cyrilzakka/clinical-trials huggingface dataset:
Cogmed for Working Memory After TBI

This study will examine a cognitive rehabilitation protocol targeted at working memory deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to improve working memory, will be examined in children with TBI. Neuropsychological and daily life functioning will be measured. Participants will be children (N=20) and adults (N=20) with a documented history of TBI. Participants will be randomized to a treatment group or a wait list control group. The Experimental Group will receive the Cogmed working memory training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time of approximately 15 hours. The Control Group will be a wait list control group that will cross over into treatment after the follow-up assessment. All subjects will undergo repeat assessments following completion of the working memory training protocol after the 7th week and again at 13 weeks to document changes in working memory performance.


Eligibility Criteria:
Inclusion Criteria:

* History of Traumatic Brain Injury

Exclusion Criteria:

* Diagnosis of other neurological conditions
Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.

OBJECTIVES:

Primary

* Characterize, morphologically and molecularly, squamous cell carcinoma of the larynx, pharynx, or oral cavity in patients without high-risk factors, such as alcohol consumption, smoking, or occupation.

Secondary

* Study the impact parameters of morphology, molecular characteristics, and genomics on disease-free survival and overall survival of these patients.
* Study the impact parameters of morphological, molecular, and genomic control in the tumor.
* Assess, in advanced tumors, the risk of heterogeneity of morphological, molecular, and genomic control in the tumor.

OUTLINE: This is a multicenter study.

Blood, tumor tissue, and healthy tissue samples are collected before treatment begins.

Patients are followed up every 3 months for 2 years (additional biopsies may be collected).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the larynx, pharynx, or oral cavity
* No risk factors of alcohol consumption, smoking, or occupational hazards such as asbestos, hydrocarbons, paints, nickel, stone dust, or wood dust.

  * Must be a life-time non-smoker, not a former smoker
* Measurable disease by RECIST criteria

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* No other serious concomitant medical conditions precluding general anesthesia
* No psychological, familial, social, or geographical reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

* Not specified
'Real Life' Monitoring of COPD no ICS Patients

The aim of the study will be to assess in patients with mild-to-moderate COPD the role of inflammation in the patient's therapeutic management and follow-up.

Studies have already shown that the risk of severe exacerbations in patients with COPD is associated with eosinophilic inflammation (1) and that patients with this type of inflammation have an increased risk of exacerbations if ICS administration is discontinued (2), but this indication does not appear in the latest GOLD recommendations to date.

The aim of the study will be to evaluate in patients with mild-to-moderate COPD the role of induced sputum and peripheral inflammation in the patient's therapeutic management and follow-up. For this purpose, the investigators will assess inflammation at the bronchial and systemic level by induced sputum and haemochrome at time 0 (recruitment), after 6,12, 18 and 24 months after therapy administration according to the updated 2017 GOLD recommendations.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to GOLD 2017 recommendations in clinical stability phase
* Post bronchodilator FEV1 ≥50 and ≤80
* Both smoker and ex-smoker
* Patients on LABA or LABA/LAMA therapy
* Patients also on ICS therapy discontinued at least 30 days after enrolment
* Patient able to cooperate with the required procedures
* Patient who has signed the informed consent

Exclusion Criteria:

* - Acute respiratory episode treated with antibiotics and/or steroids in the lower 4 weeks prior to enrolment
* Patients on roflumilast therapy
* Any exacerbation of COPD within 1 month after visit 1. A patient must not have had any hospitalisation for COPD within 6 months prior to visit 1.
* Comorbidities. History or current evidence of a clinically significant comorbidity or history of a positive test for HIV, hepatitis B or hepatitis C.
* History of adverse reactions including immediate or delayed hypersensitivity to any beta2-agonists,
* sympathomimetic drugs or any intranasal, inhaled or systemic corticosteroid therapy known or suspected sensitivity to the components of the inhalers used in the study (e.g. lactose in dry powder inhalers).
* Use of immunosuppressive drugs within 12 weeks prior to visit 1 and during the study, including use of systemic corticosteroids.
Development of a Refined Version of the Stroke Rehabilitation Assessment of Movement Scale for Stroke Patients

We will employ modern test theory (i.e., Rasch model) to refine the Stroke Rehabilitation Assessment of Movement instrument (STREAM), which will be called the refined version of the STREAM, R-STREAM).

