cyrilzakka/clinical-trials huggingface dataset:
Pilot Trial of Homebound Stem Cell Transplantation

In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. They want to find out what effects good and/or bad this will have on the patient's recovery and treatment after ASCT. Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk of infection. It is our hope that this new approach of providing care in the home setting will prove to be a feasible and safe option for patients at Memorial Sloan Kettering Cancer Center (MSK).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Plasma cell dyscrasia
* Treatment plan including Autologous HSCT
* 18-80 years of age
* Appropriate homebound setting as defined by one of the following:

  * Lodging at the MSK Residence.
  * Staying at home or a "home equivalent" in any one of the zip codes as outlined in the appendix. Home equivalent is defined as a residence which may or may not be the primary residence of the patient.
  * "Home equivalent" must pass the "Home Environment Screening Tool" for homebound stem cell transplantation (not required for other MSK recognized lodging facility).
* Adequate caregiver support as defined by:

  * Single or multiple informal caregivers willing and able to provide 24 hour a day, seven day a week supervision of the transplant recipient in their home or "home-like" environment.
  * Caregiver willing and able to fulfill the basic stem cell transplant caregiver education requirements as determined by caregiver and healthcare team, including social worker
* Have Wi-Fi connection
* Appropriate third party payer coverage for "Homebound Stem Cell Transplant Program"
* Both patient and caregiver willing to give and sign informed consent.

Exclusion Criteria:

* Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
* Uncontrolled arrhythmias
* Active or uncontrolled pulmonary disease
* Karnofsky Performance Scale (KPS) score \<80
* Sorror Co-morbidity index ≥ 4 except in patients with history of resected cancers
* Creatinine clearance (calculated or measured) of \< 50 cc/minute
* Inability of patient or caregiver to speak or read English (we currently do not have the manpower to translate nor staff a multilingual homebound stem cell transplant program with adequate educational materials).
* Inadequate housing arrangements
* Inadequate caregiver arrangements
Transcriptomic Profiling in Severely Injured Patients

Discovery of differences in the host response in patients with systemic inflammation and sepsis, and identification of novel, specific markers by using a longitudinal clinico-transcriptomic approach.

The aim of this study is to link defined clinical phenotypes with data on RNA obtained from blood samples by high throughput technologies. Genetic and molecular characteristics of the immune system after severe trauma will be crosslinked to clinical aspects of posttraumatic organ failure, with the goal of identifying typical molecular "fingerprints". Patients with and without sepsis or organ failure will be compared with the goal to develop a diagnostic test designed to predict the clinical course following severe trauma. Criteria for study enrollment includes patient age ≥18 y, an Injury Severity Score (ISS) ≥ 17 points, and time from injury to admission \< 6 h. Whole blood from trauma patients will be collected within the first 6 h after trauma (day 0) and on days 1, 2, 3, 5, 7, 10, 14, and 21.

Eligibility Criteria:
Inclusion Criteria:

* patient age ≥18 y
* Injury Severity Score (ISS) ≥ 17 points
* time from injury to admission \< 6 h.

Exclusion Criteria:

Moribund Patients with:

* PH \< 7,1 or
* Lactate \> 15 mmol/l or
* Base deficit \> 15 mEq/l
Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia

This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia.

The true prevalence of Neurocyticercosis in Zambia is not well known. Only one study which was a pilot study done in Katete district of eastern province demonstrated the prevalence of NCC among people with epilepsy. There is need to provide an accurate estimate of the prevalence of NCC among people with cysticercosis in Zambia as well as understand the clinical manifestations of the disease in humans. Data on the full range of clinical characteristics of NCC is essential to accurately estimate the burden of the disease in the community.

The epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on TSCT and NCC in various population groups (adults, children, and those living with epilepsy) in two provinces of Zambia. This will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of TSCT/NCC in the country.

Further, environmental factors that could play a role in the transmission and maintenance of T. solium eggs will be studied. This will provide essential data in understanding the epidemiology of the parasite in endemic regions.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets
* Willing and able to provide informed consent (signature or thumbprint with impartial witness; assent for minors with parental consent).
* Living in, attending school in, or regularly visiting the bore holes present in, the study communities.
* Aged 10 years or older

Exclusion Criteria:

* Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets.
* Unwilling or unable to provide written (signature or thumbprint with impartial witness) informed consent (or assent for minors).
* Living outside of, and not regularly visiting, or attending school in, the study communities.
* Children aged less than 10 years.
* Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.

