cyrilzakka/clinical-trials huggingface dataset:
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome

The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.

Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.


Eligibility Criteria:
Inclusion Criteria:

1. Non-diabetic individuals: adults (18-70 Years) with glycated hemoglobin (HBA1C)\<5.7 and/or Fasting blood glucose \<100 mg/L and with no classic symptoms of hyperglycemia
2. Pre-diabetic: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria :

   * glycated hemoglobin (HBA1C) =5.7-6.4%
   * Fasting blood glucose level = 100 mg/dL to 125 mg/dL. Fasting is deﬁned as no caloric intake for at least 8 hours.
3. Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:

   * glycated hemoglobin (HBA1C) ≥6.5%
   * Fasting blood glucose ≥126 mg/dL.
   * A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals.

Exclusion Criteria:

* Pediatric and elderly subjects
* Pregnant subjects
* Those with active Myocardial infarction
* Those with acute decompensated heart failure
* Patients with pacemaker
* Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation
Rehabilitation After Covid19-Clinical Results and Predictive Factors

The aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups:

1. SARS-CoV-2-positive patients in the isolation ward
2. Post-Covid-19 patients
3. Control group; matched for gender, age and co-morbidity


Eligibility Criteria:
Inclusion Criteria:

* Patients assigned to rehab
* Written informed consent

Exclusion Criteria:

* not able to fill in questionnaires in German
Registry and Fluid Banking of Pancreatic Cystic Lesions

The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.

The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).

Eligibility Criteria:
Inclusion Criteria:

* consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts.

Exclusion Criteria:

* Patient unable to give informed consent
* age\<18 or \>85, patients with clinically suspected pseudocysts.
Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients with Head Trauma Using Interleukin 6

in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker

patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM \& the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR \& NIBP) \& investigations (CBC \& RFT\& ABG \& ESR\& CRP \& IL-6) \& GCS and GOS for 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Both Gender.
* Age (18-50)
* GCS (8-12)
* Pt with traumatic brain insult who not indicated surgical intervention

Exclusion Criteria:

* Prior severe disability.
* Isolated brain system lesions.
* History of underlying neurologic, metabolic or psychiatric disorders.
* Alcohol or drug abuse.
* Pregnancy.
* Patients with intracranial hemorrhage who indicated surgical evacuation.
* Multisystem life-threatening trauma.
* GCS \> 12 \& \<8.
* Vitamin d deficiency.
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer

The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
2. Age ≥ 65 years;
3. ECOG Performance Status: 0-2;
4. No previous anti-cancer therapy for the locally advanced or metastatic disease;
5. Unable or unwilling to chemotherapy;
6. At least one measurable lesion as defined by RECIST 1.1;
7. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
8. Can take apatinib orally;
9. Life Expectancy: 3 months or more.

Exclusion Criteria:

1. History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
2. Patients with un-controlled blood pressure on medication (\> 140/90 mmHg);
3. Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
4. Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
5. Patients with massive hydrothorax or ascites;
6. Patients with uncontrolled central nervous system (CNS) metastases;
7. Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
8. History of drug addiction or abuse;
9. Patients cannot take apatinib orally for any reason;
10. Estimated life expectancy ˂ 3 months;
11. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
12. Inability to understand and agree to informed consent.
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis

One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.


Eligibility Criteria:
Inclusion Criteria:

* All patients male or female with no age limit
* Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
* Who had given their consent after being informed about intravitreal corticotherapy

Exclusion Criteria:

* Patients who refused or were unable to give their consent
* Prior intravitreal corticotherapy
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger

The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.

After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Suspect, probable or confirmed case of COVID-19
* Men and women aged ≥12 years, including pregnant and breastfeeding women
* SpO2 ≥93% on room air
* Signature of informed consent form

Exclusion Criteria:

* Medical indication for hospitalization at the time of enrolment
* Severe chronic liver disease
* Known infection with HIV
* Known allergy or severe intolerance to lopinavir/ritonavir
* Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)
* Treatment with an antiviral medication in the 28 days prior to enrolment
* Dementia or other condition that interferes with active participation in data collection and obtaining informed consent
Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.

