cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).

Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
* Must rate their pain at \>/=40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.

Key Exclusion Criteria:

* History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
* History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
* Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
* Current generalized myalgia
* Serum creatinine \>1.5 x upper limit of normal (ULN).
* History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
* Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sonographic Venous Doppler Imaging in End-Stage Renal Disease

Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. It takes time to provide suitable conditions (personnel and equipment), the length of stay of patients in the emergency services is prolonged, and this may cause disruption of patient care in these areas where rapid patient care is provided. Therefore, the management of ESRD patients continues to be one of the serious problems faced by emergency physicians.

Sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal vein) may be an alternative diagnostic method for need for urgent hemodialysis. Hereby, patients who don't need hemodialysis safely can be discharged from emergency services. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.

In this study, the researchers aimed to determine the diagnostic value of sonographic venous Doppler imaging the need for urgent hemodialysis in ESRD patients in the emergency services.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease

Exclusion Criteria:

* Who are pregnant,
* With cirrhosis and liver malignancy,
* Who do not give consent for the study,
* Arrest presentation
* Unable to scan in the first six hours
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation


Eligibility Criteria:
Inclusion Criteria:

* Chronological age (CA) between 3 and 10 for girls
* Chronological age between 3 and 12 for boys
* Height for CA below - 2 SD
* Birth length for CA below -2SD

Exclusion Criteria:

* Endocrine disease except well-substituted hypothyroidism
* Sever chronic disease
* Skeletal dysplasia
* Known chromosomal aberration
* Ongoing treatment with steroids
* Known intrauterine infection
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1

Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in orthodontic patients after removal of the fixed appliances.


Eligibility Criteria:
Inclusion Criteria:

* one or more white spot lesion at the time of removal of fixed appliances

Exclusion Criteria:

* white spots already present before start orthodontic treatment
Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots


Eligibility Criteria:
Inclusion Criteria:

* All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November

Exclusion Criteria:

* significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
* any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
* those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
* clinically significant macular oedema on clinical examination.
A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)

The purpose of the study is to measure how the radiolabelled test medicine \[14C\]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age 30 to 65 years of age
* Body mass index (BMI) of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
* Must provide written informed consent
* Must adhere to the contraception requirements

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption
* Current smoking or use of tobacco products or substitutes.
* Current users of e-cigarettes and nicotine replacements products
* Radiation exposure
* Subjects who have completed 2 ADME studies in the last 12 months
* Clinically significant abnormal biochemistry, hematology or urinalysis
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* Evidence of renal impairment at screening
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug
* Vaccination with any live vaccine within 4 weeks of study drug administration
The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses

Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.

This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
* Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
* A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).

Exclusion Criteria:

* Use of medication which interferes with study measurements (as judged by the study physician).
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* Reported weight loss/gain (\>10%) in the last six month before the study
Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital

Trigeminal neuralgia is defined according to the third edition of the International Classification of Headache Disorders (ICHD-3) criteria. Chronic pain can have a major impact on the quality of life. First-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. Sometimes the pain is resistant to these therapies. In this indication, sensory blocks may have a therapeutic impact but their place is not clear. In France, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. Several adjuvants to local anesthetics have been studied for acute and chronic pain. CLONIDINE and DEXAMETHASONE are of greatest interest in increasing block duration and reducing opioid consumption. The investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. After a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. The sensory block is performed as an outpatient care. It consists in a peri-neural injection of a mixture of LEVOBUPIVACAINE 5%, CORTIVAZOL 3.75mg / 1.5mL (or BETAMETHASONE 7mg / 1ml) and CLONIDINE (1μg / kg). Standard precautions are respected and patients are monitored in the recovery room after the procedure. The efficacity is evaluated before the exit and a follow-up is done within 15 days. The level of satisfaction expressed by the patients seems to be globally high. The investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. This retrospective study, by its procedure, does not change the management of patients.


Eligibility Criteria:
Inclusion Criteria:

* Major patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria
* treating by one or more trigeminal nerve blocks
* at the peri operative pain management center of Limoges University Hospital
* between 2014 and 2018

Exclusion Criteria:

* Not consent
* Another type of facial block during the previous year.
* Unavailable medical data
* Deceased patient
MEDI-557 Adult Dosing

This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.

