cyrilzakka/clinical-trials huggingface dataset:
The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery

Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin. During cardiac surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used and can lower the level of the antibiotic. The purpose of this study is to quantify the change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified ultrafiltration.

Subjects having cardiac surgery in which they will be on a heart-lung machine and will receive the antibiotic vancomycin, will be able to participate.

Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Participation will be complete once the cardiac surgery has been finished.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration
* age greater than 18 years old
* penicillin allergy or in-hospital stay greater than 24 hours
* normal renal function
* normal liver function
* absence of clinical and laboratory signs of infection

Exclusion Criteria:

* vancomycin allergy
* pregnancy
* impaired renal function
* impaired liver function
* morbid obesity
* active infections
* Jehovah's Witness
Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis

Patients with primary liver cancer (PLC) experience a range of symptoms in the early postoperative period. Symptoms include cancer-related symptoms and adverse effects of treatment. Exploring the core symptoms and their dynamics in the early post-hepatectomy patients may help provide better symptom management programs. The purpose of this study was to identify the core symptoms in early post-hepatectomy patients and to explore the trajectory of their dynamics. During the period from March 2021 to September 2022, a total of 281 patients diagnosed with PLC and undergoing radical curative surgery were recruited from the hepatobiliary surgery departments of two hospitals in Eastern China, among whom 249 individuals (88.60%) agreed to participate in the study. A comprehensive symptom assessment was administered to the patients 1-2 days after surgery (T1) and 1-2 days before discharge (T2). Network analysis was used to identify core symptoms in early post-hepatectomy patients based on symptom severity.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were ≥18 years of age; had a diagnosis of primary liver cancer based on pathologic examination; were receiving the first hepatectomy; were conscious, spoke Chinese, and had basic communication skills.

Exclusion Criteria:

* Exclusion criteria include concurrent malignant tumors, mental disorders, or consciousness impairments, as well as participation in other clinical interventions.
The Adjustment of Doses in Diabetes Mellitus Type I

The study was carried out in a diabetic patient who was starting a new approach for treatment. Previously the patient was treated with Novo-mix insulin injection twice per day, the physician decided to change the treatment strategy to be with three doses of novo-rapid insulin injections per day plus one injection of Lantus SoloStar in dinner. For two weeks we were monitoring the blood glucose level by the FreeStyle Libre sensor. Moreover, the right statistical technique was used for data analysis.

In this study a diabetic patient is starting a new approach to treatment. Previously, the patient received Novo-Mix insulin injection twice per day (48 Units in breakfast \& 28 Units in dinner). Moreover, the physician decided to change the treatment strategy to be with Novo-Rapid insulin injection three times per day (36 Units in breakfast, 36 Units in lunch \& 50 Units in dinner) plus one time injection of Lantus SoloStar (50 Units) in dinner. Thus, for monitoring blood glucose level, we are using the FreeStyle Libre-Link. Moreover. Moreover, FreeStyle Libre sensor continuously measures glucose every time when scanned by the mobile and saves the glucose data in the library. Moreover, scanning the FreeStyle Libre sensor with a phone or the reader measures the glucose levels from the interstitial fluid, a thin layer of fluid that surrounds the cells of the tissues in the skin of the patient \[4\]. The Scan was done every 1-2 hours for a full glycemic profile.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patient

Exclusion Criteria:

* Normal patient
Dynamic Posture and Head Position in Kyphotic Female and Male

This study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender.

Methods: A total of 54 female and male adolescents (between the ages of 12 and 18) with a thoracic kyphosis (TK) angle of ≥ 50° were divided into two groups according to gender.

The kyphosis angle, dynamic postural performance, and forward head position were measured using a flexible ruler, Mathiass test, and occiput wall distance.

This study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender.

Methods: This observational cross-sectional study was conducted with 54 subjects. Subjects aged 12 to 18 years with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included. Individuals with Scheurmann kyphosis, scoliosis (Cobb angle \>10°), and other congenital spine abnormalities were excluded.

