cyrilzakka/clinical-trials huggingface dataset:
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction

This was a prospective randomized, controlled trial designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a score that incorporates troponin biomarker, ecg, patient characteristics, and physician clinical judgment).

This was a prospective randomized, controlled trial conducted from February 2014 to May 2015 designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, in those deemed to be low risk based on a modified HEART score. Our study enrolled only those deemed low risk, as these are the patients we believe best served by utilization of the HEART score decision aid.

A total of 105 patients evaluated for AMI in the ED with a modified HEART score ≤ 3 (which includes cardiac troponin I \< 0.04 ng/ml at 0 and 3 hours) were randomized to immediate discharge (n = 53) vs management in an observation unit with stress testing (n = 52).

The primary endpoints were 30-day total cost and length of stay. Secondary endpoints were all-cause death, nonfatal AMI, rehospitalization for evaluation of possible AMI, and coronary revascularization at 30 days.

That such an early discharge strategy would decrease cost and length of stay is intuitively expected; our goal was to quantify such a reduction.

Eligibility Criteria:
Inclusion Criteria:

* patients 21 years or older
* patients who presented to the Emergency Department with symptoms suspicious for AMI.
* patients for whom the ED physician's intention to send the patient to the observation unit for stress testing

Exclusion Criteria:

* Cardiac Troponin I \> 0.04 ng/mL at 0 or 3 hours
* clinical presentation warranting admission
* inability or unwillingness to consent
* trauma as etiology of presenting symptoms.
IUL Study A Randomized Sham - Controlled Clinical Study

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.

Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.

Design: randomized double blinded sham - controlled clinical study

Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.

Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.

Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.

Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.

Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 80 years
* Confirmed SUI through cough stress test within the last 24 months
* SUI I-II° for more than 6 months
* At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
* Valsalva leak-point pressure (VLPP) ≤60 cm H2O
* Maximum cystometric capacity ≥250 mL
* No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
* BMI (body mass index) ≤35 kg/m2
* Willing to give informed consent and complete the follow up schedule

Exclusion Criteria:

* Active lower urinary tract infections (urethritis, cystitis or vaginitis)
* Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
* Detrusor overactivity on urodynamics
* Postvoiding residual (PVR) \> 100 ml
* Previous urethral surgery (i.e. fistula or diverticula)
* Pelvic organ prolapse grade \> 3 as defined by POP-Q and symptomatic
* Known polyuria (\>3l/24h)
* Unevaluated macro hematuria
* Neurogenic bladder
* Evidence of dysplasia in a Pap smear (done in the last 24 months)
* Tumours of the Urinary tract
* Previous radiation or brachytherapy to treat pelvic cancer
* Uncontrolled diabetes
* Active herpes genitalis
* Pregnancy
* Vaginal delivery within 6 months prior to the Screening/Baseline Visit
Efficacy of the Modified Free Gingival Graft Technique

Gingival recessions can be defined as the exposure of the root surface after an apical migration of the gingival margin in relation to the cemento-enamel junction. Gingival recessions affect both younger and older populations. Various surveys revealed that 88% of people ≥65 years of age and 50% of people between 18 and 64 years of age have ≥1 site with gingival recession. Gingival recessions can occur due to anatomical, pathological factors or trauma and will result in a loss of attachment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least two or less localized recession in mandibular incisors
* Cairo type 1 recession
* Patients who have good plaque control of less than 20%
* Patients between 18-64 years old

Exclusion Criteria:

* Systemically compromised patients
* Smoker patients
* Pregnant women, breastfeeding or use of oral contraceptives
* Patients who are taking medication that may affect healing and coagulation
* Previous periodontal surgeries in the RG area
* Patients with periodontal disease
* Patients who have undergone chemotherapy and radiotherapy
A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy

The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.

In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
3. American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
4. Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC;
5. Patients without contraindications to surgery;
6. Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;

Exclusion Criteria:

1. Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
2. Combined resection required due to other diseases (except cholecystectomy).
3. History of cancer or concurrent cancer in other organs.
4. Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
5. Patients with coagulation dysfunction which could not be corrected;
6. Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
7. Receipt of chemotherapy or radiotherapy before either surgical procedure.
Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)

The DVT-Cph RCT aims to investigate:

1. if progressive gait training in combination with standard care is superior to standard care on quality of life in patients with first time lower extremity deep venous thrombosis (clinical effectiveness part).
2. the association between progressive gait training and disease progression, late complications such as post throbotic syndrome, and severity of venous thromboembolism conditions in patients with first time lower extremity deep venous thrombosis (mechanistic part).

The DVT-Cph RCT will be qualified by a preceeding feasibility trial (NCT05761119) that aims to investigate: (1) the feasibility of the intervention and trial procedures using quantitative outcomes, and (2) patient experiences with and attititudes towards the intervention using qualitative interviews.

Simultaneously with the RCT, a prospective cohort study (The DVT-Cph cohort study; NCT05789108) will investigate and characterize acutely admitted patients with deep venous thrombosis via inflammatory, anti-inflammatory, immunological and ageing biomarkers to gain a better understanding of options about prevention and treatment of long-term complications. Patients enrolled in the feasibility trial as well as in the DVT-Cph RCT can also enroll in the DVT-Cph cohort study to utilize study synergy and enhance research information gain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above
* First time lower extremity DVT
* Hospitalized at the Emergency Department
* Can cooperate cognitively and physically (patient reported)

Exclusion Criteria:

* Patients without a Danish social security number
* Terminal patients
* Patients who do not understand or speak Danish
Cross Sectional Study of Constipation in Advanced Cancer Patients

Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients.

Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. More than half had received at least one form of TCM therapy according to the survey carried in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients.

TCM syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.

The present study is the first local study to evaluate the bowel habits and TCM syndrome of advanced cancer patients with constipation. We hope that the results not only can shed light on patient's own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a CHM formulation for advanced cancer patients with constipation.


Eligibility Criteria:
Inclusion Criteria:

* advanced cancer patients
* on medication for facilitating bowel movement and/or constipation visual analogue scale \>=2

Exclusion Criteria:

* unable to communicate
* cognitive impaired
* put on colostomy bag
* clinically diagnosed gastrointestinal obstruction
* at end-of-life
Study on Basal Joint Arthritis Prospective

The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.

Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described but few multi-center prospective evidence based trials comparing standard treatments have been done. This continuing search for consensus of best clinical practices has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Through the systematic collection of data regarding patient-specific characteristics, treatment interventions, and longitudinal functional outcome measurements the investigators believe patient outcomes and satisfaction can improve through the elucidation of risk factors for disease progression, and the timing and selection of treatment modalities, either conservative or surgical, for any particular patient. The establishment of a multi-center clinical registry will greatly facilitate these goals.

The study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have symptomatic basal joint arthritis.
* Patients who are capable of providing informed consent.

Exclusion Criteria:

* Patients younger than 18 years old at the time of enrollment.
* Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation.
* Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis.
* Patients with a history of or current infection of the basal joint of the affected hand.
* Patients who are demented or are unable to provide informed consent.
* Patients unable to comply with study guidelines.
* Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These patients will be followed and if they receive a capsulodesis or other procedure at the MCPJ at the same time as their basal joint arthroplasty this will be noted in their data records.
Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)

A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)
* mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
* the subject has given a written informed consent
* the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)

Exclusion Criteria:

* other brain disease of sufficient severity to cause dementia
* mental retardation
* terminal illness with life expectancy shorter than 6 months
* recent major changes in health status
* known epilepsy or previous convulsive seizure
* major depression
* severe dementia as defined by a Mini-mental State Examination score of 12 or lower
* moderate to severe renal impairment (i.e. serum creatinine \> 1,5 upper limit normal (ULN) or creatinin clearance \< 40ml/minute/1,73 m2
* moderate or severe heart disease (NYHA III-IV)
* moderate or severe pulmonal disease
* moderate to severe hepatic impairment (bilirubin or transaminases \> 2 times ULN
* women of childbearing potential (i.e. not post-menopausal and not taking contraceptive
* the subjects is lactating
* any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
* known allergies to the investigational product
Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus

Pelvic girdle pain (PGP), which is a common musculoskeletal problem of pregnancy, and gestational diabetes mellitus (GDM), which is diagnosed at the end of the second trimester and at the beginning of the third trimester, occur in a parallel time period. The addition of hyperglycemia to the physiological changes in pregnancy stimulates a new series of cycles and contributes to inflammation, and it is predicted that the presence of GDM may trigger the pain intensity of PGP. Therefore, the aim of this study is to investigate the effect of GDM on PGP symptom severity (pain).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have been started.
* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have not been started
* Pregnant women (with PGP) who were not diagnosed with GDM in the 2nd and 3rd trimesters

Exclusion Criteria:

* Pre-pregnancy Diabetes Mellitus
* Presence of an orthopedic or neurological problem that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
* Presence of connective tissue disease
* Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity \>4 according to VAS) before pregnancy
* History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
* History of pelvic fracture
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus as evidenced by:
* Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
* Documented diabetes by American Diabetes Association and/or World Health Organization criteria
* Age greater than or equal to 18 years old
* Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
* Able and willing to participate in study procedures and comply with study follow-up visits
* Able to give informed consent for study participation
* Not moving out of the study area during the 1 year follow-up period

Exclusion Criteria:

* Unable to cooperate with the OCT image acquisition procedure or other study procedures
* Unable or unwilling to comply with the study follow-up visits
* Unable or unwilling to sign form for release of retinal medical records
Quality of Life in Traumatic Brain Injury Patients

The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.

The assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how patients "should feel", based on objective biomedical criteria, but how they actually "perceive" themselves, based on subjective criteria.

This is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . While research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors.

The aim of this study is to describe the quality of life of CT patients at least 6 months after the trauma. This assessment is related to the patient's degree of sequelae, using the Glasgow Outcome Scale Extended GOSE.

Eligibility Criteria:
Inclusion Criteria:

All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma).

Exclusion Criteria:

Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.
DPBRN Reasons for Replacement or Repair of Dental Restorations

The purpose of this study was to document the reasons for replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth.

The aims of this study were to (1) quantify the prevalence of reason(s) for replacing existing restorations in DPBRN practices; (2) quantify the percentages and types of restorative materials of failed restorations that are being replaced in DPBRN practices; (3) quantify the percentages and types of restorative materials used to replace or repair failed restorations in DPBRN practices; and (4) test the hypothesis that DPBRN practitioner-investigators who reported in a previous study that they treat enamel lesions operatively are more likely in actual patients as in this study to replace entire restorations rather than do repairs and are more likely to report the clinical diagnosis of secondary caries as a reason for replacement.

Eligibility Criteria:
Inclusion Criteria:

* participants directly involved in this study were patients who sought dental treatment in the practitioner-investigators practices
* any tooth surface that was previously restored was eligible for this study, provided that it was on a permanent ("adult") tooth. This means that permanent first molars were eligible, which typically erupt at about age 6 years. This means that persons age 6 and older were enrolled in the study and there was no upper age limit.