cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.

PRIMARY OBJECTIVE:

I. Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest.

SECONDARY OBJECTIVES:

I. In participants with lymphedema, describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm.

II. Tolerability of the transcutaneous sensors during the participant data collection session.

III. Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema.

OUTLINE:

Participants undergo BI and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Eligibility Criteria:
Inclusion Criteria:

* COHORT A: Healthy participants
* COHORT B: Participants with pre-existing lymphedema
* COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin
* COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a \>= 2-centimeter difference in contralateral arm circumference

Exclusion Criteria:

* Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included
Insulin Sensitivity in Patients With Atopic Dermatitis

The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe atopic dermatitis for at least 5 years
* BMI \< 30 kg/m2
* HbA1c \< 42 mmol/mol

Exclusion Criteria:

* Diabetes
* Prediabetes
* First-degree relatives with diabetes
* Chronic inflammatory diseases other than atopic dermatitis and asthma
* Pregnancy
* Breast-feeding
* Daily intake of medications that are known to influence the glucose metabolism are not allowed one month before the study (e.g. asthma medicines and hormonal contraception).
3D Versus 4K Laparoscopic Cholecystectomy

Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to reduce the time required to complete tasks in laboratory settings. This benefit derives from the addition of binocular depth perception cues when compared to two-dimensional (2D) systems. This year a '4K' laparoscopic system has become commercially available, so-named as it provides a high resolution 2D image with four times the number of pixels of 2D full high definition. The improved visualisation is likely to provide additional non-binocular depth cues. It is currently unclear to what degree improving the resolution of 2D systems can compensate for binocular depth cues.

Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides benefits during laparoscopic cholecystectomy when compared to the monocular vision provided by high-resolution 4K systems.

Methods: A randomised controlled trial of 3D HD versus 4K laparoscopic systems will be performed, comparing the time to complete laparoscopic cholecystectomy, and error scores.

Impact: This study is a unique, first-of-its-kind investigation into two new surgical technologies, and is the first study to involve a 4K system. The uptake of three-dimensional systems has been curbed by financial cost and the limitations of early 3D technologies. This study aims to determine which system may be the safest, quickest and most cost- effective, in order to guide future investment and technological development towards either 3D or 2D systems. In addition, these systems may also aid in the learning curve of trainee surgeons.


Eligibility Criteria:
Inclusion Criteria:

1. Informed, written consent obtained after provision of information leaflets and face-to-face answering of any questions participants may have
2. Elective laparoscopic cholecystectomy
3. Medically fit for discharge as day case
4. Age 18 to 85 years

Exclusion Criteria:

1. Unable to obtain informed, written consent
2. Emergency cholecystectomy
3. Not medically fit for discharge as day case
4. Age \<18 or \>85 years
5. Conversion to open cholecystectomy
6. History of upper abdominal surgery
7. Recent/current involvement in another clinical trial
8. Common bile duct exploration at time of operation
Brain Neoplasms, Leukemia and Petrochemical Exposures

The aim of this study is to examine the association of exposure to air contaminants (PAH \& VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI \& exon 7) and GSTM1 \& T1) of study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan Kaohsiung, southern Taiwan.

