cyrilzakka/clinical-trials huggingface dataset:
Frailty in Children With Cardiac Disease

Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and diminished physical activity. The concept of frailty is novel in children. A study in young adult childhood cancer survivors demonstrated increased incidence of frailty in this population along with increased risk of morbidity and mortality. This suggests that frailty as a phenotype has relevance outside of the geriatric age group. Pediatric patients with single ventricle physiology, heart failure and pulmonary artery hypertension- all represent populations with significantly increased risk of mortality, morbidity and decreased quality of life. Currently, such patients are monitored outpatient by serial echocardiograms and blood work that only gives information about end organ damage. But there is no validated tool available to measure global infirmity in such children. Better understanding of the relevance and applicability of frailty in pediatrics may allow for identification of the most vulnerable pediatric cardiac patients and be of value in optimizing their clinical management and improving health outcomes.


Eligibility Criteria:
Inclusion Criteria:

SUBJECT/CASE POPULATION herein referred to as Subjects:

* Children and adolescents between the ages of 8.0-17.50 years
* Subjects must be diagnosed with one of the following heart conditions:

  * Subjects with single ventricle physiology and Fontan surgery completion at least 6 months prior to study enrollment
  * Subjects with diagnosis of heart failure by a cardiologist
  * Subjects with a diagnosis of pulmonary arterial hypertension, confirmed by cardiac catheterization, requiring use of at least 1 pulmonary vasodilator or oxygen for their pulmonary hypertension

CONTROL POPULATION herein referred to as Controls:

* Healthy children and adolescents between the ages of 8.0-17.50 years

Exclusion Criteria:

BOTH SUBJECT/CASE POPULATION AND CONTROL POPULATION:

* Subjects or controls with known severe neurological or respiratory diseases, eating disorders (such as anorexia, bulimia) or physical limitations (wheelchair bound) which may impact their ability to perform study procedures in the opinion of the provider.
* Subjects or controls with tracheostomy and ventilator dependency
* Subjects or controls with unstable angina/ myocardial infarction in the last 4 weeks
* Subjects or controls who are unable to perform 6 continuous minutes of walking, hand-grip dynamometry, or complete questionnaire measures as described.

SUBJECT/ CASE POPULATION:

* Subjects with heart transplantation within the past 1 year
* Subject will be excluded if the cardiologist feels that the study is not appropriate for the subject.

CONTROL POPULATION:

* Controls with any known chronic medical condition requiring some medication over the past 30 days.
* Controls on any chronic prescription medicines for \> 30 days
Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients

The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women

Exclusion Criteria:

* Postpartum women with contraindication for breast feeding such as HIV, untreated tuberculosis, on chemotherapeutic drugs, on radioactive drugs, substance abuse.
* Postpartum women with unstable conditions such as postpartum hemorrhage.
Magnesium and Vanadium Levels in Preeclampsia

Introduction: Vanadium important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. Magnesium sulfate therapy is used very common to prevent seizures in women with preeclampsia. However, the causes of preeclampsia are little known and heavy metals merit further investigation. The investigators will be tested whether late - onset preeclampsia (LOPE) was associated with exposure to these metals.

Methods: This study was designed to determine maternal plasma/urine/hair magnesium and vanadium concentrations in women with LOPE (n=70) compared to those of normotensive pregnant women (n=70) and to those of normotensive-healthy non-pregnant women (n=70). These metals concentrations will be measured using inductively coupled plasma-mass spectrometry were compared.

This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between May 2020 and February 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/130). The study strictly will be adhered to the principles of the Declaration of Helsinki. All participants will be included in the study gave oral and written informed consent. Two-hundred ten women will be enrolled in the study in three groups.

