cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass

Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life. The complexity of the surgical repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent periods of low flow or complete circulatory arrest. The immature neonatal vital organs are more prone to the complications of the cardiopulmonary bypass circulation, namely ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide (NO) is used frequently in neonates for the treatment of pulmonary hypertension, Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R injury and endothelial dysfunction.

The purpose of this pilot study is to assess the efficacy of NO administration via the CPB circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in neonates undergoing repair of complex congenital heart defects. Specific goals will be to demonstrate that NO use via CPB will:

* Decrease markers of I/R injury and systemic inflammatory response.
* Decrease platelet activation leading to reduced postoperative bleeding and transfusion requirements.
* Decrease postoperative organ dysfunction, and hence decrease operative mortality and postoperative morbidity.

Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the CPB circuit, for the duration of surgery. They will be compared to a control group of 12 similar patients. Serum levels of different ischemic reperfusion injury and inflammatory markers will be measured at different time points after surgery and will be correlated with different end organ function tests and clinical course in the postoperative period. The results will be compared between the two groups to try to determine the clinical benefit of NO administration through CPB circuit.


Eligibility Criteria:
Inclusion Criteria:

* Neonates, age 0-30 days
* Full term, \> 37 weeks gestation
* Birth weight ≥ 2.6 kg

Exclusion Criteria:

* Preoperative sepsis
* Preoperative renal dysfunction
* Preoperative intracranial hemorrhage
* Chromosomal abnormalities and/or genetic syndromes
* Prior intervention (catheter based or surgical)
The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults

It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)

The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older)
* Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification.

These include but are not limited to:

* Vascular surgery
* Colon and rectum
* Hepatobiliary
* Gastrointestinal
* Gynecology
* Urology
* Abdominal Aortic Aneurysm (AAA) repair
* Right hemicolectomy
* Left hemicolectomy
* Sigmoidectomy
* Anterior resection
* Abdominoperineal amputation
* Exploratory laparotomy
* Cholecystectomy
* Cholecystectomy and choledocotomy

  * Written informed consent

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patients \< 18 years old or patients who are still in the growth phase
* Contaminated and infected areas
* Hypersensitivity to silver
* Direct contact with the viscera
* Previous allergic reactions to components of the device
* Patient with previous laparotomy
* Transverse laparotomy
* Patients with previous hernia repair
* Simultaneous participation in another investigational clinical trial (drug or medical studies)
* Patients with active oncologic treatment (chemo and radiotherapy)
* Underlying autoimmune disease
* Recent cardiovascular complication
* Gynecology surgery
* Urology surgery
* Vascular surgery
Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)

Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.


Eligibility Criteria:
* Diagnosis of relapsed or refractory low-grade, CD20+, B-cell NHL \* Received and failed at least 1 prior regimen of chemotherapy \* Rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.
Effectiveness of a WeChat-based Alcohol Consumption Intervention Mini-program ("Sober Time ACT") in China

The purpose of this study is to explore whether "Sober Time ACT", a digital intervention tool for alcohol use developed based on wechat mini program, is effective in improving risky alcohol use among Chinese local drinkers.


Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18
* The total score in line with the AUDIT scale ≧8
* Provide at least one backup contact information
* Non-illiterate, able to use smart phones without barriers
* Wechat version support small program function (6.5.3 and above)
* Understand the nature of this study and sign the informed consent

Exclusion Criteria:

* Other interventions and treatments to reduce alcohol use were given during the trial
* Severe primary or secondary cognitive dysfunction, unable to complete the screening scale and baseline questionnaire
Open-Label Safety Study of AXS-05 in Subjects With Depression

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder, including treatment resistant depression
* Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Suicide risk
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules

To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.

Eligibility Criteria:
Inclusion Criteria

Patients must be:

* Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
* Available for 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* They or their sexual partners have identifiable high-risk behavior for HIV infection.
* Positive syphilis serology (e.g., VDRL).
* Positive for circulating hepatitis B antigen.

