cyrilzakka/clinical-trials huggingface dataset:
Exercise Intervention - and Impact on Hospitalization

Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.


Eligibility Criteria:
inclusion= waitlisted for liver transplant with poor 6MWT

Exclusion criteria include: age \< 18 years, recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month, large esophageal varices without primary prophylaxis, active excessive alcohol intake (in the previous 3 months), current overt uncontrolled hepatic encephalopathy, hepatopulmonary syndrome with uncontrolled hypoxia, portopulmonary hypertension, inability to perform exercise, or marked symptomatic comorbidities (cardiac, pulmonary, renal). multiorgan transplant
Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison. Extremely premature infants (born at \<28-30 weeks gestation) have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants. We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella (MMR) vaccines in relatively healthy 15 month-old children born at \<29 weeks gestation. This is a phase IV, observational study with 2 study arms having 16 infants each. The first group will enroll infants 9-12 months old that were born premature (\<29 weeks gestation). The second group will be matched for sex, race, and postnatal age, but will have been full term (\>= 37 weeks gestation) at birth. Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 (4 to 6 weeks after visit 1).

Eligibility Criteria:
Inclusion Criteria:

1. Premature infant \< 29 weeks gestation at birth or term infant \>= 37 weeks gestation at birth.
2. Postnatal age \< 16 months, 0 days.
3. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
4. Parental permission.
5. Agreement of primary care pediatrician/ health care provider.
6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
7. Healthy status at enrollment.

Exclusion Criteria:

1. Known immunodeficiency.
2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
3. Requiring oxygen therapy.
4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy

According to the random number table, all patients were divided into short-term treatment group, long-term treatment group and non-intervention stroke control group according to the proportion of (1:1:1) epilepsy disease modifier idebenone. Patients in the short-term treatment group will take idebenone for a total course of 14 days (acute period) after stroke, and patients in the long-term treatment group will take idebenone for a total course of 3 months after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital within 24 hours of stroke symptoms and diagnosed with stroke (including cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous sinus thrombosis, etc.) after relevant examinations;
* Able to cooperate with the inspection;
* Sign the informed consent form.

Exclusion Criteria:

* History of epilepsy before stroke;
* A history of serious comorbidities that may lead to seizures (including malignant tumors, specific autoimmune diseases, severe electrolyte abnormalities, end-stage renal disease, and severe head trauma);
* Secondary stroke caused by head trauma or surgery;
* Other patients that the researchers think need to be excluded.
Attention-Bias Modification Treatment for PTSD

Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. Recent findings demonstrate significant associations between attention bias and stress vulnerability. This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals with PTSD. In addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the ABM.

ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 60;
* Current DSM-IV PTSD for the last 12 months or more;
* Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol;
* Attention bias toward or away from threat assessed by Dot-probe attention bias task

Exclusion Criteria:

* Current DSM-IV Axis I disorder other than PTSD.
* Patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (MDD) will be allowed for enrollment if their HAM-D score doesn't exceed 25;
* Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders;
* Suicidal ideation or behavior that poses a significant danger to the subject. Unstable clinical condition such that participation in a controlled trial would pose a significant danger;
* Prior participation in attention bias modification treatment (ABMT);
* Current or past history of seizure disorder (except febrile seizure in childhood);
* Currently on psychotropic medication. (excluding the use of hypnotics);
* Currently participating in formal psychotherapy. This includes:

  * psychodynamic,
  * cognitive behavioral and interpersonal therapies
* Current unstable or untreated medical illness;
* Vision loss.
Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study

This study aims to iteratively develop, refine and test the Improving Asthma Care Together (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their parents.

Asthma is one of the most common chronic conditions of childhood, affecting over six million US children. Asthma treatment relies on self-management including symptom monitoring and response, trigger avoidance, and timely and appropriate medication use. Unfortunately, fewer than 50% of children with asthma are adherent to asthma treatment regimens, leading to increased disease morbidity and mortality and potentially irreversible airway damage.

