cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer

The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.

Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.

We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.

Eligibility Criteria:
Inclusion Criteria:

* Estrogen or progesterone receptor positive stage IIIb/IV non-small cell lung cancer
* Eligible patients will have stable disease on erlotinib monotherapy at FDA- approved doses after a minimum duration of erlotinib therapy of 2 months
* 18 years or older
* ECOG Performance Status ≤2
* Adequate Organ Function Requirements
* Adequate coagulation function
* Postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
* All patients must sign a written informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding women will not be entered on this study
* Patients who are currently receiving another investigational drugs
* Patients who are currently receiving other anti-cancer agents.
* Hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
* Patients who have an uncontrolled infection.
* Patients receiving less than 100mg/day of erlotinib
* Patients with evidence of progression after 2 months of erlotinib monotherapy.
* Patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation \[DIC\], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
* Patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol).
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Air Pollution and Cardio-metabolic Health

To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults.

To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in a panel study involving young healthy adults living in Beijing, China with extreme high ambient air pollution levels.

Eligibility Criteria:
Inclusion Criteria:

1. Living in Peking University Health Science Center neighborhood.
2. Non smoker and no diseases.

Exclusion Criteria:

1. Advanced microvascular complications and active cardiovascular disease.
2. Pregnancy or intent to get pregnant during the study period.
An Interventional Pilot Study to Investigate the Feasibility and Acceptance of a Structured Psychological Support Program for Patients, Caregivers, and Presymptomatic Carriers in Hereditary Transthyretin Amyloidosis With Cardiomyopathy

Hereditary transthyretin amyloidosis (ATTRv) is a genetic, progressive and disabling disease that affects multiple organs and severely compromises the quality of life of patients and their families. A holistic approach is essential, which, in addition to early diagnosis and clinical management, includes psychological support to address the emotional and psychosocial impact of the disease. Although specific interventions for mental well-being are recommended, studies evaluating support tools for patients with ATTRv cardiomyopathy and their caregivers are lacking.

The overall objective of the study is to evaluate the feasibility, acceptance and preliminary efficacy data of a structured psychological support program for patients, caregivers and presymptomatic carriers in hereditary transthyretin amyloidosis (ATTRv) with cardiomyopathy.

The primary objective is to evaluate the feasibility of a psychological support program for patients, caregivers and presymptomatic carriers.

The co-primary objective is to evaluate the acceptance by patients of the proposed psychological support program.Key secondary objective: Evaluate the effects of the psychological support program on the levels of anxiety and depression in patients and presymptomatic carriers of ATTRv during the psychological support pathway (at 6 months) and at the end (at 12 months);

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years;
* Fluent in Italian;
* Patient, presymptomatic carrier or ATTRv caregiver, in charge of UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia;
* Signing of the specific Informed Consent

Exclusion Criteria:

* Subjects who, although belonging to UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia - present a diagnosis of another type of amyloidosis.
Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin

Molutrex® a 5% potassium hydroxide solution for topical application to the skin. Molutrex® is intended for the superficial treatment of certain types of warts, molluscum contagiosum and is composed of potassium hydroxide (5%) purified water. With regard to the 2017/745 RDM, he is a class IIa medical device. In accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 relating to medical devices, as part of the Molutrex® Post-Marketing Monitoring Plan, the objective of this study is to have data on the performance , safety and suitability for real-life use of Molutrex® in a prospective cohort of patients with molluscum contagiosum.

Since molluscum contagiosum is most prevalent in children, and potassium hydroxide is used very little in adults (because most often they are immunocompromised patients requiring other antiviral treatments), the study will be conducted in children aged 2 to 10 years. This population represents the majority of patients treated with Molutrex®, although the product can be used in adults. The study includes 2 visits, the objective of the study being to evaluate the percentage of children healed at 45 days, healing defined by a reduction of more than 90% in the number of lesions present at inclusion in the study.


Eligibility Criteria:
Inclusion Criteria:

Child aged 2 to 10 years old :

* Ambulatory
* Seen in dermatology consultation for molluscum contagiosum
* For which a treatment with a 5% solution of potassium hydroxide (Molutrex®) in local cutaneous application has been decided by the dermatologist as monotherapy
* Not treated for their molluscum contagiosum in the previous month
* For which one of the parents gives their written consent to participate

Exclusion Criteria:

Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye
Gene Molecular Alterations As Disease Prognostic Markers in Patients with Non-small Cell Lung Cancer (NSCLC)

GEMA pro- NSCLC is an observational, multicenter, single cohort, retrospective clinical trial. The aim of the trial is to assess the prevalence, and prognostic value of genetic molecular alterations in unselected patients with histologically confirmed non-small cell lung cancer (NSCLC), diagnosed over a period of 20 years.

