cyrilzakka/clinical-trials huggingface dataset:
Perenteral Nutrition and Oxidative Stress in Preterm Infants

In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione to the TPN solution. However, the role of trace elements as antioxidants, and their interaction with light have not been studied. Also, the impact of TPN-related oxidants on clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm infants to evaluate the role of different components of TPN on urinary peroxides and to examine the biochemical and clinical effects of light protection.


Eligibility Criteria:
Inclusion Criteria:

Preterm infants included are:

1. with gestational age between 28 to 34 weeks
2. managed with TPN as part of their care in the NICU
3. their postnatal age on enrolment was \< 7 days

Exclusion Criteria:

Infants are excluded if they have:

1. Clinical evidence of sepsis, or a positive blood culture on admission
2. Hepatobiliary dysfunction
3. Persistent metabolic acidosis with base deficit \> 10 mEq / L
4. Renal impairment (urine output \< 1 ml/kg/hour and serum creatinine \> 1 mg/dl)
5. Disseminated intravascular coagulopathy
6. Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.
Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee

Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5 intraarticular injections at weekly intervals, for the sustained relief of pain and amelioration of joint dysfunction in patients of OA of the knee.


Eligibility Criteria:
Inclusion Criteria:

* 1.Male or female patients whose specific ages are \> 50 years old, in general health. 2.Must be ambulatory (assistive devices allowed) 3.Patient was diagnosed as OA of knee joint by American College of Rheumatology (ACR) criteria ; \[ ie,knee pain, and any one of the following:age\>50 years,crepitus, or morning stiffness\<30 minutes in duration \] 4.Radiographic confirmation of OA with Kellgren-Lawrence Ⅱ-Ⅲ score (mild to moderate)at the target joint (anterior-posterior views) with predominance in the tibia-femoral compartment 5.VAS score ≧40 mm for 50 foot of walking pain.

Exclusion Criteria:

* 1.Patients with severe degeneration of knee joint with marked joint narrowing, marked varus or valgus deformity of the knee greater than 12 o. 2.Patients with hepatic or renal failure, or other chronic severe diseases that can interfere with the outcome. 3.A known history of psychiatric diseases, significant neurological diseases, allergy or sensitivity to hyaluronic acid or avian protein. 4.Patients receive steroid intraarticular injection, anti-inflammatory agents less than two weeks. 5.Patients with joint disorders: inflammatory joint disease, specific arthropathy (chondrocalcinosis, joint effusion \>30ml), severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs, symptomatic hip. 6.Significant alcohol, drug or medication abuse as judged by the investigator. 7.Pregnancy determined by clinical evaluation or urine testing for nursing women and/or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant). 8.Patients who have taken any other "investigational" drug within one month prior to the screening visit.
Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status

This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.


Eligibility Criteria:
Inclusion Criteria:

* A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;
* age 18-75 years;
* pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
* normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score \< III without severe systemic disease;
* no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
* PG-SGA score ≥2，\<9

Exclusion Criteria:

* patients requiring conversion to open gastrectomy
* excessive bleeding (˃ 500 mL);and patients opting out of the study.
Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome.

II. Evaluate further the safety of RIS in this population.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study.

Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated.

Patients continue RIS for 4 additional weeks at the dose prescribed during week 4.

All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

DSM-IV diagnosis of Tourette Syndrome (TS)

Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS

--Prior/Concurrent Therapy--

No concurrent use of other medications during study

A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine

--Patient Characteristics--

Hepatic: No hepatic disease

Renal: No renal disease

Cardiovascular:

* No heart disease
* No hypertension

Pulmonary: No pulmonary disease

Other:

* Not pregnant
* IQ at least 70 required
* No other movement disorder allowed, such as tardive dyskinesia
* No major depression
* No pervasive developmental disorder
* No autism or psychotic disorder based on DSM-IV
* No alcohol or substance abuse
* No hypersensitivity to risperidone
* All subjects must be in good health
Assessment of Nanocrystalline Hydroxyapatite Versus Autogenous Bone Grafts : A Comparative Clinical Study in Alveolar Cleft Grafting

This work aims to evaluate Nanocrystalline Hydroxyapatite versus Autogenous bone grafts in alveolar cleft grafting

