cyrilzakka/clinical-trials huggingface dataset:
The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults

This study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.

Hypertension in older adults is a known contributor to both cardiovascular disease and falls. The Centers of Disease Control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (BP). However, sodium is recommended to treat orthostatic hypotension (OH), a risk factor of falls. The long-term effects of low sodium intake on physical function are largely unknown in older adults.

The objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on BP regulation among 40 semi-independent, older adults aged 60 and above.

Primary Aim 1: To determine the effects of a low sodium (\<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium \~2 mg per kcal of energy intake) on seated BP among independently living older adults.

Hypothesis Aim 1: Compared with the usual meal plan, a reduced sodium meal plan will lower seated BP in older adults after 2 weeks.

Feasibility Aim 1: To evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires).

Feasibility Aim 2: To determine effect size (variance) of secondary outcomes: standing BP, OH (standing minus seated BP), orthostatic symptoms, and a timed up and go test (TUG).

Eligible participants will be randomized to low versus usual sodium meal plans for two weeks. Assessments will be made at the in-person baseline visit, one week telephonic interview and 2 week in person follow-up visit.

The primary outcome is seated BP and secondary outcomes include orthostatic hypertension and Timed Up and Go (TUG) tests. Both primary and secondary outcomes will be measured twice: (1) before the study begins (baseline), and (2) after 2 week period. Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed as well.

Intent-to-treat analysis will be conducted for all endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Resident at Jack Satter House in Revere
* Age \>= 60 years
* Resting systolic blood pressure 100-149 mm Hg and diastolic blood pressure \<100 mm Hg
* Stable BP medications (no recent or intended changes)

Exclusion Criteria:

* Cognitive Impairment (Montreal Cognitive Assessment test \<18)
* Unstable blood pressure medications in the past 2 months
* Terminal or mental illness
* Severe allergies to common foods
* Unwillingness to comply with the diet
* Physical inability to do a timed up and go test
* Active kidney dialysis or history of kidney transplant
A Long-term Follow-up Study of Pulmonary Function Changes Using Phase-resolved Functional Lung MRI in Patients With COVID-19

So far, the number of COVID-19 infections worldwide has exceeded 700 million. Long-term damage to the lungs is a major sequela of COVID infection. Pulmonary function testing is an important means for the evaluation of lung damage. MRI examinations with free breathing and no contrast agent can prevent patients from suffering from ionizing radiation damage caused by multiple CT examinations.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years; Sign the informed consent; Patients diagnosed with COVID-19 by nucleic acid test and survived to be discharged; Complete clinical data during hospitalization.

Exclusion Criteria:

* Patients with bacterial pneumonia; Patients with MRI contraindications.
Evaluation of the Effect of Sensory Imagination on Food Portion Size in School-aged Children

The objective of this intervention is to evaluate the effect of sensory imagination (i.e., imagining the sensory properties of an object) on the choice of food portion size in school-aged children. Previous research showed that it may help children to choose smaller portion size. The investigators would like to assess whether this effect can be reproduced with two types of food (one with a high energy-density and one with a low energy-density), and in older children.

School-aged children (8-11 years old) will be included in their usual schools to participate in an afternoon snack, organised according to regular arrangements, during two days separated by one week. On each day, the participants will receive a choice of three portion sizes of a food (small, medium, large), and will be asked to chose one of these portions and to eat it for snack. On one day, the high energy-density food will be offered; and on the other day, the low energy-density food. This will be counterbalanced across participants. Moreover, two groups of children will be constituted: the first group, the control group, will have to perform a sensory imagination task about neutral facts. The second group, the "food sensory imagination" group, will have to perform a sensory imagination task foods.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Children with food allergies
* Children who dislike experimental foods
Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)

The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis.

The main questions it aims to answer are:

* Do the questions of the Arabic-ACSS have sufficient clarity?
* Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician.

Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract.


Eligibility Criteria:
Inclusion Criteria:

* women.
* presented to the urology or gynecology and obstetrics outpatient clinics.
* having the diagnosis of uncomplicated cystitis.

Exclusion Criteria:

* pregnancy.
* urethral catheterization.
* anatomical abnormality of the urinary tract.
* Neurologic abnormality that affects bladder function.
* urinary tract stones.
* recent antibiotic usage (within 1 month).
* immunosuppression.
A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents

Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, NY. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.

