cyrilzakka/clinical-trials huggingface dataset:
Clinical Utility and Gait Analysis of NextAR System AUS

This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.

This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.

The aims of this study are:

* To determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment
* To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion.
* To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires.
* Determining the kinematics of the replaced knee as measured by 3D gait analysis.

According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L).

CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
* Aged over 18 years.

Exclusion Criteria:

* Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
* Previous reconstructive/fracture/arthroplasty surgery on affected knee
* Active inflammation arthropathy
* Significant extra articular deformity
* Morbidly Obese (BMI \>40)
* Pregnant women
Gemcitabine and Docetaxel With Radiation in Adults With Soft Tissue Sarcoma of the Extremities

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

Primary Objective:

• To determine the maximum tolerated doses Gemcitabine and Taxotere when given weekly with concurrent radiation in the neoadjuvant setting for patients with soft tissue sarcoma of the extremities.

Secondary Objective:

• To evaluate immunological changes induced by gemcitabine and docetaxel with radiation in patient with high risk-soft tissue sarcomas in blood. This would include T cell subsets, NK, and dendritic cells and tumor macrophages all of which make up the tumor microenvironment.

Long term follow-up will occur every 3-4 months for 24 months in person or video consultation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation.
* Age greater than or equal to 18 years. No children will be enrolled on this protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives.
* Patients taking an investigational agent are excluded.
* Pregnant and nursing women are excluded.
* Patients who require amputation for local control.
* Patients who underwent unplanned excision or other previous surgery involving the affected extremity.
* Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.
* History of radiation to the limb.
Effectiveness of a Femoral Block Following Total Knee Arthroplasty (TKA)

Hospital stays after total joint replacement surgery have been getting shorter over the past 10 years. This is mostly due to new ways to manage pain and early rehabilitation. To be able to go home safely soon after surgery, patients need to:

* 1) have adequate pain control
* 2) be able to move through activities of daily living on their own (using aids)

Femoral nerve block, in combination with pain medications, is one of the new treatment strategies that are currently being used at other hospitals in Canada, the United States and the United Kingdom. Nerve blocks involve a needle filled with local anesthetic into the nerve that allows the feeling of pain around the knee. With good pain management, patients will be able to more quickly bend their knee and regain the ability to walk with aids and move from sitting and lying positions to standing and walking. Once they can do these activities with adequate pain control, they can be discharged from hospital to continue recovery at home. The purpose of this study is to examine a new way of managing postoperative pain and encourage early knee flexion and mobility, while maintaining pain control for patients after total knee replacement. We believe that patients who receive the nerve block in addition to the regular pain medication will have more knee flexion at discharge and experience less pain than patients who only receive usual pain medications.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary total knee arthroplasty
* English-speaking
* Preoperative knee ROM \> 90 degrees
* Body Mass Index \< 40

Exclusion Criteria:

* Regular preoperative opioid use
* Hepatic insufficiency
* Any contra-indications to receiving a femoral block
Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET

2-\[18F\]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging. This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In addition, bowel activity can also hinder interpretation of PET scans in other types of solid tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans for newly diagnosed or recurrent, untreated lymphoma.


Eligibility Criteria:
Inclusion Criteria

* Males and females 18 years of age or older
* Subjects pre-scheduled for clinically-indicated PET scan
* Subjects with newly diagnosed or recurrent untreated disease (lymphoma) based on abdominal and/or pelvic adenopathy or masses on CT within 6 months of PET scan Exclusion Criteria
* Allergy to Lomotil (Diphenoxylate hydrochloride, Atropine sulfate)
* Subjects with one or more episodes of diarrhea within 24 hours prior to PET scan
* Women who are breast-feeding
* Subjects with a history of severe liver disease, jaundice, dehydration, or narrow-angle glaucoma
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders

This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment. It is designed to capture information important for evaluating safety, pharmacokinetics and efficacy in young children.

Subjects who are followed by or referred to the Investigator for management of their UCD. Subjects eligible for this study will include patients ranging from newborn to \< 2 years of age with either a diagnosed or clinically suspected UCD.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects up to 2 years of age
* Signed informed consent by subject's parent/legal guardian
* UCD diagnosis or suspected diagnosis of any subtype, except N-acetyl glutamate synthetase deficiency. If UCD has not been previously confirmed by genetic testing, consent must be obtained from parent/legal guardian prior to perform genetic testing. If genetic testing is inconsistent with or excludes a UCD diagnosis, the subject will be withdrawn from the study.

Exclusion Criteria:

* Use of any investigational drug within 30 days of Day 1
* Uncontrolled infection (viral or bacterial) or any other condition known to precipitate hyperammonemic crises. Once these precipitating factors are medically controlled, patients presenting in crisis are eligible.
* Any clinical or laboratory abnormality of Grade 3 or greater severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, except Grade 3 elevations in ammonia and liver enzymes, defined as levels 5-20 times the upper limit of normal in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transpeptidase (GGT) in a clinically stable subject
* Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the subject at increased risk by participating in this study
* Known hypersensitivity to phenylacetate (PAA) or phenylbutyrate (PBA)
* Liver transplantation, including hepatocellular transplant
* Subjects on hemodialysis at time of initiating RAVICTI
* Subjects on RAVICTI for UCD management
* Currently treated with Carbaglu® (carglumic acid)
Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section

To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes.

