cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.

OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients with previously untreated extensive stage small cell lung cancer. II. Determine the overall and progression free survival of these patients in response to this treatment regimen. III. Determine the toxicity of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for 6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, then every 3 months for 2 years, and then annually for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed extensive stage small cell carcinoma of the bronchus Extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy Measurable disease One lesion that measures at least 20 mm in diameter using conventional techniques or at least 10 mm with spiral CT scan Lesions not considered measurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Cystic lesions Tumor lesions situated in a previously irradiated area Abdominal masses not confirmed and followed by imaging techniques No disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT less than 2 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for renal failure or hormones administered for nondisease related conditions Radiotherapy: At least two weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified
A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test

This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain information on Alzheimer's disease (AD) progression, the stability of healthy control (HC) MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical. The current study is intended to extend the database of AD and HC MEG scans and will include patients who previously enrolled and completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately 50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard functional tests while HC subjects will complete 2 standard functional tests. ApoE genotyping also will be determined for all subjects. The results generated in this study will be used to improve the accuracy of the SNI test for diagnosing and tracking the progression of AD.


Eligibility Criteria:
Inclusion Criteria:

* Subject enrolled and completed Orasi Protocol ADG 08-01
* Subject understands the study procedures and agrees to participate in the study by giving written informed consent. In the event the subject lacks the capacity to sign the consent form then the subject's Legally Authorized Representative (LAR) may sign on the subject's behalf. See Section 5. Informed Consent for details.
* Subject is a non-smoker.
* Subject is judged to be in good health other than AD, if applicable

Exclusion Criteria:

* Subject has a history or diagnosis of a significant neurological condition other than Alzheimer's disease including Parkinson's disease, vascular dementia, Lewy body dementia, frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, seizures, epilepsy, stroke, ADHD, dyslexia, or severe traumatic brain injury.
* Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
* Subject has a Modified Hachinski Ischemia Scale (HIS) score greater than 4.
* The subject has a recent history (within 2 years) of alcohol or substance abuse/dependence.
* Subject had an MRI within two weeks prior to Study Visit 2.
* Subject has metal dental braces, pacemaker or other common medical devices that may interfere with the MEG scan.
* Subject is unable to complete the MEG scan procedure.
* Investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation
Text Message Safety Behavior Fading for Social Anxiety

The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.

Safety behavior fading may be a viable standalone intervention for social anxiety. In the present trial, participants high in social anxiety will be randomized to either receive a daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their four most habitual social anxiety safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Individuals randomly assigned to the control condition will receive similar text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants in both conditions will complete checklists for 28 days. After day 14 of treatment, participants will re-select their target safety behaviors or unhealthy behaviors, and will then be prompted to reduce these new behaviors for another 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Social Phobia Inventory Score \>29
* Stable Psychotropic Medications for 4 weeks prior to participation

Exclusion Criteria:

* Currently participating in psychotherapy for social anxiety
School-Based Physical Education Program and Its Effects on Motor Fitness in Malaysian Children

The objective of this randomized controlled trial was to compare the effects of a standard school physical education program (SPEP) and a rhythmic and gymnastic activities-based school physical education program (RGPEP) on the physical and motor fitness parameters of Malaysian primary school children.

This randomized controlled trial evaluates the impact of two distinct physical education programs on the physical and motor fitness of Malaysian primary school children. The intervention group participates in a rhythmic and gymnastic activities-based physical education program (RGPEP), designed to enhance balance, coordination, flexibility, and agility through structured, progressive activities. The control group follows the standard school physical education program (SPEP) in line with the national curriculum, which emphasizes general fitness and physical activity without specific rhythmic or gymnastic components.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 years at the time of enrollment.
* Both boys and girls.
* Regular school attendance during the academic year.
* No diagnosed health conditions or chronic diseases that could interfere with physical activity.
* Not involved in extracurricular sports activities outside the school environment.
* Not engaged in extra traveling to and from school on foot or by bicycle.
* Parents or legal guardians provided written informed consent.
* The child provided verbal assent to participate in the study.

Exclusion Criteria:

* Children missing more than 20% of scheduled physical education classes.
* Overweight children with a BMI ≥ 23 kg/m².
* Underweight children with a BMI \< 18.5 kg/m².
* Children involved in regular sports training or participation in extracurricular sports activities during the intervention period.
* Children with any pre-existing medical conditions or injuries that could limit participation in physical activities.
* Children with developmental or motor impairments affecting their ability to perform the required fitness activities.
* Children on any medication that could interfere with their performance or physical fitness evaluation.
Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention

The project aims to increase HPV vaccination and cervical cancer screening through a web-based mobile health education program called, Wheel of Wellness (WoW) and a brief negotiated interview (BNI). The in-person BNI and WoW system will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening.

WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The researchers will conduct a single armed proof of concept where the participants will be actively using WoW. The in-person BNI will empower participants to have positive behavioral changes in regards to their health by giving them appropriate health information as well as answering their questions and concerns about cervical cancer prevention and screening.

Eligibility Criteria:
Inclusion Criteria:

1. Parent/guardian with a child between the ages of 9 to 17 who receives primary care at one of the participating sites and their male child.
2. Parent/guardian with a male child who provides consent to have child's HPV vaccination status checked in EMR.
3. Parent/guardian with a male child who has neither initiated the HPV vaccine nor completed the series
4. Parent/guardian and male child with the ability to read and write in English.
5. Parent/guardian and male child have access to a smartphone.

