cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants

The primary objective of the study is:

• To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent prior to starting study activities.
* Healthy male or female participants, between 18 and 60 years of age (inclusive) at the time of Screening. Females must be of nonchildbearing potential.
* Body mass index between 18 and 30 kg/m\^2 (inclusive) at the time of Screening. Participants must have a body mass ≥ 50kg.

Exclusion Criteria:

* History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease coronary revascularization, or angina.
* History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at Check-in.
* Systolic blood pressure \> 150 mmHg or \< 90 mmHg, or diastolic blood pressure \> 90 mmHg or \< 50 mmHg, or HR ≤ 40 and \> 100 bpm, at Screening or Check-in; one repeat blood pressure measurement will be allowed at Screening and Check-in.
* History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair.
* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc).
* Participant has received a dose of an investigational drug within the past 90 days or have previously completed or withdrawn from this study or any other study investigating olpasiran or have previously received olpasiran.
Cytokine Regulation of Natural Killer Receptors in Inhibiting Activated T Cell Function

In this study proposal, the investigators will extend their previous studies and examine the kinetic cytotoxic activity with concordant expression of inhibitory natural killer (NK) receptors (iNKR) on activated T cells. The inhibitory role of cytokines will be defined by utilizing the investigators' previously established models of mixed lymphocytes and tumor cells coculture to analyze the expression and activity of cytokines involved in the regulation of iNKRs on cancer-encountered T cells.

In our extended studies, we have directly examined the expressions of various inhibitory natural killer cell Receptors (iNKRs) on Tumor-infiltrating lymphocytes (TILs) derived from human Cervical cancer (CC) by triple-color flow cytometry with combination of different surface markers. We found up-regulated expression of certain iNKRs (CD94/NKG2A) in TILs and in mixed lymphocyte-cancer cell cocultures. In our previous studies, we demonstrated that certain cytokines, including IL-10, TGF-beta (Sheu et al, Journal of Immunology, 2001, 167:2972-2978), and IL-15 (Sheu et al, Cancer Research, 2005, 65:2921-2929) can be expressed by CC cells. We further demonstrated that activated T cells bear iNKRs which inhibit cytotoxic activity. iNKRs are proposed to restrain the T cell receptor (TCR)-mediated cytolysis. We found that CC cells had altered HLA-A, -B, and -C molecules in a cancer microenvironment. The acquisition of both NK-like activity and expression of iNKRs by these T cells is parallel to prevent damage to normal host cells. However, there is also limited knowledge about the regulatory role of iNKR expression in T cell cytotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Healthy volunteers

Exclusion Criteria:

* Immunosuppression
* HIV carrier
Maca Extract in Sexual Dysfunction Male

The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.

All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.

Eligibility Criteria:
Inclusion Criteria:

1. evaluated as sexual dysfunction for more than three months by physician
2. international index of erectile function (IIEF) score is less than or equal to 21
3. erectile hardness score (EHS) score is less than or equal to 3
4. aged over 18 years old

Exclusion Criteria:

1. unable to cooperate with the course of the treatment
2. suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
3. had Radical Prostatectomy (total removal of the prostate gland)
4. suffering from active tumors in the prostate or pelvic area
5. suffering from Hypogonadism
6. anatomical deformation of the penis
7. men with penile prosthesis
8. suffering from psychotic disorder (manic disorder, chronic depression, etc.)
9. suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
10. using Permanent pacemaker
11. considered unsuitable to participate in this experiment according to the doctor
12. alcohol or drug abuse
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer

This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.

PRIMARY OBJECTIVES:

I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients.

II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients.

OUTLINE: All patients enrolled (both frail and non-frail) will be randomized (1:1) at the time of enrollment to receive pre-operative exercise or non-preoperative exercises. Randomization will be stratified by frailty status.

ARM I: Enrolled patients undergo a physical therapy consultation and complete home exercises 3 days per week, in addition to standard guidelines.

ARM II: Enrolled patients follow standard guidelines.

All patients are followed up at 2 weeks after surgery and then every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for any abdominal (e.g., pancreatic, liver or gastric) cancer surgery or established in the GI surgical oncology clinics or
* Scheduled for neoadjuvant therapy prior with the plan to be scheduled for surgery

Exclusion Criteria:

* Non-English speaking
* Prisoners
* Persons unable to provide informed consent
Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients


Eligibility Criteria:
Inclusion criteria:

1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)

Exclusion criteria:

1. Apart from mild asthma any relevant deviation from healthy conditions
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* persistent AF (electrical cardioversion is planned)
* written informed consent

Exclusion Criteria:

* acute clinical signs of venous thromboembolism
* current oral anticoagulation
* indication for medical cardioversion
Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

The objectives of this study are

* collect subject data on a near-infrared spectroscopy-based glucose meter
* evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
* collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
* Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.

