cyrilzakka/clinical-trials huggingface dataset:
Effect of Xpert MTB/RIF on Patient Outcomes

A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.

The Centre for Infectious Disease Research in Zambia (CIDRZ) in collaboration with the Zambian National TB Program (NTP) and the Ministry of Health (MOH) will provide near point-of-care Xpert testing at a high-volume anti-retroviral treatment (ART) clinic in Lusaka, Zambia. A total 892 study participants will be enrolled into two parallel cohorts-an "Xpert" and a "standard of care" (SOC) cohort over a 7-month period. The Xpert cohort will enrol participants at the health centre implementing Xpert. The SOC cohort will enrol participants from one health centre offering the standard of care (sputum smear microscopy plus clinical evaluation). A parallel-group prospective cohort study will be conducted by following participants in one cohort from each site for 210 days from the time of sputum submission, allowing sufficient person-time to observe all outcomes of interest, including completion of a standard course of ATT as well as patient drop-out and loss to follow-up.

A systematic facility assessment survey using an adapted version of the WHO Service Availability and Readiness Assessment tool will be conducted. Key informants will be interviewed.

Eligibility Criteria:
Inclusion Criteria:

* Able to spontaneously expectorate at least 2 sputum samples, in accordance with NTP guidelines
* Intend to continue receiving care at the respective study sites for at least 7 months
* Willing to provide locator information and allow contact by phone or home visit in the case of loss to follow up after initiating ATT

Exclusion Criteria:

* Received TB treatment within 60 days prior to enrolment and/or were diagnosed with TB within the last 6 months
* Cannot spontaneously expectorate sputum
* Are already enrolled in another study with might interfere with implementation of this study protocol
* Provided a sputum sample that results in a contaminated TB culture result

A key informant will be eligible for inclusion in the SARA facility survey component of the study if they meet the following criteria:

* 18 years of age or older
* clinic staff member at either Chilenje Health Centre or Chelstone Health Centre
* have previously been attached to, or are otherwise familiar with, departments offering HIV, TB and/or laboratory health services

Exclusion criteria:

-unwilling or unable to provide verbal informed consent in English
Early Mobilization in Cardiovascular Units

Insufficient mobility contributes to functional decline in hospitalized cardiac patients. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay \[1\]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. The overall goal of this study is to adapt and implement an early mobilization program in the Cardiovascular units of the Jewish General Hospital (JGH).

Background: Insufficient mobility contributes to functional decline in cardiovascular units. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay \[1\]. One example is the Level of Function (LOF) Mobility Scale implemented in the Cardiovascular units at the Jewish General Hospital, an academic tertiary care centre in Montreal, Quebec \[2\]. Despite evidence supporting the benefits of early mobilization programs, hospitalized individuals in cardiovascular units spend most of the day in bed \[1-6\]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. This project is research nested in a quality improvement initiative for the Jewish General Hospital Cardiovascular units.

Objectives: 1) Adapt an early mobilization program in a hospital setting; 2) Develop strategies to overcome individual and organizational barriers to implementing an early mobilization program; 3) Assess the reach, acceptability, and fidelity of implementing an early mobilization program; and 4) Assess the program's impact on patients and the organization.

Methods: A 3-phase study using an iterative participative approach. Phase 1: a qualitative design to adapt an early mobilization program. Phase 2: mixed methods repeated measures design to assess barriers and facilitators to implementing the program and develop implementation strategies.

Phase 3: An interrupted time series design to assess the implementation and the impact of the program.

Expected contribution: Early mobilization programs in the Cardiovascular units can improve the quality of care provided to these patients and promote further clinician-researcher partnerships, contributing to improved uptake of best practices in this clinical context.

Eligibility Criteria:
Inclusion Criteria:

* All healthcare professionals working in the cardiovascular unit at the Jewish General Hospital.
* All patients admitted to the cardiovascular unit at the Jewish General Hospital.

Exclusion Criteria:

* Patients who don't speak English or French.
Sarcopenia and Systemic Therapy in HCC

This is a multi-center, retrospective observational study in patients with liver cancer (HCC) to assess the impact of sarcopenia (muscle loss) on the prognosis, duration, and tolerance of systemic treatment.