We will employ modern test theory (i.e., Rasch model) to refine the Stroke Rehabilitation Assessment of Movement instrument (STREAM), which will be called the refined version of the STREAM, R-STREAM).

We will devote three years to complete this project. In the first year, the item pool (about 45 items) based on the STREAM will be developed and 12-15 items will be selected from the pool to construct the R-STREAM. A therapist will administer all the items on 300 stroke patients. The other therapist will administer these items on 60 patients randomly selected from the 300 patients to examine interrater reliability of each item. The R-SATREAM (4-5 items for each of the three subscales) will be constructed based on the inter-rater reliability and Rasch analysis of these items, and the opinions of experts.

In the second and third years of this project, the psychometric properties of the R-STREAM will be comprehensively established. We will also compare the psychometric properties of the R-STREAM and the STREAM in stroke patients to determine the psychometric properties and efficiency of the R-STREAM. The R-STREAM and STREAM will be used to longitudinally assess 120 patients (at three time points: at the conception of occupational therapy, one month after therapy, and 6 months after therapy) to compare the concurrent validity, predictive validity and responsiveness of the R-STREAM and STREAM. The test-retest reliability of both scales will be established on the other 60 chronic patients.

It is anticipated that the R-STREAM will have sound psychometric properties, be simple and easy to use, and be able to be transformed to the interval level of measurement. The R-STREAM will best fit the need for simple measures in routine daily clinics. The R-STREAM will fit demands for both in-depth and efficient assessment. Clinicians and researchers both will benefit from these new, scientific measurement tools for planning treatment, giving a prognosis, and assessing outcomes in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with stroke ability to follow instructions

Exclusion Criteria:

* patients with other major diseases (e.g., cancer)
Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Breastfeeding mother who suffers from lactation insufficiency
* Breastfeeding mother from 2 weeks to 5 months post-partum
* Breastfeeding mother with healthy baby

Exclusion Criteria:

* Subject consumes drugs that are known to decrease breastmilk production
* Subject with infection or inflammation in the intended acupuncture points
* Subject with bleeding disorder
* Subject consumes anticoagulant
* Subject with known diabetic history
* Subject with body temperature \> 38 degree celcius
Laparoscopic vs Robotic-Assisted Radical Prostatectomy

This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).

Purpose: The LAP-01 trial compares outcomes between RARP and LRP.

LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.

With 782 enrolled patients it is the largest trial carried out till date on this topic.

Eligibility Criteria:
Inclusion criteria

* Histological verified prostate carcinoma (first diagnosis)
* Indication for primary curative radical prostatectomy
* Age ≤ 75 years
* Patient agrees to randomisation
* Patient is able to fill in the questionnaires on his own
* Patient is willing to provide written informed consent

Exclusion Criteria:

* Insufficient knowledge of German
* Severe cognitive impairment
* Obesity (BMI \> 35)
* Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind)
* Tumor stage: T4
* Previous malignancy (≤ 3 years before trial participation)
* Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial
* Patient is immuno-compromised
* History of intermittent urinary self-catheterization within the last year
* Psychological disorders (dementia, chronic depression, psychosis)
* Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy
* Patients with chronic urinary infection
* Dialysis patients
* Lacking willingness for data storage and handling in the frame of the trial protocol/aims
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.


Eligibility Criteria:
Inclusion Criteria:

* A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki.

