cyrilzakka/clinical-trials huggingface dataset:
Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair

The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective robot assisted hiatal hernia repair

Exclusion Criteria:

* patients less than 18 years of age
* conversion to open surgery
* BMI \> 40
* history of abdominoplasty
* history of chronic pain and/or opioid dependence
* history of COPD and/or supplemental oxygen use
* pregnant patients
* incarcerated patients
* patient refusal
Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral skin test in the region;
* To use products of the same category;

Exclusion criteria:

* Lactation or gestation;
* Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
* Cutaneous disease (local or spread) in the evaluation area;
* Pathology which may cause immunity depression, such as HIV, diabetes;
* Endocrine pathology
* Solar exposure 15 days before evaluation;
* Treatment until four months before the selection.
* Allergic or atopic history to cosmetics products

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
West Virginia WISEWOMAN Pilot Study to Test a Brief Nutrition Intervention

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

To test whether a brief, interactive, computer-based nutrition intervention (Cookin' Up Health)impacts various health outcomes

Eligibility Criteria:
Inclusion Criteria:

* NBCCEDP
* Aged 40-64
* Attends selected rural clinics

Exclusion Criteria:

-
Work of Breathing and Kangaroo Mother Care

To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants (those less than 1500g at birth)
* Respiratory insufficiency
* \>4d PMA
* Stable and receiving non-invasive respiratory support for ≥12 hours (NC, HFNC or CPAP)
* Requiring ≤40% supplemental FiO2

Exclusion Criteria:

* Infants with skeletal, neuromuscular or abdominal surgical disorders that may affect the accuracy of work of breathing measurements
* Infants who do not meet criteria to participate in kangaroo mother care
Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads

This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2 )(COVID-19) in African American (AA) adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and Black/African American from rural regions are burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke.

This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of SARS- CoV-2 (COVID-19) in African American (AA) adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and Black/African American from rural regions are burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke. Those chronic diseases contribute to more severe health consequences and higher rates of mortality from COVID-19. POC are also more likely to be impacted by social and structural determinants of health (SSDH), such as barriers to health care access, discrimination, and lack of social support, that negatively impact quality of life (QoL) and effective chronic disease self- management behaviors. To provide the fullest health benefits to participants with chronic conditions in the wake of the COVID-19 pandemic, it is critical that we design interventions targeting SSDH for improved chronic disease self-management, health, functioning, QoL.

This study will utilize an embedded mixed methods design paired with an efficacy randomized controlled trial (RCT). Our iCINGS FAM (Integrating Community-based Intervention Under Nurse Guidance with Families) is a Registered Nurse (RN)-Community Health Worker (CHW)-delivered, telehealth intervention (14-weeks) that targets compounding racial- and pandemic-related stressors for improved chronic illness management and future disease risk mitigation in adult AA COVID-19 survivor/IC dyads.

Eligibility Criteria:
Inclusion Criteria:

COVID-19 survivor inclusion criteria

* African American
* Male and female
* Living in a Medically Underserved Area of South Carolina; rural
* ≥ 18 years and above
* A history of a COVID-19-associated hospitalization since March 11th 2020
* A previous diagnosis of one or more of the following conditions: type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, or stroke (\>3 months)

  -Carepartner inclusion criteria
* Male and female
* ≥ 18 years and above
* Must live on same property or community preferably within 20-mile radius as the survivor
* Primarily responsible for care provision/ care support in the home (i.e., is not paid for services)

Exclusion Criteria:

* Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials
Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)

The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required.

This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g "Takeda," hereinafter referred to as "the drug") was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.

Eligibility Criteria:
Inclusion Criteria:

-All patients who have been confirmed as receiving the drug

Exclusion Criteria:

-None
Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

The purpose of this research project is to conduct a preliminary validation study of the Diet Quality Photo Navigation (DQPN) method of dietary intake assessment. In 150 adults, dietary intake as estimated by the DQPN will be compared to dietary intake as estimated by a food frequency questionnaire (FFQ) and with blood levels of fatty acids, folic acid, and beta-carotene as biomarkers of dietary intake.

The primary aim is to test thee principal hypotheses (n=150):

1. There will be statistically significant correlations between blood levels of fatty acids/folate/beta-carotene and their corresponding levels of dietary intake as estimated by the DQPN.
2. There will be statistically significant correlations between the DQPN and FFQ methods of dietary intake assessment. This includes individual dietary components as well as overall dietary quality and disease risk assessments.
3. User experience surveys will demonstrate that the DQPN can be completed more quickly and more enjoyably than the FFQ.

