cyrilzakka/clinical-trials huggingface dataset:
Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity

To:

1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)

Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous system.Diagnosis requires the combination of clinical signs and symptoms with paraclinical findings obtained by magnetic resonance imaging and cerebrospinal fluid analysis .which are componants of the 2017 McDonald criteria .So far, the gold standard for demonstrating intrathecal IgG synthesis is represented by selective oligoclonal bands in cerebrospinal fluid by isoelectric focusing (IEF), alongside an elevated IgG index .However, the detection of oligoclonal bands in cerebrospinal fluid has several limits as , it requires a time-consuming and expensive laboratory technique, with about three hours needed to obtain results Furthermore, it only provides aqualitative information about the presence of IgG in CSF .During CNS inflammation , kappa free light chain are secreted in the CSF and their concentration reflect the degree of intrathecal B cells and plasma cells activation .Measurement of KFLC could help diagnosis of OCB negative MS and identify intrathecal immunoglobulin synthesis in patient presenting with one isolated band on isoelectric focusing , and it is fully automated,rater independent, stable against preanalytical errors . Thus, the intrathecal synthesis of free light chains are more sensitive, less costly, and less time-consuming compared To OCB detection .The most reliable parameter used to assess FLC diagnostic value in MS is the k-index, .So κ-FLC index predicted the time to conversion to MS as well as disability progression . So patients with early MS and high κ-FLC index is an independent risk factor for conversion from CIS to MS

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CIS or MS according to the 2017 revision of the McDonald criteria
* Patients diagnosed with RIS (Radiological isolated syndrome) according to the criteria by Okuda
* Age between 18 and 40 years.

Exclusion Criteria:

* History of exposure, in the 30 days prior to CSF collection, to immunosuppressant or immunomodulatory therapies .
* Peripheral neurological disorders .
* Infectious CNS disease.
* CNS tumor.
* Monoclonal gammopathy .
* Chronic kidney injury (GFR \<30 ml /min/1.75m2 )
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?

The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.

Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.

Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage

Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.

. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.

Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .

Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided .

In the treatment of breast cancer, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the staging procedure for patients with clinically node-negative disease. It provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than ALND. Historically, patients who were clinically node-negative would undergo SLNB, whereas patients who were node-positive underwent ALND. SLNB in the neoadjuvant setting has become a topic of debate. Unfortunately, the reliability of SLNB after NAC remains questionable. Chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
2. Female Patient aged from 18 to 60 years old
3. Patients who are fit for general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

Exclusion Criteria:

1. Stage 4 breast cancer
2. Patient has no clinical response to NACT
3. Patients who are contraindicated for radiotherapy
4. Pregnant patients in first trimester
5. Patient with inflammatory carcinoma
The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly

This study aims to investigate the effects of probiotics named GI Biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.

This study is a double-blind, randomized controlled trial. A total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. The intervention group will be given GI Biome #7 pills, and the control group will be given the placebo pills for four weeks. The participants will visit the research laboratory four times as follows: A day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. Participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked.

Eligibility Criteria:
Inclusion Criteria:

* 60 years old or older
* Those who have no difficulties in daily living
* Willing to commit throughout the study

Exclusion Criteria:

* Antibiotics medication in the last month.
* Probiotics used in the last months.
* Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke
The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture

Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be treated by surgical operation, local edema, pain and wound poor healing always is noted, according to the investigator's knowledge, no good therapeutic methods to treat mention-above symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and ant-inflammation. Therefore, the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture.

the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture. The primary outcome measure was the scores change of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.

Eligibility Criteria:
Inclusion Criteria:

* 20-75 year-old male or female with acute ankle fractures with surgical indication (Joint line displacement \>2mm ; fracture dislocation)

Exclusion Criteria:

* Previous skin disease, DM or peripheral vessel disease with local foot amputation.
* Previous ankle surgery, old ankle fracture, or open fracture.
* Liver or renal dysfunction, and cardiorespiratory failure.
* Surgical infection after surgery.
* Patient refuse or can't finish the treatment course
* Patient with cancer
* Pregnancy
* HIV positive.
Ischemic Preconditioning and Type 2 Diabetes

The aim of this study is to determine the impact of 7 days of daily ischemic preconditioning (IPC) on vascular function and insulin sensitivity in Type 2 Diabetes Mellitus.

