cyrilzakka/clinical-trials huggingface dataset:
Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state.

This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* First diagnosis of histologically confirmed breast cancer
* Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy)
* Able to provide adequate informed consent
* With intact cognitive abilities

Exclusion Criteria:

* Ongoing pregnancy
* In therapy or in follow-up for other cancers at the time of the study
* Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases
* History of documented allergy or previous adverse reaction to local anesthetics
* Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management
* Unable to comply to study protocol schedule for logistic or other reasons
* Refusal to participate to the study (absence of signed informed consent)
Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.

Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
3. Age 65-90 yrs；
4. Anesthesia Society of American (ASA) Scale II\~III；
5. Anticipated surgery time 2-6 hrs； -

Exclusion Criteria:

1. Dementia patients（Mini-mental state examination\< 20）
2. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
3. Unstable metal status and mental disease；
4. The cognitive function examination in 3-6 months is not anticipated to be completed
5. II-III Atrioventricular block；
6. Heat rate \< 50 beats/minutes；
7. Parkinson's Disease；
8. May occur or have occurred the difficult airway or anticipated delayed extubation
9. Sure or suspected abuse of analgesic and sedation drug；
10. Allergic to the trial drug and other anesthesia drug contraindication； -
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[QD\] and twice daily \[BID\] regimen) or matching placebo for 24 weeks.

•During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

* Treatment duration was 24 weeks in total.
* However, at Week 12, participants on placebo who did not achieve a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) were re-randomized (automatically via interactive voice/web response \[IXRS\]) to treatment to receive GLPG0634 100 mg QD or 50 mg BID doses in a blinded fashion, participants on 50 mg QD who had not achieved a 20% improvement in SJC66 and TJC68 were assigned to 100 mg QD and participants on 25 mg BID. who did not achieve a 20% improvement in SJC66 and TJC68 were assigned to 50 mg BID. All continued the study until Week 24.
* Participants in the other groups maintained their randomized treatment until Week 24.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
* have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
* Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
* have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

* current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
* current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
* previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.

The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water delivered under pressure by manual compression of the bottle by the user. This treatment allows for management of bioburden in a wound through broad spectrum antimicrobial activity by the CHG as well as removal of debris from the wound bed.

In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) - 'full skin thickness and extending through the subcutaneous or fat layers or to deeper structures such as tendon and fascia will receive standard of care treatment with indicated off-loading device (SOC) for their condition in addition to wound bed irrigation with Irrisept™ or saline Irrigation.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Presence of a partial and full thickness DFU extending at least through the dermis and into the subcutaneous tissue down to the exposed tendon and fascia.
3. Wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel.
4. The index ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
5. Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to first screening visit (SV1) and less than 1 year, as of the date the subject consents for study.
6. Adequate circulation to the affected foot as documented by the following: palpable pedal pulses, pulses audibly biphasic or triphasic with handheld doppler, or recent (\<6 month) vascular testing (both invasive \& non-invasive).
7. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
8. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
9. Subject understands they can exit the study at any time.

Exclusion Criteria:

1. Clinical signs of infection at the start of the study
2. Exposed bone(s)
3. Immunocompromised as determined by treating physician
4. Presence of greater than one full-thickness DFU less than 2 cm apart
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation

To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Eligibility Criteria:
Inclusion Criteria:

* Subjects who weigh ≥15 kg without shoes a the Screening Visit
* Subjects with confirmed diagnosis of CF at the Screening Visit.
* Subjects who are homozygous for the F508del CFTR mutation
* Subjects with ppFEV1 of ≥70 percentage points adjusted for age, sex, and height
* Subjects with a screening LCI2.5 result greater than or equal to 7.5

Exclusion Criteria:

* History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject
* Clinically significant abnormalities in hemoglobin, liver function, or renal function at the Screening Visit.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1
* History of solid organ or hematological transplantation at the Screening Visit
Skin Tape Harvesting for Transcriptomics Analysis