Exclusion Criteria:

* Severe heart disease as evidenced by peripheral edema (self reported)
* Currently taking Lasix (self reported)
* Liver disease as evidenced by jaundice (self reported)
* Receiving dialysis or having known renal compromise (self reported)
* Skin damage at optical sampling site
* Scars, tattoos, rashes or other disruption/discoloration on the right index finger
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
* Current chemotherapy, or chemotherapy within the past 12 months (self reported)
Registry of Endoscopic Retrograde Cholangiopancreatographies Performed in Humans

Treatment of the pathology of the extrahepatic biliary tract is the most frequent indication for performing endoscopic retrograde cholangiography (ERCP). The method, which combines endoscopic and radiological vision, also allows for therapeutic (and diagnostic) procedures on some pathologies of the pancreas and the papilla of Vater.

During the maneuvers it is also possible to obtain cyto-histological material for the diagnosis of any lesions identified, through the execution of brushing.

The endoscope used for ERCP allows for microsurgical procedures to be performed on the papilla of Vater, on the biliary tract and on the pancreas, procedures that in the past required a real surgical intervention.

ERCP is a generally well tolerated procedure, but as with all medical procedures it can have limitations and be followed by some complications. In 5% of cases, the procedure may not be completed due to anatomical variants that do not allow the endoscope to reach the duodenum or to cannulate and visualize the bile and / or pancreatic ducts. The most frequent complication is acute pancreatitis, which can arise as a consequence of surgery on the common outlet of the biliary and pancreatic tracts; it occurs in 3-5% of cases and to date, it cannot be predicted or prevented in all cases. In some groups of patients (young, with non-dilated biliary tract, or with a history of previous pancreatitis) the risk of pancreatitis can reach 10-12% . In rare cases (less than 1%), pancreatitis can have a severe course and may require surgery. Other less frequent complications (with an overall incidence of less than 2%) are: infection of the biliary tract or cystic collections, bleeding resulting from papillo-sphincterotomy, and perforation of the duodenum or ducts. Infection and bleeding are generally treated medically or endoscopically; the perforation may require surgery in some cases.

This registry aims to collect in a prospective and / or retrospective way the data of the ERCP procedures performed in our center by evaluating the sex, age of the patient, the reason why the patient was subjected to the examination, diagnosis, clinical risk factors and technical risk (i.e. associated with the procedure itself), if there have been complications, the type of instrumentation in use in our operating unit and / or the operators performing the examinations.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be recruited at the ICH Gastroenterology and Digestive Endoscopy Unit. The patients in question will be subjects of both sexes, over the age of 18 and who need to undergo ERCP.

Exclusion Criteria:

* Patients under 18 or unable to express informed consent.
Behavioral Activation, Nutrition, and Activity Intervention

This study will explore if a behavioral intervention program to assist people aged 50 and older with HIV is practical. The program includes a coach who talks with participants, encouraging them to be more active, reduce loneliness, and eat healthier.

This study aims to see if a 12-week program called Behavioral Activation (BA) can help people aged 50 and above with HIV by reducing loneliness and boosting social engagement. The program includes physical activity and nutrition guidance and is led by remote coaches. Investigators will recruit participants from the University of Maryland THRIVE program and other HIV centers in Baltimore. Investigators will test the program with 10 people aged 50 and above with HIV to see if it works. If it proves to be helpful and accepted, investigators might move on to a larger study to evaluate it more thoroughly.

Eligibility Criteria:
Inclusion Criteria:

1. 50 years of age or older
2. HIV positive diagnosis
3. Montreal Cognitive Assessment score \> 13
4. Report minimal level of loneliness, isolation, and/or depression (PHQ9 \> 5)
5. Able to consent
6. Ability to read or speak English
7. Attend the UM THRIVE Center or another HIV center in Baltimore

Exclusion Criteria:

1) No severe cognitive impairment
The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR

The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP parameters in high quality CPR.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrested
* The time from cardiac arrest to receiving basic life support is less than 10 minutes
* Get advanced life support (endotracheal intubation and PETCO2 monitoring)

Exclusion Criteria:

* Defuse CPR
* chronic obstructive pulmonary disease (COPD) with type II respiratory failure
* Terminal malignant tumors or terminal stage of other diseases
* Rib fracture
* Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade
* Sever anemia(HGB\<7g/dl)
* Untreated tension pneumothorax
* Tinea unguium, dyeing Fingernails and other factors affect the monitor of Pulse Oximetry Plethysmographic Waveform such vasculitis and Raynaud's phenomenon
Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.

Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 Elective cholecystectomy surgery
* 18-65 years old patients

Exclusion Criteria:

* ASA 3-4 patients
* Patient refusal
* several lung and heart disease
* Contraindications to regional anesthesia
* BMİ \> 35 patients
* Known allergy to local anesthetics
* Bleeding diathesis
* Use of any anti-coagulants
* Severe kidney or liver disease
* Patient with psychiatric disorders
Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery

A taurolidine-based antimicrobial solution, was evaluated for its safety and efficacy in preventing infections associated with prosthetic materials, such as joint replacements, plates, nails, and screws. This prospective observational study compared Taurolidine to infection rates from scientific literature.

