cyrilzakka/clinical-trials huggingface dataset:
Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.


Eligibility Criteria:
Eligibility Criteria:

* Planning to receive radiation therapy to one of the following sites:

  * Head and neck/brain (n=10)
  * Thorax (n=10)
  * Abdomen (n=10)
  * Pelvis (n=10)
* At least 18 years of age
* If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine \< 1.4, or, for patients with chronic kidney disease, a stable serum creatinine \< 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented.
* If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy.
* Able to understand and willing to sign an IRB approved written informed consent document.
The Effect of Diflunisal on Familial Transthyretin Amyloidosis

An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for the study can no longer participate or receive treatment by diflunisal; and patients, who have participated in the trial can not continue their treatment. The investigators want to continue to monitor the effect of the drug on transthyretin (TTR) amyloidosis in an open label observational study.

Primary endpoint will be a composite score of the manifestations of the disease (Kumamoto scale) and secondary end points will be measurements of neurological impairment, heart involvement and nutritional status.

Duration of treatment in this study is dependent of the results from the ongoing IND 68092-study, which are planned to be presented 2013.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy and genetically proven systemic transthyretin amyloidosis caused by a TTR gene mutation. The amyloid shall be proven to be of transthyretin type, and the fibril composition settled.
* Age ≥ 18 years.
* Negative pregnancy test and contraception for sexually active women of child bearing potential.

Exclusion Criteria:

* Concomitant use of non-study non-steroidal anti-inflammatory drugs (NSAIDs)
* Heart failure with symptoms at daily activities (NYHA class ≥III)
* Renal insufficiency (creatinine clearance \< 30 ml calculated from the Cockcroft-Gault formula)
* Active non-haemorrhoidal bleeding within the last 18 month.
* Non-treated peptic ulcer disease.
* Anticoagulation therapy, low dose ASA permitted.
* Non-steroidal or aspirin allergy/hypersensitivity
* Thrombocytopenia (\< 100,000 platelets/mm3)
* Inability or unwillingness of subject to give written informed consent
* By the investigator regarded as unable to follow the study guidelines and scheduled controls.
Management of Bleeding Following Cardiopulmonary Bypass

We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation.

Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.


Eligibility Criteria:
Inclusion Criteria:

Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients:

1. undergoing repeat sternotomy, or
2. undergoing combined procedures (i.e. - valve and coronary artery surgery), or
3. undergoing multiple valve surgery, or
4. undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or
5. undergoing complex congenital cardiac surgery

Exclusion Criteria:

Ineligible patients include those:

1. with known coagulation factor deficiency, or
2. refusing to receive donor blood products if necessary, or
3. undergoing emergency surgery, or
4. undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
5. with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction \[if not replacing this valve in upcoming operation\], renal vein thrombosis, acute MI, DVT ), or
6. with known thrombophilia, or
7. with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
8. pregnant, or
9. weight \> 150 kg or \< 18 kg
Effect of Hip Hop Nutrition-Math Curriculum

This study is testing the efficacy of the integrative approach to:

1. teach 5th grade children menu board calorie literacy as measured by our novel recently validated menu board calorie literacy (MBCL) instrument;
2. provide strategies designed to improve food purchasing behaviors; and
3. facilitate the transmission of core lesson messages from children to parents via a procedure that we have termed "Child Mediated Health Communication (CMHC)".

Data show that nearly 25% of children aged four to eight years consumed fast food on a typical day. These trends in fast food consumption are more acute among low-income urban dwellers where higher rates of overweight and childhood obesity are seen. This has led to a focus on providing fast food consumers with point-of-purchase nutrition information, such as the calorie posting mandates, in the hopes that these decision cues will help consumers make better informed dietary decisions. Most children chose their own meals at the point-of-purchase. It is clear that additional strategies are needed to encourage the point-of-purchase use of calorie postings, however available studies provide little insight into best practices or the types of approaches needed.

It is with this in mind that the investigator developed a school-based approach to improve point-of purchase use of calorie postings, by creating a novel intervention that targets menu board calorie literacy as a means of improving food-purchasing behaviors.

Hip Hop Nutrition-Math Curriculum is a novel behaviorally focused multimedia, musical school health rap toolkit that targets what we refer to as menu board calorie literacy. 4th grade common core math standards are integrated into the program in a manner that incorporates evidence-based nutrition education recommendations by the Institute of Medicine and the Centers for Disease Control and Prevention (CDC).

The investigator proposes to test the efficacy of the integrative approach on food purchasing behaviors of children in an adequately powered, controlled trial. The investigator will test the intervention in the after-school setting among economically disadvantaged children and incorporate parental engagement in our outcome evaluations. There is a partnership with New York City's largest after-school program vendor, New York Edge (formerly called Sports and Arts in Schools foundation/SASF), for the implementation of this study.