The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* NA
Iloprost in Acute Respiratory Distress Syndrome

The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.


Eligibility Criteria:
Inclusion Criteria:

* Horowitz index \<300
* Bilateral opacities on frontal chest radiograph
* requirement of positive pressure ventilation
* no clinical evidence of left atrial hypertension
* enrollment within 48h of onset of ARDS
* mechanical ventilation \<7 days

Exclusion Criteria:

* age \<18 years
* mechanical ventilation \>7 days
* patient, surrogate or physician not committed to full intensive care support
* pregnancy
Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 18 years
* Patient diagnosed of CROHN´s disease
* Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
* Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
* Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
* Patient capable of participate in the examinations required by the study
* Patient after being informed, give his/her informed consent in writing

Exclusion Criteria:

* Patients with large intestinal stenosis (more than 6cm) and multiples
* Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
* Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
* Patients with positive screening to Tuberculosis(positive PPD)
* Established contraindication to anti-TNF drugs
* Existence of fistulous tracts associated with intestinal stenosis
* Neoplastic process associated with stenosis or in another location
* Pregnancy or breastfeeding
Pressure Opening With Electrical Impedance Tomography

Acute lung injury and ARDS (acute respiratory distress syndrome) are characterized by lung inhomogeneity, leading to a different distribution of the tidal volume (and pressure) within the lung. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, but it reflects a global behaviour of the lung. The electrical impedance tomography (EIT) is a non-invasive and radiation-free tool, monitoring dynamic changes in gas distribution. Images from EIT can be divided in several regions of interest, allowing to measure regional changes in compliance. The regional derived-EIT PV curve could provide valuable information on airway closure and AOP (airway opening pressure). Recent studies suggest that AOP measured by the ventilator seems to correspond to the AOP of the lowest injured lung. The investigators will perform one pressure-volume (PV) curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. During the low-flow insufflation, both ventilator and EIT-derived PV curves will be recorded. All PV curves will be analysed offline by the investigator to detect complete and regional airway closures, and measure AOPs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old).
* Patients with PaO2/FiO2 ratio \<300 mmHg.
* Volume- or pressure-controlled ventilation.
* Sedated, with or without infusion of neuromuscular blockage.
* Patients in supine position

Exclusion Criteria:

* Pneumothorax and bronchopleural fistula.
* Severe hemodynamic instability (\>30 % increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min).
* PaO2/FiO2 ratio \< 80 mmHg.
* Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 \< 30 % predicted).
* Known or highly suspected elevated intracranial pressure (\>18 mmHg).
* Impossibility to correctly position the EIT belt (e.g., burns chest drainage, etc.).
* Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions, etc.).
* Clinical judgement of the attending physician.
* Pregnant or breastfeeding woman
* Patient under guardianship, curators or safeguard of justice
A Comparative Study of Depth of Anesthesia Monitored by Bispectral Index (BIS) Values

The aim of this study is to determine whether induction of anesthesia with thiopental followed by propofol infusion is able to maintain sufficient depth of anesthesia .


Eligibility Criteria:
Inclusion Criteria:

* being adult
* having ASA I or II
* scheduled for elective cataract surgery under general anesthesia

Exclusion Criteria:

* massive obesity
* intake of any central nervous system (CNS) stimulants
* intake of CNS depressants
* intake of Tricyclic antidepressants
* known adverse reaction to the study drugs
To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome

To evaluate whether there is clinical improvement through the scales (Bristol, IBS severity score, and IBS quality of life) in women with irritable bowel syndrome after administration of SC-FOS (short-chain fructooligosaccharides).

