cyrilzakka/clinical-trials huggingface dataset:
Self-management of Patients With Acute Coronary Syndromes

Purpose :

The purpose of this study is to investigate the tracking effect of selfmanagement programs on anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).

Research Design :

This study the first phase is to construct and develop interventional measures for self-management of patients with ACS. According to the associated factors of study, the intervention measures are designed based on self-management. A pilot study will be conducted to improve research and to develop better selfmanagement interventions in the future. At the secondary stage: a randomized controlled trial with a random sampling design is used to investigate the effects of self-management programs on anxiety, depression, and quality of life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary intensive care center of a north medical center. Patients with ACS,who met the conditions and agreed to join the study will be recruited. Then,the informed consent will be obtained. At the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects will be enrolled, 52 in the experimental group will receive the self-management program, and 52 in the control group will receive a routine hospital care.

Method \& Results:

The data of demographic and disease characteristics, clinical indicators,depression, anxiety, self-management, and quality of life will be collected.The Hospital Anxiety and Depression Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management Scale will used as tools to collect data. The efficacy of the intervention will be collected 1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.

Hypothesis :

It is expected that the self-management program applied to patients with ACS can reduce depression and anxiety, thereby improving the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* The first diagnosis of acute coronary syndrome by a clinician,
* Clear consciousness, able to converse in Chinese and Taiwanese languages.
* Willingness to participate in this research

Exclusion Criteria:

* Those who are unable to take care of themselves
* Poor vision and inability to read
* Hard of hearing and deafness
* Inability to communicate
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.


Eligibility Criteria:
Inclusion Criteria:

* Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
* Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
* Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon \[IFN\] or pegylated interferon \[pegIFN\] with or without ribavirin \[RBV\], or sofosbuvir \[SOF\] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
* Participant must be documented as having no cirrhosis or compensated cirrhosis.

Exclusion Criteria:

* Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
* History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.

Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.

Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.

Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.

Eligibility Criteria:
Inclusion Criteria:

1. Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
2. Age between 16 and 65 year old;
3. Terms of consent signed by the patient or guardian.

Exclusion Criteria:

1. Fracture of medial or lateral third of the clavicle;
2. Cortical contact between the main fracture fragments;
3. Age below 16 years old or more than 65 years old;
4. Pathological fracture;
5. Ipsilateral previous injuries of the shoulder or upper limb;
6. Ipsilateral associated fractures of the shoulder or upper limb;
7. Neuro-vascular injury associated;
8. Open fracture not eligible for primary internal fixation;
9. Clinical contraindication for surgery;
10. Fracture older than 30 days;
11. Patient not cooperative or ineligible for the follow-up;
12. Lack of consent to participate.
Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Vs Standard Radiation Treatment Planning

The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.

This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to Standard of Care. Patients will undergo a randomization procedure with a variable allocation ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to improve their treatment planning process in the SOC arm through interactions with RapidPlan, as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time of registration as a moderator of the treatment effect.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of registration
* Receiving curative intent intensity modulated radiotherapy for head and neck primary cancer at the discretion of the treating medical doctor (MD)
* Provide written informed consent or allow legally authorized representative to consent on behalf of a participant
* Willing to return to enrolling institution for study follow-up visit

Exclusion Criteria:

* Incarcerated
* Unable to provide informed consent
* Prior Head and Neck (H\&N) radiation therapy
* Planned radiation dosing LK\<30 Gy or \>76 Gy
A Study of LY3410738 in Healthy Adult Participants

The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1
Closure of Uterine Incision by Single or Double Layer Technique

The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Objective: To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Design:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.

Setting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.

Intervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.

Main outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.

