cyrilzakka/clinical-trials huggingface dataset:
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure

The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).


Eligibility Criteria:
Inclusion Criteria:

- Have clinically stable symptomatic heart failure (HF) (heart failure with reduced ejection fraction \[HFrEF\] and heart failure with preserved ejection fraction \[HFpEF\]): (A) For HFrEF: (a) ejection fraction (EF) less than or equal to (\<=) 40 percent (%) and (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months (B) For HFpEF: (a) EF greater than (\>) 40%; (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or eplerenone (mineralocorticoid receptor antagonists), in the past 18 months

* Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of less than or equal to (\<=) 80 prior to randomization
* Be able to read and understand English
* Possess and have sole use (example: not shared with other users) of smartphone compatible with the Fitbit device
* Willing/able to wear the Fitbit device on a regular basis for the 9-month study period

Exclusion Criteria:

* Currently taking a sodium-glucose co-transporter 2 inhibitor (SGLT2i) or within the last 3 months
* History of diabetic ketoacidosis or have type 1 diabetes mellitus (T1DM)
* Have acute decompensated HF (exacerbation of symptomatic HF) requiring intravenous diuretics, inotropes, or vasodilators within the last 4 weeks
* Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration rate \[eGFR\] \<30 milliliter per minute \[ml/min\] on dialysis) from the most recent assessment
* Have a diagnosis of hypotension within 30 days
PRP & PDO Threads in Treatment of Stress Incontinence

The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.


Eligibility Criteria:
Inclusion Criteria:

* Nonpregnant Women with SUI
* Age between 20 to 45 years
* Patients had a history of failed conservative treatment
* Patients were on the waiting list for surgical treatment of SUI

Exclusion Criteria:

* Under anti-platelet agent treatment
* Under NSAIDs
* Platelet dysfunction syndrome
* Critical thrombocytopenia
* Hypofibrionogenaemia
* Sepsis
* Acute and chronic infections
* Chronic liver disease
* Anti-coagulation therapy
* History of malignancy
* Pregnancy
* history of active malignant pathology
* mental disorders making them unable to give consent
* genitourinary fistula
* pelvic organs prolapse stage \>2 according to the Pelvic Organ Prolapse Quantification system, and detrusor overactivity on urodynamics.
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function

The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
2. Documented chronic HF (NYHA Class II to IV) at the time of enrollment
3. Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
4. Signed and dated informed consent

Exclusion Criteria:

1. Any contraindication for ICD therapy
2. Abdominal implantation site
3. Acute myocarditis
4. Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
5. Planned heart transplant
6. Mechanical tricuspid valve
7. Unable to perform the 6 minute Walking Test at time of enrollment
8. Already included in another clinical study
9. Life expectancy less than 13 months
10. Inability to understand the purpose of the study or refusal to cooperate
11. Inability or refusal to provide informed consent
12. Under guardianship
13. Age of less than 18 years
14. Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Lupus Education Alliance Program

The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* Living with systemic lupus erythematosus (SLE),
* At least 18 years of age,
* Ability to speak and understand English, and
* Live, work, or seek care in Alabama or Louisiana
Can Intravenous Vitamin C Improve Skin Hyperpigmentation in Long-Term Hemodialysis Patients?

Intravenous vitamin C may improve skin hyperpigmentation in chronic hemodialysis patients

Melanogenesis is caused by enzymatic conversion of tyrosine to melanin pigments.Ascorbic acid has the ability to inhibit peroxidase and may thus inhibit melanin synthesis.

Eligibility Criteria:
Inclusion Criteria:

* chronic hemodialysis patients

Exclusion Criteria:

* allergic to vitamin C, using steroid, etc
TTV Viral Load in Heart Transplant Recipients

This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation.

The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.

TTV (Torque Teno Virus) is a ubiquitous virus that is not associated with any disease. A correlation exists between the level of TTV replication and the subject's immunocompetence: weak or non-existent in immunocompetents, very high in immunocompromised patients. In heart transplant patients, pharmacological dosing of immunosuppressants prevents their toxic manifestations but is not correlated with individual immune competence. Only clinical manifestations of overdose (infections) or under dosage (rejections) currently allow optimization of immunosuppressants. A predictive biomarker of these clinical manifestations upstream of their appearance would revolutionize the management of these patients.