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia
* healthy pregnancy
* healthy women

Exclusion Criteria:

1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and diabetes mellitus)
2. using any kind of medication/supplement intake throughout pregnancy (such as heparin)
3. history of medication for PE treatment at the time of first admission
4. smoking
5. drug user
6. patients who had fetal congenital abnormalities or genetic syndromes
7. multiple-gestation pregnancies
8. pregnancies resulting from in vitro fertilization
9. intrauterine fetal death
10. having a family history of preeclampsia
11. Women who have menstrual irregularity
12. Women who have dyed their hair in the last 9 months
13. Gestational diabetes mellitus
14. Women receiving vanadium and/or magnesium treatment
A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)

The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or healthy, permanently sterilized, women aged 18 to 50 years inclusive, non-smokers or ex-smokers, Body Mass Index 18 to 30 kg/m2 and minimum body weight of 50 kg
* Blood neutrophil count above 2.2x10\^9/L

Exclusion Criteria:

* Clinical relevant disease and/or abnormality
Povidone-Iodine for Nasal Decolonization

To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).

This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively

Eligibility Criteria:
Inclusion Criteria:

* community-based patients ages 18-80
* American Society of Anesthesiology (ASA) 1-3
* undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration

Exclusion Criteria:

* pregnancy
* allergy to povidone-iodine
* infectious indication for surgery or preexisting known infection/wound
* immunocompromised state
* use of chemotherapy or steroids within 30 days prior to surgery
* use of antimicrobial therapy within 30 days prior to surgery
* surgeries where field avoidance prevents intraoperative access to the nares
Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

For some upper ureteral and renal stones,ureteroscopic lithotripsy is often perdurbed by the patient's respiratory movement either under epidural anesthesia or general anesthesia with mechanical ventilation. So intermittent suspension of mechanical ventilation under general anesthesia can ensure the surgery to be performed continuously and successfully. But this could result in hypercapnia and hypoxia. So far, there have been few studies focused on the change of the internal environment in blood as result of suspending breath. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Eligibility Criteria:
Inclusion Criteria:

ASA I\~III general anesthesia sign the informed consent

Exclusion Criteria:

ASA IV or V woman who is pregnant or plans to bear
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes

Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated fatty acid lowering with acipimox will improve insulin action and blood vessel function and have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D treatment that may significantly improve current management of TID and of cardiovascular disease (CVD) risk in this high risk population.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, with and without type 1 diabetes between 25-59 years of age,
2. HbA1c 6.0-9.5 (T1D only),
3. Subjects who are willing to commit to:

   * 14 days of prescribed diet,
   * two 44 hour inpatient stays, and
   * two muscle biopsies.

Exclusion Criteria:

1. Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia,
2. Tobacco use,
3. Pregnancy,
4. Steroid use,
5. Scheduled physical activity \>3 days a week,
6. Angina or any other cardiovascular or pulmonary disease,
7. History of chronic obstructive pulmonary disease or asthma,
8. Systolic blood pressure \>190 at rest or \>250 with exercise, or
9. Diastolic pressure \>95 at rest, or \>105 with exercise,
10. Proteinuria (urine protein \>200 mg/dl), or
11. Creatinine \> 2 mg/dl, suggestive of severe renal disease,
12. Severe Proliferative retinopathy,
13. Niacin treatment,
14. History of peptic ulcers,
15. History of hereditary angioedema, and
16. C1 esterase deficiency.
SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.

Increasingly, transesophageal echos (TEEs) are being done on high risk patients. A TEE is a short procedure done with deep sedation, but poses an increased risk of apnea/ hypoxemia in those with pulmonary disease. It is desirable to avoid intubation, which adds risk. Use of supraglottic airway (SGA) may offer an alternative. The investigators hypothesize that TEEs can be done successfully with an SGA in place. The investigators propose a prospective RCT to compare TEE exams done with deep sedation to those done with an SGA.

Increasingly, non-operating room anesthesia (NORA) cases are being performed on patients with high risk for needing advanced airway management, ie patients with morbid obesity, chronic hypoxemic lung disease, obstructive sleep apnea.

Transesophageal echocardiography (TEE) exams are one example of this. While a TEE is typically a short, diagnostic procedure done with deep sedation, deep sedation poses an increased risk of hypoventilation and hypoxemia in patients with cardiopulmonary disease. It is desirable to avoid endotracheal intubation for TEE exams, as the procedure is short and can easily be done without muscle relaxation.

Moreover, securing the airway with an endotracheal tube (ETT) is not without significant risk. The use of a supraglottic airway (SGA) may offer an alternative for patients receiving a TEE who are high risk candidates for deep sedation with a natural airway.

