cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival.

Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected


Eligibility Criteria:
Inclusion Criteria:

1. Intravenous access/intraosseous access
2. Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics.
3. Age 18 years or older
4. Comatose

Exclusion Criteria:

1. Traumatic cause of cardiac arrest
2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
3. Known DNAR
4. Drowning as cause of arrest.
ML-004 Open-Label Extension Study in Adults and Adolescents with Autism Spectrum Disorders (ASD)

ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Has completed Study ML-004-002 within the past 90 days
* Age 12 years to 46 years at screening
* Has a designated care/study partner who can reliably report on symptoms
* Has a diagnosis of Autism Spectrum Disorder (ASD)
* Has a body mass index (BMI) ≥18 kg/m²
* Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening
* Must be able to swallow study medication

Exclusion Criteria:

* Has Rett syndrome or Child Disintegrative Disorder
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
* Has a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactating
Asian Youth and Tobacco Control Survey

The overall goal of this study is to identify and understand the environmental characteristics associated with tobacco use and tobacco initiation among Asian American youth from primarily two communities: Chinese and Vietnamese. The specific aims of this study are twofold:

* To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston area compared with non-Asian American communities.
* To study the relationship between environmental characteristics (both pro- and anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth.
* To explore if degree of acculturation is related to tobacco initiation and use among Chinese and Vietnamese youth.

This is a survey about health-related behaviors, risks, attitudes and acculturation. It includes questions about use of alcohol, tobacco, and other drugs; safety and violence; diet and physical activity; and youth programs and resources in your community. Your answers are completely anonymous, and your name will not appear anywhere on this survey or as part of this survey. Your parents will not see your responses.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified male or female of Chinese or Vietnamese descent
* Age 12-17 years
* Living in the Greater Houston area
* Intellectual age of 7 or higher

Exclusion Criteria: None
A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)

In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. In our study, we aimed to investigate the effect of pneumoperitoneum applied on acute kidney injury in patients who underwent laparoscopic surgery. Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. Our study investigates whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years of both sexes
* ASA I-III Patients

Exclusion Criteria:

* Obesity,
* Chronic Kidney Disease,
* Chronic Renal Failure,
* Acute Renal Failure,
* Peripheral and ischemic vascular disease,
* Chronic Heart Failure,
* History of anaphylaxis,
* A-V block,
* Creatinine level \>1.4,
* Neuromuscular disease,
* Malignant hypertension,
* Pyelonephritis,
* Urinary tract infectio,
* Severe inflammation/possible sepsis,
* Active malignancy,
* Patients with surgery reversion to laparotomy,
* Hemodynamic instability, need for vasopressors,
* Severe bleeding requiring blood transfusion,
Tranexamic Acid in Off-pump Coronary Surgery

The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients for elective offpump coronary artery bypass surgery

Exclusion Criteria:

* A history of bleeding disorders
* Active chronic hepatitis or cirrhosis
* Chronic renal insufficiency (serum creatinine \> 2 mg/dL)
* Preoperative anemia (Hb \< 10 g/dL)
* Previous cardiac surgery
* Myocardial infarction \< 7 days before surgery
AcandiS Stenting of Intracranial STENosis - regisTry

ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.

ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.

The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.

Eligibility Criteria:
Inclusion Criteria:

- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)

Exclusion Criteria:

* There are no specific exclusion criteria (see product IFU)
Gastric Emptying Ultrasound Research Study

The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.

In order to ensure safety for elective anesthesia, standard practice requires pre-operative fasting to ensure that the stomach is empty prior to induction. The question of timing of pre-operative consumption of oral fluids remains vexed, and challenges anesthesiologists on a frequent basis. In the past few years, a new controversy in pre-operative fasting has arisen: clear drinks with increased content of protein and carbohydrate have been introduced to the market. Families and professionals alike are confused whether to regard these products as clear liquids (2 hours fasting) or as solids (at least 6 hours).

Ultrasound is now considered an accepted tool in the anesthesia literature as a surrogate for aspiration risk with different materials and in different disease states.

Eligibility Criteria:
Inclusion Criteria:

* 8-14 years old
* Willing to not eat or drink for at least 8 hours overnight beforehand
* Have a BMI \< 35

Exclusion Criteria:

* Use tobacco of any kind
* Taking any medications (Females: oral contraceptives okay)
* Suffers from diabetes, Crohn's Disease, Celiac Disease, Malabsorption, Galactosemia
* Has ever has surgery on esophagus, stomach, or small bowel
* Has allergies or intolerances to milk, apple juice, or ensure clear
* Has any surgical condition, disease, or on any medication that could alter stomach emptying rate
* Has any disease that limits day-to-day activities
* Is pregnant or possibly could be pregnant
Cholecystitis From a Microbiological and Histopathological Perspective

The aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.

The investigators will compare two groups of patients; patients with acute calculous cholecystitis undergoing acute laparoscopic cholecystectomy and patients without cholecystitis undergoing elective laparoscopic cholecystectomy.

Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.

In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.

The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Signed consent form
* Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.

Exclusion Criteria:

* Administration of any type of antibiotics one month prior to surgery in the control group.
* Previous instrumentation of the bileducts
* Previous clinical acute cholecystitis treated conservatively with antibiotics

Patients will be precluded from the studypopulation in cases of pPerioperative perforation of the gallbladder, or conversion to open cholecystectomy or in cases of failed attempts to extract bile or samples from the gallbladder wall.
Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery

Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks.


