cyrilzakka/clinical-trials huggingface dataset:
Fitness, Activity and Lung Cancer Study

The purpose of the study is to investigate the change in pulmonary function and exercise capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect of training on aerobic capacity, muscular strength, morbidity and survival. Physical activity level by accelerometers, body composition by DXA and quality of life will also be reported.

Five year after surgery, all included patients will be reinvited to undergo a fourth health excame to study the long-term effects of exercise training on physical fitness, morbidity and survival.

Eligibility Criteria:
Inclusion Criteria:

* Non smal cell lung cancer
* Patient living in Oslo or Akershus county and accepted for lung cancer surgery at Oslo University hospital and Akershus University hospital
* were able to read and speak Norwegian

Exclusion Criteria:

* Mental incompetence or physical disability that makes it difficult to walk on a treadmill
* Treatment or medical complications affecting ability to participate in an exercise group
* \> 79 years
16.0040 Ankylosing Spondylitis Study

The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.

This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.

Eligibility Criteria:
Inclusion Criteria: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:

* Negative pregnancy test
* Subjects agree to use appropriate contraception throughout study
* Should be able to self-inject study drug or have someone who can do so
* Capable of understanding protocol and willing to provide written informed consent

Exclusion Criteria:

* Any change in NSAID or prednisone dose within 2 weeks of baseline
* Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
* Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
* Previous receipt of ani-TNF agents, other than etanercept
* Receipt of any other investigational drug within 30 days of baseline
* Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
* Abnormality in chemistry or hematology profiles or significant concurrent medical events.
Long-term Observation of Patient Engagement in Automated Insulin Delivery

The purpose of this study is to assess the long-term evolution of patient interaction with the CONTROL-IQ (Tandem™) hybrid closed-loop (HCL) system in individuals with type 1 diabetes over 24 months. Specifically, the study examines user-initiated boluses and carbohydrate announcements to determine whether initially low-engagement users increase their involvement over time or, conversely, whether highly engaged users gradually rely more on automation.

Automated insulin delivery (AID) systems have revolutionized type 1 diabetes (T1D) management, offering superior glycemic control and quality of life compared to sensor-augmented insulin pumps or multiple daily injections (MDI). However, current AID systems operate as hybrid closed-loop (HCL) systems, requiring user intervention for meal boluses, including carbohydrate counting and timely insulin administration.

Control-IQ (Tandem™) was the second AID system reimbursed by the French National Health Insurance and is now widely used in France. It combines the Tandem™ t:slim insulin pump with Dexcom™ G6 continuous glucose monitoring (CGM), adjusting basal insulin every five minutes based on glucose predictions and delivering automatic correction boluses once per hour. Despite these automation features, users must still manually initiate meal boluses, and additional correction boluses remain optional. While engagement in carbohydrate counting and timely meal announcements improves metabolic outcomes, real-world data suggest that AID benefits individuals across varying engagement levels.

Long-term data on patient behavior and engagement, particularly regarding carbohydrate announcements and the ratio of automatic to user-initiated boluses, remain limited. Understanding these patterns could reveal whether initially low-engagement users increase involvement over time or whether highly engaged users eventually rely more on automation.

This single-center, 24-month observational study will follow all T1D patients treated with Control-IQ at the Centre Hospitalier Sud-Francilien between October 2021 and October 2024.

Eligibility Criteria:
Inclusion Criteria:

* Patients using the CONTROL-IQ hybrid closed-loop system with data uploaded to the myDiabby platform at least once between October 2021 and October 2024, affiliated with the diabetology department of CHSF.

Exclusion Criteria:

* Patients with a type of diabetes other than type 1 diabetes.
* Patients who have objected to the use of their data.
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 70 years
* Weight 40 - 80 kg
* Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
* Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
* Subject able to provide informed consent

Exclusion Criteria:

* Known history of allergy to vancomycin
* Pregnancy
* Granulocytopenia (\< 1x109/L)
* Renal impairment (serum creatinine \> 177 µmol/L or eGFR \< 50 mL/min)
* Known history of vestibular disease or hearing loss
* Subjects treated with vancomycin within the previous month
* Subjects who have received more than 24 hours of vancomycin
* Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)
IVs With Buzzy in Chronic Pain Patients

The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.

IV placement is necessary for lidocaine infusions. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable. Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients. The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. The use of the Buzzy® device in adults is the investigational part of the study. This device has been FDA approved for use.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving lidocaine infusions at the pain clinic.

Exclusion Criteria:

-
Clinical Impact of EUS in Staging NSCLC

The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with presumed or known potentially resectable NSCLC
* Due to the nature of NSCLC, children (\<18 year of age) will not be considered
* Men, women, and minorities
* Subjects must be able to safely undergo conscious sedation for the EUS procedure
* Subjects must be surgical candidates
* Subjects must not have an uncorrectable coagulopathy and must be able to refrain from the used of aspirin one week prior to the EUS
* Patient must provide signed written informed consent

Exclusion Criteria:

* Subjects with a history of previously treated lung, head \& neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
* Uncorrectable coagulopathy
* Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
* Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
* Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
* Evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric illness that would preclude adequate compliance with this protocol
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above.
* Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
* Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.