The kyphosis angle was measured using a smartphone inclinometer. Dynamic posture was assessed using the Matthias test. Head position was obtained using occiput-wall distance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included.

Exclusion Criteria:

* Individuals with Scheurmann kyphosis, scoliosis (Cobb angle \>10°), and other congenital spine abnormalities were excluded.
A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 18 to 75 years (including the boundary value)
* At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history of ≥1 year prior to screening.
* During the screening period and prior to randomization: EASI score ≥16, IGA score ≥3, BSA ≥10%.

Exclusion Criteria:

* People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
* Having participated in drug or device clinical trials within 12 weeks or 5 half-lives of other investigational drugs before the study administration.
* Subjects who have received live vaccines or live-attenuated vaccines within 12 weeks prior to randomization or plan to receive such vaccines during the trial period.
Nasal Prep for Nasendoscopy in Children

Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in outpatients. The purpose of this randomized controlled double-blind study is to determine whether there is a difference in the degree of discomfort experienced by children undergoing flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C) decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride).

Null hypothesis: There is no difference in the degree of reported discomfort experienced (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after receiving either intra-nasal topical placebo, decongestant, or decongestant with local anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Fully informed consent from parent/caregiver
* Children aged 3 to 12 years
* Children deemed to require flexible nasendoscopy as part of their assessment during a Pediatric Otolaryngology clinic visit

Exclusion Criteria:

* Children who have previously undergone this procedure
* Children with current upper respiratory tract infection
* Children with known allergy to any of the trial medications
The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery

Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation.

For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially manufactured intubation tubes. This application can disrupt tissue oxygenation due to both Operation position and single lung ventilation.

Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is applied prior to the operation and is provided to assist in postoperative analgesia.

The aim of this study was to investigate the effect of thoracic epidural analgesia method on brain tissue oxygenation in patients with single lung ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent Thoracic Surgery

Exclusion Criteria:

* Local anesthetic allergy,
* Bleeding is a diathesis disorder
* Allergic to the drugs used,
* Patients who are not reluctant to participate in the study,
* Presence of infection in the block area,
* Patients whose body mass index is over 30
Neopterin Effects on Ischemic Stroke

Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Few studies have investigated the relationship between acute biomarkers of inflammation and functional outcome following stroke

This case -control observational prospective study will be conducted on 100 patients with first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean age ±years). All participants will be subjected to thorough history taking, full clinical and neurological examination. Complete neurological examination where the following clinical and demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar Duplex will be done for all patients. Blood samples will be drawn for assessment of complete blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin by using standard laboratory methods on the first day of admission.

Eligibility Criteria:
Inclusion Criteria:

* Onset is within one week
* Confirmed stroke by brain CAT and / or MRI scan infarction
* Exclusion Criteria:
* Cognitive and mental changes
* Recurrent stroke
* Hepatic and renal impairment
* Endocrinal diseases
* Steroid therapy
* Previous fractures
* brain neoplasm,
* Autoimmune diseases
* History of acute and chronic inflammatory diseases
* Malignancy,
* Trauma
* Surgery
* Acute vascular diseases that occurred within four weeks prior the onset of stroke History myocardial infarction ˂3 months.
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and females aged 8 to 17 years of age
* Diagnosis of T1DM within 100 days of receipt of study drug
* Positive for at least one islet cell autoantibody
* Peak MMTT-stimulated C-peptide level \> 0.2 pmol/mL (at the screening visit)
* Weight of ≥30 kg
* Must agree to use a reliable and acceptable method of contraception for the duration of participation
* Willing and medically acceptable to postpone live vaccine immunizations for one year after infusion
* Written informed consent and written assent

Exclusion Criteria:

* Hemoglobin less than the lower limit of normal
* Leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL
* Regulatory T-cells present in peripheral blood at \<20 cells per μL
* Current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control)
* Current or anticipated use of systemic corticosteroids or other immunomodulatory drugs
* Recent serious bacterial, viral, fungal, or other opportunistic infections
* History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
* Serologic evidence of current or past viral infection: human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and human T-lymphotropic virus (HTLV) 1/2
* Positive QuantiFERON® tuberculosis (TB) test, purified protein derivative (PPD) skin test, history of tuberculosis, or active TB infection
* Active infection with Epstein-Barr Virus or Cytomegalovirus
* Liver disease
* Pregnant or breast-feeding
* Vaccination with a live virus within 8 weeks of receipt of study drug
* Vaccination with a killed virus within 2 weeks of receipt of study drug
* Participation in an investigational drug study within 90 days prior to screening
* Previously treated with a T-Reg based cell therapy
* History of allergy to gentamicin
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback

A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy, safety, practical utility and user-friendliness of a posture correction and vibrotactile trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's disease with a stooped posture.

The subjects will be asked to arrive at the Gait laboratory for Mobility Research at Tel Aviv Medical Center. After a detailed explanation of the research procedure and after signing the consent form, they will be introduced to the UPRIGHT GO device. Participances will practice operating and placing the device on the body.

With the device attached to upper back, a number of short clinical tests will be performed:

1. Complete demographic questionnaires and medical history
2. Walking tests and balance:

   1. Short walks at a comfortable speed with or without dual task.
   2. Stairs
   3. Performing daily tasks, such as entering and exiting a room, negotiating obstacles (shoebox), walking between obstacles, buttons, tying laces, carrying small objects on a tray, bringing a glass of water etc.
   4. Timed "Get up and go test" All tests are supervised by a physiotherapist .

Upon completion of the tests, the UPRIGHT device will be delivered for use and exercise for 2 months. Physiotherapist will guide to maintain the devices (such as charging devices and connecting to power).

At the end of the training period, the participans will be invited again to Gait Lab for post tests.

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
2. Hoehn and Yahr stage I-III
3. Participants who are at stable medication regimen
4. Able to walk independently for at least 5 minutes with or without support of accessory device.

Exclusion criteria:

1. Mini Mental State Exam (MMSE) score\< 24
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of viral bronchiolitis
* Not requiring intubation and ventilation
* Admitted to high care unit
* With moderate/severe respiratory distress (Tal score \>6)
* Saturations \<92% in room air

Exclusion Criteria:

* congenital cardiac disease
* presence of multiorgan failure/multisystemic disease
* previously ventilated
* craniofacial abnormalities
* nasal pathology
* decreased level of consciousness
* Ex-prem \<34 weeks
* Possible impending respiratory failure
Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer

This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically proven adenocarcinoma of the prostate
* Patients must have progressive disease
* Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure

Exclusion Criteria:

* Patients treated with other secondary hormonal therapies
* Patients with prior chemotherapy given for castrate-resistant prostate cancer
* Patients with prior radiation therapy completed less than 4 weeks prior enrollment
* Patients with prior investigational therapies within 4 weeks before treatment with APC-100
* Evidence of active second malignancy
Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

The purpose of this study is to evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnose: therapy-naïve ALL, except for patients that performed Induction for ALL (33 days) exactly as this protocol and; documented Ph+, to be confirmed by conventional cytogenetic - t(9;22) (q34;q11) or FISH and/or gene BCR-ABL presence by RT-PCR or FISH.
2. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used during treatment. Pregnant women won't be included.
3. Life expectation \> 8 weeks.
4. Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol.
5. Signed ICF by child legal responsible.
6. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP/TGO \< 10 x ULN and albumin \> 2 g/dl.

Exclusion Criteria:

1. Any inclusion criteria missing.
2. Pregnant patient or breastfeeding.
3. Patient considered incapable to follow purposed treatment.
4. Subject with infectious process, in activity, grade IV.
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
2. Age ≥ 18 years, male or female;
3. On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit;
4. Serum phosphorus within the trial-required range.

Exclusion Criteria:

1. Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;
2. Pregnant or breastfeeding;
3. Any history of a parathyroid intervention;
4. Diarrhea or loose stools occurred within 1 week prior to randomization.