Exclusion Criteria:

1. Parent/guardian's eligible child is pregnant.
2. Parent/guardian's has begun or completed the HPV series.
3. Parent/guardian, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent.
Biocollection on Peripheral Inflammation

Most psychiatric research is based on the nosographic classifications used in current practice. At present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice. The study hypothesis is that peripheral inflammatory biomarkers could be common to several psychiatric disorders, in particular psychotic disorders (bipolar disorder, schizophreniform disorder, schizophrenia, depressive episode with psychotic features). The aim of this project is to set up a bio-collection of biological samples (peripheral blood samples) with associated phenotypic data (assessment of various symptoms using standardized scales in patients whose blood is sampled). The setting up of this cohort follows on from work carried out on a PsyCourse cohort also using a transdiagnostic approach in psychiatry, in order to be able to collaborate within a European research project.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with one of the following diagnoses confirmed by a psychiatrist:

  * Characterized depressive episode with psychotic features,
  * Bipolar disorder type I
  * Bipolar disorder type II
  * Schizoaffective disorder
  * Schizophrenia
  * Schizophreniform disorder
* Patient under psychiatric care at Nantes University Hospital
* Patients weighing at least 45kg
* Patient affiliated to a social security scheme or beneficiary of such a scheme
* Patient who has given informed consent to participate in the study

Exclusion Criteria:

* Pregnant,
* History of cancer in the last 5 years,
* Vaccination within the last 4 weeks,
* Acute or chronic infection,
* Medical history of organ transplant,
* Medical history of autoimmune disease,
* Hearing impairment making it impossible to complete study questionnaires,
* Patient under court protection
Effect of Rosuvastatin in Abdominal Sepsis

The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.

In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.

There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. Man or women \> 18 and \< 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
2. Injury by steel or firearm with contaminated abdominal cavity
3. APACHE II major or equal than 8
4. Acceptance to be included

Exclusion Criteria:

1. Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
2. Hypovolemic shock III and IV after get surgery
3. Cardio-respiratory failure pre or trans surgery
4. Allergy to used drug
5. Use previous of statin
6. Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
7. Management in other Hospital
8. Pregnancy
9. Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury
Cancer Survivor Cardiomyopathy Detection

The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.

The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction \[LVD, defined as a left ventricular ejection fraction (LVEF) \<50%\] in cancer patients at 1 year after completion of anthracycline-based chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age prior to enrollment and anthracycline start date
* Diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure.
* Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same

Exclusion Criteria:

* LVEF \<50% or prior confirmed history of cardiomyopathy, heart failure, left bundle branch block, or paced rhythm
* Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same.
* Individuals with pacemakers, defibrillators, or other implanted electronic devices
* Inability/unwillingness of individual to give written informed consent
BIOFLOW-III Canada Satellite Registry

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease or documented silent ischemia
* Subject informed consent for data release
* Subject is geographically stable and willing to participate at all follow ups assessments

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation/antiplatelet therapy required for PCI, stainless steel, sirolimus
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
Meditation and Decision Making Study III

The overarching goal of the proposed research is to investigate the role of emotions in facilitating successful lifestyle change, defined as healthy behavioral decisions repeated daily, or near daily.

Participants are asked to make two lab visits during the course of four weeks to complete electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate, blood pressure, respiration), and listen to a guided meditation audio track. Additionally, between the two visits participants will be asked to complete weekly surveys that ask about daily meditation practice (outside of the lab) and general emotions.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in written and spoken English, with a high school reading level
* Willingness or interest in learning to meditate
* Computer literate with internet access

Exclusion Criteria:

* Individuals who are able to read Chinese logographs
* Individuals who have or have had a regular meditation practice, defined as having attended a 6-week or longer meditation class, practicing meditation at least 3 days a week for up to 6-weeks.
* Individuals with allergies to adhesive materials
Accuracy of Patient Specific Guide for TMJ Injection

This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
* Patients who would not respond to conservative treatment as the first line of treatment.

Exclusion Criteria:

* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection

The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure.

GOAL: Confirm therapeutic level of glutathione following topical transdermal application.

HYPOTHESIS: The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80%.

AIM: Determine a non-invasive way to increase glutathione levels in the plasma and blood cells.

This aim will be accomplished as follows:

STEP 1: We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine (NAC) supplementation.

STEP 2: Determine baseline levels of GSH, free radicals and cytokines through analysis of venipuncture blood draws.

STEP 3: Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen. Measure the levels of GSH, free radicals and cytokines after 1 hour, 4 hour and 72 hours.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 (Control group) will include 15 healthy volunteers with the age group between 21-65. Participants belonging to Group 1 will be recruited from the local area. Group 1 will serve as controls for Group 2.

Group 2 (Glutathione Group) will include 15 healthy volunteers that are not allergic to any components of GlutarylTM who will be sprayed four times twice a day for three days with Topical glutathione Complex (GlutarylTM) formulation on their skin on their ventral part of the abdomen.

Components of Glutaryl:

Main ingredients of Glutaryl are Glutathione, ascorbic acid and cyclodextrin. The preservative system used is potassium sorbate and radish root extracts.

Exclusion Criteria:

* Pregnant and breastfeeding women. Anyone below age of 21 or above age of 65. Patients with active cancer. Patients with known liver disease, hepatitis, COVD-19, HIV, or AIDS. Patients taking some form of glutathione. Subjects who have previously fainted following venipuncture will also be excluded. By interviewing the subjects we will determine whether or not the subject will be excluded from the study based on their previous phlebotomy experiences.