cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients

The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids. Several previous studies have demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL with 6% Hydroxy Ethyl Starch (HES).

The primary objectives of this prospective, randomized and open-label study are as follows:

* To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance.
* To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial.

Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups.

Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups.

The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 45-80 years.
* CABG patients with on or off pump procedure.
* Ejection fraction \<50%
* Patients who have given their written informed consent.

Exclusion Criteria:

* Combined operations(surgeries)
* Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance.
* Severe bleeding and/or re-operation.
* Hypernatremia\> 155 mmol/L
* Severe liver failure: SGOT and SGPT more than twice normal.
* Severe renal failure: creatinine more than 2 mg%.
* Patients with major diseases such as cancer, etc.
A Serum Galectin-3 Levels in Placenta Accreta Spectrum Pregnancies

Placenta Accreta Spectrum (PAS) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. As such, early detection and proper management of PAS can significantly improve pregnancy outcomes. This study provides an in-depth examination of the serum levels of Galectin-3, a β-galactoside-binding protein, in women experiencing Placenta Accreta Spectrum compared to those with normal pregnancies.

Placenta Accreta Spectrum (PAS) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. As such, early detection and proper management of PAS can significantly improve pregnancy outcomes. This study provides an in-depth examination of the serum levels of Galectin-3, a β-galactoside-binding protein, in women experiencing Placenta Accreta Spectrum compared to those with normal pregnancies.

Galectin-3 has been implicated in various physiological processes such as cell-cell interaction, cell-matrix adhesion, and immune responses. Moreover, recent evidence suggests an increased level of Galectin-3 is also associated with inflammation, fibrosis, and adverse outcomes in several pathological conditions like cardiovascular diseases and cancer. These multiple roles of Galectin-3 underline its potential implications and predictive ability in many pathological conditions including PAS disease progression during pregnancy.

In obstetric context, research on the role and level of Galectin-3 is sparse. This study aims at filling this gap by comparing the serum Galectin-3 levels in PAS and normal pregnancies. It seeks to investigate whether there is a significant difference between the two cohorts, which could highlight the potential use of Galectin-3 as a possible biological marker in predicting or diagnosing placenta accreta spectrum.

Eligibility Criteria:
Inclusion Criteria:

* PAS diagnosis

Exclusion Criteria:Systemic diseases (e.g. chronic hypertension, diabetes, hypothyroidism, chronic renal-liver diseases, etc.), autoimmune disorders, multiple pregnancies, or the presence of fetal structural and chromosomal anomalies. Cholestasis of pregnancy, preterm delivery, or evidence of chronic and active infection.

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Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.


Eligibility Criteria:
Inclusion Criteria:

* Mastectomized adult female patient
* Abdominal flap unilateral breast reconstruction indication
* Alloplastic breast reconstruction sequelae
* Enough amount of abdominal dermofat tissue to shape a breast with a primary closure of the donor site

Exclusion Criteria:

* DIEP flap bilateral breast reconstruction indication
* Previous abdominoplasty surgery
* Untreated psychiatric disease
* Untreated infection
* Indocyanine green or iodine hypersensitivity
* Hyperthyroidism, thyroid adenoma or thyroid autonomy
* Any concomitant disease or condition that, in the opinion of the investigator, can make the patient unsuitable to receive a microsurgical technique or to join the research.
Feasibility of a Physiotherapy-led Follow-up Programme in Adult Critical Illness Survivors

Survivors of critical illness might suffer from ongoing physical, cognitive and emotional impairments after being discharged home. Furthermore, several studies have shown that these patients might have a need for ongoing support. However, up until now, it is not known what the optimal follow-up programme for survivor of critical illness after discharge home should look like or which exact patient population would benefit the most. Due to these reasons, it is important to further investigate, how these patients can be optimally supported to recover from their critical illness.

The primary aim of this study is to assess, whether a physiotherapy-led follow-up programme is feasible in adult survivors of critical illness after discharge home in the county hospital of Winterthur.

Furthermore, the investigators evaluate the influence of this physiotherapy-led follow-up programme on health related quality of life, exercise capacity, general muscle strength, inspiratory muscle strength, anxiety and depression.

All of the anticipated 20 patients will partake in the follow-up programme, which will consist out of a nine weeks exercise programme and four education sessions. During the exercise programme, the patients will exercise twice per week under supervision and once by themselves. The supervised exercise sessions will consist out of a combination of a cardiopulmonary and strength training and the unsupervised session will be a physical activity, which the participants like doing. Furthermore, they will participate in education sessions, where they learn things about the intensive care unit, the post-intensive care syndrome, relaxation techniques and how to carry on with exercising.

The whole study will last about ten months and forms a part of a master thesis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent after being informed
* Adult patient (\>18 years), who was treated in the ICU of the county hospital of Winterthur and who was ventilated for longer than 48 hours
* Patient, who received inpatient rehabilitation and then was discharged home

Exclusion Criteria:

* Head or spinal cord injury, leading to neurological deficits
* Receiving palliative care
* Fractures diminishing mobility
* Principal diagnosis of chronic obstructive pulmonary disease (COPD)
* Principal diagnosis of myocardial infarction, heart failure or reanimation
* Principal diagnosis of stroke or cerebral bleeding
* Previous diagnosis of dementia or cognitive impairment
* Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.;
* Enrolment of the investigator, his/her family members, employees and other dependent persons
EGb 761 in the Syndrome of MCI With Concomitant CVD

EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240mg in randomised controlled trials through several neuroprotective mechanisms of action. The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD.

EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240 mg in randomised controlled trials through several neuroprotective mechanisms of action.