Occlusion (cuff inflation to a pressure that reduces blood flow) using a blood pressure cuff on the upper arm for 5 mins followed by recovery (cuff deflation so blood flows normally gain), is known as ischemic preconditioning (IPC). An intervention consisting of 4 cycles of 5 min arm occlusion followed by 5 min periods of recovery on a daily basis can improve blood vessel function. This is a simple and easily applicable intervention that immediately improves the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle). However, it is currently unknown if a daily IPC can improve blood vessel function in patients with type 2 diabetes mellitus (T2DM) and if it will aid in improving blood glucose control. Therefore, the purpose of this study is to investigate if daily IPC for 7 days can improve blood vessel function and blood glucose control in T2DM.

This randomised control trial consists of 3 visits to Liverpool John Moores University; before intervention, immediately following intervention, and 8 days following the end of the intervention. Participants will be trained to apply the IPC device and then perform it at home daily for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent
* Males and females 18-75 years
* Diagnosis of T2DM
* Currently treated with diet or of metformin

Exclusion Criteria:

* Type 1 diabetes mellitus
* Previous myocardial infarction, stroke (including TIA) or thrombosis
* Diagnosed with Congestive Heart failure
* Unable to enroll for the duration of the study
* Pregnancy or lactation period
* Currently treated with sulponylureas (DDPIV inhibitors/Pioglitazone or insulin) or glucagon like peptide1
Feasibility Nutritional Supplements for Muscle Growth in CP

The purpose of this study is to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in children with cerebral palsy.

Cerebral palsy (CP) is the largest cause of childhood physical disability, with a prevalence of 2 to 3 per 1000 live births. While the disorder is caused by a non-progressive lesion in the developing brain, musculoskeletal alterations progress with age. The observed neuromuscular symptoms mainly involve spasticity and muscle weakness. Macroscopic lower limb muscle properties in CP, i.e. reduced muscle volume, length, anatomical cross-sectional area (CSA), and fiber CSA, have been reported, providing convincing evidence for impaired muscle growth in children with CP, already at young ages. Nutritional supplements may improve muscle strength and cause muscle hypertrophy. Within the muscle, protein synthesis depends on the availability of the branched chain amino acids (BCAA), and mainly on the presence of leucine. This stimulatory effect is thought to be primarily mediated by the upregulation of mRNA translation via enhanced signaling through the mTOR pathway. BCAA or leucine supplements have been widely used to improve muscle strength and achieve hypertrophy. In paediatric CP groups, such muscular effect of nutritional supplementation on macroscopic intrinsic muscle properties (i.e. muscle volume, anatomical CSA and muscle belly length) has not yet been studied. Therefore, a feasibility study will be carried out to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in five children with cerebral palsy. This feasibility study will provide proof of concept of the administration plan of the leucine supplement and of the study design. Additionally, it will provide data for power analyses, that will be used in a future comprehensive study, investigating the effect of leucine on macroscopic muscle properties in children with cerebral palsy. To cover safety issues blood and urine sampling will be performed to objectify the patient's nutritional state and to exclude underlying disorders that would contraindicate the use of protein supplements.

Eligibility Criteria:
Inclusion Criteria:

Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven)

* Uni- of bilateral involvement
* Level II or III on the Gross Motor Function Classification System (GMFCS)
* Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing children

Exclusion Criteria:

* Presence of dyskinesia or ataxia
* Severe co-morbidities
* Botulinum toxin treatment ten months prior to assessment
* Previous orthopedic or neurosurgery
* Severe ankle deformities preventing fitting in test positions
* Ankle range of motion (ROM) \<30% of normal values
Shockless Implant Evaluation

This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.

The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)

Exclusion Criteria:

* Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
* Patients on active transplant list
* Patients unwilling to provide informed consent
* Patients not available for follow-up
* Pregnancy or women of child bearing potential not following an effective method of contraception
* Anticipated right sided implantation of the ICD generator
Quality Improvement Pilot

The overall goal of this study is to develop and pilot test the use of practice facilitation as an intervention for healthcare providers and staff, with the goal of improving the implementation of cancer prevention and screening guidelines in primary care settings.


