cyrilzakka/clinical-trials huggingface dataset:
The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation

In addition to their role in allergic inflammation, mast cells are often found at the site of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.

The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.

In this work, we are interested to determine the factors in lung cancer microenvironment that attribute to mast cell activation. Beside the tumor cells themselves, the cancer microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different feature compared to normal fibroblasts (NFs). In this work we are interested to determine whether CAF cells derived from lung tumors, together with the lung cancer cells, or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/ or to release various cytokines and chemokines.

For this propose, during surgery of patients with lung cancer, we will take unnecessary sample from the cancer and from normal area for purification of CAF or normal fibroblast cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be collected for determine degranulation and cytokine release from these mast cells.


Eligibility Criteria:
Inclusion Criteria:

Patient with non small cell lung carcinoma

Exclusion Criteria:

none
The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy

The purpose of this study is to test the hypothesis that decreasing the inspired oxygen concentration during thoracic surgery requiring one lung ventilation will improve post-operative oxygenation.

One lung ventilation is frequently required during thoracic surgery and results in decreased lung function post-operatively. Supra-physiologic oxygen levels during surgery may contribute to this decrease in lung function by worsening lung injury intra-operatively.

This study will include patients undergoing surgery to remove a lung lobe requiring one lung ventilation.

The patients will be divided into two groups with the experimental group receiving a 60% oxygen in air mixture and the control group receiving 100% oxygen.

The two groups will be compared by using a measure of lung function (the ratio of the partial pressure of oxygen in arterial blood to the inspired oxygen concentration) and blood levels of a protein correlated with lung injury (receptor of advanced glycation end products RAGE).

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18 years of age and older, male or female.
2. American Society of Anesthesiology (ASA) physical status I, II, III or IV
3. Subjects who are scheduled for elective primary pulmonary lobectomy.
4. Subjects who have an arterial line placed as part of routine anesthetic management
5. Subjects who can understand and communicate in English.

Exclusion Criteria:

1. Subjects with a history of difficult intubation
2. Subjects with a high risk of aspiration during induction of anesthesia
3. Subjects with morbid obesity (BMI greater than or equal to 40)
4. Subjects with unable to provide consent
5. Subjects who are minors
6. Subjects who are not English speaking
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery


Eligibility Criteria:
Inclusion Criteria:

* Normal eye exam except for refractive error at baseline.
* Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline.

Exclusion Criteria:

* Monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.
* Any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.
* Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy, pterygium removal, corneal transplantation).
* Chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing.

Other inclusion and exclusion criteria apply.
The Sex Specific Waist Circumference Cut Off Points to Predict Overweight or Obesity

The waist circumference (WC) cut off levels of the Caucasian people may not represent the characteristics of different ethnic groups. The investigators aimed to determine sex specific WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adults.

Waist circumference (WC) is an easy and reliable measure of visceral adipose tissue and a simple index of cardiovascular risk. The World Health Organization (WHO) reported sex specific WC cut off values for the Caucasian people, named as action levels 1 and 2, to define the overweight or obese people. These cut off values, originally established in a Dutch population, were later adopted by several medical organizations in order to define Metabolic Syndrome. However, these cut off levels may not necessarily represent the characteristics of the other populations. Therefore it is recommended that the sex specific WC cut off points should be established for different ethnic groups.

The investigators aimed to investigate whether the suggested sex specific WC cut off points for the Caucasian adults are appropriate for the Turkish adult population. The secondary aim of the study is to search for better WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adult men and women.

Eligibility Criteria:
Inclusion Criteria:

* Adult Male or nonpregnant Female

Exclusion Criteria:

Pregnant females, Subjects younger than 20 or older than 83
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

The hypothesis:

Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.

Aim:

Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).