This a non- interventional, multicenter, retrospective one arm trial assessing patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC), between 2000 and 2020. Patients received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece between 2000 and 2020. Molecular alterations, including single nucleotide variants, copy number alterations and translocations are detected with next generation sequencing using the ForeSENTIA® NSCLC panel developed by NIPD Genetics. The aim of the trial is to assess the prevalence and prognostic value of molecular alterations in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Adequate tissue availability for somatiic gene alteration testing
* Suitable tissue for somatic gene alteration testing following

Exclusion Criteria:

* Unmet age eligibility inclusion criteria
* Patients with personal medical history of malignancy, other than non-small cell lung cancer (NSCLC), with the exclusion of completely resected non-melanoma skin cancers, in situ carcinomas of the cervix uteri, in situ bladder carcinomas, in situ ductal breast carcinoma, and other cancers treated with curative intent with no evidence of disease recurrence for 5 years.
Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.

This study seeks to explore whether increased physical activity in school affects children's executive function, aerobic Fitness and childrens self-regulation. The "Active school" study was a 10-month randomized controlled trial. The sample included 449 children (10-11 years old) in five intervention and four control schools. The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework. Aerobic fitness was measured using a 10-minute interval running test. Executive function was tested using four cognitive tests (Stroop, verbal fluency, digit span, and Trail Making). A composite score for executive function was computed and used in analyses.

Self-regulation was measured by the Child Behavior Rating Scale.


Eligibility Criteria:
Inclusion Criteria:

* all children attending 5th grade at the included schools in Stavanger, Norway during the school-year 2014/2015.

Exclusion Criteria:

* not able to participate in daily physical activity and physical education and complete the cognitive tests.
Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers

Background: The increase of chronic diseases has reached an increase in the suffering of advanced diseases and an inability of health care systems to give access to the population that suffers them. In this context are people with advanced cancer who are in palliative care and the family caregivers. Uncertainty in illness in palliative care and quality of life are two concepts that are altered in the patient's family caregiver in palliative care. Objective: to examine the feasibility and acceptability of a nursing intervention to reduce the uncertainty in illness and improve the quality of life of family caregivers of patients with cancer in palliative care. Methodology: Phase II clinical trial, the ratio of recruitment, follow-up of participants as well as satisfaction with the intervention will be evaluated as primary outcomes. As secondary outcomes, the possible effect of the intervention on the uncertainty in illness and the quality of life of the family caregiver will be evaluated. This study will be carry out in a health care institution in Medellin-Colombia.


Eligibility Criteria:
Inclusion Criteria:

* Being the person responsible for the care of the person in palliative care most of the time
* Being over 18 years of age;
* Caring for a person who has a diagnosis of cancer stage IV, who is receiving palliative treatment for the disease and has an expectation longer than one month of life (determined by the physician)
* Being able to communicate in Spanish.

Exclusion Criteria:

* Being included in another institutional study of an educational nature
* Not knowing how to read
* Caring for another person with cancer before
* Have a significant cognitive disability
Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.

The purpose of this project is to investigate the occurrence of neck and back pain in a population of commercial helicopter pilots, and investigate factors related to the profession that can cause these problems. The project has a biological approach assessing the supporting and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots with low back problems are invited to a controlled intervention trial to investigate whether one can achieve improved spinal health with a rigid training régime. Primary trial outcome is improved neck and back multifidus muscles pathology and function as assessed by the extent of fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick leave frequency is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Pilots must experience low back pain in at least 1 of 3 flights or
* Pilots must have at least 2 episodes of low back pain of at least 24 hours duration over the last 12 months. Each episode is separated with at least one painfree month before and after each episode, or
* Pilots may have had more than 3 sick leaves due to low back pain over the last 5 years

Exclusion Criteria:

* contraindications for physical training/activity
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.


Eligibility Criteria:
Inclusion Criteria:

* aged 65+
* current depressive and/or anxiety symptoms
* current depressive and/or anxiety disorder
* able to participate in behavioral study

Exclusion Criteria:

* unable to participate in study
Inspired: Smartphone Videogame-Based Smoking Cessation Intervention

The investigators are testing a new, smartphone videogame-based intervention for smoking cessation.

The investigators have developed a novel smartphone videogame, where smokers are required to submit breath carbon monoxide samples to demonstrate smoking abstinence, and where they will earn game-based rewards contingent on meeting CO goals. Players will be working with teams to earn group and social rewards to help advance their game.

Eligibility Criteria:
Inclusion Criteria:

* Inclusionary criteria: Participants will be required to be of legal smoking age (\>19 in Alabama, Alaska, New Jersey, Utah, and in Onondaga, Nassau and Suffolk Counties in New York, \> 18 years of age in the remainder of the United States). Participants must also report smoking \>10 cigarettes per day, report smoking for \>2 years, answer 8 or higher on a Likert scale asking how much the person wishes to quit smoking right now (1 = not at all, 10 =very much), have a smartphone with a data plan and active contract extending for at least two months from the enrollment date (i.e., the duration of the study), and reside in the U.S. Participants in the study must submit an initial CO reading \> 10ppm (to prevent nonsmokers from enrolling in the study), Literacy will be assessed by having the participant read the first few lines of the consent form out loud, and will be an inclusion criterion because elements of "Breathe Free" will require reading.

