cyrilzakka/clinical-trials huggingface dataset:
A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy

This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.

Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.

Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).

Allocetra-OTS will be administered systemically or locally (intravenous \[IV\] or intraperitoneal \[IP\]) according to the tumor location.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.

   Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
2. Patients must have measurable disease.
3. Age ≥ 18 years old.
4. ECOG performance status ≤1.
5. Adequate renal function, hepatic function, and bone marrow function.

Exclusion Criteria:

1. Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
2. Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
3. \[For patients in Stage 2\] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis

The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions.

The prospective, randomized, placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis.

Research objectives:

* To evaluate the immediate, rapid and long-term results of using Antispike as a drug for preventive adhesions in patients who have a medium and high risk factor for the development of adhesions and are undergoing surgery for acute phlegmonous appendicitis;
* Identify the possibility of undesirable effects that may occur when using the drug;
* to conduct a comparative assessment of the immediate results of using the drug Antispike as a means of preventing adhesions in patients with minor phlegmonous appendicitis with an effect in the control group, in patients in whom anti-adhesion drugs were not used;
* Detailed description of the conditions and method of use of the Antispike drug.

Eligibility Criteria:
Inclusion Criteria:

* Presence of acute phlegmonous appendicitis requiring surgical intervention.
* Presence of medium or high risk factor for the development of adhesions of the abdominal cavity;
* Age of patients from 18 to 65 years.
* Absence of severe concomitant diseases in decompensation stage, oncologic diseases, as well as diseases requiring steroid therapy.
* Presence of written informed consent of the patient to participate in the study.
* The patient's ability to fulfill the instructions of the research physician and comply with the study design.

Exclusion Criteria:

* At the subject own request without explaining the reasons for the behavior.
* At the request of the physician-researcher if the subject violates the requirements of the protocol in terms of diet, smoking, consumption of alcoholic beverages, and use of medications without the prescription of the physician-researcher.
* For reasons independent of the subject and the research physician, if the subject has drug intolerance or other life-threatening or life-threatening adverse reactions to drug administration that require emergency pharmacotherapy.
NightOwl Pulse Oximeter Calibration Study

Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead.

The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)

Exclusion Criteria:

* smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels.
* individuals subject to conditions that result in elevated levels of methaemoglobin.
* individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery

Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant

This study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of PMVT after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

- BARIATRIC PATIENTS

Exclusion Criteria:

* BLEEDING TENDENCY
Trial of a Middle School Coach Gender Violence Prevention Program

This cluster-randomized school-based study will examine the effectiveness of a program for the primary prevention of perpetration of teen dating violence and sexual violence among middle school male athletes. Engaging men and boys in preventing violence against women and girls is recognized by major global health organizations as a critical public health strategy. "Coaching Boys into Men" is a theory- and evidence based program intended to alter gender norms that foster teen dating violence/sexual violence perpetration, promote bystander intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a 60-minute training and biweekly check-in from a violence prevention advocate to administer the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport season. In a randomized trial of program effectiveness among high school athletes (Centers for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the program demonstrated increased positive bystander intervention behaviors and less verbal abuse perpetration compared to controls. This project seeks to test the effectiveness of this program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing the efficacy of a novel teen dating violence/sexual violence prevention program for middle school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence prevention thus implementing primary prevention that does not rely on teachers or classroom time; and (3) integrating the goal of changing gender norms with the technique of a bystander intervention approach to reduce teen dating violence/sexual violence prevention. The experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either intervention or control (standard coaching) condition. Coaches in intervention schools will receive Coaching Boys into Men training. Baseline surveys will be collected for all intervention and control site athletes entering grades 6-8 at the start of each sports seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months after baseline (Time 3).


