cyrilzakka/clinical-trials huggingface dataset:
Healthier Living With Arthritis Online Program

Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.

An internet-based arthritis self-management program was developed based on the widely used small-group arthritis self-management program. Individuals with arthritis were recruited via established websites, on-line newsletters, discussion groups, calendar announcements and articles in newspapers, and asked to go to the project website. Subjects who filled out an informed consent and met all of the following criteria were invited to enroll:

1. At least 18 years of age
2. A physician's diagnosis of osteoarthritis, rheumatoid arthritis or fibromyalgia.
3. Not have been in active treatment for cancer for one year.
4. Not participated in the small group Arthritis Self-Management or Chronic Disease Self-Management Program

Those eligible and wishing to continue were randomized to receive the internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). On-line questionnaires were administered at baseline, six months and twelve months after the program. Measures included health indicators, health behaviors, self efficacy and health care utilization. It is hypothesized that course participants, compared to the usual-care control group, will show statistically significant improvements (using Analyses of Covariance and Logistic Regressions) in outcome variables and that the improvements will be associated with increased self-efficacy for management of arthritis.

Eligibility Criteria:
Inclusion Criteria:

* arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)
* internet access and ability to use computer

Exclusion Criteria:

* active treatment for cancer
* taken small group arthritis self-management program
Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux

After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR) or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after LTF in patients with MR or WAR, with the majority reporting only short-term results.

It has been shown that delayed gastric emptying (DGE) might also be an important factor for abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in patients with MR or WAR is poorly investigated.

In the last years the study of gastro-oesophageal reflux has been revolutionized by the development of combined 24-h esophageal pH and multichannel intraluminal impedance (MII) monitoring.

Combined esophageal MII and pH-monitoring allow for the timed correlation of esophageal pH changes with reflux events and achieve high sensitivity for the detection of acid (pH \<4), weakly acidic (pH 4-7) and weakly alkaline (pH \>7) reflux episodes. Use of this technology is bringing into focus the potential role of weakly acidic and weakly alkaline reflux in symptoms that persist despite acid suppressive therapy or anti-reflux surgery.

Eligibility Criteria:
Inclusion Criteria:

- The study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (GER) confirmed by 24 hour pH and impedance monitoring and eligible for laparoscopic antireflux surgery (LARS).

Exclusion Criteria:

- Exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, American Association of Anaesthetists (ASA) score IV, previous upper abdominal surgery, and contraindications to pneumoperitoneum.
CT/MRI Co-registration Prostate Cancer

The target volume in prostate cancer radiotherapy typically consists of the entire prostate gland which is localized by contours drawn on axial computed tomography (CT) radiation planning images. Compared with CT, magnetic resonance (MR) can provide better definition of the prostate gland with respect to the surrounding tissues and the use of multi-plannar reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been shown to significantly overestimate the volume of the gland using the MR-defined prostate volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony landmarks, has enabled radiation planning using a MR-defined clinical target volumes, combined with CT-based electron density information necessary for radiation treatment planning.

Rationale and Hypothesis:

Co-registration may allow better delineation of tumour volumes in prostate cancer. This investigation is a fesibility study designed to evaluate and optimize imaging parameters and co-registration techniques for CT planning and MRI Simulator.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of Prostate Adenocarcinoma
* Undergoing RT with fiducial markers, IMRT or Escalated Dose Conformal RT

Exclusion Criteria:

* Contraindication for MRI
IMProving Adherence to Colonoscopy Through Teams and Technology

Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.

Follow-up colonoscopy after abnormal stool-based colorectal cancer screening (e.g., fecal immunochemical test (FIT)) results in early detection of colorectal cancer (CRC), prevention of CRC, and reduction in CRC mortality. FIT is a commonly utilized screening test that can be performed at home, is inexpensive, scalable, and often adopted in health systems where colonoscopy resources are scarce. Despite evidence that timely colonoscopy is necessary after an abnormal FIT result, completion of colonoscopy occurs in less than 50% of patients at 6 months and varies significantly by clinic and health systems. In addition to understanding the meaning of an abnormal FIT, three care transitions must occur smoothly for the patient: colonoscopy referral, scheduling, and attendance. However, multilevel factors influence missed follow-up, and multilevel solutions are needed along the care continuum to address clinic-, provider-, and patient-level factors that impair or delay colonoscopy completion.

IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT), proposes to close gaps and reduce disparities in CRC screening by improving the completion of diagnostic colonoscopy following abnormal FIT in vulnerable populations using a multilevel approach consisting of interventions at the clinic-, provider- and patient-level. The specific aims are 1) to evaluate the effect of a clinic-level intervention targeting primary care providers and staff to adopt "best practices" to support colonoscopy completion in patients with abnormal FIT results, 2) to determine the effect of a patient-level technology intervention with enhanced instructions and navigation for patients with abnormal FIT to complete a diagnostic colonoscopy, and 3) to explore the multilevel implementation factors contributing to intervention outcomes using mixed methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients with abnormal FIT result
* Patients ages 18 years or older
* English, Spanish, or Cantonese speaking

Exclusion Criteria:

* Patients with normal FIT result
* Patients younger than age 18
Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness During the COVID-19 Pandemic

This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).

The COVID-19 pandemic continues to escalate as a global health threat, leading to devastating impacts on the healthcare system. Frontline healthcare workers are dealing with increased demands and fears for their own, as well as their family's safety. Adding to the stress is the limited ability to maintain social connectedness as physical distancing measures are in place. The investigators plan to conduct an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention called Sudarshan Kriya Yoga (SKY) (n=30) versus an online control mind-body intervention called the Health Enhancement Program (HEP) (n=30) in 60 hospital and long term care frontline staff that are managing COVID-19 patients. Participants will be blinded to the treatment hypothesis while data analyst will be blinded to treatment allocation. Both SKY and HEP will be taught online in two phases in the first week followed by weekly reinforcement sessions for the following 4 weeks. Feasibility measures will be assessed as well as self-rated measures of insomnia, anxiety, depression, and resilience. The investigators expect that it will be feasible to conduct an online RCT of two mind-body interventions, SKY and HEP, in staff managing the COVID-19 pandemic, and that the investigators will be able to remotely monitor safety and efficacy of these interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be frontline hospital or long-term care home staff involved in the management of COVID-19 patients in Canada or The United States of America.
2. Participants will be aged 18 to 70.
3. Participants will be willing and able to attend, via WebEx software, the introductory phase of SKY or HEP, as well as at least two of the four weekly follow-up sessions
4. Have sufficient hearing to follow verbal instructions.
5. Have an adequate understanding of English.
6. Able to sit without physical discomfort for 60 minutes.
7. Not pregnant and willing to remain not pregnant for the duration of the study.

Exclusion Criteria:

1. Inability to independently provide informed consent.
2. Current suicidality as assessed by the suicide item of the Patient Health Questionnaire-9 scale.
3. History of bipolar disorder.
4. History of chronic PTSD.
5. History of schizophrenia or schizoaffective disorder.
6. Currently practice any type of formal meditation, mindfulness, or breathing techniques regularly (greater than 3 times per week).
7. History of complex PTSD.
Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects

The morbidity rate of Chronic Obstructive Pulmonary Disease (COPD) is increasing year by year. It is predicted to be the third leading cause of death worldwide in 2030. People with COPD have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway clearance, and the obstruction and loss of alveolar elasticity.

This study aimed to explore the effectiveness of cough and sputum assessment and respiratory physiological indicators after training with the Bubble positive expiratory pressure (Bubble PEP) inpatients with COPD. This is a randomization control trial design survey using convenient sampling and will be to select 94 inpatients with COPD in the division of chest ward of two teaching hospital in New Taipei City. The subjects who meet the conditions for admission are explained, and they need to sign a consent form confirming that they understand the risks. More, they are randomly divided into the experimental group (experimental group n=47) and the control group (control group n=47). The experimental group receives the Bubble PEP training; the control group receives the division of chest ward routine care. The study employs a structured questionnaire including a basic demography, COPD domain, COPD assessment test (CAT), cough and sputum assessment test, and check the peak expiratory flow rate (PEFR) using it for data collection. The study needs to be approve by the Institutional Review Board. The two groups agreed to participate in the study, after completing the subject consent form before the intervention, they also received the pre-test as a benchmark for the intervention effect. After completing the 7-day and 30-day intervention, the post-test was performed immediately to understand the intervention immediate effect.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients diagnosed with COPD
2. Over 40 years old
3. Awareness and ability to read articles
4. Agree to participate in this research and sign the research consent form

Exclusion Criteria:

1. Use non-invasive positive pressure breathing apparatus
2. Have received positive pressure breathing therapy before or during hospitalization
3. People with mental illness
4. Coughing up blood, pneumothorax
5. Suffer from legally infectious respiratory diseases
6. Pregnant women
7. Reject the subject
FMRI of Stress and Addictive Disorders

The purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. To examine the effect of stress on thinking and remembering. To examine the separate and interactive effects of stress, addiction, withdrawal, and genetics; and to examine fMRI brain activation associated with stressful, reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video clips in addicted individuals and in healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Between ages 13-50 years old (adolescents 13-17 years old)
* Able to read and write.
* COCAINE DEPENDENT SUBJECTS: meet DSM-IV criteria for cocaine dependence; report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine toxicology screen during initial assessments and upon admission to the CNRU.
* OPIOID DEPENDENT SUBJECTS: meet DSM-IV criteria for opiate dependence and are participating in substance abuse treatment including pharmacotherapy for opioid dependence.
* ALCOHOL DEPENDENT SUBJECTS: meet DSM-IV criteria for alcohol dependence and are currently abstinent from alcohol as documented by substance abuse treatment participation.
* HEALTHY CONTROLS: negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
* Healthy adolescent boys and girls, with no medical or psychiatric conditions;
* WOMEN: have a regular menstrual cycle.

Exclusion Criteria:

* CONTROLS: lifetime or current history of any substance abuse/dependence (excluding nicotine).
* Regular use of any psychoactive drugs including anxiolytics and antidepressants.
* Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
* Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
* Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
* IQ below 75
The North Sea Race Endurance Exercise Study

Competitions such as marathon running and endurance cycling events are increasingly popular and represent an important motivation for sustaining training among leisure-time athletes. However, there is a concern that prolonged, high-intensity exercise may increase the risk of cardiovascular (CV) events. Following prolonged high-intensity exercise there is an increase in levels of circulating markers of myocardial damage such as Troponin I (TnI). The precise cause and clinical significance of this TnI increase is unknown.

* The primary objective of this study was to determine the relationship between high-sensitive cardiac troponin I (hs-cTnI) levels and coronary artery disease and cardiovascular outcomes in 1000 presumably healthy leisure sport athletes that participated in a 91 km long, high intensity endurance cycling competition.
* The secondary objective was to assess the relationship between other CV risk factors, fitness level and outcomes following high intensity endurance cycling competition in the same population.

The NEEDED observational study was designed to be performed in two phases:

Phase 1 (NEEDED 2013) was a pilot study targeting 100 subjects to test the logistics and identify the optimal blood sampling time points following the race. A total of 97 subjects completed the pilot phase in June 2013.

Phase 2 (NEEDED 2014) aim to recruit another 1000 subjects from the participants of the race in June 2014.

The study populations will be followed for cardiovascular events for up to 20 years following the baseline blood samples.

The results from the two phases will be pooled for the main statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* participants in the "North sea race"
* presumably healthy persons
* signed informed consent
* answered internet based questionnaire prior to the race

Exclusion Criteria:

* cardiac disease
* hypertension
* diabetes mellitus
* use of primary cardiovascular medical prevention
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer

The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Disease progression after treatment with the DCF regimen
* Assessable target lesion(s) as defined by RECIST criteria
* ECOG performance status ≤ 1
* Estimated life expectancy more than 3 months
* Serum bilirubin less than 1.5 times the upper normal limit
* Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
* Creatinine Clearance ≥50 ml/min
* Neutrophil count more than 1.5x 109 /L
* Platelet count more than 100x 109 /L
* Hemoglobin more than 8g/dL
* Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

Exclusion Criteria:

* Gastrointestinal bleeding
* Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
* CNS metastases
* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
* Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
* Known hypersensitivity reaction to the component of the treatment
* Active infection or malnutrition or bowel obstruction
* Legal incapacity or limited legal capacity
* Definite contraindications for the use of corticosteroids
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
* Chronic inflammation of the bowel
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
* Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
* Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
Vocal Feature Analysis Algorithm for COVID-19 Detection

This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.

The primary objective of this observational study is to determine if the Vocal Feature Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from voice recordings. Patients eligible for the study are those being tested for COVID-19 based on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab.

No clinical decisions will be based on the recordings. The results of the algorithm analysis will not be made available to the subjects or their healthcare providers during or after the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged \> 18 years
2. Provide a valid electronic informed consent form
3. Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample.
4. Stated willingness to provide evidence of their lab test results
5. Pregnant or lactating women may participate

Exclusion Criteria:

1. Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.
2. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery
3. Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords
4. Treatment with another investigational drug or device within 30 days prior to signing Consent Form