cyrilzakka/clinical-trials huggingface dataset:
Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer

Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe，in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.

Aim: Compare the disease-free survival (DFS) and overall survival (OS) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection

Outline:

Patients are randomized assigned to the following one of two groups and are followed annually.

Arm I: Patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection Arm II: Patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
2. abnormal para-sentinel lymph node was found by ultrasound examination
3. ultrasound-guided fine needle aspiration cytology of these nodes were performed
4. the result of fine needle aspiration cytology was negative (no tumour cell was found)
5. patient planed to perform SLNB

Exclusion Criteria:

1. pathological diagnosed ductal carcinoma in situ by excisional biopsy
2. the result of fine needle aspiration cytology was positive
3. patient has received neo-adjuvant system therapy
Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial

MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Participants in the main trial will be given one of two types of fluid (Human Albumin Solution (HAS) and Balanced Crystalloid) via a drip when they present to the hospital with severe infection (sepsis). The main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. We hope our findings will explain why one fluid might be better than another. It may also give us an important information about whether we can predict which people might get sicker despite treatment.

MIS-ABC Sepsis is linked to the ABC-Sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a NEWS2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% HAS as the intravenous resuscitation fluid up to six hours after randomisation.

MIS-ABC Sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. Investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm.

This is a prospective observational study enrolling patients randomised to the ABC Sepsis study. Centres for this trial will be selected from UK NHS hospitals who are recruiting to the main ABC Sepsis study. Participants will be recruited as soon as possible, and up to 12 hours after presentation to the Emergency Department, Surgical Assessment Unit or Medical Admissions Unit.

The treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. This sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. The follow up period similarly extends to 90 days, using routine data from the medical records for follow up.

Eligibility Criteria:
Inclusion Criteria:

* Able to obtain informed consent
* Eligible for and randomised into the ABC Sepsis trial

Exclusion Criteria:

* Excluded from the ABC Sepsis trial
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)

Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Upper age to 18 years
* Planned hospital stay for a colonic resection with anastomosis without permanent or temporary digestive bypass
* Patient with pre-operative CRP lower or egal to 172 mg/L
* No opposition at the participation of the study
* Expected patient return home after surgery (or convalescent home or not medicalized institution)

Exclusion Criteria:

* Patient under guardianship
* Protected or private patient freedom
* Minor patient
* Colectomy surgery with digestive bypass or digestive anastomosis
* Complex combined surgery (significantly intestinal resection associated, another surgical procedure that can interfere with postoperative CRP)
* General inflammatory disease susceptive to modify dosage values
* Anti-inflammatory therapy (AINS/ corticosteroids/ immunosuppressive)
* Patient unable to understand the study
Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion Criteria:

* none
Functional MRI of Stress in Obesity

To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with food cues, stress and neutral/relaxing imagery

Eligibility Criteria:
Inclusion Criteria:

1. Between ages 18-50 years old.
2. Able to read and write.
3. negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
4. WOMEN: have a regular menstrual cycle.
5. BMI: 30 \< BMI \< 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 \< BMI \<25 for normal weight subjects (Institute, 2006)

Exclusion Criteria:

1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview;
2. Regular use of any psychoactive drugs including anxiolytics and antidepressants.
3. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
5. Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
A Blended Intervention for Adjustment Disorder.

The aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for Adjustment Disorder. This intervention combines a self-applied Internet-based program (TAO) with face-to-face sessions with a therapist via videoconference.

Adjustment disorder (AjD) is one of the most commonly diagnosed disorders in clinical practice. However, although there is still no evidence-based treatment for this problem, Cognitive Behavioral Therapy (CBT) is the most studied. Internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. However, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. The present study aims to test a blended treatment for AjD that combines a self-applied CBT programme online (TAO: Adjustment Disorder Online) with face-to-face sessions with a therapist via videoconference every 10-12 days. Only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months).

The study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies (Eldridge et al., 2016), the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth guidelines (Eysenbach, 2011), and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013a; 2013b).

Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Meeting diagnostic criteria for Adjustment Disorder based on the International Classification of Diseases 11 edition (ICD-11).
* Exceed the cut-off point of 47.5 on the Adjustment Disorder New Module-20 scale (ADNM-20; Lorenz et al., 2016).
* Sign an informed consent.
* Ability to understand and read Spanish.
* Ability to use a computer and having access to the Internet.
* Having an e-mail address.