PRIMARY OUTCOMES:

Intra - operative ( during the operation up to 4 hours from anesthesia )

* nausea and vomiting
* intraoperative hypotension
* intraoperative pain

Post operative ( 4 hours from anesthesia and until release from hospital )

* Blood transfusion
* Venous thromboembolism
* Febrile Morbidity
* Endometritis
* Wound Infection
* Death

Subjective measures:

* complain of pain 1-10 on day 1 post operative
* time until walking
* number of Days until having bowel movement
* overall satisfactory

SECONDARY OUTCOMES:

* Operative time
* Estimated blood loss ( ebl ) - hemoglobin levels
* Hospital stay

Cesarean section (CS) delivery is one of the most frequent surgical procedures to be performed worldwide and rates of CS delivery are increasing. In the late 80's, the rate of caesarean deliveries was 10-13 % in most of the big hospitals in Israel, and today it reaches up to 20-25% of all deliveries.

Numerous different surgical techniques for caesarean section delivery have been described, and the debate about the optimal caesarean technique to minimize surgical morbidity is ongoing.

One of the more controversial issues regarding caesarean technique is the manner by which uterine repair is conducted after delivery of the infant(s) and placenta.

Two techniques are being used depending on the uterus position during repairmen : In situ within the peritoneal cavity (intra- abdominal repair) or temporarily exteriorized onto the mother's abdomen (extra- abdominal repair).

Arguments in favor of temporary exteriorization include better visualization of any uterine extensions and more rapid uterine repair with consequent reductions in both operative time and intraoperative blood loss. Opponents of extraabdominal repair argue that this technique increases rates of intraoperative nausea and vomiting, adnexal trauma on replacement, possible infection, and venous air embolism (VAE) .

On this study the investigators prospectively recruit women who are about to be electively operated. The patients will be randomized into two groups - extra- abdominal versus intra-abdominal uterine repair using computer randomization. Different charts will be for first CS delivery versus recurrent CS delivery. The patient won't know to which group she was designated . On day three after operation - she will be asked to fill out questionnaire with one of the investigators for subjective measurements

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* term pregnancy

Exclusion Criteria:

* chorioamnionitis
* uterine rupture
* hysterotomy - adhesiolysis
High Frequency Oscillation in Pediatric Epilepsy Surgery

High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery guided by the combination of HFO on ECoG and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.

Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the gold standard.

High frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine if HFO- tailored surgery combining HFOs and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-21 years
* Refractory focal epilepsy
* Planned resective epilepsy neurosurgery
* Includes intraoperative or extraoperative electrocorticography with grids
* Planned resective epilepsy surgery approved by institutional surgery board

Exclusion Criteria:

* Subjects undergoing non-resective neurosurgery
* Does not include intraoperative or extraoperative electrocorticography with grids
* Planned resective surgery is a hemispherectomy/hemispherotomy
Knowledge and Behavior Toward Early Childhood Caries

400 mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger will be selected from the outpatient clinics of October University for Modern Sciences and arts (MSA). The questionnaire will be administrated to obtain socio demographic information and to assess their oral health beliefs, knowledge, behaviors and the possible barriers for their accessing oral health care.


Eligibility Criteria:
Inclusion Criteria:

* mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger

Exclusion Criteria:

* mothers are refuse to participate in the study or sign the consent
Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children

The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients with ASA 1 or 2 Classification.
* Patients with Frankl Behavior Classification 3-4.
* Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
* Parents' willingness to participate through informed written consent.

Exclusion Criteria:

* Patients with previous negative dental experience.
* Patients complaining of cellulitis or infection spreading in the fascial spaces.
* Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
* Patients with any Intellectual Impairment.
* Patients with a history of allergy from any of the components of the dental anesthetic carpule.
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of IMNM (Immune-Mediated Necrotizing Myopathy)
* Positive serology for anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMGCR) or anti-signal recognition particle (SRP) autoantibodies
* Clinical evidence of weakness (≤ grade 4 out of 5) on manual muscle testing in at least one proximal limb muscle group
* Creatine kinase (CK) of \>1000 U/L at Screening
* No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study
* No changes in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study

Exclusion Criteria:

* History of meningococcal disease
* Current or recent systemic infection within 2 weeks prior to Screening or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Screening
* Recent initiation of intravenous immunoglobulin (IVIG) (i.e., first cycle administered less than 90 days prior to Baseline)
* Rituximab use within 90 days prior to Baseline or anticipated to occur during study
* Statin use within 30 days prior to Baseline or anticipated to occur during study
* Plasma exchange within 4 weeks prior to Baseline or expected to occur during the 8-week Treatment Period
To Evaluate the Efficacy of DDB/Garlic Oil in Patients With Elevated Transaminase Chronic Liver Disease

Purpose

- To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients with elevated transaminase chronic liver disease.

Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and quality of life in chronic liver disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 20years of age
* Patients with more 60 ALT in screening period.
* To evaluate ALT and AST at least three months.
* Serum Transaminase abnormal(before 6months), chronic liver disease or fatty liver, liver disease medical treatment at more than 30days
* Women of childbearing age get her consent for contraception, pregnancy urine test result negative.

Exclusion Criteria:

* ALT\>10UNL on screening period.
* Current treatment on another clinical trial
* Pregnancy or breastfeeding
Improving Mobility in Diabetic Patients Through Resistance Training

Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life.

The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patients with polyneuropathy:
* valkscore \>5;
* diabetic type 2;
* age \>50 years

Exclusion Criteria:

* muscular related diseases;
* ischemia;
* amputation (except for toe amputation)
Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)

This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥18 and ≤90 years of age.
* Onset of symptoms ≥48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility.
* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening.
* Participants have systemic signs and respiratory signs or symptoms of HAP/VAP

Exclusion Criteria:

* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participant is expected to require a treatment course for HAP longer than 14 days.
* The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours.
* Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
* Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.