The impact of sarcopenia will be assessed 12 months after the start of chemotherapy. Additionally, other factors affecting prognosis will be investigated to develop a specific predictive model for the risk of death at 12 months. Finally, an external validation of this predictive model for the risk of death will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* Diagnosis of hepatocellular carcinoma based on histological and/or radiological results as defined by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). The staging of hepatocellular carcinoma was obtained through contrast-enhanced liver CT and/or MRI.
* Patients with advanced (BCLC-C) or intermediate (BCLC-B) stage hepatocellular carcinoma, or patients with early-stage (BCLC-A) hepatocellular carcinoma who have not responded to previous locoregional ablative treatments and/or liver resection.
* Treatment with TKIs according to the indications and prescription criteria defined by AIFA, with no requirement to reach a minimum treatment period.

Availability of a CT scan performed within no more than 8 weeks prior to the start of TKI therapy.

- Obtaining written informed consent.

Exclusion Criteria:

* None
Persistence of Symptoms After Improvement of Acute COVID-19

Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. This is true not only for general and respiratory symptoms but also for cardiovascular and psychosocial symptoms. This suggests that these symptoms may indeed be the sequelae of recovery for COVID-19 survivors. So, we aimed to detect the prevalence and to evaluate the type of symptoms that could persist after the recovery from COVID19 infection in Sohag governorate, Egypt.

About one hundred patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals during the period from 15th May, 2020 to 25th July, 2020 will be included in our study. Patient improvement and discharge criteria include 10 day from symptoms onset in addition to 3 day free of fever and respiratory symptoms.

Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history will be excluded from the study.

The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University A control group of healthy volunteer who were age and sex matched to our patient were included

After taken informed consent according to Sohag University Ethical Committee, the baseline data will be collected from Sohag isolation hospital of COVID19, then the researchers will perform interviews with all participants through mobile phone. The interview will include:

* Name (Optional)
* Age
* Sex
* Occupation
* Presence of DM, HTN or any chronic illness
* Asking about Smoking
* The date of catching COVID19 infection
* Asking about symptoms of COVID19 infection and duration of each symptom.
* Asking about any residual symptoms as: Fatigue, Myalgia, Arthralgia, Chest pain, Dyspnea, Dry cough, Productive cough, Sore Throat, Anosmia, Loss of taste sensation, Nausea, Anorexia, Diarrhea, Redness of the eye, Headache, Confusion and Depression

Statistical analysis:

Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

Positive for SARS-CoV2

Exclusion Criteria:

* Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.

In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).

Eligibility Criteria:
Inclusion Criteria

* Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
* Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
* Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \< 4.
* Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion Criteria

* Participants must not have impaired cardiac function or clinically significant cardiac disease.
* Participants must not have any brain metastasis.
* Participants must not have any liver metastasis.
* Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter

Peritoneal dialysis, which appeared at the end of the 1970s, quickly proved its worth both in terms of its effectiveness and of its ease of compliance, which guarantees an improved quality of life. To date there are different modes of application of this technique: Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis. Whatever the technique used, the placement of a dressing covering the exit site of the catheter is necessary just after the placement of the PD catheter and this so that the site of emergence is kept dry until healing (in general 2 to 4 weeks). Once the emergence site has healed, the technique can be started. Discharge site infections are a major predisposing factor for the development of peritonitis. Numerous studies in different parts of the world have shown that the rates of PD-related infections have steadily declined over the past 10 to 20 years. Several recommendations for the prevention and treatment of emergence site infections have been published by the International Peritoneal Dialysis Society. Several studies nonetheless call into question the recommendations by showing that catheter infection is not linked to the number of risk factors present at the time of catheter insertion, nor to the prescription of antibiotic prophylaxis, nor to the the experience of the caregiver, the antiseptic used or the early dressing change. In addition, only antibiotic prophylaxis at catheter placement is strongly recommended. Regarding the other measures, their relevance is not always demonstrated and their application varies considerably from one center to another. In addition, many authors have sought to establish a definition of catheter infections in order to allow an optimal assessment of their frequency. However, these definitions are not universal and have certain limitations. The objective of this work is on the one hand to better characterize the incidence of infections at the site of emergence in peritoneal dialysis, and on the other hand, in the absence of a definition established according to the recommendations, to use the score de Schaeffer, is in particular the value of this score which would make it possible to define more precisely the presence of an infection.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 80 inclusive
* Signature of informed consent
* Affiliation to a French social security scheme
* Patient with end stage renal disease starting renal replacement therapy by peritoneal dialysis in one of the participating centers

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
* Pregnant woman
* Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".
* Patient without health insurance
* Inability to understand the reasons for the study; psychiatric disorder judged by the investigator to be incompatible with inclusion in the study.
Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)

Background and study aims:

The Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C) was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can be adapted for different populations. The aim of this study is to assess if a EMDR-GP program may help primary school students in improving narrative complexity and specificity of autobiographical memories, as well as their subjective unit of distress (SUD) and validity of cognition (VoC).