The investigators hypothesize that the TEE procedure can be done successfully, without interruption, with an SGA in place. Our secondary hypothesis is that SGA use in high-risk patients may be safer than deep sedation, as there may be less episodes of hypoventilation and hypoxemia.

The investigators propose a prospective randomized control trial to compare TEE exams done with deep sedation (control group) to those done with SGA (intervention group). Our primary outcome will be TEE study completion, and secondary outcomes will focus on the safety profile of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration

Exclusion Criteria:

* Known or suspected difficult airway, patient refusal or inability to consent, patients to have emergent or urgent TEE exams, patients considered to have full stomach ie gastroparesis or achalasia
Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.

Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life.

PRP is an autologous concentrate of platelet in plasma and accelerate healing by production of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site.

Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period includes pain, swelling, trismus , along with disturbance in post extraction wound healing which may significantly affect patient's quality of life.

PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by production of various growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site. PRP speeds up healing by concentration of growth factors which can lessen the inflammation and decreases trismus and pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-45 iyears
2. Either gender
3. Patients requiring extraction of mandibular 3rd molars
4. ASA grade1
5. Nonsmokers \& non alcoholics
6. Not allergic to any medicines
7. No pain before the extraction procedure
8. No trismus, i.e. normal mouth opening before the extraction procedure -

Exclusion Criteria:

a) Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant females/Lactating mothers g) Presence of pericoronitis, periapical infection or any associated lesion.

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Factors Associated With Gynecological Consultation by General Practitioner

Because of the shortage of doctors in France, notably gynaecologist, general practitioners are definitely an essential partner women's health. However, few of them regularly practice gynecological acts.

A lot of studies have studied why general doctors not practice gynecological acts but it would necessary to include the women's perspective.

The aim of the study will be identify women's factors associated with gynaecological consultation by the general practitioner.

Eligibility Criteria:
Inclusion Criteria:

* women aged more than 18 years old
* woman agreeing to participate to the study

Exclusion Criteria:

* women aged less than 18 years old
* woman not agreeing to participate to the study
Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer

The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT Regimen with PD-1 antibody in localized deficient mismatch repair gastric cancer. The main question it aims to answer are:

* Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT regimen with PD-1 antibody for the treatment of localized deficient mismatch repair gastric cancer
* Disease-free survival of preoperative adjuvant SOX plus PD-1 antibody and FLOT plus PD-1 antibody for dMMR and locally advanced gastric cancer.

Participants will be divided into two groups to use a FLOT chemotherapy regimen plus PD-1 antibody and a SOX chemotherapy regimen plus PD-1 antibody.

Researchers would compare tumor regression grade, adverse effects and survival benefit of two preoperative adjuvant regimens.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>=18 years and \<100 years.
* 2. Diagnosed with locally advanced gastric cancer.
* 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
* 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
* 5. deficient mismatch repair identified by pathological detection.

Exclusion Criteria:

* 1. Locally advanced unable to resect or metastatic tumors.
* 2. Patients with recurrence of residual gastric cancer
* 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
* 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
* 5. Patients with confirmed allergy to the study drug and/or its excipients.
* 6. Severe malnutrition and active autoimmune diseases.
* 7. Pregnant or lactating women.
* 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
* 9. Patients with acute infections requiring antibiotic treatment.
* 10. Patients with acute infections requiring antibiotic treatment.
* 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
* 12. Positive test result for hepatitis B or hepatitis C virus.
* 13. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1).
* 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
* 15. Patients who are not expected to achieve R0 resection.
* 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
* 17. Patients with multiple factors affecting oral medication.
* 18. Vaccination within 4 weeks prior to the first dose of study drug.
* 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
* 20. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. It is the most common joint disease that causes serious morbidity and its prevalence increases with age. It is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities.

Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.

In this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 50-75 years
* 2-3 knee osteoarthritis by Kellgren Lawrence stage
* Knee pain and functional limitation

Exclusion Criteria:

* Past knee surgery
* Intra articular knee injections in the last six months
* Symptomatic heart and lung disease
* Joint contracture
* History of malignant disease
* Bleeding disorder