Eligibility Criteria:
Inclusion Criteria:

* Women submitted to cesarean sectio

Exclusion Criteria:

* Exclusion criteria were: Former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, SLE, rheumatoid arthritis, IDDM, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.
The Bacteriuria in Renal Transplantation (BiRT) Study: A Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation

Exclusion Criteria:

* Pregnant women or women who wish to become pregnant during the course of the study
* Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
* Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
* Urinary tract surgery during the last two months
* Surgical urological procedure planned in the next 2 weeks
* Neutropenia (≤ 500 neutrophils/mm3)
* Important intensification of immunosuppression (Solumedrol bolus and/or use of thymoglobulin) or any other treatment of an acute graft rejection in the last two months
* Use of antibiotics at the time of the asymptomatic bacteriuria (except for prevention of Pneumocystis jirovecii)
* End-Stage Renal Disease (ESRD) requiring dialysis
* Non-functioning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal neobladder)
* Recurrent acute graft pyelonephritis (≥ 2 episodes in the last year)
* Kidney transplant recipients who could not return for regular follow-up
Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Many patients continue to experience pain and functional loss for up to one year, and more than half of the patients report shoulder pain persisting for over three years.

The pathophysiology underlying rotator cuff-related shoulder pain continues to be a subject of ongoing research and uncertainty, with many aspects yet to be fully elucidated. The most common belief regarding its pathogenesis involves the role of inflammation. This hypothesis is supported by the accumulation of inflammatory cells in tendons, oxidative stress, and increased levels of pro-inflammatory cytokines. In tendon pathologies with inflammatory cell accumulation and increased cytokine levels, the use of antioxidants and anti-inflammatory agents in addition to conservative treatment contributes to tendon healing. Anti-oxidants and anti-inflammatories are substances capable of preventing or delaying certain cell damage.The use of anti-inflammatory and antioxidant supplements such as Vitamin C (Vit-C), Vitamin D (Vit-D), Omega-3, and Magnesium (Mg) is recommended. Despite indicating exercise as the gold standard for managing rotator cuff-related shoulder pain and the demonstrated anti-inflammatory and anti-oxidant properties of the mentioned supplements, there are still gaps in the understanding of their effectiveness in rotator cuff-related shoulder pain.

Based on these gaps, the goal of this study is to investigate the effects of supplements (Vit-C, Vit-D, Omega-3, and Mg) given in addition to exercise on patients' blood parameters (TNF-a, IL-6, and CRP levels), pain, functional status, quality of life, and patient satisfaction in individuals with rotator cuff-related shoulder pain.

58 participants older than 40 years of age with rotator cuff-related shoulder pain for at least 3 months will be included in the study. Signed voluntary consent will be obtained from the patients. Participants will be divided into two groups. Study groups will be as follows: a) Exercise \& Supplement Group and b) Exercise Group.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 40
* Diagnosing with rotator cuff-related shoulder pain confirming through clinical examination (Hawkins Kennedy and Empty Can tests) and MRI imaging
* Having shoulder pain for at least three months

Exclusion Criteria:

* Having full-thickness or massive rotator cuff tear,
* Having a history of symptoms onset due to trauma,
* Having a history of surgery on the same shoulder,
* Having shoulder passive external rotation \<30° and flexion \<120°,
* Having shoulder instability,
* Having an allergy to any supplement,
* Having psychological, emotional, or cognitive problems
* Presence of shoulder problems caused by systemic diseases,
* Presence of diabetes, presence of pregnancy or breastfeeding,
* Malignancy.
Therapy Light Rooms for Improved Sleep in Dementia Patients

This intervention study will investigate the effect of therapy light rooms on sleep, circadian rhythms, mood, behavioural problems and function in nursing home (NH) patients with dementia.

People with dementia often have fragmented night-time sleep, prolonged night-time awakenings and increased daytime sleep. Behavioural and psychological symptoms of dementia (BPSD) (e.g. agitation, depression) are also common. Noticeably, both sleep problems and BPSD are related to a disturbed circadian rhythm. Light is the most important input to the circadian system, and exposure to sufficient daylight is important for entrainment of the circadian rhythm to the surroundings. Dementia patients living in nursing homes (NH) are less exposed to daylight than dementia patients living at home. Bright light therapy is a promising treatment in these patients as it may improve sleep, BPSD, and independent functioning. However, traditional bright light treatment has not been routinely employed in NH patients or patients with dementia. This may be related to difficulties in achieving adherence to the traditional treatment and thus the benefit of bright light therapy for people with dementia still remains unclear.