Who can participate? Students attending the fourth or fifth year of primary school

What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with weekly 60-minute group sessions (3 sessions), while the control group will follow routine daily school activities.

Questionnaires will be used to assess narrative complexity, specificity of autobiographical memories, SUD and VoC before and after the intervention.

What are the possible benefits and risks of participating? Benefits of participating in the study may include an improvement of narrative complexity, specificity of autobiographical memories, and their SUD and VoC.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 9 to 11 years
2. Children have reasonable comprehension of spoken language and can follow simple instructions
3. Children and their parents are willing to attend all intervention sessions
4. Children and parents have an adequate understanding of Italian

Exclusion Criteria:

1. Concurrent enrollment in other intervention trials
2. Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Inpatients or outpatients, 18-65 years of age
* Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
* Evidence of unidimensional measurable disease as per RECIST criteria
* No systemic metastatic disease (M0)
* ECOG performance status of 0 or 1 at study entry
* Effective contraception
* White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
* Total bilirubin ≤ 1.5x upper reference range
* AST \& ALT ≤ 1.5x upper reference range
* Glomerular filtration rate \> 60 ml/min
* Serum creatinine ≤ 1.25x upper reference range

Exclusion Criteria:

* Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
* Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
* Known hypersensitivity reaction to any of the components of study treatments
* Pregnancy or lactation period
* Systemic metastatic disease
* Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Peripheral neuropathy \> grade 1
* Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
* Known alcohol or drug abuse
* Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
* Legal incapacity or limited legal capacity
Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty

Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. However, it has been reported that the percentage of patients who continue rehabilitation for the time required to achieve these outcomes is much lower than those who abandon therapy. This is often due to various factors such as office hours, difficult access to appointments, and sometimes insufficient infrastructure and personnel to meet the demand. Currently, due to the global situation, it is crucial to conduct these rehabilitation processes remotely and virtually, making use of various technological tools that enable patients to interact with the healthcare professionals in charge of their rehabilitation. Among these tools are mobile applications on smartphones, which not only facilitate proper physical preparation, but also offer valuable real-time feedback. Furthermore, 8% of the total cost of knee joint replacements corresponds to the rehabilitation program. These costs are significantly reduced with telerehabilitation assisted by mobile tools, which not only improves patient access but also increases adherence and satisfaction levels by allowing the customization of rehabilitation programs based on each patient's specific needs and characteristics. The aim of this study is to evaluate the effectiveness outcomes of an artificial intelligence-guided mobile tool versus conventional rehabilitation during the first three months postoperatively following total knee replacement.

A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at Clínica Universitaria Colombia and Puente Aranda Emergency Center, whose postoperative follow-up is ambulatory, and who meets the inclusion criteria.

Outcomes: Functionality will be the primary outcome, measured in terms of the WOMAC score, knee range of movement, and pain, by means of the visual analogue scale. Adherence to treatment, number of therapy sessions, patient satisfaction, and the presence of adverse events will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with degenerative osteoarthritis with an indication for primary Total Knee Replacement (TKR) surgery at Clínica Universitaria Colombia or Central de Urgencias de Puente Aranda.
* Patients in the postoperative period following primary outpatient TKR.
* Patients with functional independence.
* Patients who agree to participate in the study and sign the informed consent form.
* Patients with access to a mobile device, tablet, computer, with internet access and the ability to operate it.
* Patients who have an appropriate space to perform therapy at home.
* Patients who will be accompanied during therapy sessions at home.

Exclusion Criteria:

* ASA Class IV (American Society of Anesthesiologists)
* BMI \> 35
* Dementia and cognitive impairment
Effect of Dexmedetomidine on Oxygenation and Lung Mechanics

Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation


Eligibility Criteria:
Inclusion Criteria:

Morbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy

Exclusion Criteria:

history of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC \< 70%