Exclusion Criteria:

* Presence of risk of suicide or self-destructive behaviors.
* Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder).
* Receiving other psychological treatment during the study for AjD.
* An increase and/or change in the medication during the study period.
A Dog-assisted Therapy to Reduce Burnout Among Professionals Working in a School for Special Education

This randomized controlled trial aims to evaluate the effects of an 8-week program consisting of dog-assisted therapy on the work engagement, burnout, pain, and quality of life among professionals working in a School for Special Education. A total of 30 participants will be involved in the program, which will be comprised of eight 50-min sessions conducted once a week. The hypothesis of the researchers in this study is that this program will achieve a reduction in burnout levels in workers, as well as an improvement in engagement and quality of life.

Animal-assisted interventions have shown numerous benefits in different populations including children with cerebral palsy or autism spectrum disorder, people with chronic pain, older adults, or people in prison. Recently, different initiatives have been carried out focused on improving the work environment, especially among professionals in clinical settings and obtaining benefits in mood, as well as a reduction in the levels of stress and burnout of employees. In addition, it has also been observed that these animals in the workplace can produce an improvement in health, productivity or job satisfaction.

The presence of stress or anxiety among professionals working in Special Education Schools has been previously reported and could increase burnout and reduce the engagement and health-related quality of life of these workers.

Therefore, the current randomized controlled trial aims to evaluate the effects of an 8-week program consisting of dog-assisted therapy on the work engagement, burnout, pain, and quality of life among professionals working in a School for Special Education. A total of 30 participants will be involved in the program, which will be comprised of eight 50-min sessions conducted once a week. The hypothesis of the researchers is that this program will achieve a reduction in burnout levels in workers, as well as an improvement in engagement and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* be aged \>18 years
* be workers in a School for Special Education
* work in direct contact with children (teachers, physiotherapists, etc.)

Exclusion Criteria:

* People with dog-allergy
* People with dog phobia
* People with a history of impulsive animal aggression
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma

The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. The main question it aims to answer is: Does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram.

Researchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug).

Participants will:

* Take semaglutide or a placebo every day for 6 months.
* Visit the clinic 5 times in total for tests and interviews: At baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and speak Danish
* 45 years or older at the time of inclusion
* Visual acuity equal to or above 0.5 in the study eye
* Diagnosis of POAG with MD ≤ 16 dB with repeatable and reliable (false positive less than 15 %) VF loss measured by standard automated perimetry on at least one eye
* Receiving IOP-lowering glaucoma treatment
* Nerve fiber layer defects identified by OCT

Exclusion Criteria:

* Diabetes or renal impairment
* Medical history of significant eye disease (including ocular trauma) other than glaucoma
* Ocular inflammation/infection within three months from inclusion
* Intraocular surgery 3 months before inclusion
* Smoker at the time of inclusion
* Pregnant or breast-feeding
* Females of childbearing potential who are not using adequate contraceptive, which includes the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner; Sexual abstinence
* Subjects allergic to drug ingredients administered during the trial
* Subjects with untreated severe systemic disease or malignancies
* Previous history of pancreatitis
* BMI \< 18.5
* Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants
The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.

Study the risk of complications after dental extractions in patients recieving radiotherapy.

Dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. There are contradictory results in the literature regarding the importance timing and magnitude of extractions. It is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. Patients were extracted from the ARTSCAN register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. The aim is to evaluate which diagnoses are more prone to develop complications after extraction. If there is a relationship between occurrence of complication and magnitude of dental pathology.

Eligibility Criteria:
Inclusion Criteria:

* Malignant diagnosis
* radiotherapy pre or postoperative

Exclusion Criteria:

-
Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine

Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is not known whether the problem exist in Tanzania. This study assessed parasite clearance time and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among children with uncomplicated malaria.