Patients with the following prior conditions are excluded:

* History of positive PPD (tuberculin test).
* History of immunodeficiency or chronic illness.
* Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

* High-risk behavior for HIV infection.
* History of intravenous drug use.
* More than one sexual partner in the last 6 months.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.

Sub-study:

Full title: Optional Genetic Research

Date: 18 June 2010

Version: 1

Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* Currently taking methotrexate
* 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Liver disease or significant liver function test abnormalities
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* Recent or significant cardiovascular disease
* Significant active or recent infection including tuberculosis
* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* Severe renal impairment
* Neutropenia
Biomarkers of Pediatric Heart Failure

Heart failure (HF) is a clinical syndrome where the heart is unable to pump the blood required to meet the metabolic demands of the body. Heart failure in children can result from a variety of structural or functional cardiac disorders with subsequent failure of the ventricles to fill with or eject blood

Cardiac biomarkers are useful as diagnostic and prognostic tools, especially in patients with atypical signs and symptoms. High rate of complication in HF led to the search for suitable cardiac biomarker that diagnose heart failure as early as possible, predict outcome, reflect response to treatment and help in staging of heart failure and determine risk (6) . In pediatrics, biomarkers of heart failure are particularly important for the early identification and risk stratification of patients with systemic diseases and associated risk for early development of heart failure. Good biomarkers have the following characteristics: high sensitivity and specificity, the possibility of simultaneous processing of many samples, short analysis time, low cost, and good clinical applications, thus predicting the risk of heart failure and the associated prognosis as well as the adequacy of monitoring \[7\].

. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 kDa protein covalently bound to matrix metalloproteinase-9 which was first isolated from neutrophils. It belongs to the lipocalin family, NGAL has been found to be elevated in both plasma and urine in patients with HF.(8) NGAL also acts as a growth and differentiation factor in the renal epithelium \[9\].

Eligibility Criteria:
Inclusion Criteria Children from 1 month to 16 years old admitted to Assiut children University Hospital the Pediatric Cardiology unit with clinical manifestation of heart failure according to Ross classification either due to congenital or due to acquired heart disease will be enrolled in the study Exclusion Criteria Children with renal disease or failure, hepatic disease, pulmonary diseases will also excluded.
Perinatal Depression Treatment and Child Development

The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.


Eligibility Criteria:
Inclusion Criteria:

* children of women who were eligible to participate in the Thinking Healthy Programme

Exclusion Criteria:

* developmental disability, visual or hearing impairment
Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress

The goal of this prospective clinical trial is to evaluate the possible superiority of a treatment compared to the gold standard of reference in Orthodontics.

Apical external root resorption is defined as the loss of dental hard tissues such as dentine, cement and alveolar bone. This is considered an irrevocable effect associated to different factors, among which dental movement during orthodontic treatment is related.

This study suggest to compare root resorption after the use of two different types of alignment and levelling arches in orthodontics. Consecutive patients randomly chosen will be analysed after going through one of the two arches sequences:

1. Gold standard group: using arches that provide the same amount of force in all sections . 3M United® nickel-titanium arches (0.012, 0.014, 0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025)
2. Intervention group: using some arches that provide individual sectional forces for each dental group (incisors, premolars and molars). 3M United® nickel-titanium 0.012 and 0.014 arches and BioForce PLUS® arches (0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025).

All patients will be treated with multi-braces fixed appliances (0.022" technique and VictoryTM brackets).

Root resorption will be compared through CBCT (Cone Beam Computed Tomography) images made before the beginning of treatment (T0), after 8-9 months of the beginning of treatment (T1) and at the end of treatment (T2). Root resorption will be measured by the root volume and surface root morphology in each of the times scheduled.

Eligibility Criteria:
Study Population: patients undergoing orthodontic treatment in Orthodontic Department at Dental School of Universidad Complutense de Madrid.

