cyrilzakka/clinical-trials huggingface dataset:
Precise Oncology Interventions in Nutrition and Training (OnPoint)

The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria - Healthcare Providers

1. Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
2. Utilize the electronic medical record for patient documentation on a regular basis
3. Willing to complete a 60-90-minute interview

Inclusion Criteria - Patients

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read/understand English or Spanish
5. Diagnosis of breast, prostate or colorectal cancer, 6 months post competition of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. Internet access on a smart phone, tablet, or computer
8. Agree to be randomly assigned to any study group

Exclusion Criteria:

1. Less than 18 years of age
2. Unable to provide consent
3. Unable to read/understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Blank
6. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
8. History of dementia or major psychiatric disease which would interfere with study participation
9. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
10. Eastern Cooperative Oncology Group (ECOG) score of \>2
11. Severe lymphedema as determined by physician
12. Receiving physical therapy treatment
Evaluation of Calcinosis in Systemic Sclerosis

Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.


Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis presenting ACR-EULAR 2013 criteria
* Given their consent
* Titulary of health insurance

Exclusion Criteria:

* Dermatomyositis overlap
* Pregnant or breastfeeding women
* Imprisoned person
* Refuse of consent
TEC4Home Blood Pressure Randomized Controlled Trial

The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).

The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?

Secondary research questions will address:

1. How do these interventions (telemonitoring and case management) improve medication adherence?
2. Do these interventions reduce physician and ED visits?
3. Are these interventions safe?
4. How do these interventions influence patient experience?

Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥ 18 years of age
* Elevated triage BP AND increased average BP in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg)
* Own a smart phone
* Willing to measure and tele-transmit home BP readings

Exclusion Criteria:

* Hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome
* Pregnant women
* Acute intoxication
* Acute surgical or trauma patients
* Psychiatrically unstable patients
* Advanced cognitive impairment
* Patient requiring admission to hospital
* Inability to use or care for home BP monitor correctly
* From nursing home
* Unstable housing
* Non-English speaking or no family members who can help translate
The Healthy Life Choices Project in HIV-Positive Patients

This randomized clinical trial is designed to determine the efficacy of a dietary intervention to reduce the frequency of bowel movements and improve stool consistency as compared with subjects assigned to a control group. The study enrolled HIV patients with a history of three or more episodes of diarrhea for 3 weeks or more.

The purpose of this study was to compare the efficacy of a combined behavioral dietary intervention using normal foods (Condition 1: treatment) with HIV self-care (Condition 2: control) to reduce the frequency and improve the consistency of bowel movements after 3 weeks and 24 weeks of study intervention.

Thirty to fifty percent of individuals with HIV can be expected to have diarrhea at some point during their illness. Diarrhea can be a chronic condition in HIV disease wherein three or more daily episodes of loose, watery stools are experienced for 4 weeks or more. Chronic diarrhea has been associated with significant morbidity, weight loss, and severe malnutrition. Researchers have reported that patients with chronic diarrhea experience a marked decrease in quality of life in comparison with HIV patients without diarrhea.

The goal of nutrition management for patients with chronic diarrhea is to ensure that adequate caloric consumption meets the metabolic needs of such individuals and to provide symptomatic relief. HIV infection, regardless of stage, causes an increase in resting energy expenditure because of the response of the body to the viral infection. Proper nutrition management can therefore assist in preventing further nutritional imbalances.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosed with HIV or AIDS based on the Centers for Disease Control and Prevention criteria
* experienced a minimum of three episodes of loose, watery, or liquid stools in a 24-hour period for at least 3 weeks
* provide verification from their primary care provider of HIV status, chronic diarrhea history, documentation of medical evaluations completed
* laboratory confirmation that stool samples were negative for pathogens
* patients who were taking antidiarrheal agents were required to be on a stable regimen (same drug, dosage, and frequency) for at least 7 days before entry into the study and still meet diarrhea frequency and consistency criteria
* antiretroviral agents taken to manage HIV required a stable regimen (same drugs, dosage, and frequency) for at least 8 weeks before study entry
* patients were required to complete a mini-mental state examination, obtaining a score of 24 or higher

Exclusion Criteria:

* not meeting any of the above criteria
REGistry of Long-term AnTithrombotic TherApy-2

To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation

The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with atrial fibrillation

Eligibility Criteria:
Inclusion Criteria:

* Documented atrial fibrillation with CHA2DS2VASC \> 1

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease / renal failure with creatinine \> 3 mg/dl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention
ORal ApplianCes for sLeep Apnea of the Elderly

Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. The investigators hypothesized that oral appliances provided to the elderly may prevent hypertension and other consequences of sleep apnea in large populations, at a favorable cost/benefit relationship for the public health system.

Sleep disorders involve significant increases in morbidity and mortality, particularly in those over 60 years. Sleep apnea is the leading identifiable cause of hypertension, which is the main cause of cardiovascular disease. Some degree of sleep apnea is present in up to 95% of the elderly. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas.

We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular advancement of at least 3 mm
* Mouth opening of at least 30 mm
* Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour
* Agree to participate in the study by signing the informed consent

Exclusion Criteria:

* Already in treatment for sleep apnea
* Self-reported severe or terminal Illness
* Physical disability
* Inability to communicate verbally
* Dementia in the Mini-Mental State Examination
* Plan to move to a different a city or to be institutionalized in the next year
* Participation in another clinical trial
* Less than eight teeth, periodontal disease, or TMJ problems
Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who are able to provide informed consent will participate in the assessments.

