cyrilzakka/clinical-trials huggingface dataset:
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
* Patients willing to comply with the protocol
* Age greater than or equal to 18 years
* Virologically successful if already on an established regimen

Exclusion Criteria:

* Prior use of a protease inhibitor exclusive of nelfinavir
* Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
* Use of immunomodulators or vaccines for HIV disease
* Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
* Baseline ALT levels greater than five times the upper limit of normal
A Multi-center, Retrospective Analysis of Clinical Character, Outcome and Prognosis of Lymphoepithelioma-like Carcinoma

The investigators retrospective collect the clinical data of patients diagnosed with lymphoepithelioma-like carcinoma, including primary site, gender, age, smoking history, tumor stage, time of initial treatment, EBV-DNA copy number, first-line treatment and survival status.

Lymphoepithelioma-like carcinoma (LELC) is a rare EBV-related tumor. Its histology is similar to that of nasopharyngeal carcinoma. In 2004, the WHO classified LELC into one subtype of large cell carcinoma, and the 2015 WHO classified it as other and unclassified cancers. LELC can originate in many organs, including parotid glands, throat, lungs, digestive tract, genitourinary system, etc. Driver gene mutations are rarely seen, and most of them are PD-L1 positive. In terms of treatment, there is no standard first-line treatment for lymphoepithelioma-like cancer. Patients with early-stage lymphoepithelioma-like cancer can receive surgery or radiotherapy, while palliative radiotherapy or chemotherapy is the main treatment for patients in advanced stage. The survival time is about 107 months, the 5-year OS is 59.5%, which is better than the prognosis of lung squamous cell carcinoma in the same period. A retrospective study of Sun yat-sen University Cancer Hospital included 127 patients with advanced lung LELC who received first-line chemotherapy between 2007 and 2018. Gemcitabine and platinum based chemotherapy and paclitaxel and platinum based regimens are significantly better than pemetrexed and platinum, but most of the current studies on lymphoepithelioma-like cancer focus on LELC that originates in the lung. But for other sites, such as parotid glands, liver, digestive tract, are mostly based on case reports, and there are few retrospective studies with large samples to explore their clinical features and treatment outcome. Therefore, investigators designed this retrospective clinical study to analyze the clinical characteristics, treatment, survival, and prognostic risk factors of patients with lymphoepithelioma-like carcinoma in order to summary the clinical character and guide treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Lymphoepithelioma-like carcinoma confirmed by histopathology;
* 2. The primary lesion does not involve the nasopharynx;
* 3. Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

Exclusion Criteria:

* 1. Concomitant with other tumor components at the time of diagnosis;
* 2. Have a history of any other malignant tumors;
* 3. Lack of complete data
A Positive Activity Intervention to Promote Wellbeing in Romanian Immigrants

This study aims to test the efficacy of an intervention focused on promoting positive emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian immigrants living in Spain. It is hypothesized that the BPS intervention will significantly improve a series of positive mental health outcomes, i.e., optimism, future expectancies, and affect, compared to the Control group.

Previous studies have shown that groups of immigrants may face a series of problems unique to the process of immigration, such as working, legal, social, and mental and physical health problems.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population. Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in an immigrant population. The design employed in this study is similar to the used in other studies.

Eligibility Criteria:
Inclusion Criteria:

* Romanian immigrant in Spain
* Sign a consent form stating their willingness to participate

Exclusion Criteria:

* Presence of severe physical illness
* Presence of severe psychological disorder
* Be currently involved in another psychological treatment
QOL and GI Outcomes in Malignancies

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.


Eligibility Criteria:
Inclusion Criteria:

1. Greater than 18 years of age
2. Spanish or English speaker with ability to read one of these languages
3. Diagnosis of pancreatic cancer .
4. Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.

Exclusion Criteria:

1. Patients unable to read Spanish or English, as they will be unable to complete surveys.
2. History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
3. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
4. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women

This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with breast cancer and 120 control women, to evalyate if vitamin D status is associated with breast cancer risk.

Background: The role of vitamin D in breast cancer prevention is equivocal. Saudi Arabian women are thought to be at greater risk for vitamin D deficiency due to darker skin type and greater likelihood for reduced UVB radiation exposure. However, there is a lack of data regarding the vitamin D status of Saudi Arabian women and how this may relate to breast cancer risk.

Objective: The purpose of this research was to evaluate the association between circulating concentrations of 25(OH)D and breast cancer risk in Saudi Arabian women.

Design: A case-control study was conducted among 120 breast cancer cases and 120 controls. The study population was drawn from patients admitted to King Fahd Hospital in Jeddah, Saudi Arabia from June to August 2009. Participants completed questionnaires on diet and medical history and serum samples were collected from all women to measure circulating 25(OH)D concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer (cases) or healthy women (controls),
* receiving standard medical check-ups at the women's clinic
* Female,
* between the ages of 18 and 75 years
* BMI ≤ 40 kg/m2
* residence in Saudi Arabia for more than 5 years
* absence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.