Brain tumors and leukemia are the most common malignancies among children and adolescents in the U.S. Adequate information on the role of inherited genetic susceptibility and environmental exposures in the development of neoplasms in children and adolescents is lacking. In Taiwan, four large petrochemical industries are located in the Kaohsiung metropolitan area. These facilities are proximal to residential areas because of the high population density in the region. Data have shown that the concentrations of ambient polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) around the petrochemical industries are at least 10 and 2 times, respectively, higher than those in U.S. industrialized communities. Our preliminary case-control study in metropolitan Kaohsiung showed that young residents (under age 30) living within 3 kilometers of the vicinity of petrochemical industries have a 6.0 fold increase in brain neoplasms and a 2.9 fold increase in leukemia. The purpose of this proposal is to examine the association of exposure to air contaminants (PAH and VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI \& exon 7) and GSTM1 \&T1) from study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan Kaohsiung. Our hypothesis is that there is an increased risk of brain tumors and leukemia in patients with high cumulative exposure to these hazards, and that heritable polymorphisms in several genes modify this association. In addition to an independent association of environmental and genetic factors with brain neoplasms and leukemia, we hypothesize that there is greater risk associated with the presence of combined environmental exposure and the high risk genotype. Also, we will assess the role of parental genetic polymorphisms in the development of cancer in their siblings. This proposed study uses an environmental molecular epidemiologic approach, utilizing prospective enrollment of a cohort of brain tumor and leukemia subjects in a population-based case-control design. This proposal is responsive to the recommendation of the National Research Council that risk assessment and public health policy pay special attention to the protection of children.

Eligibility Criteria:
Young population Less than 30 Resident of Kaohsiung metropolitan, Taiwan
Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male patients with Hodgkin's lymphoma.

OBJECTIVES:

* Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma.
* Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B\[E\], IIA\[E\], IIB, or IIIA vs IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B).

* Stratum 1 (stages IA/B\[E\], IIA\[E\], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy.
* Stratum 2 (stages IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B): Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA (6-week courses). Patients then undergo radiotherapy.

After completion of study treatment, patients are followed periodically for at least 6 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of classic Hodgkin's lymphoma (HL)

  * Intermediate or advanced disease (stage I\[E\]-IV)
* No lymphocyte-predominant HL
* Previously untreated disease

PATIENT CHARACTERISTICS:

* Male
* No known hypersensitivity or contraindication to study drugs
* No other concurrent malignancies
* No severe concurrent diseases (e.g., immune deficiency syndrome)
* No known HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy or radiotherapy
* More than 30 days since prior and no other concurrent investigational drugs
* More than 30 days since prior and no concurrent participation in another clinical trial
Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting

An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.

The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years
* Clinical indication and eligible for a BAL procedure, as judged by the investigator
* Patients being admitted in the ICU at the investigational centre
* Provision of signed IC by subject, or subject's legal representative e.g. next of kin

Exclusion Criteria:

* Patients where BAL treatment cannot be clinically justified, judged by the investigator
* ETT \>7 mm and ≤8.5 mm in diameter
* Participating in other interventional clinical investigations or have previously participated in this investigation
Blood and Urine HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Treatment

The purpose of this study is to determine if ctHPVDNA (circulating tumor HPV DNA) can be used as a non-invasive biomarker for identification and treatment monitoring of cervical cancer by characterizing correlation between plasma ctHPVDNA, urine transrenal HPVDNA (TrHPVDNA) levels and presence of cervical cancer at diagnosis and following definitive intent management.

Early stage cervical cancer is managed surgically while chemoradiation is the mainstay for treatment of bulky or advanced stage disease. The primary aim of post-treatment surveillance is to detect early recurrences and guide additional therapy. There is no definitive agreement on the best practice for cervical cancer surveillance. Most recurrences are detected based on patient history and physical exam as there is limited data to support cervicovaginal cytology and routine use of imaging in follow up. Novel non-invasive biomarkers are needed to monitor disease status, detect early recurrence and guide personalized treatment decisions. Biospecimens including urine and blood plasma will be collected from patients presenting to the UNC Department of Gynecology Oncology and Multidisciplinary clinics with newly diagnosed cervical cancer to assess for HPVDNA. Archived or residual tissue will also be accessed. For patients who undergo definitive management with surgery or chemoradiation, a post-treatment blood plasma and urine sample will be collected 2-6 weeks after completion and will be compared to pre-therapy ctHPVDNA and TrHPVDNA levels.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older on day of signing informed consent
* New diagnosis of cervical cancer
* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

Exclusion Criteria:

* Women who are pregnant
Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction

This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Power Toothbrush for stains reduction and improvement of teeth shade.

The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.

One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.

For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.

Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufactur-er's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA ac-cepted PTB and the same standard fluoride toothpaste.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects aged 18-70, that are in good health.
2. Subjects should have notable extrinsic dental stains on the front teeth with a total extrin-sic facial tooth stain score ≥14 according to the LSI.
3. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
4. The subjects should be willing to comply with the study procedure and schedule, includ-ing the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
5. The subject did not perform any procedure for teeth whitening (either at home or in clin-ic) at least 3 years prior to participating in the study

Exclusion Criteria:

1. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
3. Pregnant or nursing by subject report.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the treated area within 3 months prior to treatment, or before complete healing.
6. Subjects that do not brush regularly.
7. Regular tobacco smokers.
Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women

Excessive weight gain during pregnancy, particularly in overweight and obese women, predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal health. With an inverse relationship between socioeconomic status and obesity, significant health disparities exist between obese and normal weight women. The Institute of Medicine (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid body mass index (BMI), to minimize pregnancy complications. However, these recommendations are based on cross sectional observational studies and neither the ideal method to achieve weight gain goals nor whether perinatal outcome is optimized with active management of weight gain is known. The investigators propose to investigate a behavioral incentive-based intervention to improve compliance with IOM weight gain recommendations during pregnancy in low-income overweight and obese women. The investigators will evaluate if 1) gestational weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain management during pregnancy improves perinatal outcomes. Two study groups will be compared in a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those receiving behavioral weight management counseling plus financial incentives for achieving weight gain goals. The main outcome measure will be the percentage of women gaining within the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include fetal growth and body composition changes, birth weight and the rate of cesarean delivery. The investigators hypothesize that 1) the behavioral intervention with incentives will result in greater compliance to IOM guidelines for gestational weight gain than standard care and 2) targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be examined. This intervention, if efficacious and cost-effective, has the potential to improve compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce health disparities.


Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age and ≤ 45 years of age

-≤16 weeks gestation

* BMI ≥25
* Ultrasound documented viable singleton intrauterine pregnancy
* English speaking
* Planning to deliver at Fletcher Allen Health Care
* Willing to be randomized to one of the study groups
* Written informed consent

Exclusion Criteria:

* Major fetal congenital or chromosomal anomaly
* Women with a restricted diet (i.e., celiac disease, prior bariatric surgery, Phenylketonuria, or other metabolic disorder)
Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women

This study will utilize a longitudinal study design to better understand the natural history of oncogenic Human Papillomavirus (HPV) infections in Human Immunodeficiency Virus (HIV)-infected and HIV-uninfected Kenyan women, including the potentially modifiable (and non-modifiable) factors that are associated with progression of oncogenic HPV infection to clinical disease, including cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Kenyan women who present for a cervical cancer screening at AMPATH-cervical cancer screening clinics at MTRH or Webuye and living in or within 30 km of the respective clinic at the time of informed consent
2. Between the ages of 18 -45 years old at the time of informed consent
3. Ability to provide written informed consent and HIPAA authorization
4. Must have a normal VIA
5. Must be willing and able to come to the clinic for visits and return for a 4 year follow-up visit

Exclusion Criteria:

1. History of an abnormal VIA or Pap smear
2. Diagnosis of CIN or cervical cancer
3. Signs or symptoms of a sexually transmitted infection (STI)
4. Women who are currently pregnant
5. Inability to understand and provide written informed consent due to a mental or physical disability, or a medical illness that has rendered the patient unable to understand consent or attend quarterly visits
Validation of MMS Test for Cancer Monitoring

The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colo-rectal cancer
* Clinical diagnosis of stomach cancer
* Suspected diagnosis of melanoma

Exclusion Criteria:

* Colitis ulcerosa
* Morbus Crohn
* Cancer in time period two years before
* Cancer therapy in time period two years before