Eligibility Criteria:
Inclusion Criteria:

1. Elective patients scheduled for hip arthroplasty surgery
2. Patient willingness to participate in the study
3. Patients over 18 years age of, ASA I-II-III,

Exclusion Criteria:

1. Patients not wanting to participate in the study
2. Patients who do not want regional anesthesia technique
3. Allergic or coagulated patients
4. Patients with liver, kidney, lung, heart failure and septic patients
5. Neurological disorder, history of convulsions
6. ASA IV patients
Cognitive Rehabilitation in Sickle Cell Disease

The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed. Pilot data will also be collected to establish preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12). Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week). Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. If interested, they will follow the same intervention protocol described above. These children will return to clinic for a third visit following completion of the intervention. Compliance rate and its confidence interval will be calculated for the overall study population. A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).


Eligibility Criteria:
Inclusion Criteria:

* 1) Children with a diagnosis of SCD (all genotypes)
* 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
* 3) a standard score ≥1 standard deviation below the mean (\<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)

Exclusion Criteria:

* 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
* 2) a diagnosis of depression or a pervasive developmental disorder (by history);
* 3) clinical stroke (via record medical history); or
* 4) non-English fluency.
Evaluation of Deposits on Contact Lenses Worn Extended Wear

The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of ocular conditions as prescribed in the protocol.
* One functional eye or a monofit lens.
* Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
* Use of concomitant topical ocular prescription or over-the-counter ocular medications.
* History of seasonal allergies with significant ocular side effects.
* Other protocol-defined exclusion criteria may apply.
Adapt and Incorporate dDPP Into Clinical Workflows

This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data elements (e.g. weight and daily step count) directly into EHR workflows of primary care to enhance patient engagement. It seeks to determine the impact of combining adapted visualizations and summaries of key dDPP data elements directly into the EHR with automated notifications and messaging designed to enhance patient engagement in the dDPP. The study will involve provider workflow analysis based on observation and facilitated group tool adaptation sessions.

Primary objective: to examine the impact of the dDPP tool suite on the EHR and clinical workflows, and identify optimization opportunities.

Secondary objective: to assess the "usability" of the proposed dDPP tool suite in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Physicians
* Nurses
* Practice assistants
* Health coaches
* Population health managers
* Patient navigators

Exclusion Criteria:

* Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.
Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care

The "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines. To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for vocational students. However, it must be assumed that the concept has not yet been adopted comprehensively across the Bavarian nursing landscape. Therefore, the "TakeCare!" study tackles the question of how PAHCO can be implemented most appropriately in Bavarian nursing schools. Drawing on experiences from the project PArC-AVE, three different dissemination approaches will being tested and compared with a control group. A total of 16 nursing schools from different regions of Bavaria will be assigned to four different study arms (cluster-randomized design). In the long term, the project aims to derive recommendations for all nursing schools in Bavaria.


Eligibility Criteria:
Inclusion Criteria (School/Cluster Level):

* Private or Local Sponsorship
* Location in Bavaria
* Schools with 33-64 students in the first cohort (i.e., two or three classes per cohort)
* School director providing informed written consent by March 1st 2023

Inclusion Criteria (Student Level):

* Informed written consent to participate (or their legal guardians, if aged under 18 years)
* Part of the first education year (in cohort 2023/2024)

Exclusion Criteria:

-if any of the criteria mentioned above is not given
Caracteristics of Pediatric Spinal Mobilizations

This observational study aims to create simulations using pediatric manikins to teach pediatric spinal mobilizations. We'll measure the force and duration of spinal mobilizations applied by chiropractors on pediatric manikins. Another objective is to gather feedback from both students and teachers on the effectiveness of using manikins for teaching.

The main questions it aims to answer are:

1. How much force and for how long do chiropractors apply spinal mobilizations on pediatric manikins?

This project aims to initiate the development of low-fidelity simulations to enhance the learning of skills associated with performing pediatric spinal mobilizations. This will be achieved by gathering target values for the force and duration of spinal mobilizations performed by chiropractors on pediatric manikins.

Eligibility Criteria:
Inclusion Criteria:

* Being a chiropractor in private practice and a member of the Ordre des chiropraticiens du Québec

Exclusion Criteria:

* Not been able to perform pediatric spinal mobilizations
Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

A randomized, double-blind controlled Study from a single center to evaluate the effect and safety of pramipexole on peritoneal dialysis patients with restless legs syndrome

Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into experiment group and control group, and will be prescribed with pramipexole and placebo respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating Depression Scale before and after the prescription.

Eligibility Criteria:
Inclusion Criteria:

1. PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate, using a twinbag connection system (Baxter Healthcare, Guangzhou, China).
2. For entry , all patients are required to meet all diagnositic criteria of the International RLS Study Group (IRLSSG), to have a baseline total score \>15 on the Study Group's International RLS Rating Scale (IRLS), and to have experienced RLS symptoms at least 2-3 days per week throughout the perior 3 months.
3. Each patient should write informed consent.
4. All patients are required to be interviewed to the frequency required by the research process.

Exclusion Criteria:

1. Patients with severe gastrointestinal illness can not tolerate oral drugs.
2. Patients who work on a shift schedule are not allowed to participate.
3. Women with childbearing potential are excluded for pregnancy, inadequate contraception, or current breastfeeding of a child.
4. Patients are also excluded for current use (within 14 days before baseline) of medications that might affect RLS symptoms, e.g., levodopa, dopamine agonists or antagonists, hypnotics, lithium formulations, or antidepressants.
5. Patients with serum ferritin ≤200 ng/ml, or Hb \<110g/L, or Kt/V \<1.7 are excluded.
6. Patients with severe and unstable inflammation disease (active systemic infection, acute cardiovascular disease, active liver disease, active connective tissue disorder, ,and cancer within 1 year of radiotherapy and chemotherapy, )