Exclusion Criteria:

* Planned treatment with a non-SYNERGY stent.
The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals

Nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[SNS 2018-2022, Ministère des Solidarités et de la Santé\] The 2014-2019 Cancer Plan calls for the systematic support of smokers during smoking cessation. This means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[Perriot, Underner, Peiffer, Dautzenberg, 2018\] It is recommended that these interventions be included from the beginning of the management, once the diagnosis of Cancer is made. It seems legitimate then to wonder about the place of choice the Motivational Interview (EM) could have in the course of cancer care, for the management of addictions during the treatment of cancer. We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

Nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[SNS 2018-2022, Ministère des Solidarités et de la Santé\] The 2014-2019 Cancer Plan calls for the systematic support of smokers during smoking cessation. This means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[Perriot, Underner, Peiffer, Dautzenberg, 2018\] It is recommended that these interventions be included from the beginning of the management, once the diagnosis of Cancer is made. It seems legitimate then to wonder about the place of choice the Motivational Interview (EM) could have in the course of cancer care, for the management of addictions during the treatment of cancer. We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

Eligibility Criteria:
Inclusion Criteria:

- voluntary participation of health professionals in the Lucien Neuwirth Cancer Institute

Exclusion Criteria:

- refusal to participate
Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers

The goal of this pilot randomized controlled trials is to assess the effectiveness of the stepped care approach in treating common mental disorders among foreign domestic helpers in Hong Kong and improve their access to evidence-based psychological treatments.

Participants will be required to complete an online consent form. Then, around 240 eligible participants aged 18-65 years with depression (Patient Health Questionnaire-9 \[PHQ-9\] ≥ 10) and/or anxiety (Generalized Anxiety Disorder-7 \[GAD-7\] ≥ 8) will be randomly assigned to the intervention and control group in a ratio of 1:1. Participants assigned in the intervention group will recieved the stepped-care mental health intervention while those assigned to the control group will receive care-as-usual. Assessments of depression, anxiety, and insomnia symptoms, as well as work and social adjustment, quality of life, and treatment credibility and acceptability will be conducted at baseline, week 7 (after Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up). An assessment of barriers to accessing care will also be collected before treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Foreign domestic helpers aged 18 to 65 years;
2. Able to read, write, and speak in English;
3. Have a PHQ-9 score ≥10 and/or GAD-7 ≥8, indicating caseness or a score that can be classified as a clinical case;
4. Have an internet-enabled device (e.g., laptop computer, smartphone, or tablet);
5. willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview (MINI-7);
2. Having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians);
3. Current serious suicidal risk as assessed by PHQ-9 Item 9 score \>2 (referral information to professional mental health services will be provided);
4. Hospitalization or pregnancy;
5. Current participation in any other clinical trial(s);
6. Current psychological treatment for CMD either psychotherapy or unstable medication in the past 2 months.
Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).

The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.

The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form;
2. Female sex;
3. Age ≥18 years;
4. Diagnosis of ovarian cancer;
5. Availability of tumor sample or ascites that is planned to be stored in the Institutional Biobank for research purpose

Exclusion Criteria:

1. Patients for which the tumor/ascites biobanking process could compromise the diagnostic assessments;
2. Pregnancy or breast-feeding
3. History of concomitant or previous malignancy in the last 5 years
POCT PCT in Outpatient LRTI

Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. The primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (POCT) for procalcitonin (PCT) in identifying pneumonia as a bacterial infection in outpatients with LRTI.

Lower respiratory tract infections (LRTI) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. Despite the vast majority of LRTI are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in LRTI still drives antibiotic treatment today Procalcitonin (PCT) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (POCT). The primary objective of the investigators study was to determine the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI. All patients aged 18 years or older with signs and symptoms of an LRTI as the leading diagnosis of the respiratory physicians are eligible. The medical assistant measure PCT from venous or capillary whole blood using the portable commercially available BRAHMS PCT direct point-of-care test (Thermo-Fischer Scientific). The stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. This immunoassay provides a quantitative result in 20 minutes. In suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. Members of the study team conduct standardised phone interviews of all participants on day 28.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of lower respiratory tract infection

Exclusion Criteria:

* Active malignancies
* Cystic fibrosis
* Solid organ or stem cell transplantation
* Chronic infection (endocarditis, osteomyelitis, active tuberculosis)
* Pregnancy
Does Premature Luteinization Matter?

Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Planned fresh Embryo transfer

Exclusion Criteria:

* Cancelation of the embryo transfer for any reason