The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD. This study is an open label 52-weeks study in subjects who have both MCI (based on the Petersen criteria and Albert MS criteria) and CVD. Eligibility for enrolment will be assessed initially at a screening visit, which is to occur within 42 days of baseline. 134 male and female subjects will participate and 67 of the 134 will receive the drug.

Subjects will be randomized to the EGB 761 arm and control arm in a 1:1 ratio using a block randomization method in groups of 4 subjects using an automated randomization software. The study will allow generating data in an Asian and multi-racial population and allows physicians to offer clinically efficacious and alternative treatment for patients with MCI + CVD.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with MCI based on the Petersen criteria and Albert MS criteria
* Patients who have a Global Clinical Dementia Rating Score of 0.5
* Patients aged 45 to 85 years at study entry
* Patients who are literate and able to complete the cognitive evaluations in the opinion of the investigators
* Patients with the presence of CVD, defined as the presence of white matter hyperintensities (WMH) of Fazekas grade 2 or 3 on MRI brain imaging (done up to 12 months prior to recruitment) or CT scans for patients contraindicated from MRI scans
* Patients who provide written informed consent to participate in the study

Exclusion Criteria:

* Participants should not be receiving antidepressants, antipsychotics, benzodiazepines, acetylcholinesterase inhibitors or NMDA antagonists during the study. Additionally, contraindications for EGb 761 as given in the local prescribing information/Summary of Product Characteristics (SmPC) should be observed.
Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Exacerbation of COPD
* Age \> 40 years
* Capability to use the devices provided
* Willing to participate

Exclusion Criteria:

• Participation in a previous COPD home telehealth study
Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease

The current treatment for celiac disease is a strict 100% gluten free diet. Little is known about the best way to promote adherence to such a strict diet and how to maximize quality of life at the same time.

This pilot will look at the utility of a new innovation to promote gluten free diet adherence - a portable gluten sensor device. Participants will be 30 teenagers and adults with celiac disease recruited from the Celiac Disease Center at Columbia University in New York City. Before and after the intervention, participants will be asked about their adherence to a gluten free diet, quality of life, symptoms, and feelings of anxiety, and depression. This pilot data will help to inform interventions that the investigators hope to test in a larger NIH-funded trial to better understand the best ways to promote adherence and quality of life in celiac patients.

Little is known about the best ways to promote a strict gluten-free diet while maximizing quality of life in teenagers and adults with celiac disease. The aim of the proposed pilot is to assess the acceptability and feasibility of a novel intervention - a portable gluten sensor device. The sample for this pilot will be 30 teenagers and adults with biopsy confirmed celiac disease recruited from the Celiac Center at Columbia University in New York City. Thirty participants will pilot test a portable gluten sensor device with its associated iPhone app for 3 months. At baseline and three-month follow-up, participants will complete measures of gluten free diet adherence, quality of life,symptoms, anxiety, and depression. At post-only, the investigators will collect in-depth data related to the feasibility and acceptability of the gluten sensor, as well as facilitators and barriers related to how, where, and when it was used. At the completion of the proposed pilot study, the investigators hope to have preliminary data to inform development of gluten sensor interventions that the investigators hope to test in a larger NIH-funded randomized controlled trial. These findings, in combination with a larger trial, have the potential for the development of a new standard of care in the management of patients with celiac disease.

Eligibility Criteria:
Inclusion Criteria:

* Individuals \>13 years old (15 teenagers and 15 adults), 30 in total with duodenal biopsy-confirmed diagnosis of celiac disease will be recruited to participate.
* As we are testing a gluten sensor device, we require that participants are 13 years or older as they will need to be able to operate the gluten sensor device independently

Exclusion Criteria:

* No participants will be excluded based on gender, race or ethnicity.
* Patients diagnosed with celiac disease without a duodenal biopsy.
Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A

* To outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration
* To study pharmacokinetic, side effect of low dose Emicizumab

* To compare outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration using ABR, AJBR and HJHS, HaemoQoL
* To study pharmacokinetic, side effect and effectiveness of low dose Emicizumab

Eligibility Criteria:
Inclusion Criteria:

* Severe or moderate Hemophilia A with baseline FVIII:C of \<3 IU/dl or severe bleeding phenotype
* Receiving low dose FVIII prophylaxis for at least 6 months

Exclusion Criteria:

* Detectable FVIII inhibitor at screening
* Detectable FVIII inhibitor at screening Having other underlying diseases: Juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases
Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis

it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.

The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.

Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.

Eligibility Criteria:
Inclusion Criteria:

* Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
* Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
* Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
* Subjects will be in good health (ASA Class I-II) with a BMI \< 35.
* Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
* Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
* Subjects must speak, read and understand English.
* Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
* Resting heart rate \> 100 bpm;
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Active clinical infection
* Unwilling and/or not able to give written informed consent.
Impact of Humeral Component Version on Outcomes Following RTSA

The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary reverse total shoulder arthroplasty
* Diagnosis of cuff tear arthropathy or primary OA with RCT
* Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
* 18 years or older

Exclusion Criteria:

* Revision arthroplasty
* Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
* Minors (under 18 years of age)

  * Prior open shoulder surgery
  * Concomitant latissimus dorsi transfer
  * Patients not undergoing a standard of care physical therapy protocol
  * Pregnant, patient-reported
  * Cognitively impaired
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants

Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be first-generation Japanese (born in Japan and not living outside of Japan for \> 10 years; both parents must be ethnically Japanese)
* Body Mass Index 18.0 to 25.0 kg/m2, inclusive
* Women must not be of nonchildbearing potential (cannot become pregnant)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History or evidence of abnormal bleeding or coagulation disorder

Other protocol defined inclusion and exclusion criteria apply