Artemether/Lumefantrine (AL) has been in wide scale use in Tanzania since 2007 as first line treatment for uncomplicated falciparum malaria. Nonetheless, reports of confirmed resistance against Artemisinin derivatives expressed phenotypically as prolonged parasite clearance have emerged from South-East Asia (SEA), signifying reduced parasites susceptibility to the otherwise rapidly acting artemisinins. Prolonged clearance is associated with an increase in day 28 treatment failure, gametocytes carriage and transmission of resistance. Nonetheless, no detailed study has been done in East Africa to assess parasite clearance time following treatment with Artemisinin based combination therapies (ACTs).

In order to evaluate time to parasite clearance following treatment with AL, we conducted a detailed clinical trial with twenty blood sampling time points prior, during and after treatment. Detailed sampling allowed us to assess parasite clearance, and selection of Plasmodium falciparum multidrug resistance (Pfmdr) 1 N86Y and Plasmodium falciparum chloroquine resistance transporter (Pfcrt) K76T genes between different time points and its association with parasite clearance and recurrence. Furthermore, as a sensitive tool and an ideal early warning system, nested polymerase chain reaction (PCR) was used to assess parasite clearance and compare it with microscopic findings.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-120 months
* Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
* No general danger signs or severe malaria present
* Hemoglobin ≥5 g/dL
* History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius
* No other cause of fever is detectable
* No severe malnutrition
* Guardian/patient has consented

Exclusion Criteria:

* general danger signs or signs of severe falciparum malaria
* severe malnutrition
* febrile condition due to diseases other than malaria
* regular medication which might interfere with antimalarial pharmacokinetics
* contraindications to any medicine being used
Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children

The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children.

Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes between 8 and 18 years old
* Pc BMI ≥ 95 and \<35kg/m2,
* No endocrine diseases, including diabetes mellitus
* No systemic diseases
* No genetic diseases
* No pharmacological treatment affecting lipid metabolism or glucose
* No history of acute or prolonged immobilization
* Normal aminotransferases
* Signed Informed consent and assent
The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar

The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.

Having a Caesarean leads to a scar in the uterus, which does not always heal properly. Defective healing can lead to serious complications in the next pregnancy and delivery. Different surgical techniques can be used for a Caesarean section.

The aim is to compare two surgical techniques (different ways of opening the uterus), to investigate whether one or the other technique leads to fewer defective scars in the uterus. Both these techniques are in use at the clinic. After the operation, patients are cared for in the normal way.

Six months after the Caesarean, patients are examined using vaginal ultrasound. Vaginal ultrasound allows to see if the scar after the Caesarean has healed well, or if there are defects in it.

Eligibility Criteria:
inclusion criteria:

* ≥ 18 years old
* gestational age ≥ 37 gestational weeks
* cervical dilatation ≥5 cm,
* no previous uterine surgery other than cone biopsy, loop electrosurgical excision procedure, dilatation and curettage, or dilatation and evacuation, undergoing emergency caesarean section.

exclusion criteria:

• need of immediate caesarean section, defined as delivery of the baby within 20 minutes.
S9704-S0014-S0313A Studying Genes in Samples From Patients With Limited or Advanced Diffuse Large B-Cell Lymphoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies genes in samples from patients with limited and advanced diffuse large B-cell lymphoma.

OBJECTIVES:

* To determine the proportion of the cell of origin subtypes (germinal center B-cell-like \[GCB\] vs non-GCB) and expression levels of prognostic genes previously identified in diffuse large B-cell lymphoma (DLBCL) in patient biopsy samples from SWOG trials of limited- and advanced-stage DLBCL, and to assess the association between the results and progression-free survival (PFS).
* To assess the association between these marker results and overall survival (OS).

OUTLINE: Archived formalin-fixed paraffin-embedded tissue are analyzed for gene expression profile by quantitative nuclease protection assay (qNPA) and immunohistochemical analyses. Results are then compared with each patient's progression-free survival and overall survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diffuse large B-cell lymphoma - Initial diagnostic tissue block, or 4 unstained slides
* Tissue from patients with limited-stage DLBCL enrolled on SWOG trials treated with cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine sulfate (CHOP), and monoclonal anti-CD20 antibody backbone

  * SWOG-S0014
  * SWOG-S0313
* Tissue from patients with advanced-stage DLBCL enrolled on SWOG trials treated with CHOP and monoclonal anti-CD20 antibody backbone

  * SWOG-S9704
  * SWOG-S0433
  * SWOG-S0515
  * SWOG-S0806

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics