cyrilzakka/clinical-trials huggingface dataset:
Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy

RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors.

PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.

OBJECTIVES:

* To recruit 7,000 participants who are planning to undergo colonoscopy.
* To collect questionnaires and medical records from these participants.
* To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.
* To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.

OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.

Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.

Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps \> 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.

Tissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Scheduled to undergo colonoscopy at the Vanderbilt University Medical Center or the Tennessee Valley Veterans Administration Medical Center
* No prior genetic colorectal cancer syndromes or colorectal adenoma

PATIENT CHARACTERISTICS:

* Must have a permanent residence and a telephone number
* Able to speak and understand English
* No prior inflammatory bowel disease
* No prior cancer other than nonmelanoma skin cancer
* Not a current resident in a correctional facility
* No other rare exclusion that would prevent the collection of study data (e.g., extensive memory loss for past exposures), impair ability to provide informed consent, or make the participant an atypical colonoscopy patient (e.g., colonoscopy for organ transplant evaluation)
* No prior extensive knowledge or contact with the investigation/protocol/hypotheses (the study collaborator or reviewer)

PRIOR CONCURRENT THERAPY:

* No prior partial or complete colon resection
* No concurrent participation in a clinical trial involving the prevention of colon polyps
Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination

The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.


Eligibility Criteria:
Inclusion Criteria:

* HIV+ adults patients
* negative HBsAg
* negative a-HBs Ab
* positive HBc Ab
* without HBV - vaccination
* CD4 cell above 200 /mm3
* HIV viral load below 50 copies/mL

Exclusion Criteria:

* positive HBs antigenemia in the past
* transaminitis above fivefold upper normal limit
* PT\<50% or Platelet \<50 000/mm3
* ongoing opportunistic infection
* ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors

The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.

The investigators have developed an accessible digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors), designed to enhance adolescent and young adult (AYA) cancer survivors' abilities to manage their high symptom burden and engage in follow-up health care. Informed by the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, AYA STEPS has been systematically and rigorously developed and refined through the PI's prior work (K08CA245107). AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs' self-efficacy for symptom management and activation. The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors (N=260) who received cancer care in diverse health care settings (i.e., rural, urban, medically underserved areas) across North Carolina. Self-efficacy and patient activation will be examined as mediators of intervention effects. The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden, experience barriers to care engagement, and have limited access to AYA-specific behavioral interventions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with one of the following cancers: 1) stage I-III breast cancer; 2) stage I-III colorectal cancer; 3) stage I-III sarcoma; 4) stage I-III Hodgkin or non-Hodgkin lymphoma; or 5) stage I-II testicular cancer
* treated with curative intent and off therapy (with the exception of endocrine/hormonal therapy) for the last three months
* 1 to 5 years post-diagnosis
* Able to speak and read English
* Able to give informed consent

Exclusion Criteria:

* moderate or severe cognitive impairment
* severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis

The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* 10 patients affected by chronic periodontitis
* 10 patients affected by aggressive periodontitis
* 10 healthy patients (orthodontics extraction)
* Subject who have read and understood the information note relative under investigation and who have signed the informed consent
* major patient

Exclusion Criteria:

* Patient with no contre-indication to periodontal treatment
* Patient with serious blood disease
* Patient who exhibits systemic condition incompatible with realization of the study
* Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
* Patient who presents a buccal carcinoma treated with radiotherapy
* Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
* Patient who presents a linguistic or psychic incapacity to understand information
Multimodal Sleep Pathway for Shoulder Arthroplasty

The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the constraints of sling immobilization. While in the hospital, sleep is also disrupted due to pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial, sleep deprivation in animal models has identified significant adverse effects on bone metabolism, bone mass, and recovery from post surgical pain.

Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction.

The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

All consenting adults undergoing elective total shoulder replacement

-

Exclusion Criteria:

* Allergies to zolpidem or refusal to participate in study
Study Evaluating Retinal Health Monitoring System Visual Acuity Module.

Assess the performance and usability of the RHMS Visual Acuity Module.

This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1 - Normal subjects

1. Age ≥ 50 years
2. Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
3. Able to perform self-testing with the Visual Acuity Module of the RHMS after training
4. Able and willing to give informed consent

Cohort 2 - Subjects with neovascular AMD

1. Age ≥ 50 years
2. History of neovascular age-related macular degeneration, in the study eye
3. Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye

Exclusion Criteria:

Cohort 1 - Normal subjects

1. History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
2. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Cohort 2 - Subjects with neovascular AMD

1. History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
2. History of macular hole in the study eye
3. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
Effectiveness of a Treatment Plan of Neurological Physiotherapy in Conjunction With Ultrasound-guided Ultrasound-guided Dry Needling in Stroke Patients.

The aim of the study is to assess the efficacy of dry needling in stroke patients in combination with intensive neurological physiotherapy.

together with intensive neurological physiotherapy treatment. Randomised and blinded experimental study control group where the sample recruited was 20 patients, who were randomly assigned to a control group.

randomly assigned to a control group, where they received intensive treatment, or to an intervention group, where they received intervention group, where they received ultrasound-guided dry needling of the tibialis anterior and posterior muscles followed by an intensive followed by intensive neurological physiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* left middle cerebral artery infarction
* impaired stability during walking
* patient between the age range 18 to 70 years old

Exclusion Criteria:

* patient under 18 years of age
* patients over 70 years of age
* undiagnosed left middle cerebral artery infarction patients
Mental Health Impact of the COVID-19 Pandemic Among Migrants in Chile

The mental health of a representative sample of immigrants residing in Santiago, Chile (STRING cohort) was assessed nine months prior to the COVID-19 pandemic (T0). Evidence suggests that social isolation affects mental health by increasing symptoms of anxiety and depression. One of the main components of the current COVID-19 pandemic is the social isolation imposed on the population. This study seeks to explore the short (T1) and long-term (T2) effects of the pandemic on the psychological wellbeing of the cohort.

Specific aims are to

1. Describe the variations in the levels of mental health problems (i.e. symptoms of depression, anxiety, post-traumatic stress, sleep difficulties) and wellbeing of immigrants during the first (T1) and second follow-up (T2)
2. Calculate the short (T1) and long-term (T2) effects of social isolation on the levels of mental health problems of the immigrant population, and
3. Identify risk / protective factors associated with a short (T1) and long-term (T2) increase in mental health problems

Participants were interviewed at baseline (T0) 8 months before the COVID-19 pandemic. An online survey will be applied in two follow-up moments during the pandemic:

1. At 9 months (also 1 month after lockdown measures imposed) (T1)
2. At 18 months (also 10 months after lockdown measures imposed) (T2)

Eligibility Criteria:
Inclusion Criteria:

* Country of birth other than Chile
* Time since arrival to Chile: 3 months (at baseline)

Exclusion Criteria:

* Unable to understand Spanish
Pulmonary Rehabilitation in End-Stage Liver Disease

The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

Participants will be randomized into two groups. The Pulmonary Rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. Exercises will be supervised by physiotherapists or exercise physiologists. Compliance and performance will be monitored by the trainer. They will receive a pedometer for home use. The Home based program group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Patients will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.

Eligibility Criteria:
Inclusion Criteria:

* wait listed for liver transplantation with poor 6 MWT

Exclusion Criteria:

* age \< 18 years
* recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
* large esophageal varices without primary prophylaxis
* active excessive alcohol intake (in the previous 3 months)
* current overt uncontrolled hepatic encephalopathy
* hepatopulmonary syndrome with uncontrolled hypoxia
* portopulmonary hypertension
* inability to perform exercise
* marked symptomatic comorbidities (cardiac, pulmonary, renal).
Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy

Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy

This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* \<16 weeks' gestational age
* Singleton pregnancy
* Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
* ≥1 risk factor:

  * Chronic hypertension
  * Type I or II diabetes
  * Previous preeclampsia
  * Renal disease
  * Autoimmune disease (SLE) OR

    ≥2 risk factor:
  * Nulliparity
  * IVF pregnancy
  * Black race or socioeconomic disadvantaged
  * BMI\>30
  * Prior adverse pregnancy outcome

Exclusion Criteria:

* Contraindication to aspirin
* Current or planned use of any other anticoagulation
* Current need for dialysis
* Use of aspirin therapy prior to enrollment in the current pregnancy
* Thrombocytopenia (\<150)
* Other known platelet disorder/thrombophilia at enrollment
Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality.

It is now accepted that biofilm as a role on bacterial development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.


Eligibility Criteria:
Inclusion Criteria:

* Patient or relative informed of the study and having declared their non-objection
* Patient over 18 years old
* Patient hospitalized in ICU with an arterial catheter

Exclusion Criteria:

* Patient unable to express consent
* Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
* Patient with arterial catheter removed outside the usual procedure of the ICU
* Patient admitted in ICU with an arterial catheter already in place
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids

The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids.

Intralesional corticosteroids remain the gold standard treatment for keloids. However, more effective therapies are desperately desired. Ablative fractional laser (AFL) treatment facilitates delivery of intralesional steroid more deeply and uniformly into the skin by creating vertical channels. Recent studies have showed that fractional laser assisted steroid therapy can be effective in the treatment of keloids. However the studies are lacking in comparing this treatment modality to the gold standard of intralesional steroids.

Eligibility Criteria:
Inclusion Criteria:

* Male or female older than 17 at the screening visit;
* The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;
* The subject has at least two keloids of comparative size and texture located on the same general anatomic location (trunk or back);
* The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule and concomitant therapy. The subject is willing to comply with the 4 week washout period;
* The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure

Exclusion Criteria:

Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:

* The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
* The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
* The subject has a past history of coagulopathy
* The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
* The subject has used prohibited topical or systemic treatments without sufficient protocol-defined wash-out period prior to Baseline (checked at Screening and Baseline) or is unwilling to refrain from use during the study
* The subject is treated with anticoagulants or antiplatelet therapies
* The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. EMLA or tetracaine 7%/lidocaine 23%) or a local antiseptic planned to be used for the laser.
* The subject is in an exclusion period from a previous study or is participating in another clinical trial
* The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom
* The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
The Effect of Physiotherapy on Chronic Low Back Pain

Demographic data of patients diagnosed with chronic low back pain and planned for medical treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and Short form 36 (SF-36) quality of life scoring, Lumbar range of motion (LHA), straight leg raising test (DBK) and hand-finger ground distance (EPZM) were evaluated. Hot pack, transcutaneous electrical nerve stimulation (TENS) and ultrasound were given as physical therapy agents.

Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy.

patient consents obtained and VAS, ODI and SF-36 quality of life values questioned.

Pre- and post-treatment values compared, and intragroup changes compared in both groups and evaluated whether physiotherapy contributes to pain, functionality and quality of life in treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been prescribed medical treatment or physiotherapy for mechanical back pain
* Those with demographic information as well as VAS, ODI information in their files
* Patients between the ages of 20-79 who applied to our hospital with the complaint of chronic low back pain

Exclusion Criteria:

* Non-mechanical back pain
* Patients with physiotherapy contraindications
* Those with inflammatory diseases
* Severe heart failure
* Stroke, spinal cord injury, plegia due to traumatic brain injury
* A history of malignancy
* Active infection during treatment
* Having metal implants in the waist area
* Established osteoporosis
* Those with pacemakers