Exclusion Criteria:

* Individuals will be excluded from the study if they report smoking any combustible products \>2 times per month, report unstable medical/psychiatric conditions that might interfere with the study objectives (e.g., asthma), report living with someone who smokes in the house, or has a career that results in excessive exposure to CO. All excluded participants will be emailed the following smoking cessation information: the "Clearing the Air" packet developed by the National Cancer Institute, Smokefree.gov, Quitsmokinghelpline.com, and the National Academies Press "Dying to quit."
Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Paclitaxel + Carboplatin + Gemcitabine
* Gemcitabine + Vinorelbine

For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Non-small cell bronchogenic carcinoma
* Newly diagnosed unresectable stage IIIB or stage IV disease
* Patients with stage IIIB disease should be ineligible for combined therapy
* Patients must have measurable lesion definable by X-ray or CT scan.
* No prior antineoplastic chemotherapy for lung cancer prior to study entry
* Age \> 18 years
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Written informed consent must be obtained prior to study entry
* Patients must be available for treatment and followup.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Female patient pregnant or lactating
* History of heart disease
* Serious active infection at the time of treatment
* Other serious underlying medical condition
* Brain metastasis
* Patients without measurable disease
* Uncontrolled diabetes mellitus defined as random blood sugar \> 250mg/dL
* Dementia or significantly altered mental status
* Significant peripheral neuropathy by history or physical examination.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

Adolescent Idiopathic Scoliosis (AIS) is defined as a three-dimensional lateral deformity of the spine. It is described with a cobb angle of greater than 10 degrees. There is no known etiology of AIS. Once the degrees of curvature become severe (greater than 45 degrees), surgical intervention (posterior spinal fusion - PSF) is often discussed. Most adolescent patients and their families opt for surgical correction to decrease future complications of severe scoliosis, such as decreased vital capacity of the lungs, potential future activity restrictions, cosmetic appearance, and self-esteem. While the patient and family are eager to undergo PSF, they do have concerns. The major concerns are pain control and their ability to return to activities.

In current literature, there are many studies completed regarding pharmacologic pain control management with the use of IV patient-controlled analgesia (PCA) with opioids, narcotics, non-steroidal anti-inflammatories, muscle relaxers, Tylenol, and gabapentin. However, there is not a well-established multimodal pain management plan for postoperative PSF patients. There is also no current literature discussing nonpharmacologic pain management methods, such as stretching, strengthening and yoga, for patients undergoing PSF. There are multiple studies discussing core stabilization used for helping AIS patients non-operatively. There is no literature discussing the use of nonpharmacologic pain management methods for improved pain control (including decreased use of pharmacologic agents) and quicker return to activities.

The aim of this study is to determine if patients with AIS undergoing PSF require fewer pain medications and have an earlier return to activities if completing a yoga program six weeks prior to their surgery.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Scoliosis patients
* English speaking patient and parents

Exclusion Criteria:

* Non idiopathic scoliosis diagnosis
* no access to internet or computer
* non-English speaking parents and/or patient
Intervention Effect of Shen-based Qigong Exercise on Residual Symptoms of Schizophrenia

The purpose of this study is to observe the intervention effect of shen-based Qigong exercise on residual symptoms of schizophrenia.

Shen-based Qigong exercise is a new kind of health-care Qigong exercise based on the theory of traditional Chinese medicine, aiming at the characteristics of schizophrenia. In this study, a randomized controlled trial was conducted to observe the rehabilitation effect of this new exercise on residual symptoms of schizophrenic patients. Questionnaire, test and other experimental materials were used to evaluate the intervention effect of 12-week shen-based Qigong exercise on psychiatric symptoms, cognitive function, quality of life and social function of schizophrenic patients. At the same time, the related physical function and cardiac function indexes were used to evaluate the physical and cardiac rehabilitation effects of the exercise on patients from the aspects of "body" and "heart", so as to verify whether Qigong exercise has the effects of adjusting body and heart.

Eligibility Criteria:
Inclusion Criteria:

1. Han Chinese population
2. age ≥ 18 years
3. education level ≥ 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination
4. assessed by MINI 7.0 and satisfied with the diagnostic criteria for schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fifth edition(DSM-5)
5. patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months
6. residual negative symptoms, with at least one item ≥ 2 on the negative subscale of PANSS (N1-N7)
7. taking second generation antipsychotics
8. no training history of traditional Chinese exercises
9. agreement to participate in the study and willing to give written informed consent

Exclusion Criteria:

1. having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases
2. satisfied with the diagnostic criteria for other mental disorders based on DSM-5
3. having alcohol or substance abuse/dependence
4. having mental retardation(WAIS\<70) and/or severe cognitive impairment(MMSE\<24)
5. having visual and / or hearing problems, unable to complete the relevant test
6. electroconvulsive or repetitive transcranial magnetic stimulation(rTMS) therapy in the past 3 months
7. currently enrolled or participated in other clinical studies in the past 3 months
8. participating in regular exercise training in the past 6 months
9. failure to sign or refuse to sign informed consent