Exclusion Criteria:

receiving standard medical check-ups at the women's clinic

* Male,
* less than 18 or greater than 75 years of age
* BMI \> 40 kg/m2
* Not a resident of Saudi Arabia for more than 5 years
* Presence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting

Background: Preventing type-2 diabetes mellitus begins with early screening and intervention of prediabetic participants. Until now, prediabetes screening and early intervention have not been optimal. The rapid advancement of technology, as well as its increased use, may provide an opportunity to improve the quality and cost of healthcare services. It is quite practicable to investigate and implement a valid, practical and easy-to-use mobile health application for participants and health staffs in screening and early intervention of prediabetes participants at primary health cares setting. This protocol aimed to identify and develop a valid, practical, and easy-to-use mobile health application for screening and early intervention of prediabetes participants at primary health cares.

Methods: This protocol was prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This is a mixed-methods study with sequential exploratory approach. This project will begin with in-depth interview to gather qualitative information regarding mobile health application necessity for prediabetes participants at the primary health cares. The impact of the usage will be studied quantitatively using randomized controlled trial. Prediabetic participants and primary health cares staffs at Yogyakarta province will be the research subjects. The collected findings will be examined based on the type of the data.

Discussion: The proposed research aimed to obtain information and trial results regarding mobile health application usage for prediabetes participants screening and early intervention at primary health cares setting.

The goal of this study is to create a mobile health application for prediabetes patients that included screening and early intervention in Primary Health Cares (PHCs) setting. More specifically, the objectives are as follows:

1. To portray regular prediabetes screening and early intervention practice in PHCs.
2. To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs.
3. To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs.
4. To assess internal and external factors that influence the intention-to-use, easiness, and usefulness of mobile health applications for prediabetes patients and health staff.
5. To assess the impact of early intervention using mobile health applications on prediabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as the prediabetic state using American Diabetes Association (ADA) criteria
* have no previous diagnosis of type 2 diabetes or history of taking anti-hyperglycemic drugs
* have access to and able to use a personal smartphone
* willing to undertake study activities and written informed consent

Exclusion Criteria:

* severe medical condition
* disability to perform physical activity
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

This single arm, prospective non-blinded study will enroll 50 patients initiating treatment with BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib or pirtobrutinib) without documented arrhythmia prior to starting BTK inhibitor therapy, without contraindications to an implanted loop recorder (ILR). They will be offered the option of monitoring arrhythmias using the Medtronic LINQ-2 insertable cardiac monitor (ILR). Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months. Investigators hope to obtain information on arrhythmia incidence including AF, ventricular arrhythmia (VA), and actions taken in response to awareness of such episodes.

Eligibility Criteria:
Inclusion Criteria:

* \>18yo
* Willing to sign and date consent form,
* Willing to be remotely monitored
* Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
* Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor

Exclusion Criteria:

* Documented AF/VA in past 12 months
* Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year
* Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device
* heart surgery within past 90 days
* Myocardial Infarction within past 90 days
* Patient is taking an anti-arrhythmic or anticoagulant
* has concomitant condition that precludes safe participation in study (substance abuse, etc)
* Enrollment in separate study that could confound results of this study
The Use of the "Comprehensive Complication Index" for Urinary Lithiasis Surgery.

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. The study will take place at the 2nd Urology Clinic of the University of Athens, at the Sismanoglio Hospital of Athens. It will include patients diagnosed with kidney stones after plain X-ray and/or CT scan. Percutaneous nephrolithotripsy will be performed on stones \> 2 cm, while extracorporeal or retrograde nephrolithotripsy on stones \< 2 cm. Patient demographics (age, gender, body mass index, comorbidities, anticoagulant use), stone-related data (maximum stone size, anatomic location of stone, number of stones, presence of hydronephrosis preoperatively, presence of piglet catheter preoperatively, positive urine culture, preoperative chemoprophylaxis ) as well as information about the operation (type of anesthesia, operation time, hospitalization time) will be reported. Finally, all possible complications will be recorded intraoperatively, immediately postoperatively and up to 30 days after the day of surgery. This will be followed by a statistical analysis of the resulting data and a comparison between the CDC and CCI systems using the SPSS statistical program. To describe continuous variables, the mean/standard deviation will be used if it is a normal distribution, or the median and range if it is a non-normal distribution. The Shapiro-Wilk test will be used to investigate the distribution of the data. The absolute number and the corresponding percentage will be used to describe the qualitative variables. For the comparison of continuous variables, the parametric t-test will be used if the data follow a normal distribution, or the Mann-Whitney U test if they do not follow a normal distribution. Chi-square and Fisher's exact test will be used to compare qualitative variables. Exclusion criteria from this study are:

1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
2. Recent similar operation that the patient has undergone (interval of less than one month).