Secondary objective:

* To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.
* To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI.
* To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI

Study central:

* Bursa Postgraduate Hospital, Cardiology Clinic

Study population:

* we planned to enrol 200 patients.
* Patients will randomise in two groups (control group:100 patients, study group:100 patients)

Study works:-Write case report form for all patients

* Control for inclusion criteria
* Demographic data (age, gender)
* Height, weight, BMI and glomerular filtration rate (GFR)
* Risk factors
* laboratory data (biochemical and hematologic)
* Medication history
* Echocardiographic data
* Angiographic data
* Procedure time
* PCI data(vessel diameter, stent diameter, lesion and stent length, performed percutaneous transluminal coronary angioplasty (PTCA) or not, etc)
* Before and after procedure (activated clotting time) ACT value
* Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels
* Note complication (MACE, bleeding, hematoma etc)
* Note femoral compression time.

  4 weeks later note the first control data.

Six months later note the second control data.

Eligibility Criteria:
Inclusion Criteria:

* The patients; who have planned elective PCI and have had written informed consent for participation to study.
* The native coronary artery;

  * lesion with narrowing \>=70%,
  * lesion without thrombus
  * no left main coronary artery (LMCA) lesion
  * no chronic total occlusion lesion

Exclusion Criteria:

* Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin
* Patients who performed primary PCI
* Patients with acute coronary syndrome
* Patients with have a history of myocardial infarction (MI) for two weeks
* Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours
* Patients on warfarin therapy
* Patients who have bleeding diathesis, or have high risk for bleeding.
Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery

Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy.
* Patients with good oral hygiene.
* Class II or III malocclusion.
* Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment

Exclusion Criteria:

* Patients with acute infection at the surgery site.
* Patient with Systemic disorders contraindicating surgery.
* Smokers.
* Alcohol or drug abuse is prohibited.
* patients who suffered from craniofacial syndrome;
* patients who had previous orthognathic surgery;
* patients who had previous maxillary or mandibular trauma
TD-9855 Mass Balance Study

The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]TD-9855


Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone \[FSH\] \>40 IU/mL)
* Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
* Negative for hepatitis B, hepatitis C, and HIV antibody

Exclusion Criteria:

* Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
* Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
* Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
* Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.
First Episode Psychosis and Pathway to Care in Nordland

First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and challenging access to health services. The purpose of this study is to explore the process of help seeking, including how patients and their careers discover and understand the psychotic symptoms. Research exploring the impact on families mainly focuses on parents' experiences, and there are less studies focusing on experiences and needs of siblings. This study will therefore explore siblings' experiences separate from their parents. Methods will be qualitative interviews with patients, their carers and siblings. Analysis will be influenced by Grounded theory.


Eligibility Criteria:
Inclusion Criteria:

* age 16-35,
* understand and speak Norwegian
* able to give consent
* no learning disabilities

Exclusion Criteria:
Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS

To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* IBS diarrhea

Exclusion Criteria:

* \< 18 years of age
* Pregnancy/breast feeding
* concomitant medications to reduce bowel function
A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Metastatic NSCLC
* Scheduled to initiate an immune checkpoint inhibitor
* Age \>= 18 years
* Able to provide informed consent

Exclusion Criteria:

* Other, unrelated, concomitant active, invasive malignancy
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.

We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Underwent transcatheter aortic valve replacement
* Lives within 20-mile radius of the recruiting site
* Plan to be discharged home
* Able to provide informed consent

Exclusion Criteria:

* Stroke or any other medical disease that precludes participation in the exercise program
* Severe cognitive impairment (Mini-Mental State Examination \< 15)
* Current enrollment in another clinical trial
Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in metastatic castration resistant prostate cancer


Eligibility Criteria:
Inclusion Criteria:

1. Participants provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
2. Participants must be ≥18 years of age and competent to give informed consent.
3. Participants must have progressive mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate. Participants must have documented PSA and/or radiographic progression.
4. Participants must have Gallium 68 PSMA-11 (Ga 68 PSMA-11) Positron Emission Tomography (PET)/Computed Tomography (CT) prostate-specific membrane antigen (PSMA) positive lesions ≤ 30 days prior to beginning study therapy.
5. Participant has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan.
6. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
7. Participants must have a life expectancy of more than 3 months.
8. Effective castration with testosterone level of \<50 ng/dL and plan to continue with chronic medical or surgical castration.
9. Participants must have adequate hematological and organ function.

