cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated Radiotherapy for Thymic Epithelial Tumors

The goal of this clinical trial is to learn if hypofractionated radiotherapy works to shorten the treatment time without increasing the side effects in patients of thymic epithelial tumors. The main questions it aims to answer are:

* Does Hypofractionated radiotherapy provide better results?
* Can hypofractionated radiotherapy reduce toxic and side effects compared with conventional radiotherapy? Researchers will compare the efficacy and safety of hypofractionated radiotherapy after thymic tumor surgery.

Participants will:

* Receive hypofractionated radiotherapy or conventional radiotherapy
* Visit the hospital regularly once every 12 weeks for checkups and tests

According to the World Health Organization histological classification system, thymic epithelial tumors (TET) are divided into thymoma and thymic carcinoma. Surgery is the main treatment for thymic tumors, and radiotherapy (RT), as an important auxiliary method of surgery, also plays an irreplaceable role in all stages of thymoma.

Hypofractionated radiotherapy is a common mode of radiotherapy for thoracic tumors. Unlike conventional radiotherapy, hypofractionated radiotherapy has a higher single dose and a shorter course of treatment. Because it improves the treatment efficiency, it can reduce the treatment time of patients and medical institutions and the cost of patients.

In the postoperative radiotherapy stage, conventional radiotherapy and hypofractionated radiotherapy were used. The course of hypofractionated radiotherapy was shorter than that of conventional radiotherapy. Patients chose to accept hypofractionated radiotherapy as the hypofractionated group, but not the conventional group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must provide written informed consent.
2. 18 years old ≤ age \<75 years old.
3. Thymoma confirmed by pathology: type A, type AB, type B1, type B2, type B3. Thymic carcinoma. Patients with previous thymectomy were required to have complete surgical related data.
4. Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
5. ECOG performance status 0-2.
6. Expected survival time \> 1 year.
7. Participants of childbearing age must agree to use effective contraception during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
8. Patients who are not lactating.
9. Sufficient bone marrow reserve and good function of important organs.

Exclusion Criteria:

1. patients with prior thoracic radiotherapy;
2. diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
3. Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
4. Patients with other malignant tumors that are not under stable control;
5. Known history of mental illness, substance abuse, alcohol or drug abuse.
6. Other conditions deemed unsuitable for enrollment by the attending physician.
The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children

80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of overweight children.The intervention group will use the app "Just Dance Now" and The control group will be exposed to the usual program without the app. Measurements will be performed at the beginning of the program, the end and 3 months after completion of the intervention.

80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers for the treatment of overweight children. The intervention group will use the app "Just Dance Now" and part of a weekly exercise session will be dedicated to a group app activity. The control group will be exposed to the usual program without the app.

Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and questionnaires regarding attitude and response to physical activity will be performed at the beginning of the program, the end and 3 months after completion of the intervention. Participation in the sessions will be documented and home activity recorded using a weekly log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-13 from the center for the treatment of overweight children in the MACABI health organization
* BMI≥85%.

Exclusion Criteria:

* Children with physical disabilities, that don't allow participation in physical activity during the study.
* Children who don't own a mobile phone or don't have an access to a computer to activate the app for one hour a day.
* BMI\<85%
Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department

The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC)

The main questions it aims to answer are:

* prevalence of TLOC
* prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought.

Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file.

No visit is planned after the passage to the emergency room.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin

Exclusion Criteria:

* N/A
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

To study the effects of oral ethanol (a target BAC of \~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Occasional current cannabis users.
* Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve.
* Alcohol naïve.
* Positive pregnancy screen
* Hearing deficits.
Regional Anaesthesia and Substance P in Head and Neck Cancer

In the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance P in patients with unilateral Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side will be analysed by immunohistology, measuring the expression of the Substance P.

Several investigations show that anesthetic procedures, and especially the perioperative regional anesthesia, can have a benefit for patients undergoing tumor surgery.The perioperative regional anesthesia might reduce the immunological response and therefore lower the risk of tumor relapse. Factors that might play a role in tumor relapse are various, so more prospective and randomised trials are necessary to investigate the underlying mechanisms.

In a retrospective analysis by Merquiol et al. it was shown that an cervical epidural anesthesia was associated with an extended tumorfree timeline of larynx and hypopharynx carcinoma.

Supporting results could be seen in a study by Munoz et al. performing regional anaesthesia in breast cancer patients.

Taking all these facts into consideration the investigators believe that performing regional aneasthesia could reduce the relapse of larynx carcinoma. The relapse of carcinoma is believed to be linked to substance P and the neurokinin 1 (NK-1) receptor .

It is accepted that an additional regional anesthesia could reduce the impact of substance P to gain a normal immune response in the perioperative setting and to reduce the rate of tumor relapse.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Charité - Universitaetsmedizin Berlin, Campus Charité Mitte
* Primary diagnosis of unilateral head or neck cancer
* Resection of Tumor is planned with unilateral neck dissection
* Patient did not underwent any therapeutic treatment of the cancer before start of study
* Surgical therapy is planned with curative intent

Exclusion Criteria:

* Allergy to local anesthetics
* Coagulation disorders, which can lead to complications in regional anesthesia
* Insulin-dependent diabetes mellitus, polyneuropathy
* Severe psychiatric disorders
* Dementia
* Alcohol abuse, Korsakoff syndrome
* Medication with immunosuppressants or immune modulantia
* Patient under Special Care
* Refusal of study participation
* Pregnancy and breast feeding period.
* Participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion
* Lack of consent that pseudonomized data of the study may be saved and distributed
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients

To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.

The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.

Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.

It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.

The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 18 years.
2. HIV-1 infected patients.
3. Naive to antiretroviral treatment.
4. Candidate patient for initiating antiretroviral treatment\*.
5. Subject able to follow the treatment period.
6. Signature of the informed consent.
7. Women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method.

Exclusion Criteria:

1. Hepatic tests \> 5 times above normality.
2. Pregnancy or breastfeeding.
3. Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
4. Suspected or documented resistance to any of the investigational drugs.
5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
6. Subjects with abusive consumption of alcohol or illegal drugs.
7. Patients participating in another clinical trial.
8. Terminal renal disease.
Mindfulness Based Therapy for Insomnia in Black Women

The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based Therapy for Insomnia (MBTI)

Study design is a randomized clinical trial (RCT) with attention control. Participants will be randomly assigned to participate in either Mindfulness Based Therapy for Insomnia (MBTI) or time and attention control. Participants in the experimental group will receive the MBTI that includes mindfulness meditation and behavioral strategies for sleep. Participants in the control group will receive healthy lifestyle education that includes healthy eating, physical activity and sleep hygiene practice to mitigate insomnia.

Eligibility Criteria:
Inclusion Criteria:

* self-identified Black women
* 25-45 years old
* English speaking
* meeting DSM-5/ICSD3 diagnostic criteria for insomnia disorders defined as difficulty initiating or maintaining sleep with at least one associated daytime impairment symptom (Insomnia severity index \> 7)

Exclusion Criteria:

* Psychosis or unstable/ significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)
* significant current practice of any form of meditation (\>15min per day)
* obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, pregnancy, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
* other medical conditions that confound salivary biomarkers outcomes (e.g., radiation of salivary glands, Cushing or Addison's disease)
* active or terminal cancer
The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.

Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change.

This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.

This is a prospective, randomized, controlled study of children with persistent asthma who are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into one of two arms:

* 50 children will be randomized to BreatheSmart, comprised of:

  * BreatheSmart mobile application that tracks medication usage and sends real time reminders
  * HeroTracker sensor that counts dosage and monitors real-time medication adherence
  * CoheroConnect provider portal that allows the Investigator to monitor real-time adherence and to provide targeted outreach to children with low adherence (intervention arm)
* 25 children will be randomized to "standard of care"(control arm). These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 17
* Diagnosis of persistent asthma
* Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment
* Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix)
* Parent/child possess a compatible smartphone (iOS 8.0 or higher)
* English or Spanish speaking

Exclusion Criteria:

* Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy
* Presence of other chronic medical condition such as congenital heart disease or immunodeficiency
* Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to \< 1 year
* Currently pregnant or planning to become pregnant during the trial period
Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?

In this project the investigators will be using non-invasive brain stimulation on people with multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be recruited. One group will perform strength testing with and without the brain stimulation. The second group of participants will perform a fatigue task, pulling against a wire at a low level of force, with and without the brain stimulation. This type of brain stimulation has been shown to transiently improve strength and fatigue measures in other populations, e.g. aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is the investigator's hope that the increases in performance seen in other patient groups will also occur in people with multiple sclerosis. Future investigations will look to apply the non-invasive brain stimulation technique during physical rehabilitation to improve short and long term outcomes related to physical function.


Eligibility Criteria:
Inclusion Criteria:

* Medically diagnosed with MS
* Moderate disability (Patient Determined Disease Steps score 2-6)
* Self-reported differences in function between the legs (2-5 on a 1-5 scale)
* People with MS with physician clearance

Exclusion Criteria:

* A relapse of disease symptoms in the last 60 days
* A condition unrelated to MS that would exacerbate fatigue, such as anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder
* Medical diagnosis or condition that makes participating in exercise training dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
* History of heart attack or current diagnosis of cardiovascular disease
* History of seizure disorders (or on medications known to lower seizure threshold), hydrocephalus (buildup of fluid in the brain), or diabetes
* Alcohol dependence or abuse (\>2 drinks/day), or present history (last six months) of drug abuse
* History of significant traumatic brain injury or hydrocephalus
* Pregnancy
* Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state.
* Presence of metal is present or implanted device or metal object that is not safe for TMS.
Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients

Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.

Methods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis.

Discussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* American Society of Anesthesiologists (ASA) physical status I to III
* Body mass index (BMI) 18-30 kg/m2
* Scheduled for same-day bidirectional endoscopy under sedation

Exclusion Criteria:

* Severe cardiovascular, pulmonary, renal, or liver diseases
* Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate \<50 beats/min), or hypoxemia (SpO2 \<90%)
* Neurocognitive or psychiatric disorders
* Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)
* Hypersensitivity to study medications
* Drug or alcohol misuse
* Definite upper respiratory tract infection
* Refusal for participation