cyrilzakka/clinical-trials huggingface dataset:
Dapagliflozin in Patients With Critical Illness

To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.

Critically ill patients in the intensive care unit (ICU) experience a high mortality rate. Recent data indicates that the mortality rate for unplanned ICU admissions exceeds 30%, highlighting the urgent need for therapies that can reduce mortality in these critical patients.

DEFENDER is an investigator-initiated, multi-center, randomized, open-label clinical trial, conducted in Brazilian ICUs.

The study population will consist of participants who have been admitted to an ICU with an expected length of stay of more than 48 hours with evidence of at least an acute organ dysfunction, such as hypotension, signs of acute kidney injury, and/or the need for new use of high-flow nasal catheter, noninvasive or invasive ventilation. Eligible patients will be enrolled within 24 hours after the onset of organ dysfunction.

Participants will be randomly assigned in a 1:1 ratio to receive either dapagliflozin 10mg (for 14 days or until ICU discharge, whichever occurs sooner) in addition to standard of care, or standard care alone.

The primary outcome of the study is a hierarchical composite endpoint, including: i) hospital mortality, ii) initiation of kidney-replacement therapy, and iii) ICU length of stay. These outcomes will be assessed up to 28 days after randomization, with censoring at the time of hospital discharge.

To ensure participant safety, an independent Data and Safety Monitoring Board will periodically review the data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to an intensive care unit with expected duration of admission of at least 48 hours in the opinion of the attending physician AND
2. Patients with at least one new organ dysfunction:

   1. Hypotension (mean arteria pressure below 65 mmHg or systolic blood pressure below 90 mmHg or use of vasopressors - norepinephrine, epinephrine, adrenaline, or vasopressin at any dose);
   2. Signs of acute kidney injury (increase in serum creatinine above 0.3 mg/dL over previous measurement or decrease in urinary output - below 0.5 mL/kg/h - in the past six hours;
   3. Need for new use of high-flow nasal catheter or noninvasive ventilation or invasive ventilation.

Exclusion Criteria:

1. Pregnancy or age below 18 years;
2. Patient or legal representative refusal;
3. Patients with chronic kidney disease on dialysis;
4. Planned intensive care unit admission after elective surgery;
5. Known allergy to dapagliflozin;
6. Previous use of dapagliflozin or other sodium-glucose transport protein 2 inhibitor;
7. Patients that cannot receive medications through oral or enteral route;
8. Patients with inclusion criteria number 2 for more than 24 hours.
9. Patients with type 1 diabetes or previous ketoacidosis
Airflow Limitation in Cardiac Diseases in Europe

This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.

Airflow limitation (AL) occurs in a number of respiratory diseases including asthma and COPD; in middle-aged and older patients it typically represents Chronic Obstructive Pulmonary Disease (COPD), and is associated with a high degree of co-morbidity which includes cardiovascular diseases (CVD) and risk factors such as hypertension and diabetes.

COPD often goes undiagnosed, especially in patients with established coronary disease because COPD and cardiovascular diseases share a major etiological factor: smoking.

This cross-sectional, observational study, investigating the prevalence of AL in current or former smokers with established ischemic heart disease, aims increase the knowledge and understanding of COPD in this patient population, and to highlight the burden of comorbid disease in these patient

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥40 years;
* Current or former smokers with ≥10 pack years;
* Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria:

  1. Documented history of an Ischemic event,
  2. Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
  3. Receiving regular therapy for IHD for \>1yr, Subjects meeting these criteria will be eligible for the study, even if they have other cardiac diseases or other co-morbidities;
* Subjects willing and able to sign study consent form.

