cyrilzakka/clinical-trials huggingface dataset:
Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass

This is a retrospective analysis of data collected within two previous studies. The data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. The hypothesis was that in a sample of mostly active participants, no differences in left ventricular mass between family history of hypertension groups would be observed, but the positive family history of hypertension group would have elevated left ventricular mass compared to the negative family history of hypertension group following statistical control of activity frequency.

A positive family history of hypertension (FHH) (+FHH) is associated with elevated left ventricular mass (LVM). Regular physical activity (PA) may eliminate differences in LVM between +FHH and negative family history of hypertension (-FHH) adults. PURPOSE: To determine if a +FHH is associated with a greater LVM compared to a -FHH group within a sample of young, mostly active healthy adults with and without statistically controlling for PA. METHODS: Healthy young (18-32yrs) participants self-reported FHH status and habitual moderate and vigorous PA frequency. Participants then underwent an echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy

Exclusion Criteria:

* Known hypertension, cardiovascular disease, current pregnancy, current infectious disease, diabetes mellitus, kidney disease, a history of cancer, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions
Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced (unresectable, recurrent or metastatic) RCC
* Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
* Patients with an ECOG performance status of 0-2
* Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
* Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

Exclusion Criteria:

* Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
* Patients who have participated in any other sorafenib trial
* Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
* Life expectancy of less than two months
* Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
* Patients with active coronary artery disease or ischemia
* Patients with Child-Pugh class C hepatic impairment
* Patients with severe renal impairment or who require dialysis
* Patients with active uncontrolled hypertension
* Patients with recent or active bleeding diathesis
Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft

The aim of the study is to develop a computer program which is able to classify different entities of colorectal polyps on the basis of optical polyp features. In the end, the computer program shall differentiate between (i) hypeplastic polyps, (ii) adenomas and (iii) serrated adenomas .

In the first phase of the study a computer program will be established which aims to distinguish between the above mentions entities on the basis of optical features derived from still images. A machine learning apporach will be used for creating the program. Afterwards, in a second phase of the study, still images of 100 polyps (not used in the first phase) will be presented to the computer program. Quality of the computer program will be tested by calculating the accuracy for differentiating the three different polyp types. The gold standard for true polyp diagnoses will be based on histopathological diagnoses of the polyps. The same pictures of 100 polyps will also be presented to human experts. Experts will also predict histopathological diagnoses on the basis of optical polyps featurs. Accuracy of computer-decisions and human expert predictions will be compared. The establishment of a well- functioning computer program is the primary aim of the study.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* patients \>= 18 years

Exclusion Criteria:

* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin
Partial Lacrimal Punctual Occlusion

The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Sin and symptom of dry eye
* Use more than 4 times a day topic lubricant for the eye

Exclusion Criteria:

* Ocular diseases other than dry eye
* Use of systemic drugs
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.


Eligibility Criteria:
Inclusion Criteria:

* 18years of age or older
* informed consent obtained after oral and written information
* clinical data in accordance with a malignant bile duct obstruction
* imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
* typical ERCP findings of a malignant common bile duct stenosis
* proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
* bilirubin \> 50 micromol/L
* radical surgery not deemed possible

Exclusion Criteria:

* patients with active hepatitis or other jaundice-causing hepatic diseases
* informed consent not obtained or patient unable to give informed consent
* patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
* metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
* the patient is a possible candidate for surgical resection
* suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
* the proximal end of the stenosis is \< 2 cm from the hepatic confluence
* previous BII or Roux-en-Y gastric reconstruction
* significant duodenal obstruction making ERCP difficult
* previous bile duct stent
Eat My ABCs Project

Evaluate the effects of the "Eat My ABCs" program on improving Head Start preschoolers' eating behavior and anthropometric properties (BMI, percent body fat).

The 14-week, community-led, program, aimed to establish lifelong healthy eating habits among vulnerable low-income preschoolers living in rural Michigan, includes three main components: (1) "Eat My ABCs" child curriculum, (2) child fruit/vegetable letters to parents, and (3) program cookbook.

