cyrilzakka/clinical-trials huggingface dataset:
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer

The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.

Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage I-IV lung cancer eligible for surgery
2. Patients undergoing the completely thoracoscopic lobectomy
3. The nodule size was more than 2.5 cm
4. Patients consenting for intraoperative blood sampling

Exclusion Criteria:

1. Patients who underwent primary wedge resection and open lobectomy
2. Patients who received neoadjuvant therapy before surgery
Passive Smoking and LL-37 in Children

This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)

Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking, including alteration of both microbial and host response factors.

Antimicrobial peptides are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the oral gingival epithelium and in the transition to acquired immunity.

LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria and its role in maintaining oral health has recently been stated

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy children

Exclusion Criteria:

* Any medications known to affect defense system and periodontium
* The presence of orthodontic / intraoral appliance
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).

Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.

Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions

The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.

A total of 96 patients with de novo coronary artery stenosis will be included.

After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:

A) Study group: Pre-dilation with cutting balloon followed by ASES implantation.

B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.

Stent optimisation will be performed based on intracoronary imaging findings.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \>50% in a native coronary artery.

Exclusion Criteria:

1. Cardiogenic shock
2. Patients presenting with ST-segment elevation myocardial infarction
3. Patients undergoing chronic total occlusions PCI
4. Patients undergoing left main PCI
5. Patients undergoing venous bypass graft lesions PCI
6. Patients with in-stent restenosis
7. Inability to provide informed consent
8. Life expectancy \<1year due to non-cardiac disease
9. Currently participating in another trial before reaching first endpoint

There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
Turkish Version of The Upper Limb Hypermobility Assessment Tool

Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the upper extremities. The Upper Limb Hypermobility Assessment Tool (ULHAT) has been reported to be one of the most appropriate scoring methods for assessing upper extremity hypermobility in the literature. The aim of this study is to adapt ULHAT to Turkish and measure its validity and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged between 18 to 35

Exclusion Criteria:

* Using assistive devices or orthoses for the upper extremity
* Surgery history of the upper extremity
* Pain located on the upper extremity in the last 6 months
* Previous trauma that might restrict normal range of motion.
* Having degenerative or inflamatuar disease
Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.


Eligibility Criteria:
Inclusion Criteria:

* AN patients DSM IV criteria including amenorrhea BMI \< 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (\> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
* Recovered AN patients History of AN Weight recovery and BMI \> 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (\> 12 months) despite weight recovery
* Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
* For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance

Exclusion Criteria:

* History of heart failure
* Psychotropic treatment , antiepileptics
* Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
* Intense physical activity
* Constrains for MRI (ferromagnetic implants or claustrophobia)
* Refusal to be informed in case of incidentaloma revealed by brain imaging
* Refusal for written consent
Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.

Description: This study assesses brain function measured with High Resolution Positron Emission Tomography (HR-PET) during exposure to stressful traumatic scripts paired with tcVNS or sham stimulation, with secondary measures of blood inflammatory biomarkers, and sympathetic function. Participants then undergo three months of twice daily home treatment with repeat measures.

Drug/Device Handling: \[O-15\] radiolabeled water has a half-life of 110 seconds and is made on site at the Emory Center for Systems Imaging (CSI). Dr. Bremner holds the Investigational New Drug (IND) approval for use of radiolabeled water at Emory University. The investigators have performed hundreds of studies in human subjects at Emory and there have been no adverse events or untoward effects to date.

tcVNS with the GammaCore device is approved by the Emory IRB for a recently completed study in PTSD and others in progress for Opioid Use Disorder and was shown to be well tolerated and there have been no adverse events or untoward effects with the device. The FDA granted Breakthrough Device Designation for PTSD for the gammaCore tcVNS device based on the investigators' studies. Devices are blinded by ElectroCore and the devices and information are kept by the Data Manager under double lock and key. Device records are kept by the Data Manager and stored on Redcap or secured research drives. Devices are given to the study team along with a device schedule under direct supervision from the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria

Exclusion Criteria:

Subjects will be excluded with:

* a history of mild traumatic brain injury (mTBI) based on VA Criteria
* moderate or greater TBI
* positive pregnancy test
* meningitis or other neurological disorder
* alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
* active suicidal ideation with a plan
* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI
* active opiate or benzodiazepine treatment
* history of structural abnormality on brain MRI or CT if one has been performed in the past
Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.

This was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator.

The duration of each subject's study participation was approximately 18 weeks, including a 4-week maximum screening period and a 14-week study period.

Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Have 5 to 20 AKs on the face or balding scalp
* Negative urine pregnancy test (for women who are able to become pregnant)
* Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

* Women who are pregnant, lactating or planning to become pregnant during the study.
* Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
* Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
* Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?

Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. In the older general population microalbuminuria is associated with greater annual cognitive decline and has been proposed as an easily and inexpensive measured marker predicting future cognitive function decline. Ageing of the PLH leads to an increase of cognitive disorders and chronic renal failure incidence and could imply a common underlying mechanism affecting the renal and cerebral microvasculature. In this setting the investigators undertake this prospective, cross-sectional, case-control study to determine whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years and with cART-sustained immunovirological control for at least 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Known HIV infection for at least 5 years
* Undetectable viral load under antiretroviral (ARV) treatment for at least 1 year, regardless of the type of ARV
* Number of CD4 ≥ 350, regardless of the CD4 nadir
* Unopposed to participate to the study

For cases

- Micro-albuminuria defined by microalbuminuria / creatinuria between 3 and 30 mg/mmol

For controls, matched for age +/- 5 years - Absence of microalbuminuria defined by microalbuminuria / creatinuria \<3 mg/mmol

Exclusion criteria

* Known neurological disease, active or former
* Active and regular use of drugs
* Active Chronic alcoholism
* Diabetes with known complications
* Renal failure with glomerular filtration rate \<15 ml / min
* Micro-albuminuria / creatinuria\> 30 mg / mmol
* HIVAN
* Unbalanced arterial hypertension
* Patient did not have dosing glucose and lipid levels in over a year
* Unaffiliated patient (or copyright holder) to a social security scheme
* People enjoying a measure of legal protection Pregnant or breastfeeding

Secondary exclusion criteria

- Neurological disease found during the assessment.
Pilates Program in Female Adolescent With Eating Disorders

Physical exercise helps patients with eating disorders by improving their physical fitness, quality of life and other specific variables of this pathology. Pilates has a beneficial effect both physically and mentally on healthy population and other diseases. In patients with eating disorder, Pilates will improve psychic aspects and their physical condition. For all these reasons, the affectation of psychological symptoms will decrease and the quality of life will improve.


Eligibility Criteria:
Inclusion Criteria:

* 1) clinical diagnosis of EDs in the aforementioned hospital;
* 2) aged from 10 to 17 years old;
* 3) written informed consent by the patients and their legal guardians

Exclusion Criteria:

* 1) have other diagnoses of mental illness or
* 2) consumption of narcotic toxins
Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, Stage III or axillary node positive
* Currently disease free of breast cancer and other invasive malignancies at the time of registration
* No concurrent use of bisphosphonates

Exclusion Criteria:

* Metastatic disease
Introduction of Cholera Vaccine in Bangladesh

The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.

Cholera continues to be a major cause of morbidity and mortality in low income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and 1.2 million infections in people in Bangladesh each year. Deaths annually from cholera may have decreased but overall morbidity remains high.

The project for "Introduction of Cholera Vaccine in Bangladesh" (ICVB) will examine the effectiveness of intervention with an oral cholera vaccine in reducing incidence of cholera in urban Dhaka, and the effectiveness of a handwashing and home water treatment behaviour change intervention in reducing diarrhea due to cholera. The proposal involves evaluation of a 2-dose regimen of an oral killed whole cell (WC) vaccine and a handwashing and home water treatment behavior change program promoting improved hygiene and home drinking water treatment in reducing dehydrating diarrhea in a low income area of Dhaka, Bangladesh. The study population will include 90 clusters (neighborhoods) in an area of high cholera incidence in Mirpur with a total study population of 240,000. Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone, 30 clusters will receive both cholera vaccine and behavior change and 30 neighborhoods will continue their standard habits and practices. Surveillance for cholera and diarrhea will be carried out in all the three areas during the whole project period. Following the GIS mapping and census of the target populations, the cholera vaccine will be offered to all males and non-pregnant females aged one year and above in the vaccination areas, and an aggressive hygiene and safe water promotion program will be implemented in the 30 behavior change communication clusters. Passive surveillance for cholera will be undertaken using the two ICDDR,B diarrhea treatment facilities as well as 10 other health facilities that serve the study areas. Vaccine and other public health coverage and costs effectiveness as well cost-benefit will be measured, followed by surveillance and identical follow-up studies. The hygiene and safe water behavior change program will also be continued for 4 years. The impact of interventions will be assessed by following vaccination by directly comparing the incidence of cholera and diarrhea in the intervention communities to the incidence in the standard habits and practices communities.

Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy residents of selected vaccination sites
2. Aged 1 year and above
3. Non-pregnant women
4. Written informed consent

Exclusion Criteria:

1. Age less than 1 year
2. Pregnant women