Exclusion Criteria:

* Subjects for whom spirometry is contraindicated;
* Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months);
* Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study
APEMESH II - Perineal Reconstruction

The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Curative intent abdominoperineal resection and permanent colostomy

Exclusion Criteria:

* Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
* Immunosupression (cortisone \>10mg/day) or severe malnutrition (BMI \<20)
* Diabetes with 1 or more organ damage
* Dialysis treatment
* Hepatic cirrhosis Child-Bugh B-C
* Potentially curable resection not possible
* Patient undergoing emergency procedures
* Metastatic disease
* Vaginal resection, pelvic exenteration and sacrum resection
* Vaginal perforation
* Pelvic abscess or perforated tumor
* Pregnant or suspected pregnancy
A Study of Remimazolam Tosilate for Sedation in the ICU

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
3. Meet the age criteria, male or female
4. Meet the BMI criteria

Exclusion Criteria:

1. Deep sedation is required, or continuous sedation is not needed during the study process
2. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
3. Subjects with a history of drug abuse
4. Subjects after neurosurgery operation
5. Organ failure before randomization
6. Abnormal values of the laboratory examination
7. Abnormal blood pressure and heart rate during screening
8. Allergic to relevant drugs ingredient or component
9. Pregnant or nursing women
10. Subjects who has participated in clinical trials of other interventions recently
Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research

The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted.

The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future.

Eligibility Criteria:
Inclusion Criteria:

* Participants must either have HD or be at risk for having HD
* Participants must be 18 years of age or older
* Participants must live in the United States
* Inclusion of participants will not be based on race, gender, or ethnicity.

Exclusion Criteria:

-
An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program

The purpose of this study is to determine the impact Pono Choices has among youth for teen pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward healthy sexual behaviors; skills in managing relationships and choices; and intentions about future sexual activity.

The study used a cluster randomized controlled design to evaluate the impact of Pono Choices. Thirty-six middle schools in Hawaii were randomly assigned to participate as either a treatment or control school. Treatment school teachers were trained to deliver Pono Choices. Control school teachers did not receive training and chose their own middle school sexual health education curricula.

Over 1,700 7th and 8th grade students in 34 Hawaii schools enrolled into the study. As part of the study, students were invited to participate in baseline and follow-up surveys. The student survey responses were used to determine the impact Pono Choices has on teen pregnancy and STI prevention measures.

Eligibility Criteria:
Inclusion Criteria:

* Cluster level: Schools with grades 7 and 8 in Hawaii
* Person level: Students with parent consent and who read and understand English

Exclusion Criteria:

* Cluster level: Public middle schools which included grade 6
* Person level: Students who did not provide written assent
Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients

To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).

The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma.

Tumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis.

Conversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers.

Monocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development.

Tumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.

Eligibility Criteria:
Inclusion Criteria:

Patients with child A Hepatocellular carcinoma.

Exclusion Criteria:

* Patients with child C Hepatocellular carcinoma.
* Patients with heart failure
Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation

Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to concerns of stricture formation. Therefore, the investigators aimed to investigate the effect of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment of large symptomatic CIP.


Eligibility Criteria:
Inclusion Criteria:

* negative PPI trial, ph-metry without correlation on globus sensation, prior high-resolution manometry

Exclusion Criteria:

* not willing to participate in follow up
Bedside Sedation for the Prevention of Post Dural Puncture Headache

Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is a common procedure in everyday clinical practice. The most common use for LP is to measure the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.

A notorious side effect of dural puncture is headache that ranges from mild to debilitating and may last for several days following the procedure. Among diagnosed patients, 39% experience at least 1 week of impaired ability to perform activities of daily living. The likelihood of developing a headache after dural puncture depends on a number of factors. As fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the leak seem to offer the best path to lowering the incidence of headache after diagnostic LP, the commonest clinical context of dural puncture in medical practice.

Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause adrenergic stimulation, they also cause an increase in ICP. We believe that this mild increase in ICP, occurring before the puncture as well as during the puncture itself may exacerbate the pressure difference between the CSF space and the epidural space and so worsen the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture hole to widen slightly and so further augment the leak and possibly even prolong it. Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause a sensitization effect and worsen pain. This increase in adrenergic drive as well as the sensitization to pain can be effectively blunted by the periprocedural use of mild IV sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this task.

This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the rates of headache after diagnostic LP.

Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior to the procedure and undergo the same diagnostic procedure. All patients in the study will remain under observation in the hospital for at least 6 hours.

