cyrilzakka/clinical-trials huggingface dataset:
Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions

The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

* To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
* Allow to obtain an estimation of number of patients required for a larger study.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
* Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
* Mucosal tumors with submucosal fibrosis
* Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
* Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
* Male or female patients aged ≥ 18 years old
* Patients able to fill in questionnaires written in French

Exclusion Criteria:

* Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes

The endothelium is the lining of the blood vessels that helps prevent damage to the vessels. The endothelium does not function as well as it should in adolescents with type 1 diabetes. This causes future diabetes complications. Adolescents with diabetes also have abnormalities of the cells that repair the endothelium. These abnormalities may be due to damage caused by intermittent hyperglycemia. This studied is designed to study whether low dose, combined Vitamin C and E supplementation improves endothelial function and repair in adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescent with T1D between 8 and 15 years of age will be studied.
2. Started on insulin therapy immediately after diagnosis.
3. Fasting c-peptide levels must be less than 0.4 ng/ml.
4. Hgb A1c levels greater than 8.3%.
5. All subjects must be in good health other than having diabetes. Subjects with hypothyroidism will be allowed assuming they are on stable thyroxine replacement and have normal thyroid function tests.
6. Females on oral contraceptives will also be eligible to participate.

Exclusion Criteria:

1. History oral hypoglycemic agent use.
2. BMI\>95th percentile
3. Hypertension
4. Elevated creatinine levels
5. Microalbuminuria.
Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing standard of care colonoscopy for the evaluation of colonic polyps.
* At least 40 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Pregnant and/or breastfeeding.
* Unable to tolerate sedation.
Protection Against Benzene Toxicity

We are investigating the role of an enzyme (NQO1) in protection against the bone marrow toxicity of the occupational and environmental toxicant benzene. All of the proposed studies involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated protection. Cells are obtained from healthy volunteers and protocols have undergone IRB review and approval.


Eligibility Criteria:
Healthy adult volunteers with blood counts in normal ranges and without evidence of hepatitis or HIV infection.
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions

Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.

1. This is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided interventions designed by Hangzhou Dexin Medical Technological Company with other similar products.
2. This trial will enroll about 100 subjects from 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). Proposal recruiting period is 18 months and follow-up will be performed for 30 days.

Eligibility Criteria:
Inclusion Criteria:

1. age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart.
2. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve.
3. diameter of atrial septal \> left-atrium-side diameter of occlude.
4. participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form.

Exclusion Criteria:

1. Primary atrial septal defect.
2. Sinus venosus atrial septal defects.
3. Accompany with endocarditis or hemorrhagic risks.
4. thrombosis in targeting area or venous thrombosis in inserting site.
5. severe pulmonary artery hypertension generated right-to-left shunt.
6. severe myocardial or valve disease unrelated with ASD.
7. suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.
Effect of Acute Phenylcapsaicin Intake on Trained Cross-Training Athletes

The aim of this study is to investigate the effect of acute phenylcapsaicin intake during a cross-training session on perceived exertion, performance, and recovery in cross-training athletes.

Capsaicin appears to enhance athletic performance by reducing perceived effort, increasing mechanical performance (e.g., total volume load), and decreasing muscle damage. Given the close relationship between the metabolic and physiological responses of cross-training and supplementation with Phenylcapsaicin (PC), it could be expected that consuming capsaicin during cross-training would have a favorable impact on perceived effort, recovery, and performance.

25 women and 24 men trained in CrossFit consumed either Phenylcapsaicin (PC) or a placebo during a CrossFit class, which consisted of a 16-minute weightlifting segment and a 15-minute WOD. Both the Rating of Perceived Exertion (RPE) and the Perceived Recovery Status scale (RPS) were administered at the beginning of the session and at the end of each segment of the CrossFit session. DOMS was assessed using a visual analog scale at 24 and 48 hours after the CrossFit session.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-35 years.
* Body mass index: 18.5-30 kg/m2.
* Ability to understand the instructions, objectives, and study protocol.
* Minimum of 3 years of experience in crosstraining, with at least 6 hours of weekly training over the past 3 months.
* Resident on the island of Tenerife.