This is a single-arm investigation of a novel suicide prevention intervention, called "Supporting Wellbeing with Everyday Experiences of Peers" (SWEEP). In a preliminary phase of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from Bronx Adolescents will be collected. The investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. Adolescent participants (n=46) will be provided with the SWEEP intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. The narratives will be provided, in audio and text formats via a smartphone app. That same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, the primary outcome of the study, five times per day. This app will also collect secondary and additional outcomes. The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial.

Eligibility Criteria:
Inclusion Criteria:

* past-month history of suicidal thoughts
* past-month history of Major depressive disorder
* possession of apple or android smartphone with data plan

Exclusion Criteria:

* inability to read/write in English
* Active mania
* Active psychosis
* Autism spectrum disorder
Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

There is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. Available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19 and enhance specific immune response to SARS-CoV-2 antigens.

One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5 days will be screened for the study. When the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. During observation, the patient will keep Respiratory Illness Diary. Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect Post-COVID-19 Questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 - ≤ 65 years;
2. Male or non-pregnant female;
3. Informed virtual pre-consent and paper signed consent forms;
4. Confirmed symptomatic COVID-19 lasting 0-5 days;
5. Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG;

Exclusion Criteria:

1. Risk for the complicated course of COVID-19 due to:

   1.1. Hypertension; 1.2. Diabetes mellitus; 1.3. Immunosuppressive conditions; 1.4. Chronic pathology of the respiratory system ; 1.5. Chronic pathology of the cardiovascular system ; 1.6. Malignant tumor ; 1.7. Systemic inflammatory connective tissue disease ; 1.8. Cerebrovascular disease ; 1.9. Chronic hepatitis. Hepatic cirrhosis; 1.10. Inflammatory bowel diseases ; 1.11. Chronic kidney disease ;
2. Drug or alcohol abuse as suspected by investigator;
3. History of persistent diarrhea of any cause;
4. Use of pre- or probiotics during the last 2 weeks before enrollment;
5. Allergy to any components of the TDS;
6. Technical difficulties to perform virtual study visits.
7. Inability to perform a blood test for antibodies after 6 months
8. Inability to swallow capsules, or choking / coughing while eating
Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

The study is randomized, placebo-controlled, double-blind clinical trial that aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

The study aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

Therefore it will be a randomized, placebo-controlled, double-blind clinical trial that intends to recruit 122 patients with radical prostatectomy indication who agreed to consent study inclusion.

Patients randomized to intervention group will receive 1,0g of tranexamic acid IV during anesthetic induction, followed by a maintenance dose of 1,0 mg/kg/hour of surgery. Control group will be operated normally.

Data as hemoglobin drop, estimated bleeding volume, need to transfusion, side effects, and presence of lymphocele will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years olds;
* Who accept to participate and sign the consent form;
* Compliance with the study follow-up protocol;
* Diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy.

Exclusion Criteria:

* Coronary artery disease treated with drug-using stent;
* Previous coronary procedures or coronary disease using a stent;
* Acute or chronic liver failure;
* Severe chronic renal failure (ClCr \< 30 mL/Kg.h, according to the Modification of Diet in Renal Disease formula);
* Suspected allergy to tranexamic acid;
* Known coagulopathies and refusal to sign consent form.
Cannabidiol and CES1 Interactions in Healthy Subjects

The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects

Cannabidiol (CBD) is a widely utilized nonpsychoactive cannabinoid available as an OTC supplement, a component of medical cannabis, and a prescriptive treatment of childhood epilepsies. In vitro studies suggest CBD may inhibit a number of drug-metabolizing enzymes, including carboxylesterase 1 (CES1). The aim of this study was to evaluate effect of CBD on the disposition of the CES1 substrate methylphenidate (MPH). This was a randomized, placebo-controlled, crossover study involving 12 healthy subjects. Each subject ingested 750 mg of CBD solution, or alternatively, a placebo solution twice daily for a 3-day run-in period followed by an additional CBD dose (or placebo) and a single 10 mg dose of MPH and completed serial blood sampling for pharmacokinetic analysis. MPH and CBD concentrations were measured by liquid chromatography with tandem mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Age: 21-45 years
* Gender: males and females (50:50)
* Race or ethnicity: no restrictions
* Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)
* Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.
* Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.
* With the exception of oral contraceptives, subjects must not be taking prescription or OTC medication for the duration of study participation
* Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation

Exclusion Criteria:

* The presence of a known allergy, hypersensitivity, or adverse reaction to CBD or cannabis, or sesame seed oil
* The presence of a known allergy, hypersensitivity, or adverse reaction to methylphenidate or dexmethylphenidate (Focalin®)
* A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.
* The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;

  1. Gastric bezoar
  2. Swallowing disorders
  3. Strictures
  4. Fistulas
  5. GI obstruction
  6. Severe dsyphasgia
  7. Crohn's disease
  8. Diverticulitis
  9. A positive urine pregnancy test.
  10. A positive Urine Drug Screen
  11. Any concomitant prescription medication, OTC medication, herbal or other dietary supplement or vitamins during the study period.

All subjects must be medication-free from 7 Days before initiation of the first active study day, through the duration of the study. This exclusion the use of vitamins, herbal preparations and OTC supplements.
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged \>18 years

Exclusion Criteria:

* serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
* history of any anaphylaxis, serious vaccine reactions
* hypersensitivity against vaccine components
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected impairment/alteration of immune function
* more than one injection of influenza vaccine received or laboratory confirmed influenza disease
* within last 6 months: influenza vaccination received
Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry

The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.


Eligibility Criteria:
Inclusion Criteria:

* Patient was previously treated with NBS
* Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent

Exclusion Criteria: There are no exclusion criteria for this study.
Can VI-RADS/ADC Accurately Stage Bladder Cancer??

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour

Exclusion Criteria:

* fungating lesions
* beyond the scope of enbloc resection
Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition

The aim of high dose radiotherapy treatment is to deliver enough radiation to the tumour to kill all the cancer cells while at the same time giving a low dose of radiation to the normal parts of the body to reduce the side effects of treatment. This requires the cancer specialist to accurately identify the areas of cancer on a computed tomography (CT) scan. Positron emission tomography computed tomography (PETCT) scans use radioactive sugar that is injected into the patient. This sugar goes into cancer cells and shows up as a bright spot on the PET scan, allowing the doctors to see tumours more accurately. Some cancers move with breathing, for example lung, pancreas and oesophageal (or gullet) cancers. Fourdimensional CT scanning (4DCT) is a special type of CT scan that allows the motion of the tumour to be seen and measured accurately. This information can then be used to help ensure that the radiotherapy correctly treats the moving tumour.

The aim of this study is to see if there are possible benefits to combining PET with 4DCT to get a 4D PETCT scan for tumours that move with breathing. This study is divided into three cancer types; lung, lower oesophagus and pancreatic cancer.

First the investigators are going to test the use of 4D PETCT in the radiotherapy planning of these tumours to see if it helps the doctor to identify the cancer.

Secondly, the investigators are going to see if the 4D PETCT helps to show areas within the cancer that are potentially more active. This might then allow us to target a higher dose to these areas, which could potentially improve the chance of controlling and curing the cancer. Patients' standard treatment will not be altered by participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* WHO Performance status 02 (Appendix A)
* Histologically proven non small cell lung carcinoma, distal oesophageal carcinoma or pancreatic adenocarcinoma
* Clinical decision made to proceed with a course of radiotherapy of curative intent with or without concurrent chemotherapy
* Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
* Able to provide fully informed written consent
* Able to lie flat for 1 hour
* Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.

Exclusion Criteria:

1. Hypersensitivity to Fluorine18 fludeoxyglucose (FDG)
2. Hypersensitivity to iodinated contrast media
3. Poorly controlled diabetes
4. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 mL/min)
5. Claustrophobia precluding imaging
6. Uncontrolled pain
7. Urinary incontinence
8. Female patients must not be pregnant and if of child bearing age using adequate contraception
9. Breast feeding
10. Serious psychiatric comorbidity
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child


Eligibility Criteria:
Inclusion Criteria:

* Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
* Written informed consent was required from parents of eligible children.

Exclusion Criteria:

* Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.