A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* written informed consent obtained from subject prior to performing any protocol related procedures
* healthy by medical history and physical exam
* females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
* nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
* weight \</= 110kg with a body mass index of \<32kg/m2
* ability to complete a follow-up period of approximately 360 days

Exclusion Criteria:

* inability to complete a follow-up period of 360 days
* any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
* concurrent enrollment in another clinical study
* employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
* receipt of immunoglobulin or blood products within 60 days prior to randomziation
* receipt of any investigational drug therapy within 6 months prior to IP dosing
* clinically abnormal ECG at screening
* blood donation in excess of 400mL, wihtin 6 months prior to randomization
* previous receipt fo biologics
* history of immunodeficiency
* history of allergic disease or reactions likely to be exacerbated by any component of the IP
* previous medical history or evidence of interurrent illness that may compromise the safety of the subject
* positive lab test for Hep A, B, C or HIV
* pregnancy or nursing mother
* history of alcohol or drug abuse within past 2 years
* positive urine Class A drug screen
* acute illness within 7 days prior to randomization
* fever \>/= 99.5F witin 7 days prior to randomization
* any drug therapy within 7 days prior to randomization
* systolic BP \>150mmHG and/or diastolic BP\>90mmHg
* receipt of vaccine within 14 days prior to randomization
* abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)
Metabolism and Absorption of Anthocyanins from Extract and Whole Blueberry Powder Confections in Healthy Adults

This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.

PRIMARY OBJECTIVES:

I. Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.

II. Assess the effect of blueberry source (extract versus \[vs\] whole fruit powder) on urinary metabolomics profile.

OUTLINE: Participants are randomized to of 2 groups.

GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Eligibility Criteria:
Inclusion Criteria:

* Be healthy, free-living adults
* Have a body mass index (BMI) between 18 and 35 kg/m\^2
* Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
* Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study

Exclusion Criteria:

* Report being actively treated for any metabolic, digestive or immunologic disorder including malabsorptive disorders, renal insufficiency, hepatic insufficiency, any autoimmune disorder or short bowel syndrome
* Have a known allergy or food intolerance to ingredients in study products (blueberries), other berries, wheat, or soy
* Are strict vegans (no consumption of animal, fish or egg products)
* Are planning to conceive, or are currently pregnant or lactating
* Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/ day)
* Have been on an antibiotic regime lasting for one week in the last 6 months
Triathlon® Partial Knee Replacement (PKR) Outcomes Study

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
* The subject requires a primary cemented unicompartmental knee replacement.
* The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
* The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
* The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
* The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
* The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
* The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* The subject has inflammatory arthritis or avascular necrosis(AVN).
* The subject is obese, BMI \> 35.
* The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
* The subject has a history of anterior cruciate ligament (ACL) reconstruction.
* The subject has had a high distal femoral, or proximal tibial osteotomy.
* The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
* The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
* The subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration).
* The subject has a known sensitivity to device materials.
* The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
* The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* The subject has an active or suspected latent infection in or about the knee joint.
* The subject is a prisoner.
Lifestyle Intervention of Obese Teenagers (LITE) Program

Background: Family-based lifestyle intervention programmes have been known to reduce overweight and improve cardiovascular risk in adolescent obesity \[1\]. This study was designed to address the gap in service provision of a family based weight management program for overweight and obese adolescents. The LITE (Lifestyle Intervention for obese teenagers) group program is a 6-month, family-based behavioural lifestyle intervention, specifically designed to treat obesity in adolescents 10-16 years referred to the Weight Management Clinic. The main principles underpinning LITE program are that parents are identified as the agents of change responsible for implementing lifestyle change in the family .

Methods: The study design is a two-arm randomized controlled trial that recruited 60 overweight and obese adolescents 10-16 year olds that attended Kandang Kerbau Women and Children's Hospital(KKH) weight management clinic. Adolescents with secondary cause for obesity are excluded. Participants are randomized to LITE program with usual care or usual care.

Briefly, the LITE program involves four x 180 min weekly sessions, followed by three x 90 min monthly sessions, for adolescents and parents. The key aspects covered in the LITE program are in keeping with Health Promotion Board guidelines for the management of overweight and obesity and include healthy food choices and eating patterns, increasing physical activity and reducing sedentary behavior. The parenting aspects aim to support and increase parental capacity to implement and maintain the lifestyle changes. The program takes a solution focused approach with families identifying small changes that they would like to try each week instead of a child-centric approach.

Outcome measurement are assessed at 3 and 6 months post baseline and include anthropometric measurements, physical activity, dietary intake, metabolic profile, improvement in positive parenting behaviour and measurement of family support.

Primary outcome is change in body mass index (BMI) z-score at 6 months. Secondary aim is to evaluate the changes in waist-height ratio and fat percentage change and improvement in positive parenting behaviour.


Eligibility Criteria:
Inclusion Criteria:

* All adolescents aged 10-16 years old who are currently enrolled in the Weight Management Programme

Exclusion Criteria:

* Intellectual disability, significant medical illness that precludes physical activity and significant psychiatric illness
* Secondary cause of obesity
* Taking of medications that can affect weight status
* Poor level of spoken English (adolescent/carer)
* Severe obesity as defined by BMI more than or equal to 40kg/m2
* Sibling who is already participating in the study