Exclusion Criteria:

* History of a significant adverse cardiovascular event, renal insufficiency, cirrhosis, eating disorder, weight control surgical intervention, or type 2 diabetes mellitus.
* Any chronic pathology in which the intake of nutritional supplements, especially pungent components, is not recommended.
* Any condition that, in the investigator's judgment, would impair the ability to participate in the study or represent a personal risk to the participant.
* Use of medications that may affect the study results.
* Unstable body weight for 3 months prior to the start of the study (\> 4 kg loss or gain in weight).
* Active tobacco abuse or illicit drug use, or history of treatment for alcohol abuse.
* On a special diet or prescribed for other reasons (e.g., celiac disease).
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating DSBs (double strand breaks) in prostate cancer within patients receiving central androgen suppression and brachytherapy. The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase. Subjects will be randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer
* At least one biopsy core with Gleason 7 or higher disease
* The patient has decided to undergo brachytherapy plus androgen suppression as treatment modality for his prostate cancer (with or without supplemental external beam radiation)
* Suitable volume of disease for biopsy:
* clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy
* Signed study-specific consent form prior to registration

Exclusion Criteria:

* Known hypersensitivity or allergic response to flutamide
* Severe hepatic impairment
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management.

Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function.

The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function.


Eligibility Criteria:
Inclusion Criteria:

Aim 1:

* Stage I-III rectal cancer
* Post sphincter preserving surgery with restoration of bowel continuity within last 4-6 weeks at MSKCC.
* Access to web and email from home
* Web avidity (≥2 uses of email/week)
* Able to read and write in English
* Age ≥ 18

Aim 2:

* Stage I-III colon and rectal cancer
* Post surgical resection of primary tumor at MSKCC
* Access to web and email from home
* Web avidity (≥2 uses of email/week)
* Able to read and write in English
* Age ≥ 18

Exclusion Criteria:

Aim 1:

* Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer.
* Stoma
* Participated in Aim 2
* Definitive SPS = Transanal Excision (TAE) or Transanal Endoscopic Microsurgery (TEM)

Aim 2:

* Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer.
* Stoma
* Participated in Aim 1
Study of Radiolabeled Danicopan in Healthy Male Participants

This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 (\[14C\])-ACH-014447 (\[14C\])-danicopan) containing approximately 100 microcuries (µCi) of \[14C\].


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy was defined as having no clinical relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of ≥ 18 and ≤ 30 kilograms (kg)/meter squared and weight of ≥ 50 kg and ≤ 100 kg.
* Regular daily bowel movements (that is, production of at least 1 stool per day).
* Non-smoker or ex-smoker who had not used tobacco or nicotine products for ≥ 3 months prior to screening.

Key Exclusion Criteria:

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History of conditions or procedures possibly affecting drug absorption or excretion. A history of appendectomy, cholecystectomy, and hernia repair was allowed if they were not associated with complications.
* Active bacterial infection or clinically significant active viral infection, a body temperature \> 38°Celcius, or other evidence of infection on Day 1, or with a history of febrile illness within 7 days prior to Day 1.
* Healthy participants who had been exposed to significant radiation levels of \> 5 millisieverts in the last year prior to screening.
* Clinically significant laboratory abnormalities at screening or Day -1, as well as absolute neutrophil counts, platelets, and hemoglobin outside of reference ranges.
Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy

Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound.

Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers.

Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma \> 30 mm in diameter.

Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy.

Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .

The management of ovarian endometriomas in women wishing to conceive remains challenging. Recent data suggest that excising endometriomas by ovarian tissue sparing cystectomy does not avoid inadvertent removal of ovarian parenchyma surrounding the cyst, particularly in enlarged cysts. Although several authors question whether the ovarian parenchyma immediately surrounding the cyst may still be functional, there is little doubt that postoperative fertility could be significantly impaired by loss of ovarian cortex and provokes the question as to whether pregnancy should be initiated before performing a cystectomy, whenever this scenario is possible. However ovarian surgery cannot always be delayed to the postpartum period, numerous women require endometrioma management while not seeking an immediate pregnancy and still wish to conserve their procreative capabilities.