"Eat My ABCs" Child Curriculum. Head Start teachers, along with teacher assistants/aids, will independently teach the age appropriate "Eat My ABCs" curriculum per week, for a total of 14 weeks. The "Eat My ABCs" curriculum follows the alphabet theme and incorporates the five senses into learning (hear fruit and vegetable information, see the color, feel the texture, smell the scent, and taste the flavor). Each week includes two sessions: 1) healthy eating learning on one fruit and one vegetable by incorporating school readiness knowledge on numbers, shapes, colors, and alphabets; and 2) food taste-testing activities to expose children to one fruit, one vegetable, and relevant food items made from the one fruit and one vegetable to teach children the creative ways to make fruit/vegetable healthy and tasty.

Child Letter to Parents. Every week, each child will create one letter, using stickers, regarding the one fruit and one vegetable presented in the program that he/she tasted or wanted to try at home.

Program Cookbook. The investigators have developed a targeted program cookbook for low-income families to overcome their limited cooking skills, busy schedules, and tight family budget. The program cookbook contains all budget-friendly recipes for healthy breakfasts, family meals, quick-fixes, kid-friendly snacks, and occasional sweets; and these recipes are culturally appropriate with a variety of choices such as American, Italian, Mexican, and Asian cuisines. In the cookbook, the investigators also promote slow /pressure-cooking recipes as using a slow or pressure cooker to prepare easy but healthy meals is an effective way to overcome low-income parent barriers of lack of time and cooking skills. In addition, the cookbook contains creative ways of making fruit/vegetable healthy, tasty, and kid-friendly at home.

Eligibility Criteria:
Inclusion Criteria:

* Any preschoolers aged 3-5 years old from the participating daycare classrooms.
* Having parental consent.

Exclusion Criteria:

* None
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.

Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing left-sided valve surgery for left-sided valve disease
* Presence of non-severe TR and tricuspid annular dilation (\>40 mm or \> 21 mm/m2 BSA) determined by echocardiography
* Age ≥ 18 years
* Capability to sign Informed Consent and Release of Medical Information forms

Exclusion Criteria:

* Preoperative severe TR
* Structural / organic tricuspid valve disease
* Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE
* Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV
* Any type of reoperative surgery
* Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)
* Cardiogenic shock at the time of randomization
* ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization
* Evidence of cirrhosis or hepatic synthetic failure
* Severe, irreversible pulmonary hypertension in the judgment of the investigator
* Pregnancy at the time of randomization
* Any concurrent disease with life expectancy \< 1 year
* Patient unable or unwilling to provide informed consent
Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors

The purpose of this study is to test the accuracy of using an imaging technique called breath-holding functional magnetic resonance imaging (BH fMRI) in addition to the standard imaging test described above. This study will allow the researchers to find out whether using BH fMRI in combination with the standard approach is the same as, better, or worse than the standard approach used alone.


Eligibility Criteria:
Inclusion Criteria:

Health Volunteers

* Volunteers between the ages of 18 and 80 years
* Volunteers must be able to perform the language paradigms on cue while inside the scanner Patients
* Patients between the ages of 18 and 80 years
* Patients must be able to perform the language paradigms on cue while inside the scanner
* Women of child bearing potential must have a negative pregnancy test prior to the study intervention (Serum or Urine)
* Patients diagnosed with primary glial neoplasm, meningioma and metastasis (from prior histology) or must be suspected to have primary glial neoplasm, meningioma and metastasis on imaging (to be confirmed by post-operative histology).
* Patient"s location of the tumor must involve the expected location of Broca"s area (left pars opercularis and/or pars triangularis), or the expected location of the primary motor area (the pre-central gyrus). This determination will be made on the basis of a pre-operative MRI by a fellowship-trained Neuroradiologist

Exclusion Criteria:

Healthy Volunteers

* Volunteers who are unable to comply or complete MRI exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.)

  o MSK site only - see Appendix 2
* Volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.)
* Volunteers with a history of neurological disorders, psychiatric disorders or cancer Female volunteers who are pregnant or nursing.
* Volunteers who have MRI safe pacemakers.
* Volunteers from the vulnerable population, as defined by 45 CFR 46
* Volunteers who are unable to perform the breath hold task during practice sessions Patients
* Patients who are unable to comply or complete MRI exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.)

