surgery

The purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* benign and malign disease
* any type of liver surgery
* inflow occlusion during the liver surgery

Exclusion Criteria:

* \< 18 years
* participation on other interventional and treatment randomized controlled trials,
* trauma of the liver
* liver cirrhosis
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Eligibility Criteria:
Key Inclusion Criteria:

* A written informed consent must be obtained before any study-related assessments are performed.
* Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:

  * Two negative pregnancy tests (at screening and at randomization, prior to dosing)
  * Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v.
* Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
* Stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg
* Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
* Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

Key Exclusion Criteria:

* History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®)
* Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
* Treatment with any medication for the indication of obesity within the past 30 days before screening
* Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
* Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 mL) within 14 days prior to the first dose
* Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Endoscopic Fundoplication With MUSE System

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:

* Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:

  * effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
  * effect on the use and dosage of proton pump inhibitors (PPI)
  * feasibility and safety of the endoluminal fundoplication procedure
* Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

\*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

* 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
* 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
* Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI


Eligibility Criteria:
Inclusion Criteria:

* Chronic (\> 6 months) GERD-related esophageal or extra-esophageal symptoms
* Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
* Indication to surgical fundoplication
* Patients available for a long-term follow-up

Exclusion Criteria:

* Hiatal hernia ≥ 3 cm
* Major esophageal motility disorder
* Esophageal stenosis
* Malignant neoplasia (except minor superficial skin neoplasm)
* Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
* Previous cardiac, thoracic or upper GI surgery
* BMI \>40
* Pregnancy or breast feeding
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer

The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females (aged 18 or older) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio ≥ 2.0) breast cancer
* Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible.
* Have not been treated with gemcitabine in the metastatic setting
* Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 2≤
* Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
* Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) \>1500/µL; Platelets ≥100,000/µL; Hemoglobin \>10 g/dL
* Adequate renal function, as indicated by creatinine ≤1.5x upper limit of normal (ULN)
* Adequate liver function, as indicated by bilirubin ≤1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) \<2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT \< 5x ULN is allowed).
* Signed informed consent
* Adequate birth control in sexually active women of childbearing potential

Exclusion Criteria:

* Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study
* Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging \[MRI\]) off corticosteroids for at least 1 month potential participants are eligible.
* Women who are pregnant or lactating
* Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
* Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)
* Other concomitant active malignancies
* History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
* Ejection fraction \<50% or below the lower limit of the institutional normal range, whichever is lower
* Hypersensitivity to any of the study medications
* Untreated psychiatric conditions preventing informed consent