cyrilzakka/clinical-trials huggingface dataset:
Quadratus Lumborum Block for Pediatric Hip Surgery

Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical interventions but with high incidence of motor block and urinary retention. In one study, psoas compartment block was associated with less morphine comsumption and prolonged duration of analgesia compared to single-shot caudal Block in small children undergoing open hip reduction/osteotomies. Ultasound guided anterior Quadratus lumborum block (AQLB) provides unilateral analgesia to the nerves between the psoas muscle (PM) and the quadratus lumborum muscle (QLM). The first pediatric study evaluating Quadratus lumborum block is encouraging .

The first pediatric study evaluating Quadratus lumborum block is encouraging. To the best of the investigator's knowledge, there are no previously published data comparing the AQLB with other regional techniques in infants undergoing hip surgery.

The aim of this prospective randomized study was to compare the analgesic effects between AQLB and CB in children undergoing unilateral open hip reduction/osteotomies for hip dislocation.

Patients were randomly assigned, into 1 of 2 groups, namely, group CB (n = 20) and group AQLB (n = 20).

Preoperatively all children were premedicated by using oral midazolam (0 .5mg/kg).

anesthesia was induced with 3 to 4% sevoflurane and 50% with 60% nitrous oxide in oxygen.Then fentanyl 3 μg/kg and Propofol 1 - 2mg/Kg were administered for anesthesia induction. Airway was secured with endotracheal tube placed in the mouth facilited by 0.15 mg/kg cistracurium. Anesthesia maintenance was performed with sevoflurane 2% in 50% nitrous oxide.

AQLB and CB were done with 1 ml/kg, 0.25% Ropivacaine (maximum dose limited to 20 ml)

Postoperative follow-up:

All patients received 15 mg/kg paracetamol before extubation. Tramadol 2 mg/kg intravenous was planned as rescue analgesia when CHEOPS score was more than 3. Supplemental IV tramado, 1 mg/kg could be added if necessary every 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 2 to 7 years old
* Weight ≤ 20 Kg
* American Society of Anesthesiologists (ASA) physical status I or II
* Planned to undergo unilateral open hip reduction/osteotomies

Exclusion Criteria:

* Cerebral palsy with severe intellectual disability
* Coagulation disorders
* Local or general infection
* Allergy to amide local anesthetics.
* Progressive neurological disorders
* Parenteral refusal
* Spinal dysraphism
* Cutaneous anomalies (angioma, hair truft, naevus or a dimple)near to the puncture
CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.


Eligibility Criteria:
Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):

* Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy);
* Male or female, age 14-70;
* Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
* life expectancy is at least 60 days;
* Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.

Exclusion Criteria (Patients who fulfil any of the following criteria may not be enrolled):

* Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \>30%;
* Intracranial hypertension or cerebral impaired consciousness;
* Symptomatic heart failure or severe arrhythmia;
* Symptoms of severe respiratory failure;
* With other types of malignancy;
* Diffuse intravascular coagulation;
* Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
* With sepsis or other uncontrollable infection;
* Suffering from uncontrollable diabetes mellitus;
* Severe mental disorders;
* Have significant intracranial lesions on cranial MRI;
* Organ transplantation (excluding haematopoietic stem cell transplantation) history;
* Female patients (patients of childbearing potential) with positive blood HCG test;
* Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.
The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes

A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. The refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.


Eligibility Criteria:
Inclusion Criteria:cataract patients with super high myopia (axial length \>27mm) and difference of binocular was less than 1mm Exclusion Criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, Pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and Myotonic Dystrophy, etc.; patients with ophthalmic surgery and trauma history.
Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim of the study was to assess its value in chronic intestinal failure patients.

Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D and bisphosphonates have been commonly used to treat BMD, but their efficiency is may be inadequate due to limited absorption and compliance. Denosumab represent a new drug, which helped to prevent osteoclast development and activation, hence decreased bone resorption in some studies. The aim of the study was to assess its value in chronic intestinal failure patients receiving HPN.

Between November 2011 and March 2013 denosumab was administered to 16 HPN patients (9 F, 7 M mean age 55.4) with intestinal failure. Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. BMD, T-score and Z-score were measured.

