cyrilzakka/clinical-trials huggingface dataset:
Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)

Head and neck cancers (HNSCC) are primarily squamous cell cancers represented by tumors of the upper aerodigestive tract. Locally advanced stages (stages III and IV) account for 50 to 70% of all presentations. The three main risk factors are smoking, alcohol and oropharyngeal infection with human papilloma virus (HPV).

Apart from HPV status, there is no biomarker for the prognosis in HSNCC patients. Circulating Tumor Cells (CTCs) can provide "real-time" information on tumor behavior and are already used in various cancers (colon, lung). Their detection has limited sensitivity and biomarkers cannot be used for early diagnosis, but may be useful during follow-up to assess local, regional or metastatic early tumor recurrence.

By using blood samples at different times (at diagnosis, after initial treatment and during follow-up), we will be able to measure the variation in quantification and establish a predictive role of these CTCs for the response to treatment.

Our hypothesis is that CTCs may have a key role, in addition to clinical and radiological examination, in detecting early tumor relapse.

We believe that the joint consideration of clinical parameters, treatment strategy and quantification of CTCs could optimize patient follow-up and management.

The CTC extraction system, ClearCell® FX from Biolidics, is an automated microfluidic enrichment system. It has the advantage of recovering fully intact and viable CTCs from a standard blood sample. The gentle sorting principle allows to preserve cell integrity and thus the expression of surface antigens. The CTCs thus isolated can then be re-cultured or analyzed by immunostaining. This high-performance technique, in operation since December 2017 in the Biochemistry Department of Pr Claire Rodriguez-Lafrasse (HCL), has demonstrated its usefulness in lung cancer.

Transcriptomic analysis of CTCs can be performed at the scale of a cell after isolation of the CTCs. CTCs can then be sequenced in RNAseq either in bulk (pool of cells) or cell by cell on our Illumina (Nextseq) sequencer, in order to define the heterogeneity of the tumor. Transcriptome analysis then provides information on the state of the cell as to its position in the epithelio-mesenchymal transition thanks to a molecular signature by phenotype. A priori-free characterization is therefore possible thanks to the RNAseq single-cell. This highly sensitive and innovative technique will allow the study of the gene expression profile of CTCs.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Squamous cell carcinoma proven on biopsy
* Oropharyngeal location
* Curative treatment by Surgery followed by radiotherapy (chemotherapy) Or Radiochemotherapy Or Induction chemotherapy (+/- surgery) + radiotherapy
* Did not object to their participation in the study

Exclusion Criteria:

* Carcinoma of the nasopharynx, larynx, oral cavity or hypopharynx
* Pregnant or breastfeeding woman
The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote

This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, an extended co-design process, and previous iterations of the mbv program. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at three time points over the course of the 10-week program, which will be offered remotely in response to the COVID-19 pandemic. Students will be recruited from high schools and will be randomized to receive the mbv program or an assessment-only control group.

Eating disorders have the highest mortality rate of any psychiatric condition and are the second leading cause of mental health disability among young women. Given that eating disorders have their peak onset during adolescence (ages 16-19), prevention efforts among adolescent women are critical in order to avert the onset of these chronic and disabling disorders. The mbv program targets body image and appearance related pressures, awareness of body sensations, and agency and community building skills. The program consists of 10 weekly sessions and is delivered by peer facilitators. This study will implement and evaluate the mbv program at the high school level in order to examine the extent to which the program influences young women's mental health and well-being, particularly related to eating disorder risk factors and symptoms.

Utilizing a randomized controlled trial, the study seeks to address the following aims:

1. To examine the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self- constructs, physical health and mood among participating high school women.
2. To explore young women's experiences of participating in the program, including strengths and limitations and perspectives on specific activities.

Eligibility Criteria:
Inclusion Criteria:

* High school women, grades 9-12

Exclusion Criteria:

* Prior participation in the Body Project or mind. body. voice. RCT
Quality of Life in Patients Undergoing Total Pelvic Exenteration

The purpose of this study is to learn more about the personal experiences of patients who are treated with pelvic exenteration surgery. Pelvic exenteration is a surgical procedure in which the pelvic organs including the reproductive organs, bladder and/or rectum are removed. We would like to understand more about the physical, emotional, educational, and sexual needs of patients who are treated with this surgery. We will use what we learn from this study to help find better ways of preparing patients for this type of surgery. This will also allow us to be more helpful to patients' needs after surgery.

