cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents

The metabolic syndrome represents a constellation of risk factors associated to the abdominal obesity that includes insulin resistance, lipids alterations, high blood pressure etc. Several studies support the hypothesis that the intake of soluble fiber might have a positive effect in the improvement of such of these risk factors.

So that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission of metabolic syndrome in children between 10 to 16 years old.

The prevalence of the metabolic syndrome is increasing in the last decade as well in adult people as in children and adolescents. The early diagnosis and treatment measures could be very important in order to reduce the cardiovascular risk in such populations.

Ispaghula husk could be efficacious to reach the remission of the syndrome due to its effects in several important lipidic parameters.

The study will consist in the treatment with Ispaghula husk during 4 months in patients with metabolic syndrome. The main variable is the remission of the metabolic syndrome following the IDF(International Diabetes Federation) criteria specifics for children.

Eligibility Criteria:
Inclusion Criteria:

* Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:

  1. Waist circumference \> or equal to percentile 90 according the age.
  2. Presence of 2 or more of following factors: systolic blood pressure \> or equal 130 mmHg or diastolic \> or equal to 85 mmHg, or treated hypertension
  3. Cholesterol HDL \< 1.03 mmol/l or treatment with drugs to increase cHDL
  4. Glucose blood levels \> 5.6 mmol/l or type II diabetes diagnosed treated or no.

Exclusion Criteria:

* Loss of body weight \> 3kg in the last 2 months
* Waist circumference 10 cm higher of 90 percentile according to the age
* Intake of fiber, aven supplements or phytosterols in the last 2 months
* Glycosylate haemoglobin \>7% in the time of inclusion
* Systolic blood pressure \> 145 mmHg or Diastolic blood pressure \>95 mmHg.
Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.

Eligibility Criteria:
Inclusion Criteria:

* Index patient:
* 1. Patients or accompanying caregivers hospitalized at participating medical institutions.
* 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
* 3.Age ≥ 2 years.
* 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
* Close contact:
* 1.Patients or accompanying caregivers hospitalized at participating medical institutions.
* 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and complete all study procedures and assessments
* 3.Age ≥ 12 years.
* 4.Expected to remain hospitalized for ≥ 72 hours.
* 5.The room must contain at least one hospitalized index patient diagnosed with influenza virus within the past 72 hours, and the contact is expected to stay with the hospitalized index patient in the ward for more than 24 hours.
* 6.Throat swab on the first day tested negative for influenza virus by PCR.

Exclusion Criteria:

* Close contacts
* 1.With known allergies to the active ingredients or excipients of the investigational drug.
* 2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
* 3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
* 4.Close contacts known to be pregnant or breastfeeding.
* 5. Having experienced fever (axillary temperature ≥37.3°C) in the past 3 days prior to screening.
* 6.Subjects deemed unsuitable to participate in the study by the investigator.
The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery

Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.

Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.

Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients underwent laparoscopic colorectal resection

Exclusion Criteria:

* convertion to the open surgery
The Impact of the Social Factors and Rehabilitation Program to Address the Implications on Kidney Failure in Hail

The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.

1. This study aims to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
2. Identify the health problems facing patients with kidney failure in Hail region.
3. Detect the reality of the problems facing patients with kidney failure in Hail region and ways to reduce them.
4. Identify the family, psychological, economic and social problems facing patients with kidney failure in Hail region.

Eligibility Criteria:
Inclusion Criteria:

participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.

Participants should be: Saudi persons living in Hail City, married, both genders,

Exclusion Criteria:

* (1) Severe chronic cardiac problems. (2) Chronic chest disease. (3) Chronic inflammatory orthopedic disorders and rheumatoid arthritis. (4) Mental impairments.
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy

A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).

CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.


Eligibility Criteria:
Inclusion Criteria:

* Local ethic committee approval
* Written informed consent
* ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH

Exclusion Criteria:

* Difficulty in communication
* Allergy to oxycodone and/or morphine
* Allergy to local anesthetic
* History of alcohol and substance abuse
* Treated depression
* Chronic use of opioid or tramadol or NSAIDS
* Pregnancy
* Obstructive sleep apnea
* Anticipated fiber optic intubation
* Severe hepatic or renal impairment
* Weight \<50 kg or \> 100 kg
* Conversion to laparotomy
* Patient extubated in PACU.
* Any prior abdominal surgery
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.

Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Male
* signed informed Consent,
* Neg. urine multistix

Exclusion Criteria:

* Abnormalities,
* diseases or surgical procedures performed in the lower urinary-tract
A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

Post-marketing surveillance of Telostop Plus Tab.

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is first prescribed and administered Telostop plus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients with severe renal impairment
Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis

To compare different goals of fluid resuscitation in early stage of acute pancreatitis

With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within \<=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of \>= 1 predictor of fluid resuscitation: Haematocrit \>44% (male) or \>40% (female), respectively Lactate\>4mmol/L; heart rate\>120bpm; urine \<0.5ml/kg/h for 6 hour; Mean arterial pressure\>85 or \<60 mmHg

Exclusion Criteria:

* 1. Pregnancy 2. New York Heart Association classification \>II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy \< 3 months
Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. Surgical treatment is required to prevent infectious or functional complications. A recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. Surgical treatment is the only care option for recurrent cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are seen. Temporal bone CT is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high anatomical resolution and complex anatomy, temporal bone CT is usually displayed with Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .

Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and volume are still unknown and needs further investigations. The aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.


Eligibility Criteria:
Inclusion Criteria:

- Adult woman or man who had surgery and suspicion of cholesteatoma recurrence

Exclusion Criteria:

* Chronic renal failure
* Contraindications to MRI
Influenza Vaccination in the Emergency Department

Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?

This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.

Eligibility Criteria:
Inclusion Criteria:

* Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
* Age 6-59 months or \>50 years
* Pregnant
* Health care worker
* Aged 6 months-18 years on chronic aspirin therapy
* Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)
* Household contact or caregiver of someone with at least one high risk attribute

Exclusion Criteria:

* Prior vaccination
* History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
* Allergy to influenza vaccination or eggs
* Age \< 6 months old
* Fever with more than minor illness
* Hospitalization
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.

This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females, 18 - 55 years in good general health

Exclusion Criteria:

* Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
* Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
* Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome

The purpose of this study is to determine how appropriate and practically is the EQ-5D questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the change of quality of life.

Carpal Tunnel Syndrome (CTS) is one of the most indications in hand surgery. To rate surgery's outcome, hand-specific instruments like the Michigan Hand Questionnaire (MHQ) are used as well as questionnaires which refers to the quality of life (QOL). In clinical daily grind, the SF-12 or the EQ-5D are common instruments to gain information about the patient's QOL. At the time, there is no current evidence available while using standardized questionnaires like the EQ-5D to capture the change in QOL in patients with CTS undergoing surgery. It would be interesting to assert that the investigation offers results about the patient's QOL and its change. Therefore, the aim of the study is to investigate the psychometric properties of the EQ-5D on patients with CTS undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* diagnosed CTS
* planned surgical decompression of the carpal tunnel
* signed informed consent

Exclusion Criteria:

* additional simultaneously performed hand surgery of the affected limb
* recurrent surgery on the already involved hand
* the other hand is already included in the study
* disease, which do not allow appropriated analysis of data like central-neurological, psychiatric or metabolic disease
* legal incompetence
The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study

The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.

Animal models and initial findings in humans suggest a role of the AVP signaling system in socio-emotional processes. Initial studies have employed intranasal AVP during a socio-emotional eye tracking paradigm and reported effects on both, top-down as well as bottom-up control. Within this context the present study aims to validate the effects of orally administered AVP on top-down and bottom-up attentional control towards socio-affective stimuli. To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of vasopressin (20 IU) or placebo before performing a saccade/anti-saccade task 45 minutes after administration. The task paradigm will encompass social (happy, angry, fearful, sad and neutral faces) and non-social (oval) stimuli to examine the social and emotion-specific effects of oral vasopressin.

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.

Normal or corrected-normal version

Exclusion Criteria:

* History of neuropsychiatric diseases.
* History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
* History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
* History of renal diseases, including renal stones or renal failure.
* History of hyponatremia(Serum sodium \<135mmol/L) or hyperkalemia (Serum potassium\>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
* Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.
* Infections such as COVID-19 or influenza, or unexplained fever.
* Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).
* History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.
* Blood donation (≤ 1 month prior to administration).
* Take oral contraceptives or receive hormonal medications in the three months prior to the experiment.
* Pregnant or breastfeeding.
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years.
2. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
3. ECOG: 0-1.
4. Life expectancy greater than 3 months.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.

Exclusion Criteria:

1. Pregnant or lactating.
2. Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive.
3. Central nervous system (CNS) metastases.
4. Participated in other clinical studies within 4 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.