DEM.LIGHT uses modern LED (light-emitting diodes) technology that enables light therapy with the least possible interference of the day-to-day life in NHs, as the treatment is not confined to a light source presupposing behavioural compliance. Ceiling-mounted LED-sources can be programmed in terms of timing, light intensity and colour temperature. DEM.LIGHT uses this to provide therapy light rooms with a dynamic light condition that better emulates natural light throughout the day. The study is a cluster-randomized trial evaluating the effect of therapy light rooms on various measures of physical and mental health in NH patients with dementia. Data will be collected at baseline, after 8 and 16 weeks of treatment, and at the end of the intervention period (24 weeks).

Eligibility Criteria:
Inclusion Criteria:

* 60 years or more of age and in long term care (longer than 4 weeks)
* have dementia in accordance with DSM-V
* have either sleep/circadian rhythm disturbances, BPSD as identified by NPI-NH, or severely reduced ADL function
* provide written informed consent if the participant has capacity, if not, a written proxy informed consent from a legally authorized representative

Exclusion Criteria:

* are blind or may otherwise not benefit from light
* partake in another trial
* have a condition contra-indicated to the intervention
* have an advanced, severe medical disease/disorder and/or expected survival of less than 6 months or other aspects that could interfere with participation
* are psychotic or have a severe mental disorder
Population-based Investigation of Aneurysm Incidence

Most intracranial aneurysms are found accidentally in neurovascular imaging. And these inspection methods are limited by the problems of instrument fixation, radiation, time-consuming, contrast agent toxicity and so on. At present, blood test is an ideal alternative method for early diagnosis. Compared with imaging examination, it is economical, general screening and convenient. Blood test is simple to operate, easy to be accepted by patients, and less invasive. Early screening of aneurysms can be performed.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-75
* Individuals with normal cognitive and communication abilities
* No serious complications, such as uncontrolled hypertension, diabetes or other chronic diseases that may affect the test results.
* Basic blood test is normal or close to normal range.

Exclusion Criteria:

* Pregnancy
* Severe heart disease, renal insufficiency, liver dysfunction and other major diseases.
* In the past 6 months, there were strokes, or other types of intracranial tumors, infections and other diseases that may affect the screening results.
* There are metal implants, including dentures, pacemakers, etc.
* Using or recently used drugs that may affect blood biomarkers ( such as anticoagulant drugs, immunosuppressive agents, etc. ).
* There are serious mental illness or cognitive dysfunction, such as claustrophobia, unable to cooperate with the completion of the test.
* It is currently participating in other clinical trials or has participated in other clinical trials in the past 3 months.
Evaluation of Early Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis

Establishing that mucosal healing (MH) has occurred after therapy is an important treatment goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has demonstrated good correlations for clinical remission and disease severity, but its role for establishing mucosal healing after therapy has not been validated . The ability to predict mucosal healing may be different for patients in long term remission compared to assessment after obtaining clinical remission. No previous study has prospectively validated the use of PUCAI as a proxy for MH specifically during clinical remission after therapy.

All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess. This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score at the time of assessment of mucosal healing by endoscopy. Patients could be included if they have establish ulcerative colitis, while they are on remission for at least 3 months after treatment of flare. For this study, complete clinical remission was absence of abdominal pain, and no diarrhea or bleeding (PUCAI\<10). sigmoidoscopy will be performed between 12-24 weeks after remission was documented.

Eligibility Criteria:
Inclusion Criteria:

1. Ulcerative Colitis patient
2. clinical remission (PUCAI\<10) for at least 3 months.
3. Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented

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