cyrilzakka/clinical-trials huggingface dataset:
Study of Patient Satisfaction With the Cancer Clinical Trial Experience

The primary objective of this study is to evaluate the quality of the clinical trial experience of cancer patients participating in cancer research studies through Summa Health System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons for participating, facility, consent and treatment, personal issues and overall assessment.

The secondary objective of this study is to determine areas for improvement to make the patient's clinical trial experience a satisfying and positive journey.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program.
* Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey.

Exclusion Criteria:

* Participant has withdrawn consent for clinical trial participation and/or follow up.
* Participant has a major medical illness that would prevent completion of the survey.
Differential DNA Methylation as a Function of a Parenting Intervention

The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.

This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment. Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families). Biological samples and behavioral observations of parenting will be collected pre- and post- intervention. Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention. Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.

Exclusion Criteria:

* Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
* If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
* If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.
Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Stage I：preoperative therapy

* Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy
* Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone;
* A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)
2. Histologically confirmed primary adenocarcinoma
3. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0，
4. ECOG performance status ≦2

AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia.

The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus,which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above;

* AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction;
* AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below.

Exclusion Criteria:

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
6. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
7. Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
8. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -
abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release

Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.

Carpal Tunnel Syndrome is a prevalent condition; up to 9% in women and 0.6% in men. It causes complaints of paresthesia, pain, numbness and loss of strength. Surgical decompression is the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of suture material which is used can influence the prevalence of wound infection. In current clinical practice both absorbable and non absorbable sutures are used. In literature, various hypothesis are described: Absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. This would not be the case for non-absorbable sutures, since they will be removed. However, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.

The primary outcome is the ASEPSIS wound score. This will be scored by independent investigators.

Use of antibiotics, handtherapy and extra outpatient visits will be recorded.

Patients are asked to register their NRS scores the first three weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

• indication for carpal tunnel release

Exclusion Criteria:

* carpal tunnel syndrome which has yet been operated
* injection with corticosteroids
Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV

The purpose of this study is to determine whether the supplementation of vitamin D and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin D deficiency/insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* brief episodes of vertigo induced by head motion
* a typical positioning nystagmus characteristic of BPPV
* no supplementation of vitamin D or calcium at the time of recruitment
* informed consent to participate in this study
* subject treated by repositioning maneuver

Exclusion Criteria:

* other identifiable disorders of the central nervous system
* supplementation of vitamin D or calcium at the time of recruitment
* pregnancy
* a history of an allergic reaction, or a medically significant adverse reaction to the investigational product
* contraindication to cholecalciferol and calcium carbonate
Early Changes Among FLEx, LASIK and FS-LASIK

To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.

Laser in situ keratomileusis (LASIK) with a microkeratome has been accepted wildly in the past 20 years. Gradually, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.

Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.

This prospective clinical study is going to analyze the short-term changes in ocular surface measures and tear inflammatory mediators after FLEx, LASIK and FS-LASIK procedures.

Eligibility Criteria:
Inclusion Criteria:

* minimum age of 18 years(range from 18 year to 31 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between
* 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 42.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery

Exclusion Criteria:

* systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year
Intensity of Task-Oriented Exercises

In an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous.

Community reintegration is often significantly affected in the majority of stroke individuals. To fulfill the requirements of a proper home exercise program in walking rehabilitation for stroke victims, investigators structured the task-oriented exercise program with minimal supervision. This exercise program is structured with challenging walking-related activities based on motor learning principle and Gentile's progression of the motor task. The strengthening and balance components, aerobic conditioning and walking adaptability are composed of an exercise program to optimize walking ability. There are sixty minutes last ten exercises in each three progression steps of this exercise program. For the training effect to occur, each step of exercise program is designed by increasing demand of intensity in the range from moderate to vigorous. To confirming progressive energy demand, the purpose of this study is to investigate the intensity demand of three steps task- oriented home exercise program on walking competency in individual post stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Either side of both type first stroke with confirmatory diagnosis by CT Scan and MRI.
2. Age above 20 years old.
3. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
4. Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE \> 23).

Exclusion Criteria:

1. Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
2. Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
3. Fugl Meyer Assessment score (lower extremity) less than ≤ 21
4. Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
5. Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
Evaluation of an Educational Intervention on Abscesses in People Who Self-inject Drugs

The goal of this cluster randomised controlled trial (cRCT) is to to evaluate the effectiveness of an educational intervention combining training in hand-washing with the supply of MONO-RUBs on the reduction of skin abscesses (both observed and self-reported) in people who inject drugs (PWID).

The main questions it aims to answer are:

* does an educational intervention change the incidence of injection-related skin and soft tissue infection (SSTI) like abscesses in PWID?
* does the educational hand-washing intervention improve injection practices in terms of hand-hygiene in PWID?

According to cluster randomisation, PWID will be assigned to:

* Standard harm reduction (HR) services to reduce abscesses plus an educational hand-washing intervention (intervention arm)
* Standard HR services only (control arm)

To measure the effectiveness of the educational hand-washing intervention, the primary outcome will be the reduction in abscess prevalence compared in both groups. Statistical analyses for the primary outcome will involve comparing the reduction in abscess prevalence in the intervention arm with that in the control arm. This prevalence will be measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related SSTI questionnaire, respectively.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old,
* French-speaking,
* reporting to have injected drugs at least once during the previous week,
* and providing free and informed consent to participate.

Exclusion Criteria:

* not regularly going to the participating HR centre in the relevant city,
* having an alcohol and/or alcohol-based hand rub (ABHR) excipient intolerance/allergy,
* being under legal protection (guardianship or judicial protection),
* current pregnancy.
Immunological Characterization of Blood of Normal Individuals

This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for other approved protocols and for analysis. These include determination of the functional capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine will have similar testing which may also be compared to the blood testing results. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of normal volunteers and compare it to immune function in disease states.

Blood will be obtained via peripheral venipuncture. The blood will be divided into components (e.g. plasma, serum, microvesicles, and cells) then analyzed. Flow cytometry will be used to determine cell and microvesicle subsets. RNA will be extracted from the various components of blood and will be subjected to gene and microRNA profiling to determine gene expression. DNA will be isolated from the cells to be used in studies investigating epigenetic regulation of genes identified in the screens. Protein will also be isolated from the multiple components to examine the impact of genetic regulation by epigenetic mechanisms or microRNA on protein expression. Peripheral blood mononuclear cells will be placed in tissue culture for study.

Saliva and urine will be obtained the same day as blood for testing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
* At least 18 years or older.
* Are capable of reading, understanding and providing written informed consent.

Exclusion Criteria:

* Non-English speaking.
* Individuals under 18 years old.
* Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
* Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
* Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
* Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.
Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome

In this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of Healon 5 viscoelastic into the anterior chamber.


Eligibility Criteria:
Inclusion Criteria:

* All cataract patients taking tamsulosin

Exclusion Criteria:

* Patients with any history of iridocyclitis
* Presence of iris neovascularization
* History of prior iris surgery
* Presence of traumatic cataracts
* Presence of zonular dialysis
Osteopathic Manipulation Makes a Neuropsychological Difference

Patients with pain commonly experience cognitive impairment. While symptoms of pain are effectively treated with osteopathic manipulative treatment (OMT), the cognitive piece is vastly ignored. Pain-induced cognitive dysfunction can be severe and is particularly apparent in working memory and attention. There is good reason to also expect cognitive responsiveness to OMT. Previous research has already reported related psychiatric outcomes, including relief from stress, self-perception and anxiety, suggesting that OMT may produce more global effects on cortical processing than currently thought.

Patients with pain commonly experience cognitive impairment. While symptoms of pain are effectively treated with osteopathic manipulative treatment (OMT), the cognitive piece is vastly ignored. Previous research has already reported related psychiatric outcomes, including relief from stress, self-perception and anxiety, suggesting that OMT may produce more global effects on cortical processing than currently thought. The current study is designed to extend previous research in several ways:

1. To describe the neuropsychological (NP) characteristics of adults with pain within an osteopathic and allopathic setting
2. To correlate NP with clinical outcomes (pain severity, number/location of osteopathic lesions)
3. To determine if OMT is associated with improved NP function.
4. To use saliva to measure cytokine concentration of IL-1β,IL-6, IL-8, TNF-α
5. To correlate cytokine concentrations with clinical outcomes (pain severity, number/location of osteopathic lesions, NP)

Eligibility Criteria:
Inclusion Criteria:

1. 40 years of age or older;
2. seeking treatment for acute or chronic pain (neck, thoracic, shoulder, back)
3. gives a positive response to the item, "Have you had thinking problems because of your pain?";
4. agree to forego extra-trial manipulation (e.g., massage, chiropractic, physical therapy);
5. Score \> 23 on the Telephone Interview for Cognitive Status;
6. written informed consent.

Exclusion Criteria:

1. recent (\< 2 month) or planned surgery within the duration of the study;
2. use of medication that could interfere with cytokine measurements;
3. recent (\< 2 month) changes to psychotropic medication within the duration of the study;
4. history of manipulation within the past six months.
5. diagnosed neurocognitive disorders;
6. contraindication to receiving OMT.
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

OBJECTIVES:

* Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel.
* Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment
* Measurable disease or evaluable disease

PATIENT CHARACTERISTICS:

Age:

* 18 to physiological 60

Performance status:

* ECOG 0-2

Life expectancy:

* Greater than 2 months

Hematopoietic:

* WBC greater than 3000/mm3
* Platelet count greater than 100,000/mm3

Hepatic:

* Bilirubin less than 1.5 times normal
* SGOT/SGPT less than 1.5 times normal

Renal:

* BUN less than 1.5 times normal
* Creatinine less than 1.5 times normal
* Creatinine clearance greater than 50 mL/min

Other:

* Ineligible for other high priority national or institutional study
* Not pregnant or nursing
* HIV negative
* No prior malignancy except nonmelanoma skin cancer
* No serious medical or psychiatric illness preventing treatment or informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Greater than 4 weeks since prior chemotherapy
* No greater than 2 prior chemotherapy regimens
* No prior taxane or camptothecin

Endocrine therapy:

* No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes)

Radiotherapy:

* Greater than 4 weeks since prior radiation therapy
* No concurrent radiation therapy

Surgery:

* Greater than 4 weeks since prior surgery