cyrilzakka/clinical-trials huggingface dataset:
Study Assessing CLENPIQ As Bowel Preparation for Pediatric Colonoscopy

Bowel preparation for pediatric colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 2 years to \<9 years being scheduled to undergo elective colonoscopy.
* Weight ≥10 kg (≥22 lbs).
* Participants must have had an average of three or more spontaneous bowel movements (SBM) per week for 1 month prior to the colonoscopy.
* Written informed consent (by parent(s)/ caregiver(s)/ guardian(s)) and assent (if applicable) obtained at screening.

Exclusion Criteria:

* History of significant liver, cardiovascular, or renal disease (including recent or ongoing oliguria).
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation) during the screening period.
* Clinically significant abdominal pain during the screening period.
* Severe acute inflammatory bowel disease (IBD) during the screening period.
* Any prior colorectal surgery, excluding appendectomy and polyp removal.
* History of colon disease (e.g., Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome).
* History of or ongoing intestinal ulceration, toxic megacolon or other toxic colitis.
* History of upper gastrointestinal disorder (e.g., active ulcer, pyloric stenosis or other cause of gastric retention, gastroparesis, or ileus).
* History of upper gastrointestinal surgery (e.g., gastric resection or gastric bypass), excluding cholecystectomy.
* Chronic or persistent, severe nausea or vomiting during the screening period.
* Moderate to severe dehydration during the screening period.
* Prior history of epileptic reaction, convulsions, or seizures.
* Any clinically relevant neurological events with or without association with hyponatremia during the screening period.
* Serum creatinine, estimated glomerular filtration rate (eGFR), potassium, or sodium outside normal limits during the screening period.
* Hypermagnesemia during the screening period.
* Use of the following prohibited medication: lithium (within 48 hours prior to procedure), laxatives (within 24 hours prior to procedure), drugs that in the opinion of the investigator are causing constipation in the participant (within 48 hours prior to procedure), antidiarrheal drugs (within 72 hours prior to procedure), or oral iron preparations (within 1 week prior to procedure).
* Participation in an interventional investigational trial requiring administration of an investigational drug within 30 days prior to receiving trial medication (or within 60 days for investigational drugs with an elimination half-life \>15 days).
* Any clinically relevant abnormal findings in medical history, physical examination, vital signs, electrocardiogram (ECG), clinical chemistry, hematology, coagulation, or urinalysis at screening which in the opinion of the investigator(s), might put the participant at risk because of his/her participation in the trial.
* Hypersensitivity to any of the ingredients of the trial medications.
* Inability to comply with the dietary restrictions in the trial or the fluid requirements before and after investigational medicinal product (IMP) administration.
Leucine, MTOR and Athero

High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. Recent work in mice has implicated monocytes/macrophages and mTOR signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. We aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mTOR activator) contents on circulating human monocytes and platelets. Study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. Activation of amino acid-dependent signaling pathways (particularly mTOR) and downstream sequelae will be evaluated in the isolated monocytes and platelets.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* able to drink milk-based liquid mixed meal

Exclusion Criteria:

* Current Pregnancy
* Allergies to meal ingredients
* History of Diabetes
* History of Heart Disease
* History of High blood pressure
* History of Stroke
* History of Cancer
* History of Organ transplant
* Taking Rapamycin/Sirolimus
* Taking Torisel/Temsirolimus
* Taking Afinitor/Everolimus
* Taking any statin medication
Insertion of Copper T380 Versus Multiload IUD Post Partum

To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

Insertion of an intrauterine device (IUD) immediately after delivery is appealing for several reasons. The woman is known not to be pregnant, her motivation for contraception may be high, and the setting may be convenient for both the woman and her provider The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes.

Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It provides immediate contraception without interfering with breast feeding, and it may avoid discomfort related to insertion. Inserting an IUD immediately after placental removal has not been associated with increased infection, uterine perforation, postpartum bleeding, or uterine subinvolution . The expulsion rate is higher (approximately 12% in the first postpartum year) after immediate postpartum insertion compared to insertion 4 to 8 weeks later. Continuation rates are relatively high (87.6% and 76.3%, at 6 and 12 months, respectively Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery

Eligibility Criteria:
Inclusion Criteria:

women delivered by elective CS ≥ 36 wks

Exclusion Criteria:

Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent
Predictors of Clinical and Neurological Outcome in Traumatic Posterior Fossa Epidural Hematoma

The posterior fossa is a small space in the skull containing the brainstem and cerebellum. If a mass such as a hemorrhage grows in this region, particularly the brainstem and 4th ventricle, it can block the normal flow of cerebral spinal fluid leading to hydrocephalus, increased intracranial pressure.Posterior fossa extradural hematoma (PFEDH) is a rare neurosurgical entity, resulting in rapid clinical deterioration. The accumulation of blood in a potentially small space between the dura and occipital bone cause compression of the brain stem.These hematomas constitute almost 4% to 12.9% of all extradural hematoma cases.

The extradural hematomas of the posterior fossa may be categorized as acute or delayed defined with respect to the brainstem compression appearing within or after 24 hours of injury, respectively. Acute PFEDH is characterized by medullar failure, occipital trauma associated with severe pain in the nuchal area, altered consciousness followed by rapid brainstem compression, respiratory depression, and subsequent death if not treated timely and appropriately.Whereas, headache, neck pain, dysfunction of lower cranial nerve in response to PF lesions and cerebellar signs. The clinical features of PFEDH are nonspecific; it may include occipital headache, vomiting due to raised intracranial pressure, and decreased consciousness level leading to death. The skull fractures must be considered as a predisposing factor for the development of delayed extradural hematomas.

The aim of this study is :

* To evaluate the outcome of patients with traumatic post fossa Epidural hematoma
* list the predictors of outcome for patients with post fossa Epidural hematoma


Eligibility Criteria:
Inclusion Criteria:

* Any age
* Traumatic Posterior fossa epidural hematoma

Exclusion Criteria:

* Spontaneous type of epidural heamatoma
Yoga Empowers Seniors Study

This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning \& intermediate), 32-week yoga program designed for community-dwelling older adults. Additionally, the IDS will explore the adherence and adverse events of participation in the program. Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy. The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.

Yoga is currently being recommended to restore and preserve strength, flexibility, balance, \& physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors. To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, \& safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling men and women volunteers, aged 65 years or older.

Exclusion Criteria:

* Safety exclusions:

  --the following safety exclusions are adopted in order to decrease potential \*cardiovascular
  * musculoskeletal
  * neurological risks to the participants:
* active angina
* uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
* high resting pulse or respiratory rate (HR \>90 or RR\>24 after 5 minutes seated)
* unstable asthma or exacerbated COPD
* cervical spine instability or other significant neck injury
* rheumatoid arthritis
* unstable ankle, knee, hip, shoulder, elbow, or wrist joints
* hemiparesis or paraparesis
* movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
* walker or wheelchair use
* insufficient hearing to permit safety in a yoga group setting
* not able to attend in-person classes
* has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
* Feasibility/adherence exclusions:

  1. unable to understand their commitment to the project, (laboratory visits \& regular program participation)
  2. cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery

The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay.

A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA), blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5), and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and stay time in PACU were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. age between 25 and 62 years
2. body mass index （BMI）of 18.5-24.9kg/m2
3. American Society of Anesthesiologists (ASA) score from I to III.

Exclusion Criteria:

1. history of allergy to narcotic drugs and other drugs
2. cardiopulmonary insufficiency
3. congestive heart failure
4. neuromuscular disease，such as myasthenia gravis
5. severe liver dysfunction
6. hyperkalemia
7. history of malignant hyperfever .
SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.

Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

Eligibility Criteria:
Inclusion Criteria:

* patients in need for total hip arthroplasty

Exclusion Criteria:

* patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
* patients on corticosteroid treatment,
* patients who had already participated in a clinical study with an investigational product in the last 6 months.
Application of Standardized Cleaning and Disinfection Mode of HFT Surface in Hospital Infection Prevention and Control

The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified.

This study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the ICU traditional cleaning and disinfection method on the basis of the ICU high-frequency contact surface status survey, explore the best frequency and disinfection method of ICU high-frequency contact surface cleaning and disinfection, establish a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of ICU hospital infection occurrence and transmission.

Eligibility Criteria:
Inclusion Criteria:

* High-frequency contact with the surface of an object by ICU patients and their surroundings; informed consent.