Alveolar cleft is the most common congenital bone defect. Since its introduction in 1972, alveolar bone grafting (ABG) has been widely accepted to correct alveolar bone defect in most cleft centres.The purpose of ABG is to restore the dental arch continuity, stabilize the maxilla, close the oronasal fistulae, facilitate subsequent orthodontic treatment, enhance nasal symmetry, establish better oral hygiene, limit growth disturbances, etc . Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest , bone being the most widely accepted donor site(Tan, Brogan et al. 1996.New bone graft substitutes have been devised in recent decades, such as demineralized bone matrix (DBM), bone morphogenetic proteins (BMPs), calcium phosphate (CP), calcium sulfate (CS), hydroxyapatite (HA), highly purified bovine xenograft, and more, but clinical evidence of their efficacy varies among clinical and experimental studies \[4\] With the advent of new biomaterials, which may include or consist of allogenic bone source such as collagen membranes, hydroxyapatite crystals, tricalcium phosphate powder that has been increased consideration for their placement in the repair of alveolar clefts as well as other dental applications

Eligibility Criteria:
Inclusion Criteria:

* Age (7 - 12 years )
* Non-syndromic CLA or CLP
* More than 6 months of follow-up

Exclusion Criteria:

* History of previous alveolar surgery
* History of active infection or underlying disease such as hematologic disorders , neoplasm, and immune deficiency
* Patients who had received primary or tertiary ABG
Older Cancer Caregiver Needs Post Hospital Discharge

The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.

The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.

Baseline demographic data about the caregiver and patient will be collected at patient beside prior to hospital discharge. Qualitative interviews will be conducted with the cancer caregivers in their home at 1-week after their loved one was discharged from the hospital, and at 2-weeks after discharge from the hospital. This study utilizes a qualitative descriptive design.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver must speak English
* Caregiver must be at least 60 years of age
* Patients must be 18 years of age or older \& speak English
* Patients must have been admitted to either the 9100 or 9300 oncology unit for treatment of cancer, or treatment-related/cancer-related complications
* Patients must be discharged home to participate in the study

Exclusion Criteria:

* Dyads who received hospice referral prior to the care recipient's discharge
* Patient must not have any diagnosis of dementia in their medical records, or any cognitive impairment as assessed by hospital providers (physicians and nurses)
An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
* Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.
SUBLOCADE Rapid Initiation Extension Study

A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.

This study is being conducted to assess the longer-term safety of an abbreviated initiation protocol of SUBLOCADE in subjects who have completed the INDV-6000-403 study. It is also to provide treatment to these individuals while they seek longer-term treatment arrangements, as on average it can take an individual with opioid use disorder (OUD) 6 months between seeking treatment and achieving an appointment at a provider in the United States (US).

Subjects who have completed the end of treatment (EOT) procedures for the INDV-6000-403 study may be eligible for participation. It is planned that the EOT visit for INDV-6000-403, which will occur approximately 28 days after the subject's first dose of SUBLOCADE, and Day 1 for INDV-6000-404 will occur within 2 days of the EOT visit, and that EOT assessments will serve as the screening assessments for this study.

On Day 1, eligible subjects will receive a subcutaneous (SC) injection of 300 mg SUBLOCADE. Subjects will return to the clinic for subsequent injections approximately every 4 weeks for a total of up to 5 injections. Adverse events and concomitant medications will be captured throughout the study, female subjects of childbearing potential will receive urine pregnancy tests and all subjects will have urine drug screening (UDS) and evaluation of the previous injection site performed. Subjects will otherwise be treated in accordance with local standard of care, and SUBLOCADE doses will be based on the medical judgment of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
* Completed the EOT Visit for the INDV-6000-403 Study.
* Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.

Exclusion Criteria:

* Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.
* Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging

This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
* At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
* Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
* Patient must be ≥ 18 years of age.
* Patient must have Karnofsky Performance Status (KPS) of at least 60
* Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
* Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
* Patient must not be pregnant or breastfeeding.
* Patient must not have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2.
* Patient must not have melanoma.
* Patient must not have hemorrhagic lesions.
A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD

This is a Phase 2a study to assess the the safety and tolerability of TPN-101 in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated with Hexanucleotide Repeat Expansion in the C9orf72 gene (C9ORF72 ALS/FTD).

This is a Phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group, 2-arm study with a long-term, open-label treatment phase in patients with C9ORF72 ALS and/or FTD. This study includes a 6-week Screening Period, a 24-week Double-blind Treatment Period, a 24-week Open-label Treatment Period, and a Follow-up Visit 4 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of a clinical genetic test demonstrating a hexanucleotide repeat expansion (HRE) in the C9orf72 gene
* Has a reliable caregiver/informant to accompany the patient to all study visits

For patients with ALS (with or without FTD):

* Diagnosis of ALS (probable, possible, laboratory-supported probable or definite) according to the World Federation of Neurology revised E1 Escorial criteria
* Onset of weakness within 3 years prior to Screening
* Slow vital capacity (SVC) ≥ 60% of predicted normal adjusted for sex, age, and height (from the sitting position)
* Able to perform reproducible pulmonary function tests.
* ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 and score of 3 or 4 on Item #3 (swallowing) at Screening