Patients will be evaluated for headache and specifically for headache. Clinical follow up will continue for 72 hours by administering a short questionnaire over the telephone.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* Undergoing diagnostic LP for any indication for the first time

Exclusion Criteria:

* COPD
* Any known chronic pulmonary disease
* Acute febrile illness
* Persistent headaches
* Known sensitivity to Benzodiazepines
* Current or prior substance abuse disorder
* Cognitive decline
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.


Eligibility Criteria:
Inclusion Criteria:

* healthy males
* not smoking

Exclusion Criteria:

* use of NSAIDS and/or antibiotics
* no blood donation 1 months prior to screening
The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening

The aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This prospective and randomized study will be performed at the Instituto Valenciano de Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PGD for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, X \& Y

Exclusion Criteria:

* Patients undergoing PGD for monogenic diseases (PCR)
* Patients undergoing PGD for structural chromosomal abnormalities
* Ovum donation cycles
* Cryopreserved oocyte/embryos
Bimatoprost as a Treatment for Graves' Orbitopathy

Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease


Eligibility Criteria:
Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids

-
Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

This study evaluates the value of different bronchoscopy combination for diagnosing peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with a guiding equipment and the other one-third of participants will receive bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects are adults with solitary peripheral pulmonary lesions (mean diameter, ≤30mm and \>8mm from axial CT images) suspected to be cancer but were not pathologically confirmed.

Exclusion Criteria:

* Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
* Patient has uncontrollable hypertension (SBP \> 180mmHg).
* Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
* Patient has blood coagulation disorders (PT\>2 times the upper limit of normal(ULN) or Platelet(PLT)\<50000/ul）.
* Patient has severe dyspnea.
* Patient is allergic to local anesthetic.
* Patient is unable to provide informed consent.
* Patient is not an appropriate candidate for of is unable to tolerate flexible bronchoscopy procedures.
* Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
* Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
* Female patient of childbearing potential has a positive result from a pregnancy test.
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS

We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.


Eligibility Criteria:
Inclusion Criteria:

* All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment

Exclusion Criteria:

* Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for \>3 weeks.
Economic Empowerment Program Suubi-Maka

The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family economic empowerment intervention that creates economic opportunities (specifically Children Development Accounts) for families in Uganda who are caring for children orphaned due to the AIDS pandemic, and to lay groundwork for a bigger study with practice and policy implications for Sub-Saharan Africa.

The study has two specific aims (1) To conduct formative work in order to understand children and families´ ability and interest in participating in a family-level economic empowerment intervention focused on savings and family income generation, and their response to this family-focused economic empowerment approach alongside additional intervention components, including savings for youth education and adult mentorship. (2) Based on formative data (Aim #1), to adapt the intervention and examine issues related to feasibility and preliminary outcome on a small scale in order to prepare for a larger study.

The intervention, SUUBI-MAKA, uses a novel approach by focusing on economic empowerment of families caring for children orphaned due to AIDS. The intervention has three key components (1) it promotes family-level income generating projects (micro-enterprises) which we believe will enhance economic stability, reduce poverty, and enhance protective family processes for youth orphaned by AIDS. (2) It promotes monetary savings for educational opportunities for AIDS-orphaned children. (3) It provides an adult mentor to children. The intervention will be evaluated via a two-group randomized trial. The two groups are SUUBI-MAKA or Usual care for orphaned children. The participating children will be nested within 20 primary schools that will be randomly assigned such that all children from a particular school receive the same intervention.

Eligibility Criteria:
Inclusion Criteria:

1. An AIDS-orphaned child, defined as a child who has lost one or both parents to AIDS;
2. Enrolled in the last two years of primary school (even though possibly not attending regularly);
3. Between the ages of 11 to 16 years;
4. Living within a family.

Exclusion Criteria:

1. Any youth below 11 years or above 16 years at the time of enrollment in the study;
2. Any youth not enrolled in the final two years of primary school;
3. Any youth who does not self-identify as an AIDS-orphan;
4. Any youth not being raised primarily within a family context at the start of the study.