Eligibility Criteria:
Inclusion Criteria:

Patients with urinary lithiasis undergoing ureterolithotripsy, percutaneous nephrolithotripsy or extracorporeal shockwave lithotripsy.

Exclusion Criteria:

- 1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.

2. Recent similar operation that the patient has undergone (interval of less than one month).
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?

Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal damage. A variety of published studies have demonstrated this treatment to be both safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a popular type of pain treatment. The application of PRF is also a safe and useful intervention for neck pain. Although these treatment types are described in the literature, the available evidence for efficacy is not sufficient to allow definitive conclusions on the optimal therapy to be made. The purpose of this study is to investigate which technique is the most effective in terms of pain relief on short term in patients with contained cervical disc herniation: PCN or PRF?


Eligibility Criteria:
Inclusion Criteria:

* Patients are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
* Patients of either sex and of all races have been diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level;
* Patients received a diagnostic block;
* Patients failed conservative therapy during at least six weeks;
* Patients have complaints of radicular pain with or without neck pain, corresponding the herniated level;
* Patients score \>=50 mm on 100 mm Visual Analogue Scale for pain (VAS-100 mm);
* Patients are able and willing to return for follow-up evaluations;
* Patients have a stable drug regime.

Exclusion Criteria:

* Patients have contraindications for intervention with PCN or PRF;
* Patients have been diagnosed with an extruded or sequestered disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis;
* Patients have been diagnosed with uncovertebral or facet arthrosis;
* Patients underwent previous surgery or received any type of infiltrations at the indicated cervical level;
* Patients diagnosed with a contained cervical disc herniation \>1/3 spinal canal;
* Patients with radiographically confirmed loss of \>30% of disc height compared to adjacent level;
* Patients with evidence of severe disc degeneration;
* Patients suffer from uncontrolled psychological disorders;
* Patients suffer from unstable medical condition.
Removable Devices in Overjet Reduction

The goal of this clinical trial si to compare two removable devices used to treat the mandibular retrusion in growing patients.

The main questions it aims to answer are:

* the efficacy of the two devices in the reduction of the overjet
* the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.


Eligibility Criteria:
Inclusion Criteria:

* skeletal class II relationship,
* complete eruption of upper first premolars
* presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).

Exclusion Criteria:

* IOTN (INDEX OF ORTHODONTIC TREATMENT NEED) index \> 4;
* presence of epilepsy,
* systemic disease,
* TMD, or periodontal disease;
* lack of written informed consent from a parent or legal guardian.
Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)

Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.

Purpose of this pilot study is to modulate the motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation. Electromyography will be recorded on right abductor digiti minimi muscle to find the motor threshold and measure motor evoked potentials for each healthy participant. In addition, electroencephalography (EEG) data will be collected on the scalp with a high-density EEG net. Eighteen healthy participants will be in this study. Each participant will be seated in a reclining chair and applied non-invasive magnetic and electrical stimulations on the scalp. At baseline, the participant's resting motor threshold (RMT) will be estimated by adjusting the intensity of TMS applied on the left motor cortex to achieve motor-evoked potentials of about 50 uV with 10 TMS pulses at a rate of 0.25 Hz. Then a 3-condition, 3-session, 6-sequence randomized crossover experiment will be used to characterize and compare three versions of tDCS stimulation: anode, cathode, sham. Before and after a 10-min tDCS condition is applied, TMS pulses at 120% of RMT intensity will be applied for 10 minutes and TMS-evoked potential and motor-evoked potential amplitudes will be measured. Each session has at least 1-day gap to remove outlasting effects. We will also be collecting structural magnetic resonance imaging (sMRI) to target primary motor cortex precisely.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Between the ages of 18 and 35
* Right-handed
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Willing to comply with all study procedures and be available for the duration of the study
* Speak and understand English

Exclusion Criteria:

* Prior concussion
* Diagnosis of eating disorder (current or within the past 6 months)
* Diagnosis of obsessive compulsive disorder (lifetime)
* Attention-deficit/hyperactivity disorder (currently under treatment)
* Neurological disorders and conditions, including, but not limited to:

  * History of epilepsy
  * Seizures (except childhood febrile seizures and electroconvulsive therapy-induced seizures)
  * Dementia
  * History of stroke
  * Parkinson's disease
  * Multiple sclerosis
  * Cerebral aneurysm
  * Brain tumors
* Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment)
* Prior brain surgery
* Any brain devices/implants, including cochlear implants and aneurysm clips
* Traumatic brain injury
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study