cyrilzakka/clinical-trials huggingface dataset:
Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description

This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy

Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven primary gastric adenocarcinoma before surgery
3. Clinical stage is locally advanced cT2-4a any N and M0
4. In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
5. No preoperative therapy, including chemotherapy and radiotherapy
6. No known cancer diagnosis within last five years
7. Signed informed consent

Exclusion Criteria:

1. Gastrectomy cannot be achieved during operation due to metastasis
2. Patient fails to follow-up and provide postoperative samples
ETERNALS: Remote Monitoring in Lung Cancer Patients

The primary objective of this project is to determine the feasibility of an integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic chemotherapy.

Lung cancer is a highly prevalent malignant tumor with 5.563 new cases in Belgium in 20201. Up to 70% of patients present with locally advanced or metastatic disease at diagnosis 1. Most of these patients require systemic therapy including cytotoxic chemotherapy as part of their treatment plan. The mortality rate in this patient population remains high due to the aggressive nature of the disease, but also due to treatment related toxicities such as dehydration, infection, and anemia, resulting in emergency department (ED) visits and rehospitalizations. Routine administration of highly effective anti-emetics and the use of granulocyte colony-stimulating growth factors greatly reduced the complication rate in these patients 2, 3. Also, remote symptom monitoring using a web-based tool to which patients can self-report their toxicities (i.e., patient-reported outcomes; PROs) had a marked impact on reducing ED visits and increasing overall survival in the patient-reported outcome (PRO) group 4-6. Despite these successes there is still a large proportion of lung cancer patients for whom weekly self-reports are not feasible. More specific: low socio-economic status, elderly patients and social isolation are associated with low compliance 7, 8. The latter lung cancer patient subgroup is at the highest risk of under-detection when presenting with treatment- or disease-related toxicity. The investigators hypothesize that implementation of an integrated remote monitoring system tracking heart rate, heart rate variability, body temperature, respiration rate, nocturnal oxygen saturation, sleep tracking and daily activity level via an unobtrusive wearable device is more performant and less burdensome compared to other self-reporting methods (e.g., PROs). The primary aim of this project is to set up and implement an integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic chemotherapy, in which the remote monitoring is enabled via an unobtrusive wearable device. Via this innovative implementation the investigators believe that patient care can be drastically improved due to the earlier detection of deterioration (i.e., less rehospitalizations and ED visits), especially for those high-risk frail patients.

Eligibility Criteria:
Inclusion Criteria:-

* Patient must be in the possession of a phone
* Diagnosis of Stage IV lung cancer patients treated with cytotoxic chemotherapy
* Older than 18 years of age

Exclusion Criteria:

* Life expectancy of less than 6 weeks
* Not able to understand the Dutch language
Optimization of EKG Method for Long Term Central Venous Catheter Tip Placement

Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique to correctly position the catheter tip. The investigators sought to evaluate the superiority of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a more correct, safer and longer lasting device placement, with a lower incidence of complications and secondary misplacement.

This prospective randomized trial was designed to observe the placement of long term iv catheters obtained with the IVECG method. Patients were randomised into 2 groups: in group A the catheter tip was placed in correspondence to the P-max, in group B in correspondence to the P-submax. We followed up the tip position by measuring the variation of its distances from the tracheal carina on multiplanar reconstructions of volumetric CT scans taken within a month (T0) and a year (T1) from the port implant.

Eligibility Criteria:
Inclusion Criteria:

* indication to chemo port insertion
* ability to give informed consent

Exclusion Criteria:

* younger than 18
* inability to give consent
* atrial fibrillation or flutter
* pace-maker or implantable cardioverter-defibrillator
Study of Idursulfase-beta (GC1111) in Hunter Syndrome

This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.

This is a randomized, double-blind, active-controlled, dose-ranging study, where patient will receive one of the three doses of GC1111 (0.5 mg/kg, 1.0 mg/kg, and 1.5 mg/kg) or ELAPRASE 0.5 mg/kg. Approximately 20 patients will be administrated each study drug once every week as an iv infusion for 24 weeks. Efficacy of GC1111 will be evaluated in Six-Minute Walk Test (6MWT), urine Glycosaminoglycans(uGAG), liver and spleen volume, percent predicted Forced Vital Capacity(FVC), and cardiac size and function. Also immunogenicity, Pharmacokinetics(PK) and safety will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male patients between 5 and 35 years of age
* Informed consent form signed
* Patients diagnosed with hunter syndrome
* Previously untreated with an enzyme replacement therapy

Exclusion Criteria:

* History of tracheostomy, bone marrow transplant, or cord blood transplant
* Treatment with another investigational product within 30 days prior to the start of study drug
* Known hypersensitivity of any of the ingredients of study drug
* Patient with severe hunter syndrome who cannot perform 6MWT
* Female patients
Efficacy of Acceptance and Commitment Therapy for the Management of Quality of Life in Patients Post Myocardial Infarction

The present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction

The current quantitative study is carried out in two steps. A cross-sectional survey assesses quality of life and associated factors during the first step. A randomized controlled trial will be done during the second step where patients with myocardial infarction who are identified with type D personality characteristics, psychological distress, low level of medication adherence, low social support, low quality of life, low acceptance and psychological flexibility will be randomly assigned to two groups i.e. waitlist control group and intervention group. The acceptance and commitment therapy would be implemented on participants in the interventional group. As the control group is the waitlist control group; initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed.

Eligibility Criteria:
Inclusion Criteria:

1. First-time diagnosed, non-hospitalized patients with myocardial infarction (MI).
2. Patients attending follow-up visits at the hospital.
3. Patients experiencing distress.
4. Patients exhibiting features of Type D personality.
5. Patients reporting low levels of:

   * Quality of Life (QoL)
   * Medication adherence
   * Social support
   * Acceptance
   * Psychological flexibility
6. Patients aged 18 years and above.
7. Both genders.
8. Patients who can understand Urdu.
9. Patients who can provide informed consent.

Exclusion Criteria:

1. Hospitalized patients with myocardial infarction (MI).
2. Patients with myocardial infarction (MI) and other chronic co-morbid diseases, such as:

   * Cancer
   * Cognitive deficits
   * Chronic psychological disorders
3. Patients with silent myocardial infarction.
4. Patients younger than 18 years.
The Effect of a Physical Activity Program on Burnout Risk Among Secondary School Teachers

The purpose of this study is to assess the effect of a 6 weeks physical activity program on burnout risk in secondary school teachers. Also, the difference between the effects of moderate en vigorous-intensity physical activity will be investigated.

Given the increased risk of burnout among secondary school teachers, effective interventions are needed. Physical activity may play a big role in preventing and/or reducing burnout. Therefore the purpose of this research is to investigate the effect of physical activity on the risk of burnout in secondary school teachers. The participants in the intervention group will be asked to perform a specific physical activity program (including running and/or cycling at a moderate or vigorous intensity) for 6 weeks. The control group will be asked to keep their lifestyle as it was prior to the study. To assess the effect of this activity program, the participants will have to fill in a questionnaire at three time points. Lastly, the participants have to fill in an activity diary every day, enabling to assess intervention adherence.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are not meeting the guidelines for physical activity.
* Participants who are willing to run or cycle.

Exclusion Criteria:

* Participants who are not speaking the Dutch language.
* Participants unable or unwilling to give informed consent.
* Participants who are not able to be physically active, due to injuries, physical disabilities, etc.
* Participants who already met the guidelines for physical activity.
* Participants who are following a diet.
* Participants who have been following psychological treatment in the past 6 months.
The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

This study compares the duration of active phase of labour in women who received buscopan and those who don't.

A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)

Eligibility Criteria:
Inclusion Criteria:

* Primigravida
* Vertex presentation
* Term gestation (37-41w)
* Active phase of labor (4cm with regular contraction at least 2:10)
* Spontaneous labor
* Oxytocin augmentation
* Maternal height ≥150cm

Exclusion Criteria:

* Multiple pregnancies
* Previous uterine surgery
* Hypertensive disease in pregnancy
* Gestational diabetes on treatment
* Clinical estimation of fetal weight \>3.8kg
* Induction of labor
* Meconium stained liquor
* Allergy to hyoscine
* Medical contraindication to hyoscine (i.e Myasthenia gravis, glaucoma, megacolon)
Left vs. Right Non-Inferiority Trial

The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).

In this multi-centre, triple-blinded, non-inferiority trial 420 patients with TRD will be recruited at two academic centres (UBC, CAMH). Patients will be randomised to receive either iTBS or LFR for 30 sessions. The primary outcome will be the improvement on a depression scale. Secondary outcome will be improvement of suicidal ideation. A secondary aim is to test the predictive capacity of a novel, easy to implement heart rate based biomarkers (i.e. heart rate variability).

Eligibility Criteria:
Inclusion Criteria:

1. are female or male;
2. are outpatients;
3. are voluntary and competent to consent to treatment;
4. have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;
5. are 18yo to 65yo;
6. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \> 3 in the current episode OR have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and/or duration (ATHF 1 or 2);
7. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item);
8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
9. are able to adhere to the treatment schedule;
10. pass the TMS and MRI adult safety screening questionnaires.