Patients will be selected according to the inclusion and exclusion criteria of the study population for randomization into two groups: one group will be administered short-chain Fructooligosaccharides at a dose of 12 gr. every 24 hours, and the other group will be administered corn starch as a placebo for 10 days.The protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will sign the informed consent. It should be specified to each patient and/or family member that their participation in the protocol will not generate any extra cost for the administration of SC-FOS, and furthermore, that no reward of any kind will be granted for their participation in the protocol.Once informed consent has been obtained, the preparation (placebo or not) will be delivered to the surgery department of the Central State Hospital. It will come in bags in which the content can be visualized (10 pieces in total, one for each day), numbered according to the folio obtained by the corresponding randomization. It should be emphasized that neither the patient nor the surgery department will know which is a placebo and which contains SC-FOS.There will be a placebo control group and a group that will be administered 12g of SC-FOS, which should be diluted in 250 ml and taken daily for 10 days. Before starting the administration of SC-FOS or placebo, data will be collected on each patient (Bristol Scale, IBS severity score to evaluate severity, IBS quality of life, age, physical activity, drugs, food restriction, time of diagnosis of IBS, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age 18 to 65 years
* Irritable Bowel Syndrome diagnosed by Rome Criterion
* Useful enteral feeding

Exclusion Criteria:

* Recent gastrointestinal disease \< 2 weeks different to IBS
* Previous consumption of SC-FOS
* Pregnancy
Study of Weight Loss Effect of the Sequential Balloons

The effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.

We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 45 and weight \>120 Kg
* Patients refused to have bariatric surgery.

Exclusion Criteria:

* Esophageal or gastric or duodenal lesions.
* Bleeding disorders.
* uncooperative patients.
Loving Kindness Meditation Among Adults 50 Years and Older

The goal of this clinical trial is to test the feasibility and acceptability of loving-kindness meditation among adults 50 years and older. It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

The main aim of the research is to assess the feasibility and acceptability of the Loving-kindness meditation intervention among adults 50 years or older. It will also examine the intervention's preliminary impact on loneliness, self-compassion, cognitive function, and psychological well-being. The study will use a randomized controlled trial with waitlist control.

Eligibility Criteria:
Inclusion Criteria:

• Adults 50 years or older living in Southern Nevada

Exclusion Criteria:

• Cognitive or language barrier that would make it difficult to understand and sign the informed consent
Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Care to Geriatric Patients

The goal of this observational study (Cross sectional study) is to assess the level of knowledge of Egyptian and Sudanese dentists about the oral health care needs of geriatric patients and to evaluate the attitude towards treating geriatric patients and barriers in providing care.

The data collection by validated questionnaires. The Dentists would fill out structured surveys addressing their knowledge, attitudes, and perceived barriers regarding geriatric dental care.


Eligibility Criteria:
Inclusion Criteria:

* Post graduated Sudanese and Egyptian Dentists currently practicing in Egypt and Sudan
* Experience: Dentists who have been practicing for at least 1 year to ensure they have enough experience to have formed opinions and practices regarding geriatric care.
* Age: 20-60 years

Exclusion Criteria:

* • Dentists Not Providing Geriatric Care: Dentists who exclusively work with Paediatric and do not treat elderly populations will be excluded.
ElderTree Smart System for Older Adults

Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills.

The primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (Elder Tree, or ET) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

An Agency for Health Care Research and Quality (AHRQ)-funded randomized controlled trial (RCT) found that ET improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. However, many people did not use it extensively, which is a common problem with all web apps.


Eligibility Criteria:
Inclusion Criteria:

* Be ≥60 years old;
* Have been treated in University of Wisconsin (UW) Health clinics, with no plans to leave during the study period (only relevant for UW Health patients, not patients recruited from the community);
* Have a chronic pain diagnosis AND a medical diagnoses of three or more of the following common chronic conditions: Chronic obstructive pulmonary disease (COPD), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function;
* Be willing to share healthcare use (e.g. 30-day readmissions) in electronic health records (only relevant for UW Health patients, not patients recruited from the community); and
* Allow researchers to share information about a patient's health status with their primary care physician (PCP).

Exclusion Criteria:

* Require an interpreter
* Have a medical diagnosis of any of the following:

  * Alzheimer's
  * Schizophrenia/other psychotic disorders
  * Dementia
  * Autism spectrum disorder
  * Known terminal illness with less than 6 months to live
  * Acute medical problem requiring immediate hospitalization