cyrilzakka/clinical-trials huggingface dataset:
Identifying Good and Poor Surgical Behaviour in the Danish Operating Room

Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery.

Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with empirical background knowledge of observed surgical behaviour as well as an understanding of surgical culture. The knowledge will be used to qualify the interviewguide.

8 semi-structured group interviews and 3 individual interviews will be conducted and tape recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as a co-moderator. The groups will contain 4 - 12 participants.

The interview guide will be developed with a Scottish behavioural marker system as a framework, drawing upon the literature as well as the observations. It will contain questions regarding leadership, communication, teamwork, situation awareness and decision making to facilitate a discussion about surgeons' good and poor behaviours.

Material: Data will be collected in two hospitals in the capital Region of Denmark, Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups is included to get the perspectives of the surgeons' team members since international studies have demonstrated differences of opinion regarding the perceived quality of teamwork amongst operating theatre staff. This study will be the first to build in the opinions of the team members into a behavioural marker system. 3 individual interviews with surgeons will afterwards conducted in one of the hospitals to get a more in-depth discussion.

Data analysis and statistics: The interviews will be fully transcribed and analysed using qualitative method of systematic text condensation. Power calculations are not relevant in this qualitative study. Accepted guidelines state that the number of participants in each group should range between 5 and 15 and the data are from two large university hospitals receiving different patient categories to ensure a certain representative sample of informants.


Eligibility Criteria:
Inclusion Criteria:

* medical professionals at Rigshospitalet and Herlev Hospital
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment
* Reaching stable course

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines

In this study, two distractors will be used to retract maxillary canines into the extraction sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands connected to a canine and a molar; and the second one is a similar to the first one but with the addition of a third arm.

The purpose of this investigation is to compare the two distractors in terms of: final position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the appliance.

The retraction of the canines is one of the longest and most important stages in the orthodontic treatment of cases that require premolars extraction. The retraction phase of the canines into an extraction site with conventional treatment method usually lasts about 4 to 6 months under normal circumstances. The use of dentoalveolar distraction (DAD) technique has been considered a very important step in this field. It has been shown by early case reports that this technique can be employed to retract canines within 10 to 14 days.

Although DAD is thought to accelerate tooth movement during canine retraction, a significant amount of tipping (distal tilting) was observed in many case reports. So in this study, there is an intention to apply a modified DAD device on one side of the mouth and to compare it with the conventional one applied on the opposite side of the mouth in each participating patient.

Eligibility Criteria:
Inclusion Criteria:

* Indication for extraction of upper first premolar and conducting canine retraction
* Good oral hygiene

Exclusion Criteria:

* Buccal or palatal inclination of the canines
* Mesial or distal inclination of the canines
* Contraindication to minor surgery
* Previous orthodontic or surgical treatment
* Root canal treatment to the canines
* Malformation of the canines
Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients

The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is safe and well-tolerated, reduces viral load, and improves immune function in patients infected with HIV.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected man or woman at least 18 years of age who is available for a follow up period of at least 3 months
* Has been on a stable antiretroviral regimen for ≥3 months and willing to remain on current antiretroviral regimen for an additional 3 months or has been off of antiretroviral therapy for at least 8 weeks and willing to remain off of antiretroviral therapy for another 3 months
* Plasma HIV 1 RNA ≥5,000 copies/mL measured by Roche Amplicor HIV 1 Monitor at the screening visit
* CD4 T-cells ≥200 cells/mm3

Exclusion Criteria:

* History of, or significant evidence of risk for, chronic inflammatory or autoimmunedisease (eg, Addison's disease, asthma, celiac disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc)
* History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT-scan only
* Exposure within the previous 3 months to a drug known to have immunomodulatory effects (eg, IL 2)
Parents Make the Difference II: Trial of a Parenting Intervention

Multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. Two main objectives of the "Parents Make the Difference" program are to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children, including interactions that encourage learning. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that future abuse and poor developmental outcomes will be prevented in the long-term.

This is a multisite randomized trial of a parenting intervention in Liberia for caregivers of young children. The "Parents Make the Difference" program is designed to teach parents (a) skills for decreasing harsh punishments and replacing those with positive ways to manage children's behavior and (b) skills for having more positive interactions with their children. As a result of positive changes in parenting, the investigators expect that, over time, children's behavioral and cognitive well-being will improve and that the intervention will prevent future abuse and poor developmental outcomes in the long-term. This study will randomize 816 caregivers of children ages 3 or 4 years to 1 of 3 study arms: standard group program, group program plus home visits, waitlist control.