Exclusion Criteria:

* Current episode duration greater than 3 years.
* Failed more than 3 adequate antidepressant trials in current episode.
* DSM-IV psychotic disorder.
* Drug or alcohol abuse or dependence (preceding 3 months).
* Inadequate response to ECT in the current episode of depression.
* Rapid clinical response required, e.g., high suicide risk.
* Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
* Clinically defined neurological disorder or insult.
* Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Pregnancy.
* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
Teens Against Tobacco Use: A Model for Universal Tobacco Prevention and Youth Advocacy

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen Middle School of the El Paso Independent School District to implement smoke free youth coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco Use (TATU) model developed by the American Lung Association, the American Cancer Society, and the American Heart Association. Participating youth will be trained to develop and deliver anti-tobacco presentations to younger students. Each school will have a separate youth coalition operating under the guidance of an adult coordinator. High school youth will present to middle school classes, whereas middle school youth will present to 4th and 5th graders.

To evaluate the efficacy of the smoke-free presentations, the investigators will first match pairs of classrooms willing to have a presentation and then randomly assign one classroom in each pair to either receive the presentation first (intervention condition) or later in the school year (control condition). Following a presentation to a classroom in the intervention condition, investigators will administer a brief survey about tobacco to students in both the intervention class and its matched control class, who have not yet received a presentation. Analyses will compare intervention and control classrooms on smoking susceptibility, perceptions of harm from tobacco use, tobacco industry perceptions, and social norms on tobacco use.

Eligibility Criteria:
Inclusion Criteria:

* 4th to 8th grade student
* Classroom must be willing to be randomly assigned to either receive presentations earlier in the school year or late in the school year

Exclusion Criteria:

* Classes in participating schools that are not in the 4th to 8th grade
* Students not able to read English or Spanish
Male Reproduction COVID Sequelae Study (MARCOS).

The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.


Eligibility Criteria:
Inclusion Criteria:

1. Receiving COVID-19 vaccines
2. Male age 18-50 years old

Exclusion Criteria:

1. Adults unable to consent
2. Women
3. Prisoners
4. Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
5. Men with a history of Azoospermia
6. Men with a genetic or other medical condition known to be associated with decreased semen parameters (i.e. Klinefelter's syndrome, Y-Chromosome Microdeletion (YCMD), post-chemotherapy treatment, etc.)
7. Positive COVID-19 test within the last 3 weeks
Traduction and Validation of the Central Sentitization Inventory Into French

The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires).


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Fibromyalgia (Group 1)
* Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2)
* Healthy Volunteer (Group 3)

Exclusion Criteria:

* Having any chronic pain (group 1 and group 2)
The Use of Focused Ultrasound and DCE K-trans Imaging to Evaluate Permeability of the Blood-Brain Barrier

The limitation of treating intrinsic brain pathologies has been circumvented with neurosurgical techniques; however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required. This study seeks to investigate the efficacy of focused ultrasound.

Patients with either low grade gliomas or neurodegenerative dementias will be evaluated for study candidacy.

There are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

Treatment of intrinsic brain diseases is challenging because brain barrier (BBB) limits the delivery of drugs, particulates and cellular elements such as stem cells to the central nervous system (CNS). This limitation is often circumvented with neurosurgical techniques, however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required.

The diagnosis for the participants will be either low grade gliomas. A baseline fMRI and follow up routine fMRI's will be taken and evaluated for any changes in perfusion. During the scans, The ultrasound placement will last for one hour.

This study seeks to investigate the efficacy of focused ultrasound in opening the blood brain barrier. This physiological effect would have significant clinical applications. The ability to open the blood brain barrier has the potential to revolutionize the delivery of therapeutic agents to the brain, allowing for more localized and efficient delivery. There are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing routine, repetitive MRI scanning for monitoring low grade gliomas
* 18 or older

Exclusion Criteria:

• Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia CDR stages 1 and 2
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer

The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
* An estimated survival time of at least twelve months according to the investigator's assessment.
* A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.

Exclusion Criteria:

* Previous surgical castration.
* Previous or has planned curative prostate cancer therapy (radiation/surgery)
* Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
* Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam

All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:

1. below five years of age
2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
4. the mother/guardian or caretaker consented to participate.

Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals

Eligibility Criteria:
Inclusion Criteria:

1. below five years of age
2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
4. the mother/guardian or caretaker consented to participate

Exclusion Criteria:

a) N/A
The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building

This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics in Malawi. Primary outcomes are clinical care indicators measured at the level of the visit (patient screened yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the level of the participant.

This 10-site cluster-randomized implementation science trial compares the success of two clinic-level strategies in achieving high-quality integration of depression treatment into 10 non-communicable diseases (NCD) clinics in Malawi. Clinics are randomized 1:1 to one of two clinic-level implementation strategies: a basic strategy involving an internal coordinator, and an enhanced strategy combining the internal coordinator with an external quality assurance monitoring and supervision team. During a pre-randomization run-in period (months 1-5), all clinics receive the basic strategy. During a post-randomization intervention period (months 6-38), half of the clinics continue to receive the basic strategy and half receive the enhanced strategy. Visit-level data (for primary outcomes) and participant enrollment and follow-up (for secondary outcomes) are collected from all 10 clinics during the run-in and intervention periods.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following eligibility criteria will be invited to participate:

* Ages 18-65 years (antidepressant treatment considerations differ for those \<18 or \>65 years, and these age groups are expected to be very rare in the target clinics),
* Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic
* Elevated depressive symptoms (PHQ-9 score ≥5)

Exclusion Criteria:

Patients will be excluded if they have

* a history of bipolar or psychotic disorder, or show emergent threat of self-harm.