SAD/Part A.

* All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for injection in 250 cc of saline over 180 minutes.
* Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
* Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
* Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400 mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.

MAD/Part B

* Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or 200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
* Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or 300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.

BA/Part C

* Subjects in Cohort 6 will receive a single 60 minute infusion of 200 mg TR-701 FA for injection in 250 cc of saline and a singe oral dose of 200 mg TR-701 FA tablet in an open-label crossover design.

Venous Tolerability/Part D

- Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a blinded crossover design.

Eligibility Criteria:
Inclusion Criteria:

* in good health
* body mass index of 20 to 29.9 kg/m2
* female subjects must be post menopausal for at least 1 year, surgically sterile, abstinent or agree to use an effective method of birth control

Exclusion Criteria:

* history or clinical manifestation of any clinically significant disorder
* history of hypersensitivity to any drug compound
* history of stomach or intestinal surgery or resection
* history of infections of unexplained frequency or severity
* history of alcoholism or drug addiction within 1 year
* use of any tobacco- or nicotine-containing products within 6 months
* use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or beverages
* use of any other medications
* pregnancy, lactation, or breastfeeding
Buprenorphine Disposition and Cyclosporine

The determine the effect of cyclosporine on buprenorphine disposition

Subjects studied on four occasions:

1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days

Eligibility Criteria:
Inclusion Criteria:

* 18-50 yr old
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provide informed consent

Exclusion Criteria:

* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)
Healthy Data: Improving Health Information Quality Using Intelligent Systems

Electronic Health Record Systems (EHR) play an integral role in healthcare practice, enabling health organisations to collect, access and manage data more consistently. There is also a great deal of interest in using EHR data to improve decision-making and accelerate medical interventions. However, like all information systems, they are prone to data quality problems such as incomplete records, values outside normal ranges and implausible relationships. These problems are expected to become more prevalent as more organisations adopt electronic health record systems, aggregate, share and explore health data. The investigators believe current efforts to improve health data quality can be made more effective if backed by appropriate technology in the form of a readily accessible intelligent tool. Building on this, the investigators developed an Artificial Intelligence (AI) tool for automating data quality assessment of health data. In this study, the investigators evaluate the AI tool using a real-world dataset.

The main aim of this study is to assess the reliability and utility of an AI tool in identifying data quality dimensions of interest for secondary use of health data, including completeness, conformance and plausibility. In assessing this tool, this study will retrospectively analyse data captured during routine clinical care and identify records containing listed data quality dimensions. This study will also assess the consistency of the AI tool in generating and executing data quality checks.

Eligibility Criteria:
Inclusion Criteria:

* No specific exclusion criteria

Exclusion Criteria:

* No specific exclusion criteria
Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy

The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

The treatment consists of tumor ablation by USF, guided by MRI, performed under local anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after ablation.

Eligibility Criteria:
Inclusion Criteria:

* Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-2.
* Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications
* Lesion recognizable and identifiable in MRI
* Indication of mastectomy with or without axillary
* Lesion located more than 10 mm from the skin, the nipple and pectoralis major
* No cons-indication to MRI (pacemaker)
* Women whose age is ≥ 18 years
* If premenopausal patient: patient contraceptives
* Patient has signed informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Tumor-TD T4B classified or non-palpable lesion
* If age \<70 years: no indication of adjuvant chemotherapy and neoadjuvant
* MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
* Inability to hold still in the prone position, arms extended, for 30 minutes
* Contraindication to MRI
* Patient deprived of liberty and major subject of a measure of legal protection or unable to consent
* Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.
The Effect of (ASMR) Videos on Sleep Quality and Stress Levels on Nursing Students

This study was planned to evaluate the effect of Autonomous Sensory Meridian Response (ASMR) videos on sleep quality and stress levels of nursing students before clinical practice.

Autonomous Sensory Meridian Response (ASMR) is a physiological phenomenon that describes a tingling sensation caused by specific visual and auditory triggers, usually starting on the scalp and travelling down the body. These trigger stimuli are often socially intimate in nature and often involve repetition of movements and/or sounds.