Eligibility Criteria:
Inclusion Criteria:

* caregiver of child ages 3 or 4
* live within catchment area of each study site
* caregiver is at least 18 years old

Exclusion Criteria:

* does not live with child
Rapid Diagnostic Test for Septic Arthritis

Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age

Arthritis is an inflammation of the joints that can have many causes. In children, septic arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per 100,000 children. Finally, in approximately 40% of children the origin of acute arthritis remains undetermined (ND arthritis). In this group, all the examinations performed are not in favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA to be retained and no other disease is found.

During the first few days of arthritis, differentiation between AS and non-septic arthritis is difficult. The available clinical and biological parameters do not allow for easy and rapid differentiation between AS and non-septic arthritis.

This project aims to develop a new diagnostic technique based on molecular analysis of the proteome in the joint puncture fluid.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>3 months of age \<16 years of age
* Hospitalized for arthritis that started less than 6 weeks ago or patients with diagnosed inflammatory arthritis whose clinical course suggests bacterial superinfection
* Indication of a joint puncture for diagnostic purposes, confirmed by a senior physician after study of all available clinical and biological elements.
* Holders of parental authority who have accepted the participation of their children
* Patients benefiting from a social security scheme (excluding AME)

Exclusion Criteria:

* Contraindications to joint puncture
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years and older
* Life expectancy ≥ 6 months
* Unresectable or metastatic breast cancer subjects
* Presence of at least one measurable lesion per RECIST v 1.1
* Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report
* Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy in the metastatic setting. One of these prior treatments must have been treatment with T-DXd.
* Subjects with stable brain metastases
* Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement.
* Adequate organ functions
* Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol

Key Exclusion Criteria:

Any subject who meets any of the following criteria is excluded from the study:

* History of allergic reactions to any component of ARX788.
* Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.
* Any active ocular infections or chronic corneal disorders
* History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
* Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
* History of unstable central nervous system (CNS) metastases
* Radiotherapy outside of the brain administered \< 7 days prior to first dose of ARX788
* Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)
* Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments
* Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788
Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer

The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.

Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-edited video-recordings of procedures.

Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.

After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.

This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.

The intent-to-treat principle is used for the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
* clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
* indications for surgical colonic resection
* ECOG status 0-2
* At least 18 years of age
* Written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
* Pregnancy or breast feeding
* Medical contraindications for surgical treatment
* Synchronous or metachronous malignancy
* Non-resectable distant metastases
* Colon obstruction, perforation or bleeding complicating the tumor
* Indications for isolated transverse colon resection
* Neoadjuvant chemotherapy
Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects

Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.

As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.

The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the \[11C\]raclopride bolus-plus-continuous-infusion method.


Eligibility Criteria:
Inclusion Criteria:

* Non smoker
* No pyschotrope consumption
* No medical treatment
* No psychiatric or somatic (neurological, endocrine, cardiac, renal)
* Affiliated to the french social security

Exclusion Criteria:

* No consent
* For females : Pregnant or without birth control
* Contraindications to stimulation by tDCS or to an MRI exam
* Being in an exclusion period or over the annual compensation ceiling
* Participation in another study using ionizing radiation in less than a year
Clinical Performance Evaluation of Veye Lung Nodules

Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans.

This clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.


Eligibility Criteria:
Inclusion Criteria:

- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice

Exclusion Criteria:

* Subjects with \>10 pulmonary nodules;
* Subjects with pulmonary mass(es) = largest axial diameter \>30mm;
* Subjects with interstitial lung disease.
Partial Wave Spectroscopic Detection of Colon Cancer Risk

The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).

The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years old or older.
* Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy.
* Patient has not received chemotherapy.
* History of ulcerative colitis.

Exclusion Criteria:

* Patient is unable to give informed consent..
* Patient has received chemo or radiation therapy within the past 3 months.
Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine and ketamine in patients with multiple fracture ribs on conservative treatment.

A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to three groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group K) low dose ketamine infusion 2.5 µ/kg/min for 5 days. In (Group C) the same dose and duration of normal saline will be given.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II
* Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT
* Undergoing conservative treatment (chest strappings)
* Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies
* Glasgow Coma Scale (GCS) ≥ 13.

Exclusion Criteria:

* Multiple traumas to body parts other than chest with an abbreviated injury scale over 3
* Serious head trauma with a Glasgow coma scale lower than 13
* Mechanically ventilated patients
* Massive hemothorax
* Injury to the trachea or bronchus with requirement for immediate surgery
* Dementia
* Use of corticosteroids during ICU stay
* Sepsis
* Continued use of neuromuscular blocking agents and aminoglycosides antibiotic use as they are known risk factors for ICU-acquired weakness and any known hypersensitivity
* Contraindication to the study drugs.