This protocol represents the first study to comprehensively evaluate QOL in a mixed population of male and female patients treated with total, anterior or posterior pelvic exenteration. This unique approach to QOL assessment which is both domain-centered and able to emphasize individual differences through the C-SHIP model has the potential to set the standard for evaluating QOL in patients who undergo extensive pelvic surgery. The longitudinal design of this study facilitates the documentation of patients'responsiveness to change. By analyzing participants' responses at intervals we will be able to document the redefinition of life goals which occurs as patients adapt to their new health status. The data and analysis completed in first three years of this study will be used to generate further hypotheses for future investigation.

Eligibility Criteria:
Inclusion Criteria:

* All patients (male and female) who are scheduled to undergo total, anterior or posterior pelvic exenteration for pelvic malignancies arising in gynecologic, colorectal or urologic organs are eligible for participation in the study. Anterior or posterior pelvic exenteration must involve formation of a permanent ostomy (urostomy or colostomy).
* Participants must be able to speak and read English proficiently.
* Participants must be able to provide written informed consent.
* Patients must be 18 years of age or older to enroll.

Exclusion Criteria:

* Subjects may be excluded or withdrawn from the study based on the following criteria.
* Development of a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent
* Inability to speak or read in English.
The Mamma HiToP Study

The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia.

The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

The study is multicenter, randomized, double-blind, and placebo-controlled.

Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires

Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* - Patients with histologically verified breast cancer and neoadjuvant or adjuvant treatment with a taxane derivate (e.g., Paclitaxel, Docetaxel): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9.
* Cumulative dose of at least 3 cycles
* Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying)
* Ability to walk (with or without aids)
* European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2
* Intensity of paresthesias of \> 3/10 on the Visual Analog Scale (VAS)

Exclusion Criteria:

* - Prevalent neuropathy of different etiology
* Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators
* Epilepsy
* Minors or persons unable to give informed consent
* Current neurotoxic medication
* Implanted pacemakers or defibrillators
* Pregnancy
* Wounds in the area to be treated, acute local or systemic infection
* Peripheral arterial occlusive disease \> grade 2
Followup of Infants Fed Non-routine Infant Formula

The purpose of this study is to compare physical development of infants fed one of three study formulas.


Eligibility Criteria:
Inclusion Criteria:

* Completed Study 3369-5

Exclusion Criteria:

* None
Developing an Injury Prevention Simulation Game to Better Engage Parents in Services -Home Safety Hero

This study will test the effectiveness of novel technology-based game to teach parents and parents to be home safety skills. These include the identification of home child injury risks under two conditions (with and without distraction) and how to resolve these risks to better protect preschool children from injuries. Few empirically validated home safety interventions exist and the best ones involve individual home visitors. These and others that use didactic instruction or provision of written material have poor response from low socioeconomic parents who are less literate and more resistant to outsiders entering their homes. The use of a computer game to provide education in this area is being tested for effectiveness and the game's engagement will also be examined.

Given cognitive problems in parents have been linked in the PI's work to child neglect (e.g., poor child supervision), links of performance on the game to cognitive capacities will also be examined in a preliminary way.

The study will compare a group of parents and parents to be who play the game multiple times (n=15) to a wait list group (n=15) who just play it once. The study will examine reaction times to identification and resolution of the risks overall and by category of risk (e.g., poisoning, burns, suffocation, etc.). The study will also examine failures on levels of the game which are graded for difficulty. The game was designed for low failure rate to increase engagement and to improve motivation.

Changes in the participants' perception of efficacy in preventing injuries to children and their engagement with the game (using a standardized usability survey) will be examined. The study will also examine the role of experience with the use of technology and cognitive capacities in relation to performance and pre-post changes with multiple plays of the game.

Eligibility Criteria:
Inclusion Criteria:participants who are parents or parents to be from a high school program in Altoona, PA. For those less than age 18, parental permission for participation is required

-

Exclusion Criteria: non-English Speaking; ones whose due date falls in the study period and who are not likely to complete the project.
Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm)

OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.

DESIGN : A Randomised interventional study. Sample size: 330

* This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
* In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
* After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.

  * A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps

Eligibility Criteria:
Inclusion Criteria:

* Adult above 18 years
* polyp size greater than 5-10mm.

Exclusion Criteria:

* Inflammatory bowel disease
* Familial Polyposis Syndromes
* Patient who is unable to understand study protocol or not consenting
* Severe coagulopathy (INR Greater than 1.5 platelets)
* Receiving antiplatelets withing 5 days of procedure
* If antiplatelets stopped for 5 days-they were restarted on next day after procedure.
Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)

The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.