According to studies conducted among university students, it is generally stated that university students have poor sleep quality and sleep inadequately. Negative impact on students' sleep quality is a factor that causes them to experience stress. Nursing students are faced with an important source of stress due to the various situations they encounter in the education and practice processes. Although clinical education offers rich opportunities to gain hands-on experience, it is reported that the clinical component of nursing education provides the highest source of stress for nursing students.

This study was planned to evaluate the effect of Autonomous Sensory Meridian Response (ASMR) videos on sleep quality and stress levels of nursing students before clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years,
* illiterate,
* volunteer to participate in the study
* First-year nursing students who have not done clinical practice before

Exclusion Criteria:

* have done clinical practice before
Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV

The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years
* Naive patient to treatment with positive pressure with AHIc \> 15 requiring the establishment of an ASV to a central or combined SAS without any systolic HF (LVEF ≤ 45%) with predominant central SAS.

  * OR Patient with a predominant obstructive SAS ( ≤ 50% central event ) whose Continuous Positive Airway Pressure treatment (CPAP) does not allow adequate control of the central events: treated for at least 1 month CPAP with a residual central apnea hypopnea index greater than or equal to 10 events per hour (AHI global\> 15, which AHIc ≥ 10) pressure to control obstructive events ( IAHo \<5 ) controlled by polygraphy or polysomnography with a pressure test \<10 cm H2O.
* Before inclusion, for patients who have previously been treated with CPAP, a PSG diagnosis will be made after a period of wash-out of CPAP of a 1-week period.
* Patient affiliated to the national social security (beneficiary or assignee ).
* Patient being aware of the information form and signed informed consent.

Exclusion Criteria:

* Patients with against -indication for the use of ASV :

  * History of massive epistaxis.
  * Diseases related to barotrauma particularly pneumothorax and pneumo- mediastinum.
  * Suspicions of meningeal gaps or trauma history of the prior stage of the skull base.
  * Shortness of breath or hypercapnia deemed incompatible by the doctor with the ASV treatment.
* Patients with predominant obstructive sleep apnea (OSA) (\> 85% obstructive events ).
* Standardized central SAS by the Continuous Positive Airway Pressure
* Patients with a diagnosis of systolic heart failure (LVEF ≤45 %) with a predominant central SAS ( \> 50% central events ).
* Person deprived of liberty by judicial or administrative decision, person under a legal protection measure (pregnant or lactating women, patients under guardianship)
* Lack of signature for the information form and the informed consent form.
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers

To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.

A Randomized Clinical Trial

When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?

The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.

The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.

Eligibility Criteria:
Inclusion Criteria:

* Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
* Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period.
* Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
* According to space analysis, available space is less than or equal to the needed space
* 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars
* Children are mentally capable of communication.
* Children aged 4-6 years

Exclusion Criteria:

* Children with any parafunctional habits.
* Children with previous allergies to stainless steel.
* Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
* Parental refusal of participation.
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma

Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.

The eligible patients will receive 4-6 cycles chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors. Then, SBRT for oligometastatic lesions will be assigned to eligible patients. The efficacy and side-effect will be evaluated and analyzed. The relation of liquid biopsy data with treatment outcome（such as EBV DNA, CTCs, CTC subtype，PD-L1 and so on）will be valued.

Eligibility Criteria:
Inclusion Criteria:

* Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm)
* age 18-70 years old
* Karnofsky scores ≥70
* Estimated life ≥ 6 months
* Adequate organ function including the following: Absolute neutrophil count (ANC) \>= 2.0 \* 109/l; Platelets count \>= 100 \* 109/l ;Hemoglobin \>= 90 g/dl; Creatinine clearance \>= 60 ml/min; For patients without liver metastasis, AST and ALT \<= 1.5 times institutional upper limit of normal (ULN), Total bilirubin \<= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT \<= 3 times institutional upper limit of normal (ULN), Total bilirubin \<= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume \>700 mL
* Signed written informed consent

Exclusion Criteria:

* Patients who achieve complete remission after comprehensive treatment
* Pathology confirmed as second primary tumor
* Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy
* Femoral bone metastasis
* With serious medical complications and contraindications of radiotherapy
* With uncontrollable malignant pleural effusion
* Positive pregnancy test for women of childbearing age or lactating women
* Uncontrolled or active infections, such as immunodeficiency or HIV infection
* Active mental disorder or other mental disorder that affects the patient's ability to sign informed consent and understanding.