Eligibility Criteria:
Inclusion Criteria:

* intestinal failure requiring home parental nutrition
* bone disease measurement

Exclusion Criteria:

* intestinal failure not requiring HPN
* diagnostic modalities impossible
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)

Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.

Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).

Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.

Proof of hypothesis:

* Pilot study with n=20 patients with PSC
* Explorative, open-label, mono-centric study
* Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Exclusion Criteria:

* patients with coeliac disease or wheat allergy
* patients with active colitis
* patients already on gluten-free diet
* liver transplanted patients
* patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
* coloscopy within 2 months before study
* Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
* antibiotics within 3 month before study
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease

The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with PD within a maximum of 3 years prior to screening.
* Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day 1. Maximum total duration of prior PD regimens should not exceed 30 days.
* Score of less than equal to (\<=) 2.5 on the Modified Hoehn and Yahr Scale.
* Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader).

Key Exclusion Criteria:

* Presence of freezing of gait.
* History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV).
* Screening value for hemoglobin less than (\<)12 gram per deciliter (g/dL) for men or \<11 g/dL for women.
* Montreal Cognitive Assessment (MoCA) score \<23 or other significant cognitive impairment or clinical dementia.
* History of any brain surgery for PD.
* Participation in any passive or active immunotherapy targeting alpha-synuclein or other PD-related protein.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Distracted Driving App Study for Teens and Parents/Caregivers

The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application

This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving. Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver. The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Licensed teen drivers 16 years to 18 years and one parent/caregiver
* Teen and parent/caregiver are both Android smartphone users
* Teen and parent/caregiver both drive a minimum of 2 days per week

Exclusion Criteria:

* Non-fluency in written or spoken English
Chronicare for Type 2 Diabetes (Chronicare-T2D)

This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. The Chronicare Solution comprises connected devices (a Bluetooth-enabled insulin pen sensor, a Bluetooth-enabled medication container, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx Health), an automated support system (Intervention Engine), and a remote care application (CRx Care) used by a team of clinicians to monitor and support patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 75 years of age, inclusive, at Screening.
* Diagnosed with T2D
* Have a baseline HbA1c level between 7.5% and 10.0%, inclusive, while receiving insulin glargine and metformin.
* Prescribed insulin glargine and an oral diabetes medication for ≥ 6 months prior to Screening.
* The ability to follow an evening dosing schedule for insulin glargine.
* Have an eGFR level \>30 L/min, inclusive, according to their most recent measurement.
* If female, must be post-menopausal or surgically sterile, or be established on (≥ 3 months prior to Screening) and agree to continue to use the same highly effective method of birth control throughout the study. Females must agree to avoid pregnancy during their participation in the study.
* Able to comprehend and give informed consent.
* Able to comply with the requirements of the study, which include being able to speak and read English, and to complete the full sequence of protocol-related procedures.

Exclusion Criteria:

* Females who are pregnant (positive pregnancy test at Screening), lactating, or if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice.
* Have type 1 diabetes.
* Have had or have a malignant neoplasm within the past five years.
* Undergoing chronic or recurrent treatment with systemic corticosteroids or niacin treatment for hyperlipidemia.
* Use of one or more of the following agents affecting glycemic control:

mifepristone, GLP-1RA, or any insulin other than insulin glargine.

* Concurrent treatment with experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to study start.
* Unable or unwilling to follow the evening insulin glargine regimen required by the titration protocol (once daily dose must be scheduled between 5pm and 12am).
* Blood transfusions or severe blood loss in the last 3 months.
* Any other unspecified reason that, in the opinion of the Investigator (or designee) or Sponsor, makes the subject unsuitable for enrollment.
* Active diagnosis of hypoglycemic unawareness.
* Hypoglycemia (blood glucose \<70 mg/dl with or without symptoms) greater than one episode per week (on average)
Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients

Health-Related Quality of Life (HRQoL) was commonly impaired in atrial fibrillation patients. Depression, anxiety, and illness perception are psychological correlates of HRQoL. Our previous study had shown good effects of CBT on the quality of life in AF patients. This study aimed to establish the long-term efficacy of CBT on both psychological distress and HRQoL. Method: The study was a prospective, open study, pseudo-randomization with a pretest-posttest design and a 6-month follow-up. A total of 102 patients with paroxysmal AF were enrolled, and 90 patients were assigned (1:1) to 10 weeks of CBT focused on anxiety symptoms or to treat as usual in the end. Item Short Form Health Survey (SF-12), GAD-7, PHQ-9, University of Toronto Atrial Fibrillation (AFSS), and Brief Illness Perception Questionnaire (BIPQ) were measured as outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for participation were: (a) age 18-75 years; (b) AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation5 and (c) paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week 18. (d) ability to read and write in Chinese.