A two-arm, randomized study will be conducted in patients about to undergo consent discussion for participation in two large, multicenter BMT CTN clinical trials. Once they agree to participate in this Easy-to-Read Informed Consent (ETRIC) study, they will go through the consent process for the parent trial using either a standard or the ETRIC consent form. The content of both forms will be similar but the ETRIC form will incorporate a two-column format with specific attention towards enhanced readability and processability. Following the consent discussion for the BMT CTN parent trial, patients will complete assessments of health literacy, comprehension of the parent trial and satisfaction and anxiety related to the consent process. These assessments will be completed within 7 business days of the consent discussion of the parent trial.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.

Eligibility Criteria:
Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901 (NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical, BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility criteria.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.

Additional inclusion criteria specific for the ETRIC study will include:

1. Adult patients (≥ 18 years)
2. Speaking and reading proficiency in English (as most of this study's instruments have not been translated and validated in languages other than English)
3. Willing and able to provide informed consent
4. Stated willingness to comply with study procedures and reporting requirements

Exclusion Criteria: N/A
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients

Skin care for seriously ill patients in the intensive care unit (ICU) is one of the key components in the prevention of serious complications that affect the treatment outcome. Bed rest, prolonged skin contact with biological secretions (urine, faeces, etc.) containing active irritating metabolic products (urea, faecal proteases, lipase, bile salts), and the use of diapers (disposable or otherwise) result in patient skin damage. Skin microbiota metabolizes urine that leads to alteration of skin pH, and promotes the propagation of opportunistic microorganisms causing infectious complications of skin and soft tissues. Additional factors, such as pressure on soft tissues, friction, or soft tissue displacement, lead to the formation of pressure sores which seriously worsens clinical results, patients' life quality, and significantly increases treatment costs. Statistics on the incidence of pressure sores in Russian medical institutions are rather scarce. It was reported that the incidence of pressure sores in hospice patients is up to 22.4%, and when assessing skin and soft tissues infections in ICU patients, the incidence of pressure sores is 28.9%.

A meta-analysis of foreign studies on the prevalence of pressure sores in ICU showed an incidence range of 7.8%-54% in studies using the methodology of the European Pressure Ulcer Advisory Panel, 6-22% in studies applying the methodology of the National Pressure Ulcer Advisory Panel, and 4.94% for a study that used the Torrance system. The probable range of the prevalence of pressure sores worldwide in intensive care facilities is from 6% to 18.5%. A recent UK randomized study found the development of new pressure sores or progression of existing ones in 15% of ICU patients with an expected stay in the ward for at least 36 hours.

Unfortunately, premorbid skin conditions that contribute to the formation of trophic disorders are largely overlooked, which results in the absence of a proper risk management system. Use of the traditional method of skin care in patients including liquid soap, napkins, and diapers can disrupt the skin barrier function and increase the risk of bedsores. This treatment method contributes to probable damage of the hydrolipid skin layer, the formation of skin microcracks, and the chemical irritation of skin, which is aggravated by frequent washing. The current trend is the use of methods that allow frequent skin washing without compromising its barrier function.


Eligibility Criteria:
Inclusion Criteria:

1. Estimated length of stay in ICU - 3 days or more.
2. Signed informed consent form.

Exclusion Criteria:

1. The presence of trophic skin changes (bedsores, maceration, intertrigo).
2. Allergy to any component of the investigated products for skin and hair care.
Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis

To characterise and understand the current UK COPD population including demographics, active comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis

Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections \[LRTIs\], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years or older
* Electronically coded diagnosis of COPD made between 1990 and 2009
* A minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis
* Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1.

Exclusion Criteria:

* Aged less than 40 years
* No diagnosis of COPD between 1990 and 2009
* Less than three years continuous practice data including two years prior to and one year post diagnosis
* Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.
"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth

An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient should be above 18 years of age.
2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
6. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
6. Subjects with soft or hard tissue tumor of the oral cavity.
7. Presence of severe gingivitis.
8. Chronic disease with concomitant oral manifestations other than xerostomia
9. History of radiation therapy to head and neck
10. Subjects with conditions the investigator may feel will interfere with the study.
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool

In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable Screening questionnaires in postoperative period in patients who underwent bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>40
* bariatric surgery patients

Exclusion Criteria:

* malignancy
* patients who are unable to complete the questionnaire
* patients who needs laparotomy