  °MSK site only - see Appendix 2
* Patients who have MRI safe pacemakers.
* Patient who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.)
* Female patients who are pregnant or nursing.
* Patients from the vulnerable population, as defined by 45 CFR 46
* Patients who are unable to perform the breath hold task during practice sessions
Web Based CBT-I in Patients With OSA and Insomnia

Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. The presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is associated with OSA. After six month of treatment we will test the efficacy of web-based CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Apnea-Hypopnea Index (AHI) ≥5

Exclusion Criteria:

* Complex sleep apnea
* AHI \>35
* Psychiatric comorbidies
Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence

The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.

Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.

Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.

The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.

Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Informed consent
* Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
* fecal incontinence after primary/secondary sphincter repair
* Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
* Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
* Willing and competent to fill out diary cards

Exclusion Criteria:

* Colorectal/proctological surgery since IPG-implant
* Pregnancy
* Anorectal Pain
Reducing Disparities in Access to Kidney Transplantation (RaDIANT) Regional Study

The purpose of this study is to facilitate coordination of transplant centers in North Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.

Disparities exist in access to kidney transplantation where poor and minority patients are less likely to access each step of the kidney transplant process. Current national surveillance data does not capture information on transplant referral, and it is unclear to what extent dialysis facility-level factors may influence disparities in access to transplantation. Due to significant variability in the standardized transplant ratios observed at each facility, the investigators hypothesize that there may be facility-related reasons that impact disparities in access to the first step of the kidney transplant process -- referral to the transplant center to undergo an evaluation for the suitability for transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplant centers in the geographic area of North Carolina (NC), South Carolina (SC) and Georgia (GA)
2. Low rates of referral for kidney transplantation (6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean)
3. The presence of a racial disparity (African American vs. Caucasian) in referrals for kidney transplantation (racial disparity calculated based on the crude referral risk difference and the standardized referral risk difference.)

The final pool of 440 facilities will be randomized to either the intervention or control group using a one to one ratio.

Exclusion Criteria:

1. Close out date populated
2. Transplant and hospital-based facility
3. Home dialysis facility
4. Patient census \<25
5. \>100 miles from nearest transplant center
6. Non-profit facility (except Wake Forest University Dialysis)
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with bacterial conjunctivitis

Exclusion Criteria:

* chemical or foreign body trauma to either eye
* infection in either eye (besides bacterial conjunctivitis)
* white spots in the cornea or ulcers in either eye
* clinical diagnosis of chlamydia or gonorrhea in either eye
Bronchoscopic Cryo-Immunotherapy of Lung Cancer

This is a safety and feasibility study of bronchoscopic cryo-immunotherapy (BCI) of peripheral lung tumors in advanced non-small cell lung cancer for the intention of inducing anti-tumor immune responses. The sample size for this study will be 15 patients. Pre- and post- BCI peripheral blood samples will be analyzed to assess for anti-tumor immune responses. Post-BCI peripheral blood will be collected 7 and 14 days after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral lung tumor on pre-procedure chest CT scan, which is known or suspected to be advanced, inoperable non-small cell lung cancer (stages IIIA/B/C and IVA/B) based on the 8th edition TNM staging guidelines
* Pre-procedure chest CT scan with the presence of a bronchus or airway path leading directly to the peripheral lung tumor (also known as a "bronchus sign")
* Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study.
* Documentation of non-small cell lung cancer either prior to procedure or via on-site pathology review during bronchoscopy (prior to proceeding with planned BCI)
* Ability to provide informed consent
* Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Pregnancy
* Currently on a platelet inhibitor (such as Clopidogrel) other than aspirin or NSAIDS, or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy
* INR \>= 1.5 (post correction)
* Platelets =\< 100,000 (post correction)
* Bleeding diathesis
* Contraindication to bronchoscopy
* Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.