Outcome variables include selected gait and balance parameters such as cadence, gait-cycle, stride-length, stride-velocity, turning duration, turning steps, postural sway and anticipatory postural control. These parameters will be measured by the portable inertial sensors developed by APDM® and the Zeno/GaitRite.

Testing

Participants after screening and consenting will:

1. Have their height measured and fit with the APDM Opals (each device is a two inch square attached by velcro), one device is attached to each leg, each arm, and the trunk and chest and receive an introduction to walking on the gait mat.
2. Participants are then asked to walk at a self selected walking speed down the gait mat. The participants will complete multiple passes (8-10 passes, total 75-100 feet) across the gait mat while wearing the APDM units to concurrently collect all temporal and spatial data needed to answer the research question. The Zeno mat is the intended primary gait mat for this study. The GaitRite will only be utilized in the case of a technical issue with the Zeno in order to insure completion of the data collection.

Eligibility Criteria:
Inclusion Criteria

1. Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes
2. Individuals able to walk 100 feet independently, with or without the use of an assistive device (walker, cane) and follow simple instructions.
3. Individuals with sufficient physiological systemic support to participate in the study protocol

Exclusion Criteria

1. Inability to speak English secondary to the need to understand and follow multistep directions
2. A secondary diagnosis (musculoskeletal, cardiopulmonary, neurological) that excludes participation in the study
3. Inability to ambulate 100 feet independently with or without an assistive device.
4. Inability to follow simple instructions necessary for completion of the testing tasks.
Lucentis to Treat Retinopathy of Prematurity (ROP) 3 Plus Disease

Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab.

The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.

The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6 months.

Eligibility Criteria:
Inclusion Criteria:

* ROP stage 3 plus disease

Exclusion Criteria:

* Severe systemic co-morbidity that did not allow systemic sedation for injection, or were antiVEGF (vascual endothelial growth factor) therapy was contra-indicated
CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery

Eligibility Criteria:
Inclusion Criteria:

singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel \> 10 gm/dl

• Noncomplicated pregnancy

Exclusion Criteria:

* Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer

RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.

PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.

OBJECTIVES:

* Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
* Compare 5-year rate of distant metastases in these patients.
* Determine overall survival rate in these patients.
* Determine prognostic factors for relapse and morbidity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
* Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility Criteria:
INCLUSION CRITERIA:

* Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:

  * Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
  * Age ≥60, stage IB grade 2 or 3 (with \< 50% myometrial invasion)
  * Stage IIA, any age
* No grade 3 endometrial carcinoma with deep myometrial invasion
* Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
* WHO performance status 0-2

EXCLUSION CRITERIA:

* Serous or clear cell histology or uterine sarcoma
* staging lymphadenectomy
* interval between surgery and radiotherapy \> 8 weeks
* history of previous malignant disease (except basal cell carcinoma of skin)
* previous radiotherapy, hormonal therapy or chemotherapy
* diagnosis of Chrohn's disease or ulcerative colitis
"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge

This is a multi-centered randomized controlled trial to investigate the effects of "Remind-to-Move" (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.

This is a proof-of-principle study to investigate the effects of "Remind-to-Move" (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.

A multi-center, parallel-group, randomized controlled trial with blinded assessment was carried out in four hospitals. Eighty-four eligible participants who had suffered from stroke with less than 6 months and could slightly move their arms were randomly allocated to either an experimental, sham, or control group stratified by hemiplegic arm functional levels. Patients in the experimental group were treated by RTM using wearable devices, 3 consecutive hours daily, for 4 weeks. The sham group used sham devices. The control group received the usual care. A masked assessor evaluated the participants at 0, 4th, 8th and 12th weeks. Outcome measures included arm function tests, motor activity log, movement amount and percentage recorded by wearable devices. All patients allocated to treatment were included in intention-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography
2. Unilateral hemispherical involvement
3. Aged 18 or above
4. Time since onset less than 6 months
5. Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7)
6. Able to understand verbal instruction and follow one-step commands
7. Modified Ashworth Scale (MAS) ≤ 2
8. Mini-mental State Examination (MMSE) ≥ 19
9. No complaint of excessive pain or swelling over hemiplegic arm
10. Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1).

Exclusion Criteria:

1. Participating in any experimental or drug study
2. Unable to give consent to participate
3. Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support
4. Having history of botulinum toxin injection in 3 months.
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease

To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.

25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or younger
* Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.

Exclusion Criteria:

* Subjects with suspected or newly diagnosed Crohn disease
* Subject who have the following in their body may not undergo MRE imaging:

  * Metal chips/shrapnel
  * Surgical clips
  * Artificial joints
  * Metallic bone plates
  * Prosthetic devices
  * Heart pacemakers
  * Clips in or around the eye balls
  * artificial heart valves
  * Bullet fragments
  * Chemotherapy or insulin pumps
Non Invasive and Non-Contact Imaging Of Tissue Oxygenation and Vascular Reactivity

1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
2. Quantitative validation of non-contact vascular function imaging by the CWC imaging system
3. Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement

The hyperspectral imaging technique estimates cutaneous tissue oxygenation by illuminating tissue and detecting tissue reflectance at different wavelengths. One major advantage of hyperspectral imaging is non-invasive and non-contact detection of tissue functional properties. The dual-mode imaging system integrates hyperspectral and thermal imaging modalities for simultaneous assessment of cutaneous tissue oxygenation and vascular function. This clinical protocol is defined to validate the CWC system on healthy human subjects

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older
* No history of diabetes.
* No history of vascular disease

Exclusion Criteria:

* Under 18 years of age
* Unable to provide informed consent
* Prisoners
* Current smoker