After a period of some years during which cystectomy appeared to be the best surgical technique in the treatment of ovarian endometriomas in women wishing to become pregnant, recent data have suggested that ablation of the inner layer of the endometrioma may be a valuable alternative technique, as long as the energy employed avoids thermal diffusion to surrounding ovarian tissue. The Department of Gynecology at the University Hospital in Rouen, France have introduced ablation by plasma energy using the PlasmaJet system (Plasma Surgical Ltd, Abingdon, UK) and have already been able to report encouraging results based on non comparative pilot studies and on retrospective "before and after" comparative study.

The aim of the study is to prospectively compare loss of ovarian parenchyma and decrease in antral follicle count (AFC) following ovarian endometrioma ablation using plasma energy versus cystectomy, when performed by only two expert surgeons. Postoperative examination is carried out by 3D ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years;
* Surgery required by pelvic pain or infertility related to endometriosis;
* Clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm.

Exclusion Criteria:

* Previous surgery on ovaries or IVF procedures;
* Bilateral endometriomas;
* Pregnancy
* Woman not French speaker.
Does Lead Burden Alter Neuropsychological Development?

Inner city children are at an increased risk for lead overburden. This in turn affects cognitive functioning. However, the underlying neuropsychological effects of lead overburden and its age-specific effects have not been well delineated. This study is part of a larger study on the effects of lead overburden on the development of attention and memory. The larger study is using a multi-model approach to study the effects of lead overburden on these effects including the event-related potential (ERP), electrophysiologic measures of attention and memory are studied. Every eight months, for a total of three sessions the subjects will complete ERP measures of attention and memory which require them to watch various computer images while wearing scalp electrodes recording from 11 sites. It is this test that we are going to be doing on CRC. There will be 30 lead overburdened children recruited from the larger study for participation in the ERP studies on CRC. These 30 children will be matched with 30 children without lead overburden. This portion of the study is important in providing an index of physiological functioning to be used along with behaviorally based measures of attention and memory, and for providing information about the different measures.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject recruitment will take place in local clinics which serve pregnant women and offspring
Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals

The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. Maximum oxygen consumption is measured by performing gas exchange analysis with CPET, offering an objective measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk test (SWT) are field tests that produce oxygen consumption results similar to those during CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in individuals with PCD. Additionally, the physiological responses of individuals with PCD to different exercise tests will be compared with the responses of healthy individuals. Low aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives of individuals. This influence may cause a decrease in the quality of life of individuals with PCD. The relationship between exercise capacity and quality of life in individuals with PSD will be investigated with this study.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with PCD in the Pediatrics Department, Pediatric Chest Diseases Unit of Hacettepe University Faculty of Medicine and being routinely referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy applications and pulmonary rehabilitation program,
* Being clinically stable,
* Being between 8-18 years old,
* Having a forced expiratory volume in the first second (FEV1) ≥ 40%,

The healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. For healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study.

Exclusion Criteria:

* Having unstable clinical condition
* Having severe neuromuscular and musculoskeletal problems,
* Having any congenital heart diseases other than situs inversus,
* Unable to cooperate
Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making

Determine the effect of a culturally sensitive prenatal genetic testing (PGT) education intervention delivered via a mobile application on pregnant women's perceptions, knowledge, and uptake of PGT. Our working hypothesis, based on prior studies, is that pregnant women who receive a culturally sensitive intervention to enhance their knowledge and understanding of PGT will feel more confident in their decision-making regarding PGT.


Eligibility Criteria:
Inclusion Criteria -

Women who:

1. age over 18 years old;
2. are able to speak, read and, write English or Spanish;
3. are currently pregnant;
4. have a smartphone with IOS or Android;
5. are current prenatal patients in one of the prenatal clinics in the Driscoll Health System;
6. were referred to the clinic because they are at high risk of having a baby with genetic conditions (e.g., advanced maternal age, family history, history of delivering affected baby, abnormal blood or ultrasound screening results).

Exclusion Criteria -

Women who:

1. are unable to speak, read, and write English or Spanish;
2. do not own a smartphone with IOS or Android system.