Inclusion Criteria:

1. Completed permanent dentition (third molars are excluded)
2. Completed root formation
3. Need of orthodontic treatment

Exclusion Criteria:

1. Tooth agenesis in the anterior region (incisors)
2. Included or ankylosed teeth in the anterior region (incisors)
3. Periodontal pocket \>3 mm in any anterior teeth (incisors)
4. Need of a combined surgical and orthodontic treatment
5. Root resorptions observed at the initial CBCT (in more than 3 teeth)
6. Delay of the treatment due to a external reason or complication during treatment
7. Systemic disease or cranio-facial malformation
8. Tooth fracture or restoration in the anterior region (incisors) at the beginning of treatment
9. Problems from roots such as lacerated root, trauma or fractures during treatment 10 Severe occlusal attrition
Evaluation of Peripartum Blood Loss and Postpartum Anaemia in Macrosomia & Gemini

Anaemia in pregnant women occurs at a haemoglobin (Hb) concentration \<11 g/dL and treatment is essential to prevent increased maternal morbidity, fetal morbidity and mortality. Studies show a distinct risk of haemorrhage in pregnant women due to increased uterine dilatation, due to twins or macrosomic singletons. Currently, prepartum anaemia management, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied. The investigators intend to conduct a monocentric retrospective analysis of this subcohort.

Patient blood management is essentially based on three pillars, and a meta-analysis has already shown that consistent use can reduce transfusions and mortality. The WHO defines anaemia in pregnant patients as a haemoglobin (Hb) concentration \<11 g/dl.

Treatment of iron deficiency anaemia is essential because data show that iron deficiency anaemia is associated with increased maternal morbidity, fetal morbidity and mortality. Studies show a separate risk of bleeding in pregnant women due to increased uterine prolapse, for example in twin pregnancies or macrosomic singletons. At present, the prepartum anaemia management of patients, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied, which the investigators intend to investigate.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* pre-existing coagulation disorder
Clinical Signs and Changes in Cervical Muscles Activity Evaluated by Magnetic Resonance Imaging During an Endurance Test

The aim of this present study is to compare the radio-clinic correlation between the ability to hold the head and neck (by inertial sensor) and the changes in neck muscles activity (by functional magnetic resonance imaging) during the cervical extensor endurance test between an asymptomatic population and one suffering from chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck Disability Index score \> 8/50 for the symptomatic group OR \< 4/50 for the asymptomatic group
* numerical rating scale \< 7/10 for the symptomatic group
* suffering from idiopathic or traumatic chronic neck pain for the neck pain group OR being free of neck pain which required therapeutic, medical or medicinal treatment in the last 12 months.

Exclusion Criteria:

* fibromyalgia, cervical radiculopathy, previous cervical surgery
Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study

The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners

Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.

Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.

After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 and over
* With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
* medical follow-up in one of the two nutrition departments of the study
* Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.

Exclusion Criteria:

* Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews
* Person who does not speak French easily
* Generally, any person unlikely to cooperate in the study
* Adults under guardianship
A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors

This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab.

This study includes a dose escalation part (Part 1) in which the MTD or OBD and RDE(s) will be determined. This trial includes an expansion part (Part 2) to evaluate efficacy and safety of BYON4228 in combination with pembrolizumab in specific patient cohorts.

BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:

  * Part 1 (dose escalation): Solid tumors of any origin;
  * Part 2 (expansion): Patients with other solid tumor types indicated for pembrolizumab monotherapy;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
* For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1);
* Adequate baseline organ function.

Exclusion Criteria:

* Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment;
* History of hypersensitivity or allergic reaction to any of the excipients of BYON4228;
* Any contraindication to pembrolizumab treatment;
* For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation;
* Symptomatic brain metastases;
* History of autoimmune disorders;
* Severe active infection or other severe uncontrolled systemic disease;
* Having clinically significant cardiovascular disease;
* Known infection of Hepatitis B, C or E.

Key inclusion and exclusion criteria details are listed here, additional requirements may apply.