Transcriptomics is the study of how RNA is expressed under specific conditions. Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient responds to a drug and separate out drug responders from non-responders. However, biopsies are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such as tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our capabilities to monitor patients on treatment and potentially help us predict if the drug will be effective sooner. However, it is not known how well tape-harvesting can capture transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to address how well tape-harvesting captures the transcriptomic changes that are occurring in psoriatic skin.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between ages of 18 to 75 years
2. Psoriasis Group Only: Clinical diagnosis of moderate to severe plaque psoriasis at least 6 months prior to enrollment with a PASI equal to 5 or greater and PGA 3-4;
3. Psoriasis Group Only: Have lesional and non-lesional skin appropriate for biopsy which has not been treated with topical therapies 2 weeks prior to biopsy collection;
4. Psoriasis Group Only: Lesional skin for biopsy must have a Target Lesion Severity Score equal to 6 or greater;
5. Psoriasis Group Only: If subject was on biologic therapy, lesion to be biopsied should have minimal response to therapy;
6. Psoriasis Group Only: Psoriatic plaque lesion for biopsy on skin areas typically affected by psoriasis and representative of overall disease severity;
7. Healthy controls will have neither history of skin diseases nor current evidence of other active inflammatory skin disease.

Exclusion Criteria:

1. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
2. Evidence of skin conditions other than psoriasis that would interfere with the evaluations.
3. Use of systemic anti-psoriasis therapies within 28 days of study initiation, or three times the half-life of the drug, whichever is longer;
4. Use of UVB therapy or moderate strength non-steroidal topical treatments on lesion to be biopsied within 14 days of study initiation;
5. Current enrollment in investigational device or investigational drug trial(s), or receipt of any investigational agent(s) within 28 days before baseline visit;
6. Use of JAK inhibitor within 4 weeks of screening;
7. Known HIV-positive status or known history of any other immuno-suppressing disease;
8. Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C, such as intravenous drug use in patient;
9. Pregnant or nursing females;
10. Subjects with a history of keloid formation or hypertrophic scarring;
11. Individuals who have lidocaine sensitivity.
Healthy Futures Project: A Community Based Obesity Prevention Program

The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.

The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.

The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. Through community education, family-based strategies and partnerships with schools, 3rd, 4th and 5th graders are encouraged to: Switch what you Do™ Switch what you View™ Switch what you Chew™.

Eligibility Criteria:
Inclusion Criteria:

* All children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project.

Exclusion Criteria:

* Participants who meet the following exclusion criteria will not be considered for participation.
* Do not provide consent
* unable or unwilling to adhere to project procedures
Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects

This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.


Eligibility Criteria:
Inclusion Criteria:

* Helicobacter negative obese subject (BMI 30 to 40),
* 18 to 55 years old,
* normal hepatic biology and morphology (echography)
* Contraceptive methods in women.

Exclusion Criteria:

* Subjects with previous abdominal surgery, with diabetic or immunosuppressive treatment.
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Participants administered with MabThera subcutaneously within the approved indication in Korea
* Participants previously untreated with MabThera subcutaneously

Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:

* Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
* Previously untreated FL participants in combination with chemotherapy
* Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
* Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy

Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:

- Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy

Exclusion Criteria:

* Pregnant or breastfeeding women
* Participants who are out of locally approved indications, dosage, and administration including medication error
* Contraindication in use by locally approved indications, dosage, and administration
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Singleton pregnancy ≥20 weeks gestation
* Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
* Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver

Exclusion Criteria:

* Chronic immunosuppression
* Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
* Known allergy to medical grade adhesives
* Pre-gestational diabetes
* Multifetal gestation
* Current alcohol or illicit drug use
* Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.
Treatment of Macrolide-resistant Mycoplasma Pneumoniae

A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. Genotyping based on multiple-locus variable-number tandem-repeat and resistance analysis (MLVA) will be used to study the classification and possibly the evolution of M. pneumoniae strains. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae. On the other hand, the investigators are going to update the macrolide-resistant rates in Taiwan and analyze M. pneumoniae strains in Taiwan by MLVA. By using this rapid and highly discriminatory tool, the investigators could provide more reliable information about the relationship between resistance strains

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
* The diagnosis is made within 72 hours after fever onset.
* The patient and his/her guardians are willing to participate the study and able to follow the instruction.

Exclusion Criteria:

* Patients who have already taken macrolides, tetracyclines, or fluoroquinolones.
* Patient's with congenital or acquired immunodeficiency.
* Severe patients who needs ICU care.
* Patients or their guardians who are not willing to participate in the study.
A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.

This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR.


Eligibility Criteria:
Inclusion Criteria:

* The patients were diagnosed with a liver tumor.
* The patients underwent robotic liver resection.

Exclusion Criteria:

* The patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
* existing matched control in existing study databases
* have started of treatment within three months of last progress

Key Exclusion Criteria:

* Patients newly diagnosed or in first relapse.