cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Self-management Education in First Time Hearing Aid Users

The study will assess the impact of a hearing aid self-management intervention in first time hearing aid users compared to standard hearing aid self-management. Namely, the C2Hear multimedia videos, or Reusable Learning Objects (RLOs) will be used as the self-management intervention. A departmental hearing aid booklet (standard clinical care) will be used as the control intervention.

The study will determine the role of these RLOs in self-efficacy for hearing aid(s), hearing aid knowledge and readiness for action compared with standard hearing aid self-management education (hearing aid booklet) in groups of first time hearing aid users. Both groups will receive the education at the earliest audiology appointment (hearing assessment), helping to distinguish any impact of earlier education delivery.

Research question: To assess the role of interactive hearing aid self-management education on self-efficacy for hearing aid(s), readiness for action and hearing aid knowledge in first time hearing aid users.

Objectives:

Primary research question:

- Does the early delivery of interactive hearing aid self-management education improve self-efficacy for hearing aid(s) compared with standard care in first-time hearing aid users?

Secondary research questions:

i. Does the early delivery of interactive hearing aid self-management education improve readiness for hearing aids (their chosen intervention) compared with standard care in first-time hearing aid users?

ii. Does the early delivery of interactive hearing aid education improve hearing aid knowledge compared with standard care in first-time hearing aid users?

Study design:

A single centre, prospective study with two randomised arms; intervention group (access to RLOs in DVD/ or online format, patients' preference) and control (standard hearing aid education booklet).

Prospective first-time hearing aid users will be invited to take part in the study at hearing assessment, where they will be randomised to either the control or intervention group. Following 6-8 weeks of independent use prior to receiving hearing aids, study investigators will assess the impact of each education type on individuals self-efficacy for hearing aids, readiness for action and hearing aid knowledge.

Comparisons will be made to previous evaluation of the RLOs to allow exploration of the impact of earlier hearing aid self-management education on self-report measures.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \> 18 years
* Prospective first-time hearing aid users (defined as no hearing aid use in the last 2 years)
* English as their spoken language or good understanding of English

Exclusion Criteria:

* Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)
Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES).

CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.


Eligibility Criteria:
Inclusion Criteria:

* Presentation with acute coronary syndrome (ACS)
* Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion

Exclusion Criteria:

* Known pregnancy
* Life expectancy less than one year
* Planned elective surgery requiring interruption of DAPT in the first 6 months
* Known intolerance to components of the DES available
* Indication for oral anticoagulation at baseline
Energy Turnover and Appetite

The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.

A total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) Moderate energy turnover and ; iii) High energy turnover. Their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

Previous surgical interventions that is considered as non-compatible with the study.

* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Fosamprenavir Versus Other Protease Inhibitors

This study was designed to evaluate and compare safety, tolerability of subjects who successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir. This is a 48-week study, where subjects who were assigned to be in their original PI-group have the option of switching to fosamprenavir on week 24. Prior to being assigned their treatment group, subjects had to be suppressed for at least three months. All subjects also take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Be on your first protease inhibitor (PI) containing regimen, and the regimen must consist of a PI +/- ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (N\[t\]RTIs).
* Have a plasma HIV-1 RNA level (viral load) at screening of less than 400 copies/mL, for at least 3 months prior to Screening and at Screening while on your current regimen of a PI +/- ritonavir + 2 N(t)RTIs.
* Females must not be pregnant or breastfeeding or plan to become pregnant during the study.
* Females of child-bearing potential must agree to use one of the approved methods of birth control.

Exclusion Criteria:

* Not able to follow the medication schedules and attend the study visits for the entire length of the study.
* Have any other illnesses, laboratory test results, medication use, allergies, or medical conditions that would make it unsafe for the subject to participate in this study.
* Currently be enrolled in any other research studies that could affect the subject''''s HIV-1 RNA levels.
The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer Treatment

This study assesses the feasibility and acceptability of a brief electronic patient-reported outcome (ePRO) tool that allows patients to self-identify impending delays. The risk of treatment delays according to tumor type and race will be measured by both ePRO and electronic health record (EHR) tools. Data from this study and the association of social determinants of health could be useful to flag patients at risk of delay and due timely intervention for modifiable treatment barriers. The prediction of the risk of treatment delay will be helpful to design another study using electronic tracking systems to prevent cancer treatment delays. The long-term goal of this research is to alert care teams when patients may be at risk of treatment days and to help patients get treatment faster. It was planned to enroll a total of 240 subjects with newly diagnosed cancer. Sixty colorectal and 180 breast cancer patients will be included.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Male and female patients of age \>18 years.
2. Pathologic diagnosis of breasts or colorectal cancer within 6 weeks (42 days) prior to the enrollment date.
3. Have not yet initiated cancer treatment on the date of enrollment.
4. Indicate intent to receive cancer treatment at the University of North Carolina.

Exclusion Criteria:

1. Patient unwilling or unable to receive electronic survey links via email or text link on a mobile device, tablet, laptop, or desktop computer.
2. Patient unwilling or unable to provide verbal or signed consent to participate.
3. Patient cannot read and speak English.
4. Patients who do not have email access or a smartphone are able to receive Short Message/Messaging Service (SMS) text messages.
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures.
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
* Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
* Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

This will be a prospective, observational, single-arm, registry study based on data received from Chinese Registry of rheumatoid arthritis (CREDIT) database to register 200 Chinese RA patients treated with golimumab in one year. Patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.