Children with asthma are missing a voice in their own care. The school-age years (7-11) represent a natural transition in asthma management, as children must assume some responsibility for asthma-related care while they spend increasing time away from parents at school and other extracurricular activities. Yet, existing interventions focus on parents alone and use prescriptive approaches, telling the parent what to "do" to the child to manage their asthma. As a result, current strategies are failing to provide children with asthma and their families the tools they need to manage asthma successfully within the realities of their daily lives.

Using a Human-Centered Design (HCD) framework, the investigators co-designed a tailored asthma shared management mobile health application that pairs the parent and child together as a team and facilitates the intentional transition of some asthma management to the child. The hypothesis is that by involving children in their own care, participants will improve asthma management in the present, but also establish lifelong successful self-management skills. The objective of the proposed study is to pilot test the Improving Asthma Care Together (IMPACT) mobile health application with parent-child dyads. Based on the preliminary data, the central hypothesis is that IMPACT will be effective for delivering a shared asthma management intervention for children and their parents.

Eligibility Criteria:
CHILD Inclusion Criteria:

* Clinician diagnosis of persistent asthma (prescription for daily asthma medication)
* Speak English

PARENT Inclusion Criteria:

* 18 years or older
* Child's primary caregiver
* Able to understand and read English
* Reside with the child 50% or more
* Legal guardian who can consent for child to participate
* Have access to a smart phone and reliable home internet access
* Reported Asthma Responsibility Questionnaire score \< or = 2.5 at screening

CHILD Exclusion Criteria:

* Parent report of developmental delay (language \< 5 year level)
* Co-morbid cancer, diabetes, attention deficit hyperactivity disorder (ADHD)
* Current asthma exacerbation at the time of recruitment
Estimation of VO2Max Using Smartphone Application

The aim of this observational study Is to examine the validity of the Smartphone application (VO2max calculator) in calculating VO2max in elderly population.

Research hypotheses:

this study will test the following null hypothesis: (Vo2max calculator) application will not have criterion validity in estimating VO2max values in the elderly population.

Research question:

Is the Smartphone application (VO2max calculator) considered a valid tool for estimating accurate values of VO2max in the elderly population in comparison to the golden standard method?

Although maximal oxygen consumption (VO2max) is growing in evidence as a powerful indicator of several health conditions it's rarely used in clinical practice due to the high expense, requirement of specialized equipment, and related risks of maximal exertion. So, we aim to develop a simpler method for estimating VO2max using modern smartphone technologies.

Method: participants of this study will be divided into 2 equal groups. The first group will perform a gold standard treadmill-based VO2max measurement and the other group will perform a smartphone based 1-mile walk test for VO2max estimation.

Eligibility Criteria:
Inclusion Criteria:

* Elderly subjects aged from (65 to 75) years.
* BMI 18.5-29.9 kg/m2
* Answer (NO) to all of the questions in the Physical activity readiness questionnaire (PAR-Q)
* Do not have any absolute or relative contraindications for exercise testing according to the American Heart Association (AHA) statement.

Exclusion Criteria:

* Recent surgical conditions.
* Skeletal deformities.
* Blood pressure regulating medication intake.
* Any respiratory disorders.
* Back, hip, knee or ankle pain within last month.
* Any neurological or psychiatric conditions.
* Implanted pacemaker.
* Anemic patients.
Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue.

The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.


Eligibility Criteria:
Inclusion Criteria:

* Age ranging between 18 to 35 years, all genders.
* Healthy subjects
* Moderate physical activity (evaluated by IPAQ questionnaire)
* Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed.

Exclusion Criteria:

* Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.
Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer

One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination

Exclusion Criteria:

* (1) \<60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.
A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma (MM) diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Participants must have measurable, secretory disease as defined by any of the following:

  1. Serum monoclonal paraprotein (M-protein) level greater than or equal to(\>=)1.0 gram/deciliter (g/dL) or \>= 0.5 g/dL for Immunoglobulin (Ig) A, IgD, IgE or IgM MM; or
  2. Urine M-protein level \>= 200 milligram (mg)/24 hours; or
  3. Serum Ig free light chain (FLC) \>= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio if participant does not have measurable M-protein in serum and urine
* Relapsed or refractory MM after receiving at least 2 prior lines of therapy: Received both, a PI (\>=2 cycles or 2 months of treatment) and an IMiD (\>=2 cycles or 2 months of treatment)in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months); A "line of therapy" is defined as 1 or more cycles of a planned treatment program, Radiotherapy, bisphosphonate therapy, or a single short course of steroids (that is, less than or equal to equivalent of cumulative dose of dexamethasone 160 mg within 21 days of 1st dose) would not be considered prior lines of therapy
* Response (partial response or better based on investigator's determination of response) to at least 1 prior treatment regimen
* Progressive disease based on investigator's determination of response on or after their last regimen
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Participant has received daratumumab or other anti-CD38 therapies previously
* Participant has received prior antitumor therapy as follows, prior to the first dose of study drug:

  1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less;
  2. Monoclonal antibody treatment for multiple myeloma within 21 days;
  3. Cytotoxic therapy within 21 days;
  4. Proteasome inhibitor therapy within 14 days;
  5. Immunomodulatory agent therapy within 7 days;
  6. Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (\<=) 5 percent (%) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
* Participant has had a plasmapheresis within 28 days before Cycle 1 Day 1
* Participant has known meningeal or central nervous system involvement of MM
* Concurrent medical condition or disease (example \[e.g.\], active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males, 18 - 45 years of age.
* BMI 20-30 m2.

Exclusion Criteria:

* Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
* Clinically significant ECG, vital signs and clinical laboratory indices.
Long-term Effect of Lanthanum Carbonate on Bone

Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who had exposure to lanthanum carbonate in SPD405-309
Glucose Variability in Cancer Patients Receiving Dexamethasone

Dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea and vomiting (CINV). While effective, high dose dexamethasone is associated with numerous side effects, even when used for a short duration. One such effect is elevated blood glucose, or hyperglycemia. Current literature suggests increased risk of infection, poor wound healing, and increased mortality in non-cancer surgical patients with steroid-induced hyperglycemia. There is also evidence to support that elevations in blood glucose are associated with worsened outcomes in cancer patients. Much of this data comes from cancer patients that are treated in an inpatient setting where blood glucose is routinely checked. Limited data is available describing the fluctuations in blood glucose following dexamethasone administration in cancer patients being managed in an outpatient setting, such as the Anschutz Cancer Pavilion (ACP) Infusion Clinic. This study aims to characterize the effects dexamethasone has on blood glucose in cancer patients by utilizing Continuous Glucose Monitoring (CGM) devices. These devices are minimally invasive, are FDA approved, and can produce real-time data of blood glucose fluctuations over a course of 3-7 days. By inserting the devices under the skin of the abdomen, the investigators can evaluate the temporal relationship between glucose abnormalities and dexamethasone administration. Results from this study will not only increase the knowledge base of dexamethasone-induced hyperglycemia and identify patients at increased risk, but also allow future research to be conducted in order to determine if standard protocols can proactively minimize steroid-induced glucose fluctuations.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant adult patients
* between 18-75 years of age
* are seen in the UCH outpatient cancer clinics for management of solid tumor and/or non-leukemia malignancies
* are prescribed high dose dexamethasone for CINV for no longer than 5 days, and
* have an absolute neutrophil count (ANC) \> 1,500/mm3 and platelet count \> 100,000/mm3 at time of glucose sensor placement.
* ANC of 1,500/mm3 is standard criteria for receiving outpatient chemotherapy.

Exclusion Criteria:

* leukemia-type malignancy
* require inpatient administration of chemotherapy
* are receiving chronic steroids
* have an ECOG/WHO/Zubrod score of 3 or 4
* have an ANC \< 1,500 cells/mm3 at time of CGM device placement or are anticipated to have a decrease in ANC \< 1,500 cells/mm3 during 5 days after sensor placement,
* have an active infection, or have significant cognitive impairment limiting their ability to use the CGM or complete a take-home diary.
* to further minimize the potential for infection, patients receiving chemotherapy regimens associated with a high (\>20%) risk of febrile neutropenia, according to the 2014 NCCN guidelines, will also be excluded from study