cyrilzakka/clinical-trials huggingface dataset:
Prednisolone for Pain Reduction in Knee OA

Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the leading symptom and is often chronic in nature leading to significant morbidity and decreased quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis may reduce pain.

Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic low-grade inflammation, in the short term and to determine if it sustained long term at 12 weeks in older adults with moderate to severe knee OA.

Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive placebo together with their usual therapy for 6 weeks. The primary outcome measure will be pain reduction. Secondary outcome measures will be reduction in systemic inflammation and improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability were also assessed. Data will be collected at baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6 weeks. Exclusion criteria will include any inflammatory or serious medical condition.

Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale. Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional Index (LFI)score \> 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS, 0-100), self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute walk distance (6MWD). All patients will undergo a physical examination and will be questioned about the number of flares, pain and analgesic use. Blood samples will be collected and serum levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all patients.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee

Exclusion Criteria:

* Any inflammatory or serious medical condition
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment.

To evaluate the clinical safety of Di-valproate.


Eligibility Criteria:
Inclusion Criteria:

* In or out patients
* Patients with a current diagnosis of Bipolar I Disorder according to DSM IV (296)
* Patients suffering from a current manic episode or mixed episode

Exclusion Criteria:

* Patients who participated in a clinical trial within the three preceding months
* Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects.
* Patients with a CNS neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder
* Patients with a history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
* Patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
* Patients with acute or chronic hepatitis
* Patients with current or past pancreatitis
* Patients with recent history (3 months or less) of substance or alcohol dependence according to DSM IV
* Pregnancy or lactation. Women of child bearing age should be using a reliable contraceptive method
* Patients that require more than 325 mg of aspirin per day
* Patients with a medical condition which requires the continuous use of medication which could interfere with the evaluation of safety or efficacy of valproate : anticonvulsant or anticoagulant therapy, MAO inhibitors, zidovudine
* Patients having received any depot neuroleptic within six weeks prior to baseline
* Patients who received antidepressant drugs within 5 days before baseline and patients who received fluoxetine within 20 days
* Patients judged by the investigator to have serious risk of suicide
* Patients necessitating an Electro Convulsive Therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children

Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been thoroughly studied, and a large global experience exists.

Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.

Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for approximately 4-6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2-10 years.
* Weight: 15-40 kg.
* Sex: both males and females.
* ASA physical status: 1-II.
* Operation: surgery below the umbilicus.

Exclusion Criteria:

* Allergic reaction to local anesthetics (LAs).
* Local or systemic infection (risk of meningitis).
* Intracranial hypertension.
* Hydrocephalus.
* Intracranial hemorrhage.
* Coagulopathy.
* Hypovolemia.
* Parental refusal.
* Spinal deformities, such as spina bifida or myelomeningocele.
* Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Under care of physician at least 2 months (for CKD)
* Not on active Vitamin D therapy for at least 4 weeks prior
* If female:

  * Not of childbearing potential, OR,
  * Practicing birth control
  * Not breastfeeding
* If taking phosphate binders, on a stable regimen at least 4 weeks prior
* For entry into Pretreatment Phase:

  * iPTH at least 120 pg/mL
  * GFR of 15-60 mL/min and no dialysis expected for at least 6 months
* For entry into Treatment Phase:

  * Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL_
  * 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
  * 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

* History of allergic reaction or sensitivity to similar drugs
* Acute Renal Failure within 12 weeks of study
* Chronic gastrointestinal disease
* Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0,2, or a history of renal stones
* Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
* Current malignancy, or clinically significant liver disease
* Active granulomatous disease (TB, sarcoidosis, etc.)
* History of drug or alcohol abuse within 6 months prior
* Evidence of poor compliance with diet or medication
* Received any investigational drug or participated in any device trial within 30 days prior
* Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
* On glucocorticoids for a period of more than 14 days within the last 6 months
* HIV positive
Cardiovascular Effects of Energy Drinks in Healthy Adults

This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of this study is to elucidate the physiological/cardiovascular response to an energy drink consumption as compared to a control drink both at rest and during stressful conditions in healthy adults.

The study will collect data to determine the hemodynamic changes (magnitude of heart rate and blood pressure response) in healthy adults after consumption of an energy drink and compare these responses to those after a control drink. Study will be performed at a hospital Clinical Research Unit on two separate days; minimum 24 hours and maximum 1 month apart. Participants will be fasting 4 hours prior to the study and will be asked to abstain from caffeine and alcohol for at least 24 hours prior to initiation of this study. Baseline measurements will be obtained during and after 10 minutes of rest. After the end of baseline recordings, the subjects will be given up to 500 ml (1 can, approximately 16 fluid ounces) of caffeinated energy drink or a control drink, based on randomization. They will have 30 minutes to drink it. The second set of measurements will be obtained after an energy drink or control drink intake, using exactly the same protocol as at baseline. The second study visit, participant will receive the alternate intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older
* Healthy subjects without known cardiovascular disease and thyroid disease
* Subjects who are on no medications (except oral contraceptive pill)
* Nonsmokers
* No prior history of caffeine sensitivity or allergy