For patients with FTD:

* A gradual, progressive decline in behavior, language, or motor function consistent with mild cognitive impairment, mild behavioral impairment, mild cognitive/behavioral impairment, behavioral variant FTD, primary progressive aphasia, or amnestic syndrome
* CDR Dementia Staging Instrument plus National Alzheimer's Coordinating Center Behavior and Language Domains (CDR plus NACC FTLD) global score of 0.5-2.0 at Screening

Exclusion Criteria:

* Presence of other significant neurological or psychiatric disorders
* History of clinically significant brain abnormality
* Clinically significant medical illness
* Tracheostomy or diaphragmatic pacing
* Autoimmune disease requiring treatment or management (quiescent rheumatoid arthritis, psoriasis, or controlled Type 1 diabetes are acceptable)
* History of human immunodeficiency virus (HIV) or hepatitis B infection, or any active infection during Screening, unless the patient will have been symptom-free for at least 30 days prior to randomization
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.

Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.

In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid.

This is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.

Eligibility Criteria:
Inclusion Criteria:

* Patients with oral pyogenic granuloma at the esthetic zone

Exclusion Criteria:

* Patients who were not compliant to oral hygiene instructions and can not be motivated
Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants

Large-for-gestational-age (LGA) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes. The purpose of this study is to explore whether comprehensive lifestyle intervention in the first year after birth in LGA infants will reduce the rate of overweight/obesity at childhood and improve neurodevelopmental outcomes and its possible mechanism.

Term LGA infants will be randomly divided into two groups shortly after birth: intervention group and control group. Infants in intervention group will attend the follow-up clinic and motor development assessment and guidance will be provided every three months in the first year. Other lifestyle interventions include feeding guidance and healthcare education. Infants in control group will routinely attend the follow-up clinic every six months. Primary outcome is the rate of overweight/obesity at two years old and seven years old. Neurodevelopmental assessment, carotid intima-media thickness (CIMT) and blood pressure at childhood will also be evaluated. The association of the outcome of LGA infants at two years old and the biomarkers in cord blood will be investigated, which includes serum leptin, insulin, insulin-like growth factors -1 (IGF-1), blood lipid series and adiponectin.

Eligibility Criteria:
Inclusion Criteria:

* term
* large-for-gestational-age infants

Exclusion Criteria:

* major genetic disorder
* congenital anomalies
* severe digestive disease
Catalytic Antibodies and Lupus in Martinique

* The Martinique island (French West-Indies) is an area of high prevalence and incidence for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are excessively high; also, organic damages are frequent. The disease can be fatal.
* Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm hydrolase activity dealing with the Lupus disease in order to measure the link between the disease activity and the catalytic activity. Patients concerned by this study will be Martinique people.

This study will be conducted as an case-control survey.

* The first group with patients: 60 SLE patients, 30 patients with a quiescent lupus and 30 patients with an active lupus. Patients that will be included are followed by the University hospital of Fort-de-France.
* The second group is the control group: subjects will be recruited by the French organisation responsible for donation of blood.

Test will be done at the UMRS 872 laboratory of the INSERM - Laboratory of Immunopathology and Therapeutic immunointervention - in Paris ; two catalytic activities will be tested: the DNase activity and the hydrolase activity.

Means to analyse the two activities: digestion of plasmid and Affinity-linked Oligonucleotide Nuclease Assay for DNase activity and hydrolysis of a peptide PFR-MCA for hydrolase activity.

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Presence of systemic lupus erythematosus according to the criteria of the modified 1997 ARA 1982 Lupus systemic evolution: Rates of anti DNA\> 100 U/L in ELISA and SLEDAI\> 7. Quiescent systemic Lupus: SLEDAI \<7
* Be aged 18 years and over
* Patient who has his main home in Martinique
* Patient who gave his agreement to participate in this clinical study

For control subjects:

* Voluntary donor who gave freely his agreement to participate in this study
* Be aged 18 years and over
* Patient who has his main home in Martinique
* Voluntary who gave his agreement to participate in this clinical study

Exclusion Criteria:

For patients:

* Presence of mixed connective tissue disease, Hashimoto
* Patients with other diseases: cancer, current infection
* Patient pregnant or breast-feeding
* Patient who refuse to participate in the study
* Patient not affiliated with a social security scheme (beneficiary or beneficiary)
* Specially Protected Persons (or under guardianship)
* Patient who has not his main home in Martinique

For control subjects:

* Voluntary donor who refused to participate in this study
* Voluntary who has not main home in Martinique