cyrilzakka/clinical-trials huggingface dataset:
Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection

The risk for the development of complications from COVID-19 occurs mainly in patients over 65 years of age, with obesity, arterial hypertension, chronic lung diseases and immunosuppression states. Since the persistence of radiological imaging correlates with physiological deterioration, these patients are likely to be at increased risk of parenchymal lung disease.

It is known that the administration of Ozone, in any of the three phases of COVID-19 infection, is useful in the management of acute disease, both for its viricidal and anti-inflammatory activity, however, in the convalescence stage when the persistence of sequelae that can severely affect the quality of life of patients is identified.

The objective of this study is to evaluate whether the administration by inhalation of ozone plasma favorably modifies lung function and inflammatory parameters in patients with pulmonary sequelae associated with coronavirus 19 infection (SARS-COV-2). We will conduct an open-ended, uncontrolled clinical trial in 35 male and female patients, between 25-80 years of age with previous confirmed diagnosis of COVID-19 infection with negative nasopharyngeal polymerase chain reaction assay (PCR) test and without active disease, patients will also continue with their usual treatment. Clinical findings and laboratory and cabinet tests include a basal and 14-day metabolic and inflammatory profile, body weight, body mass index (BMI) and blood pressure will be determined during the initial and final visit, as well as respiratory parameters by pulmonary function tests (spirometry, TLCo) and performing the 6 min walk test in endless band with pre- and post-walk oximetry measurements at the beginning and end of the study. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U test and Wilcoxon exact test. A p \<0.05 shall be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 25-80 years
* Individuals without active disease with previous confirmed diagnosis of COVID-19 infection with negative nasopharyngeal PCR test
* With characteristic chest radiographic images compatible with lung infection, particularly interstitial pneumonitis with previous unburied glass patches, cobblestone or areas of consolidation (during active disease)
* Sign a letter of consent under information

Exclusion Criteria:

* Patients taking the following medicines: Ivermectin, azithromycin, corticosteroids, colchicine, chlorine dioxide, oral anticoagulants such as acenocoumarin, apixaban, rivaroxaban; bronchodilators such as β2-agonists such as salbutamol and derivatives, as well as inhaled anticholinergics of the ipratropium bromide type and derivatives.
* Patients who present medical difficulty or contraindication to perform the 6 km walk test in band
* Patients with a history of community-acquired pneumonia, pulmonary neoplasms, heart, renal, or hepatic failure
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
* 18 to 50 years of age at the time of screening
* Heavy menstrual bleeding \>80 mL documented by MP during the bleeding episode following the screening visit
* Normal or clinically insignificant cervical smear not requiring further follow-up
* An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
* Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
* Good general health (except for findings related to uterine fibroids)

Exclusion Criteria:

* Pregnancy or lactation
* Uterine fibroid with largest diameter \>10.0 cm
* Hypersensitivity to any ingredient of the study drug
* Laboratory values outside inclusion range before randomization and considered as clinically relevant
* Hemoglobin values \<6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values \<10.9 g/dL will receive iron supplementation)
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided
* Age \> or = to 18 years of age
* Patient group FAP

  - Clinical diagnosis of familial adenomatous polyposis
* Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome
* Patient group MAP

  - Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps
* Control group (FAP)

  - Genetically related family member of patient
* Patients: Able and willing to attend routine follow-up as advised
* Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative

Exclusion Criteria:

* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
* Current diagnosis of colorectal cancer
* Pregnancy
Enhance the Use of Genetic Counseling and Testing in Latinas

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations \[Georgetown University (DC); Virginia Commonwealth University (VA)\].

Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.

Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.

Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years-old
* Self-identify as Latina
* Fluent in Spanish
* Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer
* Have not received genetic counseling or genetic testing
* Able to provide informed consent
* No other members of the same family have participated
* Must have access to the internet via smartphone, computer, or another device.

Exclusion Criteria:

* Not fluent in Spanish
* Previously received genetic counseling or genetic testing for HBOC
* Previously participated in another interventional study about HBOC and GCRA
Non-Invasive Estimation of Hemoglobin Levels in Blood Using Combined Deep Learning Methods

Hemoglobin is an important protein that gives the blood its red color and helps transport oxygen to organs. There are quite a lot of people in the world who need to have their hemoglobin levels checked regularly, especially anemia patients. It is important to keep the hemoglobin levels in the blood of these individuals under control. For this, it is necessary to measure in frequent periods. A large group, from adults to children, needs to take these measurements. Most of these are invasive measurements made with blood that require devices and trained people. These painful methods are quite uncomfortable.

In this study, non-invasive hemoglobin level measurement was aimed with a combined DL model created by using nail images with age, height, weight, BMI, and gender information of the volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Individuals need to be healthy.
* Individuals should not have any active hand or nail disease.
* Individuals should know their hemoglobin level.

Exclusion Criteria:

-In case of any condition that hides the natural nail color, such as henna, nail polish, protective or trauma-induced dents, bruises on the nails of individuals, it is removed from the study.
Type 2 Diabetes Primary Prevention for At Risk Girls

Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.