Eligibility Criteria:
Inclusion Criteria:

School eligibility:

Urban and suburban middle schools in the Pittsburgh, PA region with athletics program

Athlete eligibility:

Ages 11-14 (grades 6-8), student at a participating middle school, participating in an athletic program led by coach participating in the research study

Exclusion Criteria:

School Eligibility:

Middle schools not in the Pittsburgh area

Athlete eligibility:

Outside age range, not participating on a sports team at the middle school in which they are enrolled
Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery

This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and intra-articular local anaesthetic injection. Both techniques are currently used for providing postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be a randomised controlled trial involving 30 patients in two groups.


Eligibility Criteria:
Inclusion Criteria:

• All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation

Exclusion Criteria:

* Patients not meeting inclusion criteria
* Patients unable to give informed consent
* Patient refusal to participate in the study
* Contraindications to Interscalene block
* Allergy to local anaesthetics
* Peripheral neuropathy from any cause
* Patients on opiates for chronic pain
* Pregnant women
Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury

Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.


Eligibility Criteria:
Inclusion Criteria:

* TBI diagnosis
* admission to ICU
* age \>18 y

Exclusion Criteria:

* initially lethal injury
* age \<18 y
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)


Eligibility Criteria:
Inclusion Criteria:

1) children aged 5 to 11.9 who visit pediatric urology department for enuresis.

Exclusion Criteria:

1. If children have experience of performing uroflowmetry or uroflowmetry-electromyography.
2. If children do not cooperate on performing the test
3. If enuresis is caused by neurological or anatomical problem.
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning

The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* You must be female
* You must be 21 to 50 years old
* You must not have or have had breast cancer.
* You must not have or have had breast implants or breast surgery
* You must not have had a breast biopsy or injury, or a breast infection, in 90 days.

Exclusion Criteria:

* Any one or more of the above conditions not met
* Lack of informed consent
Regional Anesthesia

Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II

  --Age(25-55)years
* Height(150-170cm)

Exclusion Criteria:

* patient refusal
* severe mitral or aortic stenosis
Mind-body Approach and Gut Microbiota in Osteoarthritis

This exploratory study is to compares mechanisms of mind-body exercise with wellness education program on gut microbiota for osteoarthritis as a basis for a future large-scale trial.

This exploratory study is to determine the effect of mind-body exercise on gut microbiota in patients with osteoarthritis. We will randomize 80 eligible individuals who meet the American College of Rheumatology criteria for osteoarthritis into Tai Chi or wellness education interventions for 12 weeks. Using 16S rRNA amplicon sequencing of fecal DNA samples we will compare the changes in gut microbiota profiles using 16S rRNA gene amplicon sequencing, and quantity of Streptococcus species using quantitative PCR, as well as their association with clinical outcomes. This exploratory study will guide the development of theoretically informed, effective treatment for a high-risk population further enlighten us about the pathogenesis of metabolic osteoarthritis pain.This proposal will provide crucial preliminary knowledge of the mechanism underlying Tai Chi mind-body therapy for metabolic osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years
* Fulfills the American College of Rheumatology Criteria for symptomatic OA
* Baseline (Month 0) WOMAC pain subscale score ≥ 40

Exclusion Criteria:

* Dementia, neurological disease, cancer, cardiovascular disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the programs.
* Factors known or likely to impact the intestinal microbiota or known to be associated with microbial translocation: antibiotic or probiotic use within the previous 4 weeks, gastrointestinal morbidity (irritable bowel syndrome, inflammatory bowel disease, history of gastrointestinal cancer or surgical resection, or acute, severe gastrointestinal symptoms requiring medical attention), opportunistic infection, and evidence of hepatitis B or C virus infection
NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo

The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.


Eligibility Criteria:
Inclusion Criteria:

* NORMAL cohort

  1. Breast size and epithelial integrity adequate to allow NIR imaging exams
  2. No serious associated psychiatric illnesses
  3. Female, ≥25 and \<76 years old
  4. Written informed consent
* UNDER TREATMENT cohort

  1. Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy
  2. Breast size and epithelial integrity adequate to allow NIR imaging exams
  3. No serious associated psychiatric illnesses
  4. Female, ≥25 and \<76 years old
  5. Written informed consent

Exclusion Criteria:

* both cohorts

  1. Pre-existing respiratory conditions:

     1. severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema)
     2. Other respiratory or lung conditions which would place the patient at risk
     3. presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea
  2. Congestive heart failure
  3. Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct breathing circuit
  4. Pregnancy
Is Verapamil In TransRadial Interventions OmittabLe?

Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.

Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
* successful cannulation of the radial artery

Exclusion Criteria:

* reduced left ventricular systolic function (LVEF\<35%)
* significant aortic stenosis
* bradycardia (\<50/min.)
* myocardial infarction complicated by cardiogenic shock and/or high grade AV block
Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation

It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have tried to reduce the noise experienced by patients by supplying them with active noise cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling headphones with white noise to try and reduce noise experienced by patients, with the aim of improving their sleep. Sleep deprivation is known to negatively impact health, and so improving sleep may improve patient outcomes as well as improve the patient's experience in critical care.

The Investigators will screen all patients in the critical care wards in the Royal Infirmary of Edinburgh. Patients that are receiving ventilation, are delirious or have already been enrolled in the study will be excluded. After allowing patients to give informed consent, we will randomise them into one of two study groups:

Study group A will receive standard care on the 1st night (no headphones), and will receive the intervention (active noise cancelling headphones with white noise) on the 2nd night.

Study group B will receive the intervention on the 1st night, and will receive standard care on the 2nd night.

All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.

Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to establish usual sleeping habits.

Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire (RCSQ), which will be filled in by the patient the morning after each night.

Our secondary outcome measure is the data from the wrist band, noise levels measured overnight, and patient experience of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Critical care patient in Royal Infirmary of Edinburgh

Exclusion Criteria:

* \< 18 years of age
* If the patient is delirious. This will be clarified by asking the nurses, who use the Confusion Assessment method for the ICU (CAM-ICU) Score.
* If the patient is receiving any form of ventilation (invasive or non-invasive ventilation, continuous positive airway pressure (CPAP), High flow nasal oxygen (HFNO) or respiratory support at night)
* Physical reasons why they can't wear over-ear headphones
* Pre-existing severe hearing impairment
* Previous participation in the study.
* If the patient is likely to receive medical interventions during the night that would disturb their sleep.
* Patients expected to leave the critical care wards within the following 48hours.
* Refusing consent or inability to give consent.
NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins

The objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects.

The study aims at evaluating the effects of a symbiotic, consisting of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by achieving two objectives:

1. Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD
2. Reduction of intestinal permeability, inflammatory markers and oxidative stress


Eligibility Criteria:
CKD patients

Inclusion Criteria:

* CKD patients stage 3b-4 not on dialysis
* Aged between 30 to 65
* BMI between 18.5 and 29.9
* Controlled diet
* Informed consent signed

Exclusion Criteria:

* Type 2 diabetes mellitus
* Use of antibiotics or probiotics up to 30 days prior to recruitment
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Suspicion or clinical diagnosis of malignancy
* Chronic liver disease
* Treatment with corticosteroids or immunosuppressive drugs
* Previous acute cardiovascular diseases (myocardial infarction, stroke)
* Psychiatric conditions reducing the compliance to treatment protocols

Healthy volunteers

Inclusion Criteria:

* Healthy subjects
* Aged between 35 to 60
* BMI between 18.5 and 29.9
* Medium score of adherence to Mediterranean Diet (PREDIMED score between 6 and 9)
* Informed consent signed

Exclusion Criteria:

* Type 2 diabetes mellitus
* Use of antibiotics or probiotics up to 30 days prior to recruitment
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Suspicion or clinical diagnosis of malignancy
* Chronic liver disease
* Treatment with corticosteroids or immunosuppressive drugs
* Previous acute cardiovascular diseases (myocardial infarction, stroke)
* Psychiatric conditions reducing the compliance to treatment protocols