In addition, investigators will assess whether blood levels of fatty acids/folate/beta-carotene are similarly associated with the DQPN method and the FFQ method, and will measure the test-retest reliability of the DQPN method.

Eligibility Criteria:
Inclusion Criteria:

* Clinical provider has ordered fasting Boston Heart Fatty Acid Balance and participation in the Boston Heart Lifestyle Program as part of clinical practice.
* Willing to fill out Food Frequency Questionnaire
* Willing to complete DQPN Diet IDTM (on-line), and to repeat that 1 week later
* Willing to complete user experience surveys about each dietary assessment method

Exclusion Criteria:

* Taking fatty acid or vitamin supplements (such as fish oil capsules, or multivitamin tablets)
* Following a diet outside the capabilities of the DQPN cannot be included in this study. The vast majority of eating styles are within the assessment capabilities of the DQPN (Standard American, Low-fat, Mediterranean, Pescatarian, Flexitarian, Low-carb, DASH, AHA, TLC, MIND, Vegetarian, Vegan, Paleo, Southern).
Study of Bone Marrow Samples From Patients With Acute Leukemia

RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow samples from patients with acute leukemia.

OBJECTIVES:

* To perform high throughput sequencing of a set of megakaryocyte specific transcription factors, tyrosine kinases, and Src kinases in DNA isolated from bone marrow specimens of adults with acute megakaryoblastic leukemia (AMKL).
* To assay the ability of Src kinase inhibitors (SU6656, dasatinib) to induce differentiation of AMKL blasts in these patients.

OUTLINE: DNA from previously collected bone marrow samples are sequenced to analyze genes associated with transcription factors (GATA1, GATA2, SCL, FOG-1, ETS1, ETS2, ERG, FLI-1, GABP, HOXA11, NF-E2, and RUNX1), tyrosine kinases (JAK2, JAK3, and c-MPL), and Src family kinases (LYN, FYN, and HCK) and compared with control DNA. Using bioinformatics, gene alterations are compared to known polymorphisms and subsequent changes in the amino acid sequence of the encoded protein. Subsequent assays assess the effect on proliferation and differentiation and in vitro studies evaluate the consequences of mutations on transcription factor and kinase activity abilities. The effect of SU6656 and dasatinib on cell death and polyploidization is evaluated by flow cytometry and compared with control DNA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adult acute megakaryoblastic leukemia
* Archived bone marrow specimens from the ECOG tissue repository

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
PPG vs. ICG in Gastrointestinal Resections

In this study, gastrointestinal anastomoses are examined with imaging Photoplethysmography and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared.

All gastrointestinal anastomoses were examined in all patients with written informed consent.

As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Imaging photoplethysmography (iPPG) as new method.IPPG is an optical technique in which a conventional video camera is used to detect tiny modulations associated with blood pulsation in vessels.This technique is contactless, extremely simple, and does not affect hemodynamic processes in living organs. It is an emerging technique that allows to sense cardiovascular signals in the outer skin layers.Various research groups recently applied iPPG to monitor the vascular changes (dilatation or vasoconstriction) caused by functional tests.These experiments suggest that the normalized amplitude of the photoplethysmography (PPG) waveform can be considered as a perfusion index. More recently, our group has demonstrated the feasibility of using iPPG to assess changes in cortical blood flow in open brain neurosurgery and tissue perfusion during abdominal surgery.

As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.

Eligibility Criteria:
Inclusion Criteria:

* all gastrointestinal anastomoses

Exclusion Criteria:

* inability to consent
* allergy against indocyaningreen dye
Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection

The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters.

This experiment was a single-center clinical study with randomized, open, positive drug control and single dose increment. The test group will be conducted in the order of incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO). After 7 days of administration, the researchers looked at the drug safety tolerance of the test to determine whether to proceed with the next higher dose group test.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) in the range of 19.0\~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
* Understand and sign the informed consent form

Exclusion Criteria:

1. Persons with allergic physique or sensitive skin;
2. Any person with any skin disease;
3. have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
4. Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
5. Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
6. Having a fertility plan within 2 weeks of screening and within 6 months of the end of the trial and not having to take it during the trial period