The goal of a health literacy intervention is to improve health decision-making and/or behavior. For this reason, the investigator will measure both menu board calorie literacy and food choice behavior at a point-of-purchase.

Eligibility Criteria:
Inclusion Criteria:

* 5th grade student participating in the New York Edge after school program

Exclusion Criteria:

* Absence of Internet access at home
* No working phone line
* Major psychiatric disability or medical condition that may affect participation (e.g., psychotic illness, terminal illness)
* Non-English speaking students
Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)

A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. The intervention group will receive counselling from the researcher based on ST-NEPCO, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. The study will be conducted for duration of 24 weeks. The individual counseling session will be held once a month for each participant during the weekend.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 to 11 years old
* Children classified as obese (\>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).

Exclusion Criteria:

* Children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
* Children receiving medications that can potentially promote weight gain or weight loss.
* Children participating in any weight management program
Ureteral Jets and Patient Positioning Study

The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.

Patients will be randomized to one of two arms: 0 degree supine position and 10-20 degree angle in reverse Trendelenburg. Our working hypothesis is that positioning a patient in 10-20 degree angle reverse Trendelenburg will result in shorter time to confirmation of bilateral ureteral patency and shorter total cystoscopy time, without a change in delayed diagnosis of ureteric injury.

Primary outcome: time to confirmation of bilateral ureteral patency Secondary outcome: total cystoscopy time, need for alternative modalities to aid in ureteral efflux visualization, delayed diagnosis of ureteric injury (evaluated 6 weeks postoperatively via chart review)

Eligibility Criteria:
Inclusion Criteria:

1. Female patients
2. Greater than or equal to 18 years old
3. English-speaking
4. Scheduled benign gynecologic or urogynecologic surgery in which routine cystoscopy at Banner University Medical Center - Phoenix; Dr. Mourad, Dr. Mahnert or Dr. Rachael Smith.

Exclusion Criteria:

1. Patients with underlying chronic kidney disease (creatinine \<1)
2. Known renal anomaly such as prior surgical removal of a kidney or underlying ureteral obstruction
3. Current ureteral stent in place,
4. Pregnancy,
5. Contraindication to any of the interventions (i.e., documented allergies)
Use of Glucose and Saline for Fetal Movement Perception

The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman.


Eligibility Criteria:
Inclusion Criteria:

* Healthy parturients with singleton pregnancy during 3rd trimester

Exclusion Criteria:

* Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios
The Use of Reconstructive Surgery for Sexually Mutilated Women at the University Hospitals of Strasbourg

Despite awareness since the 1980s and a legal framework to punish sexual mutilation, this tradition continues in many countries, particularly in Africa but not only in the Middle East, Malaysia and Indonesia. This custom, carried out among increasingly young little girls, exposes them to infectious, hemorrhagic and even death risks and sometimes significant obstetric complications.

Every year, 3 million girls and young women are sexually mutilated around the world, or one woman every 15 seconds.

In recent years, a surgical repair technique has been created by a French urologist, Professor Foldès. This technique allows clitoral reconstruction. Sensory reacquisition after this intervention may take a few months, but the functional results are quite good.

There is little or no data concerning the use of reconstructive surgery for these mutilated patients consulting in sexology and the future of patients post-operatively or who have not had recourse to reconstructive surgery. The investigators then questioned the decision of these patients and their future.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 years old)
* having consulted sexology at the HUS for sexual mutilation between 01/01/2011 and 12/31/2021.
* having had clitoral repair surgery at the HUS between 01/01/2011 and 12/31/2021
* not objecting, after information, to the reuse of their data for the purposes of this research

Exclusion Criteria:

* Woman who expressed her opposition to participating in the study
* impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
* Woman under judicial protection or under guardianship or curatorship.
Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission

Conduct a pilot study (n = 20) to explore the feasibility and acceptability of the MAJOR CHORD music therapy (MT) intervention (i.e., two in-person MT sessions prior to discharge and two virtual MT sessions post-discharge) and collection of patient-reported outcomes through 30 days after hospital discharge. The investigators will uncover any potential modifications that need to be made to the intervention and data collection process prior to initiating the randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Age range: ≥40 to ≤89 years
* Hospitalized at UH Cleveland Medical Center (UHCMC) with anticipated length of stay following recruitment ≥ 2 days as documented in electronic health record (EHR)
* Diagnosed (i.e., ICD-10 code within the EHR) with either COPD (J44) or HF (I50) with confirmed ICD-10 code in EHR
* Able to read and understand English
* Screening positive for depression and/or anxiety as evidenced by: GAD-7 anxiety score ≥ 10 and PHQ-9 depression score ≥ 10
* Access to WiFi, active email address \& laptop, tablet, and/or PC with videoconferencing capabilities
* Has reliable support person who can be available to respond in case of a medical emergency at any time
* Has reliable access to a mobile device with active data plan

Exclusion Criteria:

* Significant hearing and/or visual impairment as documented in EHR
* Unable to independently provide consent (i.e., no proxy consent)
* Active suicidal ideation documented in inpatient psychiatry note during current hospital admission or expressed at any point verbally or in writing to study staff
* Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in EHR
* Currently admitted to intensive care unit
* Receiving active cancer treatment (e.g., chemotherapy, radiation, immunotherapy) as documented in EHR
* Diagnosed with medical condition likely to be terminal within 24 weeks as documented in EHR
* On wait list for heart transplantation or ventricular assist device (VAD) as documented in EHR
* NYHA Stage IV HF or end-stage COPD as documented in EHR
* Receiving hospice care as documented in EHR
* Active substance abuse as documented in EHR
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
* Life expectancy of at least 12 weeks.
* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
* Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Leukemia or lymphoma.
* Current gastrointestinal bleeding by stool guaiac.
* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
* Acute intercurrent infection other than genital herpes.
* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.

Concurrent Medication:

Excluded:

* Other anticancer therapy.
* Other investigational agents.

Patients with the following prior conditions are excluded:

* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
* History of myocardial infarction within past 6 months.

Prior Medication:

Excluded:

* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
* Investigational agents within the past 4 weeks.
PET-CT Based Radiotherapy in Esophageal Cancer Patients

The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.

The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
* Local curable disease able to undergo Chemoradiotherapy.

Exclusion Criteria:

* Metastasized disease.
* Previous or concurrent malignancies.
Nasal Allergen Challenge in Rhinitic Subjects

Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure.

Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma.

The study will be performed outside the pollen season. On a baseline visit, 2 to 7 days prior to control challenge, allergy skin prick tests and methacholine inhalation test will be done. Prior to first allergen challenge, skin titration will be done using tenfold dilutions of the allergen chosen for nasal challenges. Subsequent to baseline visit, a control challenge will be done, followed, a week later, by repeated NACs. NACs will be done over 4 consecutive days, in the morning. Nasal peak inspiratory flows (NPIF), oral peak expiratory flows (PEF), and symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on each challenge day. Induced sputum and nasal lavage specimen will be obtained 7 hours following the control challenge and the first and last NAC.

Eligibility Criteria:
Inclusion Criteria:

* To have a positive reaction to one or more allergen on prick tests.
* Non smokers
* No respiratory track infection for at least one month prior to the study.
* Positive reaction to cat hair and/or house dust mite (Dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen.
* Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
* Asthmatic subjects with a history of asthma of at least 6 months.
* Asthmatic subjects with PC20 methacholine lower or equal to 8 mg/ml.
* Allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past.
* Allergic rhinitic subjects with a provocative concentration of methacholine (PC20 higher than 16 mg/ml.

Exclusion Criteria:

* Smokers or ex smokers less than 6 months or more than 10 pack-years.
* Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
Physical Activity in CKD

The goal of this is to test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD.

For youth with chronic kidney disease (CKD), cardiovascular disease (CVD) is a leading cause of morbidity and early mortality. Physical activity is a well-recognized determinant of health and quality of life, but, youth with CKD are less physically active than their healthy peers. Identification of effective strategies to increase physical activity in youth with CKD is paramount to improving outcomes. The investigators will test the efficacy of a 12-week physical activity intervention in 64 adolescents with CKD. Guided by the Multiphase Optimization Strategy (MOST) framework, an optimization trial will identify intervention components that increase average daily moderate to vigorous physical activity by 15 min/day, a clinically meaningful increase. The components will be grounded in established behavioral change theories and be delivered via Way to Health, a web-based platform, to overcome barriers at the point of clinical care where time and resources are limited.

Eligibility Criteria:
Inclusion criteria:

For adolescent participants:

1. Males or females age 13 - 18 years
2. Diagnosis of CKD stage II - V not yet on dialysis or with a transplant
3. English proficiency
4. Parental/guardian permission (informed consent), and if applicable, child assent

For caregiver participants:

1. Parent/legal guardian of an enrolled adolescent participant
2. English proficiency

Exclusion Criteria:

For adolescent participants:

1. Pregnant or lactating
2. Non-ambulatory
3. Have high physical activity at baseline (\>45 min/day of MVPA)
4. Provide \<2 days of physical activity data during the run-in period
5. Have a condition, such as heart or lung disease, that preclude safely engaging in physical activity
6. Have received a solid organ transplant
7. Have limited English proficiency
8. Are on dialysis
9. In the opinion of the investigator, are unable to comply with the requirements of the study protocol or are unsuitable for the study for any reason

For caregivers participants:

1. Limited English proficiency
Evaluate Safety & Efficacy of Condroflex in Subjects With OA

Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

To have osteoarthritis degree 2 or 3 / To be capable to consent

Eligibility Criteria:
Inclusion Criteria:

* to have knee osteoarthritis degree 2 or 3
* to be capable to consent

Exclusion Criteria:

* previous drug treatment
* concomitant diseases
* concomitant drugs