cyrilzakka/clinical-trials huggingface dataset:
Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation

Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity.

1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity.

It is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity.

That is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.

The objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.

Eligibility Criteria:
Inclusion Criteria:

* Patient participating in cardiac rehabilitation
* Patient with a smartphone compatible with the application
* Patient with internet connection
* Patient having signed the written consent to participate

Exclusion Criteria:

* Patient reluctant or unable to comply with the protocol
* Pregnant, parturient and nursing mothers
* Persons deprived of their liberty or under guardianship
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient starting capecitabine-containing chemotherapy
* Has never had capecitabine before
* Performance status 0-2 using the ECOG classification
* Life expectancy more than 6 months
* Agreed to stop any vitamin supplements, apart from vitamin D.
* Liver function studies including AST/ALT within 3x upper limit of normal
* Signed informed consent must be obtained from participating individuals
Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients

High dose atorvastatin may worsen insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* chronic renal disease
Examining the Effect of Role-playing Exercise by Utilizing an Obesity Suit in a Simulation Scenario on Weight Bias and Empathy Levels Among Nutrition Sciences Students

A quasi-experimental design (i.e., "One-Group Pretest-Posttest Design") will be applied among 34 convenient samples of undergraduate students in their first year of nutrition sciences program at Ariel University and Tel-Hai College. The intervention will take place at the simulation centers of the institutions. All participants will be asked to wear an obesity simulation suit (Unisex obesity Simulation suit, Erler-Zimmer, Germany) and to participate in a standardized scenario that simulates meetings between a person with obesity and a 'registered dietitian'. The 'registered dietitian' will be presented by a professional role-player and the scenario will encompass different levels of weight bias. At baseline, 1- and 3-week post-intervention both groups will be asked to fill in a survey using "Qualtrics" software. The survey will include the Anti-Fat Attitudes questionnaire (AFA), the Short-Form of Fat-Phobia scale (F-scale), the Weight-Implicit Association-Test (weight-IAT), and the Jefferson Scale of Empathy. Data on demographics, weight history, and perception, measurement of actual weight and height, and the beliefs about the causes of obesity questionnaire will be collected at baseline.


Eligibility Criteria:
Inclusion Criteria:

* undergraduate students in their first year of the nutrition sciences program at Ariel University or Tel-Hai College
* age ≥18 years
* having fluency in Hebrew
* ability to wear an obesity suit
* willingness to participate in the study
Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma

The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the patients'dysglycemia will be also investigated.

This retrospective cohort study will include all consecutive adult patients who underwent surgery for PHEOs and catecholamine-secreting PGLs from January 2018 to June 2020. Patients with recurrent PPGLs, those who required steroids after adrenalectomy, and those with inadequate clinical records were excluded. The patients' electronic medical files were reviewed. Patients with dysglycemia included those with diabetes, or impaired fasting glucose, or impaired glucose tolerance. Clinical history data such as age, sex, body mass index (BMI), the presence of preoperative symptoms, biochemical test results, and tumor characteristics, such as tumor diameters and locations were extracted and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old
* patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)

Exclusion Criteria:

* recurrent PPGLs
* patients who required steroids after adrenalectomy
* patients with inadequate clinical records were excluded.
Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
* Participants who agree to undergo tubeless PCNL
* The participants' maximum diameter of the stone should be less than 3.5cm

Exclusion Criteria:

* Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
* Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
* Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
* Renal trauma or congenital malformation of the urinary system
Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State

This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. The prevalence of exceptionally high levels of residential radon in North Dakota (ND), coupled with public's poor understanding of this hazard, is a critical public health problem.


Eligibility Criteria:
Inclusion Criteria:

* The principal eligibility criterion is that participants own a smartphone.

Exclusion Criteria:

* The principal exclusion criterion is previous testing for radon within the past two years.
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes

Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA) agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an exciting development, representing a novel mechanism for improving IR. BCQR has not been studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data support the proposed study of possible benefits of BCQR on insulin action, glycemic control, and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes will include fasting and postprandial glucose, glycemic variability, insulin dosing, hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Diabetes (T1D) of \>1 year duration based on a clinical course consistent with T1D and rapid conversion to insulin requirement after diagnosis.
2. HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)
3. age 12-60 years of age

Exclusion Criteria:

1. Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia including cancer, heart failure, active or end stage liver disease, kidney disease (except microalbuminuria), inadequately treated thyroid disease, or rheumatologic disease;
2. Tobacco or marijuana use;
3. Pregnancy;
4. Regular or frequent oral steroid use;
5. Current use of insulin sensitizing medications, neuroleptics, ergot-related medications, or triptan medications for migraine,
6. Diagnosis or history of psychosis,
7. Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic fibrosis-related diabetes.
A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer

This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 to 32.0 kg/m2
* Body weight ≥50 kg
* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
* All clinical laboratory test results within the normal range or showing no clinically relevant deviations as judged by the Investigator.
* Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the study drug administration. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.

Exclusion Criteria:

* Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical research center.
* Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
* Irregular defecation pattern (less than once per 2 days).
* For a study with a radiation burden of superior to 0.1 mSv, the subject will be excluded if he participated in another study with a radiation burden of superior to 0.1 mSv and inferior or equal to 1 mSv in the period of 1 year prior to screening; a radiation burden of superior to 1.1 mSv and inferior or equal 2 mSv in the period of 2 years prior to screening; a radiation burden of superior to 2.1 mSv and inferior or equal 3 mSv in the period of 3 years prior to screening.
* Exposure to radiation for diagnostic reasons (except dental X rays and plain X rays of thorax and bony skeleton \[excluding spinal column\]), during work, or during participation in a clinical study in the period of 1 year prior to screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Clinico-biological Characterization and Survival of Patients With Adult T-cell Leukemia / Lymphoma (ATL) and Patients Chronically Infected With the HTLV-1 Virus (HTLV-OBS)

The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* HTLV-1 infected
* T lymphoproliferation induced by HTLV-1 (cohort 1)
* without T lymphoproliferation induced by HTLV-1 (cohort 2)
* informed and accepted the collection of data

Exclusion Criteria

- Patients refusal of participation
Changes in Biomarkers Using Prostaglandin Inhibitors

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

This is a biomarker study with the goal of measuring changes in protein and rna expression. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

66 women at normal risk for developing breast cancer will be recruited and enrolled. 22 women will be randomized into each arm, with anticipation of 2 women in each group will not be evaluable, leaving 20 in each group for evaluation.

A combination of vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism.

Specific Aims:

-Evaluate vitamin D metabolism, through the measurement of CYP24 in the breast.

2-Evaluate breast specific levels of vitamin D and celecoxib, and assess if the levels of these compounds correlate with response to markers which influence prostaglandin synthesis and metabolism. Additionally, in women without active breast cancer , we will determine the effect of vitamin D, with or without celecoxib, on 1) PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast, 2) proliferative activity in the breast,, and 3) circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.

Eligibility Criteria:
Inclusion Criteria:

* Woman \>18 years old
* Healthy women who are at normal risk for developing breast cancer
* ECOG Performance Status score 0-1
* Premenopausal women must not be pregnant

Exclusion Criteria:

* History of bilateral mastectomy, or bilateral breast irradiation
* Significant medical or psychiatric problems making the participant a poor candiate
* Evidence of excess use of narcotics or drug dependency
* Have been pregnant and lactating in the past 2 years
* Significant history of peptic ulcer disease or upper gastrointestinal bleeding
* History of severe congestive heart failure that requires hospitalization or intervention
* History of asthma requiring medication for treatment
* Allergy to sulfonamides or NSAID medications
* History of myocardial infarction or stroke
* Currently on Coumadin
* Currently on Tamoxifen (nolvadex),Evista (raloxifene), Femara (letrozole), Arimidex (anastrozole), or Aromasin (exemestane)
* Undergone prior subaeolar breast surgery
The Effects of Including Almonds in a Weight Loss Trial

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

The purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Eligibility Criteria:
Inclusion Criteria:

Adult participants

* Overweight or obese (BMI 25-40 kg/m2)
* Fasting blood glucose ≤6.9 mmol/L via capillary finger-stick blood samples
* No nut allergies
* Willing to comply to study protocol and to eat test meals

Exclusion Criteria:

Those not meeting inclusion criteria.
Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic (SCD Online).

This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches. Additionally, this study will provide insight into the benefits of the program while people are not able to meet in person during a pandemic.

Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.

RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.

The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.

Eligibility Criteria:
Inclusion Criteria:

* Have access to high speed internet and a computer or mobile device with a webcam
* Have subjective cognitive complaints
* Be fluent in written and spoken English
* Able to self-identify areas of their everyday lives in which they would like to improve.

Exclusion Criteria:

* Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
* Presence of severe depression
* Presence of substance abuse
* History of hospitalization for psychiatric reasons
The Effect of Buzzy and Puppet on Pain and Fear

Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.

Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.


Eligibility Criteria:
Inclusion Criteria:

* Participants whose child and parents agreed to participate in the study
* Children who had successful phlebotomy on the first attempt

Exclusion Criteria:

* Children with chronic disease, mental disability, or mental retardation
* Children who had taken analgesics in the last 24 hours
* Children who were hospitalized
* Children who had undergone a surgical procedure
* Children who did not have successful phlebotomy on the first attempt