Eligibility Criteria:
Inclusion Criteria:

* Normal Volunteers

Exclusion Criteria:

* None
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy

This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled in PACE organizations. Our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in elderly patients infected with COVID-19.

Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide and the new investigational drug, remdesivir have been proposed for repurposing to fight COVID-19 and its complications.

A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 on the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data of elderly patients with polypharmacy.

Patients meeting all the following criteria will be included:

1. Patient enrolled in a PACE organization during the implementation period;
2. PACE organization contractually receiving pharmacy services from CareKinesis;

Exclusion Criteria

a) No drug claims data available for the period of 2019-2020

This retrospective cohort will utilize 178,867 drug claims from approximately 12,123 patients enrolled in PACE. MRS will be calculated using the last available 3-month period of drug claims in 2019. The data elements required for the calculation of the full set of risk scores are: prescribed drugs, dose, age, gender. Medication risk stratification using 5 factors will be performed to obtain the MRS. Various repurposed drugs (drugs associated with the highest probability or efficacy or shown interest as per their inclusion in current clinical trials will be prioritized) will be added to the patient drug regimen except for the patients that are currently taking the repurposed drug. A new MRS will be generated for all stratified patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled in a PACE organization during the implementation period;
* PACE organization contractually receiving pharmacy services from CareKinesis;

Exclusion Criteria:

* No drug claims data available for the period of 2019-2020
Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.

The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.


Eligibility Criteria:
Inclusion Criteria:

* We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission.

Exclusion Criteria:

* pregnant patients
Evaluation of a Multi-Purpose Solution

This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
* Must be able and willing to comply with all treatment and follow-up study procedures.
* Must have a clear central cornea.
* VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

* Systemic disease affecting ocular health.
* Using systemic or topical medications.
* Wear monovision, multifocal or toric contact lenses.
* Any grade 2 or greater slit lamp findings.
* Pregnancy
The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome

To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin), in obese and non-obese patients with polycystic ovary syndrome (PCOS).

Seventy selected PCOS patients will be recruited for this study, and will be divided into two groups based on their body mass index (BMI): 35 obese (BMI≥ 25 kg/m2, group A), 35 non-obese (BMI\<25 kg/m2, group B). In addition, 35 healthy non-obese women (BMI\<25 kg/m2) will bw enrolled as the control (group C). Serum levels of FSH (follicle stimulating hormone), LH (luteinizing hormone), T(testosterone), glucose, insulin, adiponectin, resistin and resistin will bw detected, and compared the differences of them among three groups

Eligibility Criteria:
Inclusion Criteria:

* Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital

Exclusion Criteria:

* Known androgen secreting tumor.
* PCO on ovarian stimulation medications
* PCO with any other medical illness.
Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach

An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.

It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.

Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a LUHCI code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.

Exclusion Criteria:

* Patients who did not allow the reuse of their medical file data for research related to COVID-19-
Turkish Version of Pain Modulation Index

In order to assess the validity and reliability of the Turkish version of Pain Modulation Index, 125 volunteers with chronic pain were enrolled in the study. Test and re-test method was used to assess reliability and correlation analyses with Pain Detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire. Turkish version of the Pain Modulation Index was found to be a valid and reliable tool for evaluating chronic pain.

Pain Modulation Index is a questionnaire that was developed in English for the assessment of chronic pain for qualities consistent with central sensitization. The English version of the questionnaire was translated into Turkish by two physicians than back translated into English by two separate bilingual translators. Initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study. They answered the questions twice, 15 days apart. In addition to the Turkish version of the Pain Modulation Index, on the first visit, they were also asked to answer Pain Detect and Central Sensitization Inventory. Their answers were analysed to assess the validity and reliability of the Turkish version of Pain Modulation Index.

Eligibility Criteria:
Inclusion Criteria:

* presence of chronic non-cancer pain of more than 3 months duration

Exclusion Criteria:

* Illiteracy
* Refusal to take part in the study