The TTV fulfills the conditions to be an ideal biomarker: classic blood sampling, possible follow-up in all patients, low cost, carrying out the analysis on already existing molecular biology platforms, reproducibility of inter- and intra-laboratory results, defined thresholds for the reliable interpretation of the results.

We believe that this marker will provide the clinician with a useful tool for the management of immunosuppressants and the patient with personalized medicine which will allow their management to be individualized. If this study confirms the expected results, then it will allow, secondly, the setting up of interventional studies to validate the TTV viral load as a biomarker, and a tool for piloting immunosuppressive treatment.

The TTV viral load of heart transplant patients will be follow during the first year after transplantation.

A tube of blood will be taken during the transplant and then once or twice a month.

Samples will be taken at the same time as those taken as part of standard care. The TTV viral load will be measured at the end of the study.

The occurrence of events of interest (infections and rejections) will be collected at each corresponding visit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Heart transplant only
* First transplant
* Patient not having objected to carrying out the research
* Affiliated to a French Health Insurance system.

Exclusion Criteria:

* Patient transplanted from more than one solid organ
* Patient who has already been transplanted before
* Patient under guardianship or curatorship
* Patient under legal protection
* Pregnant or breastfeeding woman
Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents.

Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Eligibility Criteria:
Inclusion Criteria:

* Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy.
* Recurrent and symptomatic malignant pleural effusion.
* Full pulmonary expansion (\>90%) post thoracocentesis, confirmed via chest x-ray.
* Karnofsky Performance Status \>30
* Agreement to participate of the study by signing of the Informed Consent Term.

Exclusion Criteria:

* Coagulopathies (prothrombin activity \<50%) and/or thrombocytopenia (\<80000 count).
* Active pleural or systemic infection.
* Massive skin neoplastic infiltration.
* Inability of understanding the pain scale.
* Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).
* Refusal to participate of the study.
Non-pharmacological Pain Care During Complex Wound Care Procedures

The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car in adults.

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system or headphone with audio during wound care or not wearing the VR system or headphone with audio.

Patients are randomly assigned to one of three groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Intervention group 2, Music Therapy Group 3 - Control group, care as usual

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 or older who have wounds receiving wound care
* Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures before discharge
* At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.

Exclusion Criteria:

* Individuals not being able to understand Dutch language at primary school level
* Individuals not being able to read or write Dutch
* Individuals diagnosed with dementia and/or cognitive impairment
* Individuals diagnosed with epilepsy
* Individuals diagnosed with migraine
* Individuals with severe dizziness and/or nausea
* Individuals with a known history of claustrophobia
* Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
* Individuals who have no feeling in the wound care area
* Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. No matter which way, either spontaneous or surgical, they would choose, many factors influence their psychological state. Cesarean section poses higher risks for women than vaginal delivery. Therefore, how to seek effective methods to alleviate parturients' psychological stress response possesses pivotal clinical implications. Herein the investigators proposed that different linguistic interventions given pre-, intra- or post-operatively would produce different effect on maternal psychology and internal stress level.


Eligibility Criteria:
Inclusion Criteria:

* Chinese gravidas
* Gestational age \>=36 wk
* Nulliparas
* Undergoing selective Cesarean section

Exclusion Criteria:

* With recognition problem
* Used or using centrally acting drugs
* With chronic pain
* Refusal participation
* With existed psychiatric disorders
* With history of psychological diseases
* Contraindications for neuraxial anesthesia
Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

The purpose of this study is to evaluate the safety and tolerability of OMS721 (narsoplimab) in subjects with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 (C3) Glomerulopathy including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of OMS721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of Asian descent with IgA Nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at screening and competent to provide informed consent; For Cohort 4 only, participants are of Asian descent
* Have a diagnosis of one of the following:

  1. IgAN on kidney biopsy
  2. LN, MN and C3 Glomerulopathy including Dense Deposit Disease on kidney biopsy and 24-hour Urine Protein Excretion (UPE) \> 1000 mg/24 hours (for Cohort 1 only)
  3. IgAN diagnosis is confirmed by biopsy within 8 years of screening for Asian descent (for Cohort 4 only)
* For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hour UPE \> 1 g within 6 months prior to Screening or Urine Protein-Creatinine Ratio (uPCR) \> 0.75 by spot urine at screening
* Screening Estimated Glomerular Filtration Rate (eGFR) \>= 30 mL/min/1.73 m\^2
* Are on physician-directed, stable, optimized treatment with angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have a systolic blood pressure of \< 150 mmHg and a diastolic blood pressure of \< 90 mmHg at rest

Exclusion Criteria:

* Have a hemoglobin less than 9.0 g/dL
* Have a platelet count =less than 100,000/mm\^3
* Have an absolute neutrophil count \<500 cells/mm\^3
* Have an Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) greater than 5.0 x the upper limit of normal (ULN)
* Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior to Screening
* Have used: belimumab, eculizumab, or rituximab within 6 months prior to Screening
* Have a history of renal transplant
* History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody
* Have a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for 5 years or more
Intra-Abdominal Sepsis and Relationship Between Cumulative Fluid Balance and Serum Sodium and Chloride Levels and In-Hospital Mortality

Intra-abdominal sepsis and septic shock in critically ill surgical patients have a high mortality rate. Fluid therapy is one of the initial resuscitation measures, but it can contribute to poor treatment outcomes through fluid overload and accumulation of sodium and chloride. This study aimed to examine an association among cumulative fluid balance and serum sodium and chloride levels in the intensive care unit (ICU) and in-hospital mortality in critically ill surgical patients with intra-abdominal sepsis after emergency surgical treatment. The study was designed as a retrospective, cohort study.

Data were collected and analyzed from 100 critically ill surgical patients with intra-abdominal sepsis, consecutively admitted to the ICU of a university medical center. Patients were immediately subjected to surgical treatment for intra-abdominal sepsis upon hospital admission. Postoperative care continued in the ICU for at least seven days. Patients who were hospitalized in the ICU for less than seven days, immunocompromised, and patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study. Data related to daily fluid intake and loss were taken from medical records where these data are recorded daily. Intake included both enteral and parenteral, while fluid losses from the body included urine, losses through drains, and nasogastric tube. The cumulative fluid balance was calculated for the periods from days 1 to 3 of treatment, and from days 1 to 7 of treatment. Data on serum sodium and chloride levels were recorded at the same time points as for cumulative fluid balance. The impact of variables on treatment outcomes was determined using binary logistic regression. The predictive quality of the variables on the outcome was assessed using ROC curves.

Eligibility Criteria:
Inclusion Criteria:

* critically ill surgical patients with intra-abdominal sepsis/septic shock consecutively admitted to a university medical center
* Patients who were immediately subjected to surgical treatment for intra-abdominal sepsis/sepstic shock upon hospital admission and postoperative care continued in the ICU for at least seven days

Exclusion Criteria:

* Patients who were hospitalized in the ICU for less than seven days
* immunocompromised
* patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study
Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery

The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on hospitalization time (readiness to discharge), time to ambulation, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.

This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.

Eligibility Criteria:
Inclusion criteria:

- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.

Exclusion criteria:

- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)

Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or over.
2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
3. Visually significant cataract with visual acuity of less than or equal to 6/12.
4. Subject able and willing to cooperate with investigation plan.
5. Subject willing to sign informed consent form.

Exclusion Criteria:

1. Known allergic reaction to collagen.
2. Subject is on Warfarin and discontinuation is not recommended.
3. Subject with normal tension glaucoma or aphakic glaucoma.
4. Subject with corneal disease.
5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
6. Ocular infection within 14 days prior to phacotrabeculectomy.
7. Pregnant or breast-feeding women.
8. Monocular subject.
Pain Processing in Anxiety and Depression

The purpose of the study is to investigate pain, anxiety and depression in patients with panic anxiety disorders without pain or depression without pain compared with healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Patients with panic disorder or depression

Exclusion Criteria:

* Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol, SSRI and benzodiazepines
* Serious or unstable medical disease
* Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
* Patients who cannot cooperate and do not understand Danish