   (a) Effective non-drug contraceptive measures;
7. Within 14 days prior to screening or within 5 half-life of the drug (whichever is the oldest of the two) there has been any Prescription drugs, over-the-counter drugs, Chinese herbal medicine, health care products medicine history;
8. Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version number: 1.2 Version date: September 30, 2018 26 sexual);
9. The percentage of erythrocyte red blood cells ≥ 3%;
10. ferritin \<200 ng/ml (male), ferritin \<80 ng/ml (female);
11. The use of drugs known to have damage to an organ during the first 3 months of screening;
12. A person who has received a blood transfusion or rhEPO treatment;
13. Clinically determined to be vitamin B12 or folic acid deficiency;
14. Have a history of dizziness and needle sickness;
15. A clinical trial person who has participated in other drugs within the first 3 months of screening;
16. Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;
17. Women during pregnancy and lactation;
18. The researchers did not consider it appropriate to enter the trial.
Decompensation of Cirrhosis and Iron Metabolism

Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.

A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.

Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
* Hospitalization for acute on chronic liver failure:
* Ascites decompensation.
* Or spontaneous infection of the ascites fluid (defined as PNN \> 250/mm3 of ascites).
* Or digestive hemorrhage related to portal hypertension (digestive fibroscopy showing active bleeding or stigmas of recent bleeding from esophageal and/or gastric varices).
* Or hepatic encephalopathy (clinically defined +/- increase in ammonia and/or by electroencephalogram and classified in stages according to West-Haven).
* Or hepato-renal syndrome (HRS-AKI criteria, EASL 2018).
* Or bacterial infection (defined by a bacteremia identified by at least one blood culture and/or an infectious site authenticated on imaging).
* Or Acute Alcoholic Hepatitis (histologically proven or not).
* Non-opposition of the patient, relative or legal representative.

Exclusion Criteria:

* Treatment with oral or intravenous iron in the month prior to hospitalization.
* Implementation of a TIPS in the month prior to admission.
* Presence of hepatocellular carcinoma with an expected survival \< 3 months or any other progressive cancer.
* Adult person subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
Prediction of Muscle Responsiveness to FES Therapy

Reduced arm and hand function has a significant impact on independence and quality of life after spinal cord injury. Functional electrical stimulation therapy (FES-T) is a treatment that can produce improvements in reaching and grasping function after neurological injuries. However, not all paralyzed muscles respond equally well to the therapy. Currently, therapists cannot predict which muscles will respond, limiting their ability to create a personalized therapy plan that can maximize outcomes while making the best use of the limited treatment time available. The objective of this study is to develop a diagnostic method that will allow therapists to quickly and easily screen muscles in the clinic, in order to predict how they will respond to FES-T.

Participants with cervical spinal cord injury will receive FES-T through the Rocket Family Upper Extremity Clinic at the Toronto Rehabilitation Institute - University Health Network. Muscles receiving training will undergo a electrophysiological examination before the start of therapy, and will then be tracked for strength recovery over the course of 30 sessions. Lastly, signal processing and machine learning techniques will be applied to the electrophysiological data to predict the recovery profile of each muscle.

The significance of this work will be to provide personalized therapy planning in FES-T, leading to more effective use of healthcare resource as well as improved outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Cervical spinal cord injury
* Paralysis or paresis in at least one upper extremity
* At least 6 months post SCI
* Able to understand and follow instructions
* Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
* Willing to attend treatment sessions and all assessment sessions
* Able to understand and provide informed consent
* Male and female participants ≥ 18 years of age at the time of enrollment

Exclusion Criteria:

* Previous history of any other neuromuscular disorder or conditions that may affect motor response
* Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
* In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
* Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
* Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 3 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment.
* Females who are pregnant or planning to become pregnant in the duration of the trial
* Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers

This study evaluates the role of socioeconomic and individual factors in the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) in oeso-gastric cancer.

Reducing the time between the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) is essential to improve the vital prognosis and quality of life of patients. Recent data suggest that some sociocognitive and emotional determinants may explain patient delay from a complementary point of view. The main objective of this study is to assess whether, in oeso-gastric cancer, patient delay is linked to these sociocognitive and emotional factors, in addition to previously known factors.

We intend to include in this study 300 patients with a not yet treated oeso-gastric cancer diagnosed in one of 10 health centres in the North of France region. The collected data will be analysed to underline the differences between patients who consulted a doctor earlier versus those who consulted later with a cut off at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* oesophageal, oeso-gastric junction or gastric cancer non treated cancer
* patient informed of his diagnosis
* speak fluent french

Exclusion Criteria:

* history of cancer
* psychological history
* patient under guardianship-
* fortuitous diagnosis of cancer