Exclusion Criteria:

* Subjects with known cardiovascular and/or thyroid disease
* Subjects currently taking medications other than oral contraceptive pill
* Smokers
* Prior history of caffeine sensitivity or allergy
* Pregnancy
The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation

The purpose of this study is to test the (a) feasibility, (b) usability, and (c) acceptability of using the Oculus Virtual Reality (VR) for chronic stroke survivors who have mild-moderate cognitive and unilateral arm impairment to administer upper extremity and cognitive rehabilitation, to calculate the change in upper extremity and cognition scores on standardized measurements per standard of care and to qualitatively explore the impact of engaging caregivers in supporting the stroke survivor's rehabilitation and the impact of this engagement on the stroke survivor and caregiver dyad using semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke diagnosis within 6 months to 2 years of enrollment
* can read, write, comprehend, speak English
* willing and able to provide informed consent
* Caregivers must live in the home with the stroke survivor

Exclusion Criteria:

* do not have score ranges that indicate mild to moderate severity on the Montreal Cognitive Assessment (MoCA )(15-25) or other appropriate cognitive screening test selected by the speech language pathologist
* has aphasia, hemiopsia, and other neurological deficits that prevents the participant from being examined using MoCA or a modified MoCA, Fugl-Meyer Assessment - Upper Extremity (FM) (20-50)
* unstable while standing unassisted
* have a history of motion sickness/ vertigo/ dizziness/seizures, claustrophobia, blind/deaf, and cannot hold the controller in their affected arm.
Specimens for Septin 9 Performance

Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older at the time of the blood draw
* Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
* CRC defined as invasive adenocarcinoma

Exclusion Criteria:

* Previous personal history of colorectal cancer
* Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
* Known infection with HIV, HBV or HCV
* Subject concurrently receiving intravenous fluid at the time of the specimen collection
Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis

The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.

Methodology :

DESIGN:

Retrospective observational study single center, non-interventional Term study over 2 years, retrospectively

Acquisition of data:

* Study of computer file: report available on DxCare hospital and Cora
* Collection of data as excel spreadsheet
* Statistical analysis: local management
* Anonymity of data:

  * For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.

Development of the study:

* Procedure:

  * Series includable patients from the PMSI data
  * Select folders according the inclusion criteria
  * Collecting information from files on Excel spreadsheet by the internal charge of data collection (Sylvain CHAWKI)
  * Statistical Analysis
  * Writing Article
* Expected duration of patient recruitment: Retrospective of 2 and a half years from January 1, 2013 to April 31, 2015

Eligibility Criteria:
Inclusion Criteria:

* Admitted USINV for ischemic or hemorrhagic stroke
* Admitted secondarily in ICU

Exclusion Criteria:

* Admission in ICU in first
* Administrative Admission in Intensive Care Requiring Neurosurgical within the thrombolysis alert regulated by the neurovascular guard but going directly to ICU imaging waning
* Subarachnoid hemorrhage
Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer

This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0 (according to AJCC 8th edition) ;
2. Plans to proceed to surgery after completion of neoadjuvant therapy;
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
4. Has adequate organ function.
5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer.
6. Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.

Exclusion Criteria:

1. Known HER2 positive;
2. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
3. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
4. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)；
5. Known hypersensitivity to any of the study drugs or excipients;
6. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
7. Congenital or acquired immune deficiency (e.g. HIV infected)
Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis

Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

1. Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
3. Obtain data on the total body water content of healthy full term infants from BIA.


Eligibility Criteria:
Inclusion Criteria:

* Full-term infants
* 10th percentile for gestational age, according to the Audipog's growth chart

Exclusion Criteria:

* Congenital diseases
* Chromosomal abnormalities
* Any disease requiring intensive care
Ideal Marker for Targeted Axillary Dissection

A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.

There are two basic aims of the study

1. Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
2. Comparison of the number of complications during localizing and detection of individual markers and postoperative complications.

In individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. The usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. The study will bring an answer to the question of which marker is the best for marking lymph nodes.

Apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed:

* depth of marker implantation (measured in mm)
* marker migration (measured in mm)
* success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker
* time from localizing the pathological lymph node using the marker to surgery (measured n days)

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer, confirmed with a biopsy
* indication of neoadjuvant therapy
* biopsy of pathologically enlarged axillary lymph node and marking of the lymph node using one of the markers before neoadjuvant chemotherapy
* surgical treatment after neoadjuvant chemotherapy (targeted axillary dissection)

Exclusion Criteria:

* refusal to participate in the study
* another treatment protocol, which does not include targeted axillary dissection