Exclusion Criteria:

1. have a history of substance use within the last 3 months;
2. have a concomitant major unstable medical illness;
3. have active suicidal intent;
4. are pregnant;
5. have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
6. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;
7. have failed a course of ECT in the current episode;
8. have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for \> 5 min;
9. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
10. are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;
11. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
Neurocognitive Rehabilitation After Hip Replacement

The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.


Eligibility Criteria:
Inclusion Criteria:

* Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.

Exclusion Criteria:

* Different diagnosis from hip osteoarthritis (eg. Fracture)
* Concomitant osteoarthrosis of the hip or knee with gait restrictions
* Lameness for more than six months
* Central nervous system or Peripheral nervous system disorders
* Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
* Systemic infectious disorders
* Cognitive impairment
* Neoplastic disorders
* Surgical revisions
* Intraoperative complications
* Suspected hip replacement infection
* Hip replacement with endoprosthesis.
Distress in Crisis Situations During COVID-19

There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention.

The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.

The Peritraumatic Distress Inventory is the standard tool designed to assess distress in times of crisis. It consists of 13 questions.

Questions will be submitted to the participants from the Vik chatbot. Responses will be analysed and compared according to the demographics and pathologies encountered.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old

  * Collection of the subject's non-opposition
  * Patient registration on Vik breast, Vik asthma, Vik migraine, Vik depression

Exclusion Criteria:

* Patient unable to formulate non-opposition
A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants

This study will evaluate the effect of multiple oral doses of itraconazole, on the pharmacokinetics of etrumadenant when etrumadenant is administered as a single dose in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female (of non-childbearing potential), at the screening visit
* Body mass index between 18 and 32 kilograms/m\^2 inclusive, at screening
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
* Clinical laboratory test results clinically acceptable at screening and check-in
* Non-smokers or ex-smokers (must have ceased smoking and stopped using nicotine containing products \>3 months prior to the first dosing) based on participant self-reporting

Exclusion Criteria:

* Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, rheumatological, endocrine, connective tissue diseases or disorders
* Have a clinically relevant surgical history in the opinion of the principal investigator or designee
* Have a history of relevant atopy or hypersensitivity to the study drugs or related compounds (e.g., allergy to itraconazole or other azole antifungals
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing

Note: This is not an exhaustive list of criterias.
Computer Debriefing and Screen-based Simulation

Debriefing after simulation plays a crucial role in student learning and medical practice. This paper focuses on impact of computer debriefing technique on knowledge retention of midwives during screen-based simulation of neonatal resuscitation.

Simulation, including screen-based simulation, is employed in medicine to enhance competency and improve care. It has been practiced for centuries in its primitive form as uses of wax Venus or obstetrics dolls to teaching anatomical knowledge or know-how/gestures. Many benefits come from simulations as the capacity to practiced procedures without any risk to the patient, the possibility of trainees to commit errors and learn from these errors, the repeatability of scenario that can be different or presented to learners many times, and then the opportunity to improved technical and non-technical skills among learners. Specifically, screen-based simulation has many advantages as portability (easy to move), distribution and replicability (usable by many learners at differences places in the world), repeatability (people not faced frequently in their regular practice), even be remotely usable. Screen-based simulation appears in literature to be a complement of mannequin simulation. Indeed, since last years the development of computer science has made it possible to create new kind of simulators in the medical field for the acquisition of knowledge, know-how and technical gestures, more realistic and interactively rich.

Debriefing is considered as a part of simulation-based training and cannot be separated of simulators. Debriefing improve professional practice, clinical skills and competences. It exists different debriefing methods: post simulation debriefing, in-simulation debriefing, verbal instructor debriefing, video-assisted instructor debriefing, self-debriefing or also multimedia debriefing. However, debriefing is considered by many as a communication between student/learner and teacher, after a situation (e.g. simulation), and about this experience. It is not just a feedback on performance but also a communication process about the impact of the experience or performance explanation.

This study aims to evaluate the impact of a computer integrated debriefing of technical and non-technical skills on retention and performance of neonatal resuscitation management by trainee's midwives.

Thirty student in midwifery in fourth year will participate. The study protocol is the following:

Baseline knowledge questionnaire, randomization of the participants. Day one: Tutorial of the simulator, First scenario (+/- debriefing depending of the allocation group), second scenario (+/- debriefing depending of the allocation group).

Day two (two month later): knowledge questionnaire, tutorial of the simulator, one scenario (+/- debriefing depending of the allocation group).

Eligibility Criteria:
Inclusion Criteria:

* Student in midwifery in fourth year in france (penultimate year of the midwifery studies)

Exclusion Criteria:

* None