Exclusion Criteria:

* (a) severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%); (b)AF soon after thoracic surgery; (c) malignant disease with a 1-year survival rate or a terminal illness diagnosis; (d) a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder);(e) regular psychological therapy with a mental health condition; (f) participation in another study; (g) cognitive impairment interfering with their ability to participate in the study.
Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection

Aortic dissection is dangerous and difficult to predict, so it is particularly important to carry out early prevention, diagnosis and rational treatment for high-risk groups. The related genes found in previous studies can not be detected in all patients with dissection; at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about 20% of patients have family aggregation and have the general representative characteristics of non-syndromic dissection. In this project, the peripheral blood samples of core family subjects were detected by sequencing technique. analyze disease-related susceptibility genes; 2 determine the effect of susceptibility genes on the incidence of dissection in mice through animal experiments; and 3 explore the effect of susceptibility genes on cell function at the cellular level.


Eligibility Criteria:
Inclusion Criteria:

* Family inclusion criteria: 1 at least one person in each generation of a family has aortic dissection, and at least two generations of members can be included;

Exclusion Criteria:

* Pedigree exclusion criteria: pedigree members have marfan syndrome, Loeys-Dietz syndrome, Ehler-Danlos syndrome, aneurysm-Osteoarthritis syndrome and other syndroms
Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?

The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.


Eligibility Criteria:
Inclusion Criteria:

* distal radius fractures
* undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)

Exclusion Criteria:

* pregnancy
* history of chronic pain conditions
* currently taking opioids
The Effects of Inter-set Stretching on Muscle Performance

Static passive muscle stretching, performed weekly, can increase muscle flexibility and range of motion. Typically, static stretching is performed either before starting specific exercises or at the end of a workout. However, the effects of static passive stretching when performed during sets are still not entirely clear in terms of performance. This study aims to evaluate the effects of inter-set stretching on muscle performance

This project aims to evaluate the potential effects of stretching exercises on muscular performance. In particular, we aim to administer passive static stretching between sets of a bench press performance. Within this project we will carry out a crossover design project in which the participants will be tested for two conditions and one control session. The main protocol consists of performing five sets of bench press at 70% of 1-RM. The 1-RM will be calculated before the start of the data collection procedure, through a standardized and validated approach. The experimental sessions will comprise two interventions. The first intervention will be to administer the stretching protocol to the agonist muscles involved in the bench press performance (pectoralis muscles). While the second intervention will be to administer the stretching protocol to the antagonist muscles involved in the bench press performance (dorsal muscles). Within the control session the participants will not perform any stretching between sets. The three arms will be randomized. As outcome variables, the primary outcome will be the comparison of the total volume across each agonist, antagonist, and control session. The secondary outcomes to be assessed are strength, power, velocity, and volume.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged ≥ 18 years.
* At least 6-month experience of resistance training.
* No previous musculoskeletal injuries in the 6 months prior to the study will be recruited

Exclusion Criteria:

* Participants who suffered an injury within the 6 months prior to the study and/or participants with pathological conditions affecting the musculoskeletal system will not be recruited.
* Female participants
* Participants with less than 18 years.
* Participants who match all inclusion criteria but who fail to attend one or more of the agonist/antagonist stretching sessions will be also excluded.
Effect of Fetuin A in Hemodialysis Patients

The purpose of this study is to examined the effect of fetuin A on atherosclerosis and prognosis in hemodialysis patients.

Fetuin A is known to be a potent inhibitor of ectopic calcification in plasma, and the concentration of fetuin A is closely associated with protein nutritional status. The purpose of this study is to examine whether the plasma concentration of fetuin A is associated with atherosclerosis and 5-year prognosis in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis for at least 6 months

Exclusion Criteria:

* Disabled patients