Exclusion Criteria:

1. Participants with any medical condition or other circumstances that, in the opinion of the investigator, would preclude participation in this study, compromise obtaining reliable data, achieving study objectives, or completion.
2. Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma.
3. Participants with any PSMA-negative metastatic lesion these criteria were ineligible.
4. Less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy or prior treatment with 223Radium, 89Strontium or 153Samarium containing compounds).
5. With active or uncontrolled infection.
6. Have used any other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment, or have used any investigational medical devices within 4 weeks prior to the start of the study treatment, and plan to receive other investigational drugs or medical devices during the course of this study.
7. Previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol.
8. Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy during and for 90 days after discontinuation of study treatment.
Immediate Maintained Cannulation of a Newly Implanted Prosthetic Arteriovenous Access for Acute Hemodialysis

Objectives: Examine the acute utility of immediate maintained cannulations of a newly implanted prosthetic arteriovenous access. Background: Recurrent failure of central catheterization is not uncommon. An alternative access is necessary for acute hemodialysis after the exhaustion of central veins. Methods: We constructed the access by cannulating two dialysis needle-catheters and securing them on the skin after the implantation of the graft. The access was used immediately and maintained for one week and thereafter used as a long-term access.


Eligibility Criteria:
Inclusion Criteria:

* end-stage renal disease underwent the specific prosthetic arteriovenous access creation in our hospital from November 2003 to October 2005

Exclusion Criteria:

* patients' poor health as long as they did not have other options and needed an access for acute hemodialysis. Exclusions included shock, active systemic infection, and rejection by the attending nephrologists
Pilot Study of BCAA on Sleep

Individuals will be recruited from the VA Portland Health Care System and the community affiliated with Oregon Health \& Science University. Traumatic brain injury status will be assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.

The goal of this proposal is to explore the feasibility of, and potential for, dietary supplementation with branched chain amino acids (BCAAs) to effect sleep quality and cognitive function in Veterans. The BCAAs (Leucine, Isoleucine, and Valine) cannot be synthesized endogenously (i.e., they must be obtained through the diet) and are the precursors to \>50% of de novo glutamate and GABA synthesis in the brain, which are the primary excitatory and inhibitory neurotransmitters, respectively. Preclinical evidence strongly suggests that dietary BCAA supplementation restores normal sleep-wake patterns and cognitive function following TBI through a restoration in the global cortical excitation:inhibition ratio. BCAA supplementation has been studied extensively in healthy humans and in a variety of disease states, including following TBI, but not yet in Veterans in the chronic phase of recovery from TBI. BCAAs are a commercially available dietary supplement and very well tolerated with minimal side-effects.

Subjects will be randomized in a double-blind fashion through the VA Research Pharmacy to one of three groups: 1) BCAA; 60 g/day in two 30 g doses, 2) rice protein; 60 g/day in two 30 g doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. BCAA and placebo will be prepared by the VA Research Pharmacy and dispensed in a blinded fashion to Veterans after demonstrating informed consent. Following a \~4-week period of baseline, Veterans will be instructed to consume study product after waking and \~6 hours later, on an empty stomach for a period of up to 21-days. Self-report questionnaires assessing sleep quality, cognitive function, trauma-related symptom severity, and other measures of mental and physical well-being will be administered before and after the experimental period. Wrist actigraphy will be continuously collected over the baseline and the experimental period. Cognitive function will be assessed before and after the experimental period using an established battery of neuropsychological tests (i.e., selected tests from WAIS, D-KEFS, HVLT, COWAT, among others. Pressure pain testing will be conducted before and after the experimental period.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* English Speaking
* Accessible via phone
* Sleep problems

Exclusion Criteria:

* Decisional impairment
* Nickel allergy
* Maple syrup urine disease or family history of disease
* Allergy to sucralose
* Currently taking BCAAs