cyrilzakka/clinical-trials huggingface dataset:
Comparing Postoperative Pain After Pericapsular Nerve Block and Fascia Iliaca Block in Total Hip Arthroplasty

The aim of this study is to investigate the efficiency of post-operative analgesia by fascia iliaca compartment block versus pericapsular nerve group block block in reducing narcotic consumption during the first 24 hour post-operatively by using the Visual Analogue Scale.

Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.

Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.

The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after THA while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.

Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.

Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
4. Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.

Exclusion Criteria:

1. Declining to give a written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy, and local infection).
4. Psychiatric disorders.
5. Significant cognitive dysfunction.
6. American Society of Anesthesiologists (ASA) Physical Status Class IV.
7. Liver failure, renal insufficiency (estimated glomerular filtration rate \< 15 mL/min/1.73 m2).
8. Patients who had failed spinal anaesthesia were excluded from the study.
9. Pregnancy.
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time

The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.

Exclusion Criteria:

* Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
* Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model

An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the investigational drug on the markers of inflammation. Safety and tolerability will also be assessed.

The trial was terminated on 25 March 2015 due to safety concerns regarding the administration of endotoxin and because of the uncertain availability of future endotoxin lots.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women (non-childbearing potential) between the ages of 18-40 years.
* Body Mass Index (BMI) 18-30 kg/m2 and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* History or evidence of habitual use of tobacco- or nicotine-containing products within 3 months of screening.
* History of frequent headaches or migraines (\>3 per month), or headaches from an absence of caffeine.
* Caffeine consumption in excess of 3 cups per day.
* Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks of the first administration of study drug/placebo of each period.
* History of recurrent or chronic infections of any type such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc. Also excluded are subjects with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for worsening if enrolled in this study.
* Treatment with LPS in the past 12 months and/or a history of an allergic type reaction or known hypersensitivity to endotoxin at any time.
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects.

SPECIFIC HYPOTHESES

1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals.
2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.

15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \[18F\]-AV-45 and \[11C\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
* Alzheimer's subjects: MMSE 18-26, CDR \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI

Exclusion Criteria:

* other neurological disease
* evidence of MRI abnormality
* psychiatric disorder
* alcohol abuse
* clinically significant lab abnormalities
* residence in nursing facility
* participation in clinical trial with experimental medication in past 1 month
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar

There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients.

Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours.

The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients intubated in a medical intensive care unit

Exclusion Criteria:

* Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients
Educating Anesthesia Residents to Improve Perioperative Care for the Elderly

1. The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology.
2. The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. We will assess their medical knowledge, and the amount of anesthesia delivered to patients after the curriculum is implemented.
3. The investigators will analyze any changes in clinical practice of residents in the care of elderly patients. Enrollment will be voluntary for all residents. Also, the investigators will not interfere with clinical management of any patients by residents which are done under direct supervision of faculty.


Eligibility Criteria:
Inclusion Criteria:

* Duke Anesthesiology Resident
* Willing to comply with study activities and guidelines

Exclusion Criteria:

* Unable to comply with study activities and guidelines
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24.

This study is constituted of 2 parts. In the first part (Part A), only subjects with daily prandial insulin dose ≤ 40 U/day will be enrolled.

Following the completion of the part A, an extension part (Part B) will be conducted to particularly assess the safety and tolerability of higher daily doses of ADO09 in patients with insulin requirements ≥ 40 U/day.

The clinical conduct and procedures will not change for the Extension Part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities.
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
* Treated with insulin ≥ 12 months.
* Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.
* HbA1c ≤ 9.0%.
* Fasting negative C-peptide (≤ 0.30 nmol/L).
* Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B

Exclusion Criteria:

* Known or suspected hypersensitivity to products used in the clinical trial
* Type 2 diabetes mellitus
* Previous participation in this trial. Participation is defined as randomized.
* Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
* Known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
* Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening.
Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer

In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment: a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral zinc supplementation on humoral immunity and neutrophil function. The study will be conducted on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical resection of colonic neoplastic lesions without metastatic lesion. Patients will be randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for 16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n = 15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study groups will start two days before the volunteers received the pneumococcal vaccine, polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as pre-established criteria by the Oncology Service. Will be monitored the parameters of nutritional status (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects, according to rules of the CTCAE. In the evaluation of humoral immunity, antibodies opsonization and in the pneumococcal polysaccharide will be measured. Will be evaluated the function of neutrophils by measuring DNA NETs and quantified calprotectin and elastase released in the culture supernatants of activated neutrophils. RT-qPCR will be done of genes differentially expressed(DEGS) on activated leukocytes. In six volunteers from each group will be analyzed global gene expression from RNA extracted from leukocytes by microarray; will be detected and correlated the molecular pathways modulated by zinc by MetaCore software (GeneGo). The DEGS will be validated by RT-qPCR.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Diagnostic histopathology of colon cancer stage III (Dukes' stage C)
* Performance Scale Karnofsky greater or equal to 70%
* Have been subjected to resection of the primary neoplastic lesion in more than 8 weeks before start of chemotherapy
* Patient in the first cycle of chemotherapy in adjuvant XELOX regimen.

Exclusion Criteria:

* Patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease, renal failure or diabetes mellitus
* Patients with metastatic disease
* Have previously received radiotherapy or chemotherapy
* Use of GCSF-Granulokine ® (growth-stimulating factor granulocyte)
* Use of immunosuppressive drugs, diuretics and supplements of zinc or copper.
Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain

Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.