This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Eligibility Criteria:
Inclusion Criteria:

* - 18 years and older
* Fulfil the ACR/EULAR classification criteria for RA in 2010
* Patients able to understand and complete self-evaluation questionnaires.

Exclusion Criteria:

* - Contraindications for golimumab
* Prior exposure to TNFi/JAKi
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to provide informed consent
* Male or female subjects aged 18 to 65 years inclusive
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
* Non-smokers or ex-smokers

Exclusion Criteria:

* Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
* Subjects who have a significant infection or known inflammatory process on screening or admission.
* Subjects who are unlikely to co-operate with the requirements of the study.
* Positive serology for infectious disease (hepatitisB or C , HIV) at screening
Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain

This study will compare online yoga with Acceptance and Commitment Therapy (ACT), an established treatment for chronic pain. We will compare the efficacy of the two treatments for reducing chronic musculoskeletal pain in veterans.

This study will test if online yoga is not inferior than ACT for treating chronic pain in veterans. Participants will be randomly assigned to receive either online yoga instruction or ACT, once a week for 12 weeks in an online group class. They will complete self-report questionnaires about their experience of chronic pain. There will be a 6-month follow up period, during which the research team will check in with the participant to record any adverse events and maintain study contact.

Eligibility Criteria:
Inclusion Criteria:

* Veteran of the United States Armed Forces ≥ 18 years old
* Chronic pain \> 6 months related to at least one musculoskeletal pain-related diagnosis indicated by an ICD-9 or -10 code
* Minimum pain intensity at screening ≥4 on a 0-10 using the Defense and Veterans Pain Rating Scale (DVPRS)
* Not begun new pain treatments or medications in the past month
* Stable medication regimen for at least 4 weeks prior to entry to the study
* English literacy
* Wireless internet connection at home

Exclusion Criteria:

* Participation in another clinical trial, unless given prior authorization from both our research team and that of the other study
* Back surgery within the last 12 months
* Back pain potentially attributed to a specific known condition
* Baseline pain \<4 or ≥9 on a 0-10 Numeric Rating Scale
* Unstable, serious coexisting medical illness, mental illness or psychiatric conditions
* Attended or practiced yoga ≥ 1 x in the past 12 months
* Current suicidal intent or plan
Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.

Eligibility Criteria:
General Inclusion Criteria

* A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
* Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
* Aneurysm with a history of growth ≥ 0.5 cm per year
* Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

General Exclusion Criteria

* Less than 18 years of age
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent by the patient or a legally authorized representative
* Pregnant or breastfeeding
* Life expectancy \< 2-years
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury

This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of post-traumatic stress disorder in people who have survived a traumatic injury.

Approximately 2.5 million people in the U.S. are hospitalized each year having sustained injuries during a traumatic event. Injured trauma survivors are at high risk for developing post-traumatic stress disorder (PTSD) and other related conditions. In addition, many of these people experience several physical, financial, social, legal, and medical problems over the course of the year following the trauma. Effective interventions to prevent or remedy these issues have yet to be developed for individuals who undergo inpatient surgery following a traumatic injury and who then continue with outpatient treatment and community rehabilitation. This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of PTSD and substance use. The study will also assess the intervention's effectiveness in increasing participants' general functioning and satisfaction with their care post-injury.

Participants in this open label study will be randomly assigned to receive either the standard care provided to injured trauma survivors or a combination of behavioral therapy and drug therapy. Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline; paroxetine; buspirone; propranolol; trazodone; and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Behavioral therapy will also be administered on the basis of the participants' individual needs and may continue for up to 12 months. Participants will also take part in motivational interviews, the first of which will be conducted upon study entry in the hospital ward. Subsequent interviews will be conducted over the phone at Months 1, 3, 6, 9, and 12. Participants will be required to report to the study site only for the initial baseline visit. Outcome measures will include PTSD severity ratings, frequency of substance use, and general functioning reports.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Admitted to Harborview Medical Center with injuries sufficiently severe to require inpatient admission
* Experienced a traumatic injury
* Exhibits symptoms of PTSD while in the hospital ward

Exclusion Criteria:

* History of head, spinal, or other injury that may prevent participation in the ward interview
* Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania
* Currently incarcerated
* Likely to face criminal charges
* Lives more than 50-100 miles from Harborview Medical Center
Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.

For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).

Eligibility Criteria:
Inclusion Criteria:

* Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
* Informed consent
* Eastern Cooperative Oncology Group (ECOG): 0 ot 1
* American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ

Exclusion Criteria:

* Pregnancy or female in suckling period
* Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
* Severe mental disease
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
* Body mass index (BMI) \> 30 kg/m2
Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain

It has not been objectively clarified how the thoracolumbar fascia (TLF) changes the biomechanical adaptations that occur in the lumbopelvic region during pregnancy and whether it is associated with pelvic girdle pain (PGP). Therefore, the aim of this study is to determine the biomechanical and viscoelastic properties of TLF, which adapts to the changes in the lumbopelvic region in pregnant women with pelvic girdle pain, and to investigate its relationship with PGP.


Eligibility Criteria:
Inclusion Criteria:

* First-time pregnancy
* Pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters
* Pregnant women who do not have pelvic girdle pain in 1st and 2nd trimesters
* Women not being pregnant
* Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2

Exclusion Criteria:

* Presence of connective tissue disease
* Deterioration of skin integrity in measurement areas
* Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
* History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
* Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity \>4 according to VAS) before pregnancy
* Identification of metabolic disorders such as Type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia before and/or during pregnancy)