Exclusion Criteria:

* Admission \< 24 hours; \< 18 years old; hospital infection prior to admission to the ICU.
The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.

* Controlled, randomized trial
* RA patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection
* Assessments were made at entry, 12 and 24 weeks
* The overall sample size was assessed before the enrollment
* Randomization was performed using concealed random allocation method
* The collected data was processed and assessed by two reviewers
* All the measurement and analysis procedures concerning CIMT were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment
* The reproducibility of the ultrasonographic method was test before the trial

Eligibility Criteria:
Inclusion Criteria:

* patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
* aged from 18 to 75 years
* without conflict to the written, informed consent signed prior to the enrollment
* no severe hepatic or renal disorders
* no known carotid artery stenosis
* no coagulation disorders
* no hypertension

Exclusion Criteria:

* being in pregnancy, lactation period or under a pregnancy plan
* being allergic to the test drug
* not compatible for the trial medication
* without full legal capacity
Joovvin' for Your Skin Health Study

Sixty day single arm trial examining self-report and remote dermatology assessment of cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device (the Joovv Mini)


Eligibility Criteria:
Inclusion Criteria:

* willingness to use device for 60 days
* willingness to place security deposit on device of $149.99
* US resident with an address than can accept UPS deliveries
* 18 years old
* no serious medical conditions
* no medically treatable skin diseases
* willingness to take a selfie with mobile phone

Exclusion Criteria:

* Retinoid use
* prior use of light therapy within the past 6 months
* pregnant or nursing
* dietary supplements for skin, hair or nail health
Relationship Between Serotonin and Brain Response to Social Dominance and Emotion Perception.

Previous studies have already revealed the involvement of the serotoninergic system in the social behavior process. For example, more serotonin (5HT) was found in dominant male adult monkeys. Little is known about the serotoninergic implication in human's social behavior. The project aims to clarify the role of the serotoninergic system in social behavior in relation to the process of social hierarchical information. In order to determine how serotoninergic system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us to measure the brain activity and the serotoninergic transporter occupancy (using the \[C11\]-DASB) at the same time. The current study aims to investigate whether serotonin transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection of social dominance in facial expressions or other measures of social information processing. Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and neuropsychological questionnaires will give at the investigator more information and allow to investigate whether performance on social information processing is modulated by personality trait and genotype.


Eligibility Criteria:
Inclusion Criteria:

* French speaking
* Normal vision
* Age from 18 to 45
* Without psychiatric antecedent
* Without any neurologic antecedent
* Not taking psychotropic or anxiolytic drugs
* Having health insurance coverage

Exclusion Criteria:

* The subject does not wish to be notified of any anomalies detected during MRI
* Subjects suffering from claustrophobia
* Subjects carrying magnetic metal objects that cannot be removed as cochlear implant, surgical clips, piercings, pacemakers, mechanical valves
* Subjects participating in a clinical trial or being in a period of exclusion from a previous clinical trial
* Person under guardianship or curatorship or deprived of liberty or in emergencies
* Taking unauthorized treatment in the month before the completion of the review
* Person whose physical or mental condition does not allow him to pass the test study
Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis

The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).

Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT. A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group. The immediate, mid- and long-term outcomes will be recorded. Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test. Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons. A difference with P \< 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of iliofemoral deep venous thrombosis
* Symptoms of less than 14 days' duration
* With good function status
* A life expectancy of more than 1 year
* A low risk of bleeding

Exclusion Criteria:

* Without iliac vein thrombosis
* Anticoagulation and/or thrombolysis contraindications
* Systemic infection
* Heart, hepatic, renal function insufficiency
Errors in Prescription Antibiotics in Ventilator-associated Pneumonia

The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.

In patients who had a diagnosis of ventilator-associated pneumonia by asssistente physician will be assessed initially prescribed antibiotics empirically and what conduct adopted after culture results.

We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) . The deescalation consists of discontinuing the use of antimicrobial or antibiotic change to another with lower coverage and spectrum is performed, escalation occurs when adding a new antibiotic or antibiotic to change the coverage of other larger spectrum after culture results .

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age;
* Having the diagnosis of ventilator-associated pneumonia.

Exclusion Criteria:

* Be under 18 years of age;