A prospective randomized double blind placebo controlled study was designed. Local injection of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal fossa through endoscopic view in the sphenopalatine region.

Pain was measured in the postoperative course with visual analogic scale in the recovery room and the rhinologic department.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring endoscopic sinus surgery
* ASA score 1 or 2
* patients with health care insurance
* approved consent

Exclusion Criteria:

* any sinonasal malignant tumor
* renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases
* neurologic disorders
* alcohol or drugs addiction
* preoperative facial pain from an extranasal origin
* coagulation disorders
* antidepressive treatment
Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

To the investigators' knowledge, no single long-term prospective observational study has assessed dietary factors, diabetes clinical variables (metabolic control and associated complications), and self -perceived health and wellness in T1D patients (both pediatric and adult) with CD identified by screening (positive/weakly positive serology). The aim of the current study is to observe the short- and long-term outcomes for Type 1 diabetic patients with new serology positive asymptomatic CD.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 8 and 50 years with positive/weakly positive serologic CD screening or who have completed the CD-DIET trial.
2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D equal to or greater than 1 year from time of signing Screening Informed Consent for CD-DIET trial.
3. Ability of the subject or a legally authorized representative to speak and read English or French.
4. Participation in the screening portion of the CD-DIET Study.

Exclusion Criteria:

1. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Effectiveness of Whole-Body Vibration

Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.

Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Cerebral Palsy is the most common cause of severe physical disability in childhood (1.5 - 3 cases per thousand live births) and may or may not be accompanied by intellectual, sensory, communication deficits and epileptic syndromes depending on the brain region affected. The most frequent form of presentation is spastic cerebral palsy, characterized by atypical motor development, abnormal movement or posture, hyperreflexia, and increased muscle tone. These difficulties and limitations will have an impact on their independence and integration in all social areas.

The use of Whole-Body Vibration (WBV) to reduce spasticity of the lower limb and thereby improve functionality has been used for more than a decade showing some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The purpose of this randomized controlled trial is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with spastic cerebral palsy.
* Aged between 8 and 14 years.
* GMFCS I, II or III: with the ability to walk independently with or without technical aids; with the ability to stand for 3 minutes independently or gripped on the stand; with the ability to understand and follow simple instructions; with the ability to tolerate clinical tests and examinations.

Exclusion Criteria:

* Participation in treatments with serial casting or botulinum toxin during the 3 months prior to the study.
* Recent orthopedic surgery (less than 12 months).
* Participation in other muscle strengthening programs during the 4 months prior to this clinical study.
* Children who have developed fixed contractures in lower limbs joints.
* Medical conditions where physical exercise is contraindicated.
Effects of PG2 on Fatigue-Related Symptom Clusters

This study is for an "add-on" study to the "main" study (Protocol No.: PH-CP012). The information of patients from main study will be collected by questionnaire survey and actigraphy measurement to evaluate the relationship between fatigue, depression and sleep disorder and the efficacy of PG2 after treatment.The association between symptom cluster and circadian rhythm will be also further explored.

The study is "PG2 Treatment for Improving Fatigue among Advanced Cancer Patients under Standard Palliative Care" (Protocol Number: PH-CP012) of the additional plan, through questionnaires and using actigraphy measuring circadian rhythm collect patient data master plans, assessed for "PG2" treatment of cancer patients before and after treatment fatigue, depression, sleep disorders and other related symptoms of resistance and the effectiveness of treatment, and to further explore the symptom clusters in cancer patients associated with the circadian rhythm

Eligibility Criteria:
Inclusion Criteria:

* Patients who signed the informed consent form
* The age of eligible patients should be 20 years old.
* Eligible patients must have locally advanced or metastatic cancer or inoperable advanced cancer.
* Patients are under standard palliative care (SPC) at hospice setting and have no further curative options available.
* Patients with BFI fatigue score 4 during screening.
* Patients have a life expectancy of at least 3 months as determined by the investigator.
* Patient must be willing and able to complete quality of life questionnaires.

Exclusion Criteria:

* Female patients are pregnant or breast-feeding.
* Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.
* Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening.
* Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
* Patients with Karnofsky Performance Scores less than 30 % at time of screening
* Patients who are diagnosed as dying status
Pheno- & Genotyping POF (WHO III)

This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).

First goal of the study is to phenotype patiens with hypergonadotropic ovarian dysfunction (WHO III) adequately. This group includes women with premature ovarian failure (POF), incipient ovarian failure (IOF), poor response after ovarian hyperstimulation, early menopause and hypergonadotropic primary amenorrhea. The standardized phenotyping consists of a questionnaire focusing on reproductive, medical, and family history; ultrasonography to assess ovarian reserve and/or antral follicle count and obtaining an extra blood sampling during routine endocrine screening for genotyping.

Phenotyping of patients presenting with ovarian dysfunction is of crucial importance when genotyping will be performed. The goal of this genotyping will be the identification of genetic factors associated with the (premature) depletion of the stock of ovarian follicles. It will be performed for isolated WHO III patients in an association (case-control) study for known candidate genes. In familial WHO III cases, genome wide linkage analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* POF; defined as secondary amenorrhea before 40 years of age and basal FSH \> 40 IU/L
* Incipient ovarian failure; defined as normo-ovulatory cycles, raised basal FSH \> 12 IU/L
* Poor response patients; defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins or cancellation in case of absent follicle growth
* Women with early menopause (between 40-45 years)
* Hypergonadotropic primary amenorrhea

Exclusion Criteria:

* Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)