During any invasive procedure involving prosthetic materials at the corresponding author's institution, the surgical site was irrigated, and all accessible hardware (including nails, screws, plates, and prosthetic joint replacement therapy devices) was wiped with Taurolidine. Only procedures performed between 01/01/2022 and 01/10/2023, where Taurolidine was applied, were included in the analysis.

Patients who underwent multiple procedures were censored for the last treatment group and reassigned at the next procedure. Preoperative antibiotic prophylaxis was administered according to institutional guidelines, and no additional intraoperative antimicrobial agents were used aside from Taurolidine.

The primary endpoint was the occurrence of a major infection within three months post-procedure, defined as:

1. Infection necessitating revision procedure,
2. A requirement for prolonged antibiotic therapy, or
3. Infection leading to mortality. Secondary endpoints included infections beyond three months, adverse events potentially related to the antimicrobial solution, procedural complications (i.e., hematoma formation, nerval lesions, etc), and mortality during all follow-up.

Eligibility Criteria:
Inclusion Criteria:

* requires osteosynthesis with placement of prosthetic materials

Exclusion Criteria:

* minor, can't or won't sign PIC, can't undergo surgical procedure
Artificial Intelligence in Subarachnoid Hemorrhage

The overall aim of this study is to, with the help of computer/data scientist and machine learning processes, analyse collected heart rate variability data in order to evaluate whether specific patterns could be found in patients developing delayed cerebral ischemia after subarachnoid hemorrhage.

Patients with aneurysmal subarachnoid haemorrhage (aSAH), develop delayed cerebral ischemia (DCI) in about 30% of the cases. DCI is associated with increased mortality, persistent neurological deficit as well as impaired quality of life. It would benefit both patients and society to decrease these neurological injuries. One clinical problem is that the diagnosis of cerebral ischemia in SAH patients often is delayed due to limitations in monitoring abilities. When detected, the neurological damage often turns out to be irreversible.

Several studies have used univariate and multivariate logistic regression analysis to identify risk factors for the development of delayed cerebral ischemia (DCI) in patients with subarachnoid haemorrhage. However, these studies are based on data collected about the patients (e.g. age, gender), and the precision of these statistical models has generally been found to be low. Recently, machine learning algorithms for the prediction of DCI using a combination of clinical and image data have also been evaluated .

However, prediction of DCI does not prevent DCI, to prevent DCI a monitoring system needs to be developed that can warn physicians of imminent risk of cerebral ischemia, making it possible to intervene and prevent cerebral ischemia.

Variations in the autonomous nervous system, such as changes in the balance between the sympathetic and the parasympathetic nervous systems, can be detected by using heart rate variability (HRV) monitoring. HRV has been reported as a predictor of poor outcome after traumatic brain injury and stroke, including subarachnoid haemorrhage. However, HRV monitoring for detection of incipient cerebral ischemia has not been thoroughly evaluated. In a study of patients with aSAH, we collected HRV continuously in up to 10 days after admission, but just a small part of the HRV data was analysed off-line. Fifteen of 55 patients developed DCI during the acute phase, and the off-line analyse of HRV showed that the low/high-frequency ratio increased more in patients that developed DCI (Ref). This led us to try to analyse all of the collected HRV with the help of machine learning processes, and a collaboration with computer/data scientists was initiated.

The overall aim of this study is to, with the help of computer/data scientist and machine learning processes, analyse collected HRV data in order to evaluate whether specific patterns could be found in patients developing DCI during the acute phase after subarachnoid hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* aneurysmal subarachnoid hemorrhage
* admitted to Neurointensive care unit at Sahlgrenska University Hospital, Gothenburg, Sweden

Exclusion Criteria:

* cardiac arrythmias
* use of pacemaker
Surveillance of High-risk Early Postsurgical Patients for Real-time Detection of Complications

The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.

Every year, approximately 1,500,000 surgical procedures are performed in The Netherlands alone. After major surgery, the complication rate is conservatively estimated at 25%, with a rate of 15% for major complications. In these patients, the most important problems are a failure to timely detect developing complications and a failure to adequately rescue those patients. Currently, measurement of vital signs and standardized assessment of patient wellbeing are routinely performed intermittently for every 8-12 hours, which may lead to a failure to detect of patients with complications.

The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, the investigators hypothesize that this tight control regimen decreases length of hospital stay and treatment costs in patients with complications.

The investigators will carry out this study as an interventional, randomized (per surgical ward), prospective, clinical trial; participating wards will be included using a stepped-wedge design.

Primary outcome is disability-free survival at three months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing acute or elective major or intermediate surgery
* American Society of Anesthesiology (ASA) score of I to IV

Exclusion Criteria:

* Inability to give written and informed consent
* Refusal to participate