The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke.

Our Two Approaches:

1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
2. After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.

Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years.

Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.


Eligibility Criteria:
Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they:

* have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
* are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids)
* have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
* have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease)
* are pregnant
* are unable to complete the informed consent process.
Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry

The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

Cardiac and thoracic surgery is plagued by severe morbidity and mortality. Understanding and being able to predict postoperative outcomes may allow to better fit peri-operative care of cardio-thoracic patients.

RIPOSTE database aims to prospectively collect baseline characteristics and per-operative information in order to test associations with the incidence of postoperative outcomes.

Baseline characteristics include: age, EuroSCORE 2 and its components (age, gender, New York Heart Association (NYHA) functional class, angina symptoms, insulin-dependent diabetes mellitus, extracardiac arteriopathy, chronic pulmonary dysfunction, neurological or musculoskeletal dysfunction severely affecting mobility, previous cardiac surgery, renal function with creatinin clearance, active endocarditis, critical preoperative state, left ventricle ejection fraction, recent myocardial infarction, pulmonary artery systolic pressure, procedure urgency and weight of the procedure (coronary artery bypass graft, valve surgery and/or thoracic aorta)) weight, height, preoperative biology and preoperative echocardiography parameters when measured.

Peroperative information include: cardiac bypass duration, type of procedure, implanted device, valve size.

Postoperative outcomes include: death, postoperative shock, mediastinitis, length of stay in intensive care unit, overall length of stay, blood transfusion.

Eligibility Criteria:
Inclusion Criteria:

* all patients eligible for cardiac or thoracic surgery

Exclusion Criteria:

* non applicable
The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles

The primary aim of this study was to evaluate the intra-rater and inter-rater reliability of MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor muscles in healthy young adults. The secondary aim is to examine whether grip strength has any effect on muscle tone and biomechanical properties.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Body mass index \< 30 kg/meter square
* Having no upper extremity injuries
* Willing and able to provide the written informed consent for the study

Exclusion Criteria:

* Use of medication that will affect muscle tone
* History of lateral or medial epicondylitis, trauma (elbow, hand or wrist), cervical radiculopathy, peripheral neuropathy or nerve injury (axillary, median, ulnar, radial, musculocutaneous), systemical diseases, muscle disorders (e.g. genetic diseases, neuromuscular disorders)
Effect of Skipping Breakfast on Metabolic Function

The purpose of this study is to test the hypothesis that the disruption of the "normal" (three meals a day) eating pattern and prolonged overnight fasting caused by skipping breakfast: i) alters the expression of specific clock genes and clock gene targets involved in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA) concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying healthy, lean persons either randomized to consume either 3 standard meals per day or omit breakfast and consume 2 meals per day without changing daily calorie intake (skipping breakfast group).


Eligibility Criteria:
Inclusion Criteria:

* Males \& females
* 18-55 years old
* BMI between 18.5 - 29.9 kg/m²
* Sleeps \>7 hours/night
* Normally consume 3 meals/day, including breakfast

Exclusion Criteria:

* Pregnancy, lactating or breastfeeding
* Diabetes
* Sleep disorders
* Significant organ dysfunction
* Shift or nighttime workers
* Smokers
* Breakfast skippers
* People who regularly sleep \<7 hours/night
* Consume excess amounts of alcohol
* Medications that could alter the results of this study
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery

Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling.

The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase.

Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old,
2. Signature of consent,
3. Any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases,
4. Affiliation to the ''National security'' regimen or beneficiary of this regimen.

Exclusion Criteria:

1. Emergency surgery,
2. Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)
3. Portal hypertension: depending on availability of imaging data, history of esophageal varices
4. Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example),
5. Benign tumors,
6. Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic),
7. Laparoscopy,
8. Liver transplantation,
9. Woman pregnant or likely to be (without effective contraception) or breastfeeding,
10. Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent,
11. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage transferred to the Department of Rehabilitation Medicine of 4 hospitals in China between January 2023 to June 2023.

The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively.

.

Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. Nasogastric tube feeding has been the mainstay in China but has a significant risk of adverse events. Intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace Nasogastric tube feeding. This study reports the clinical effect of Intermittent oro-esophageal tube feeding vs Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy.

However, in the field of intracerebral hemorrhage combined with tracheostomy, research on Intermittent oro-esophageal tube feeding is still relatively limited. Therefore, this study was carried out to explore the clinical effect of Intermittent oro-esophageal tube feeding vs. Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria for Intracerebral Hemorrhage.
* with placement of a tracheotomy tube.
* requiring enteral nutrition support.
* age over 18 years.
* able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) .

Exclusion Criteria:

* combined with tumors in the head, neck, esophagus, or gastrointestinal tract
* an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
* with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
* with severe hemorrhagic disease or bleeding tendency; 5) with contraindications for enteral nutrition
* with dysphagia caused by non-stroke-related reasons in the past