cyrilzakka/clinical-trials huggingface dataset:
The Application of Pectoral Nerve II(PECS II)block in Breast Fibroadenoma Resection Surgery

Patients were randomly assigned to the GA group, PECS II group, or TPVB group using a computer-generated random number table. Group assignments were kept in a sealed envelope, which was opened only after induction of general anesthesia on the day of surgery. This study was a double-blind trial, ensuring that neither the patients nor the investigators were aware of the analgesic method used. The same anesthesiologist was responsible for PECS II block or TPVB, while different anesthesiologists were responsible for anesthesia implementation and postoperative follow-up.

Written informed consent was obtained from all participants.90 female patients aged 18 to 65 with ASA I-II status were selected at Baogang Hospital, Inner Mongolia, who had been diagnosed with breast fibroadenomas. Exclusion criteria included pre-existing infection at the site of block, coagulation disorders, morbid obesity (body mass index \&amp;gt; 40 kg/m²), allergy to local anesthetics, impaired lung function, significant cardiac disease, renal dysfunction, pre-existing neurological disorders, and psychiatric conditions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast fibromas

Exclusion Criteria:

* heart attack mental disorder
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease

The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).

Participants will:

* undergo pupillary dilation
* have photographs taken of the inside of the eyes using three different cameras


Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
* Participants that are willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

* Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
* Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
* Patients with advanced IRDs who are unable to fixate for imaging
* Patients unable to tolerate ocular imaging
* Patients who do not wish to participate
Prolonged Isolated Thrombocytopenia After Allo-SCT : N-acetyl-L-cysteine (NAC) Versus Supportive Therapy

Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. No standard treatment is available. The current study assigned PT randomly to 2 arms: intervention arm with N-acetyl-L-cysteine (NAC) and control arm with supportive therapy.This is a prospective randomized controlled study.

1. patients diagnosed with PT at day 60 post transplant will be randomized assigned to intervention arm (NAC) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when platelet count \<20000/ul.)
2. Response will be evaluated at day 90. Response was defined as platelet recovery to \>= 20000/ul for 7 consecutive days without transfusion support during the enrollment period. All the other patients not achieved above criteria was defined as no response.
3. For those without response in both arms, patients will received NAC plus recombinant human thrombopoietin (rhTPO) for an additional 30 days. rhTPO was given at 300IU/kg/d for 28 consecutive days or platelet \> 50000/ul independent of platelet transfusion.

Eligibility Criteria:
Inclusion Criteria:

* age\>= 14 years
* diagnosed as PT (defined as platelet count in peripheral blood never achieve 20000/miro-liter for 7 consecutive days without transfusion at day 60 post transplantation)
* serum creatine level \< ULN (upper limit of normal), serum ALT/AST /TBil\<=2 ULN
* without active CMV/EBV/ADV reactivation, active GVHD, without relapse or minimal residual disease at enrollment

Exclusion Criteria:

* history of asthma
* allergy to NAC
* refuse to participate
Music in Urgent and Emergent Settings

The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED.

The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED. This study follows a prospective experimental design where patients will be assigned to two groups: one that receives the music intervention and one that does not receive music intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18
2. Chief complaint of musculoskeletal pain
3. Gender: Male or Female
4. Ethnicity: Any
5. Physical ability: Any
6. Language: English
7. Cognitive skill/education: grade 2 reading level or above
8. Physically and cognitively able to participate in study procedures

Exclusion Criteria:

1. Patients who are unable to participate in the informed consent process
2. Prisoners
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
* Be fluent in English and able to understand the consent form

Exclusion Criteria:

* Have an opioid use disorder of any severity
* Have a greater than moderate substance use disorder on any other substance
* Undergoing medication-assisted treatment for withdrawal of any substance
* Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
* Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
* Are pregnant or breast feeding
* BMI \> 30 (women only)
* Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
* Have history of seizure disorder
* Have a head injury with loss of consciousness in the last 5 years
Kefir Cholesterol Lowering Pilot Study

High cholesterol (a type of fat in humans blood) may be one factor that can lead to heart disease. If people have higher cholesterol, it is possible that kefir (a food similar to yogurt) may help to control blood cholesterol levels.

New research shows that kefir (which contains bacteria also known as microbes), similar to yogurt, may improve health by lowering cholesterol levels. Much of this research however, focuses on traditional types of kefir, which differ significantly from commercially prepared kefir with regards to the types of microbes in each kefir. Additionally, there is a lack of research looking at how commercial kefir compares to traditional kefir in its ability to improve health. This has led to the consumer being confused about the health benefits they believe they are receiving, such as reduced weight gain, and improved cholesterol levels, when they purchase and consume commercial kefir. The researchers have produced a commercially usable kefir that has the health benefits of traditional grain fermented kefir. This was accomplished with only a small subset of microbes present in the traditional kefir, leading to a much easier product to commercialize and produce. Thus, this study aims to look at whether kefir, produced in the researchers laboratory and commercially available kefir, given to males for in two separate months, results in any cholesterol lowering effects. Successful completion of this project could potentially result in the development of a new commercial kefir with health benefits that are supported by scientific research and testing. In addition, if positive results are seen, a larger study will be carried out to ensure that results of the current study are consistent for the Canadian population.

Eligibility Criteria:
Inclusion Criteria:

1. Males, aged 18-65y
2. Moderately hypercholesterolemic adults: LDL-C between 3.2 and 4.9 mM, but otherwise healthy
3. No history of CVD, type 2 diabetes, monogenic dyslipidemia or use of medications for hyperlipidemia (including statins).
4. No dairy allergy

Exclusion Criteria:

-
Women's Health Initiative Silent Atrial Fibrillation Recording Study

The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.

The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.

Eligibility Criteria:
Inclusion Criteria:

* Subjects already enrolled in the parent WHISH study.
* Subjects who are at high risk of developing atrial fibrillation.

Exclusion Criteria:

* Subjects who have had atrial fibrillation at baseline.
Evaluation of Enhanced Syphilis Screening Among HIV-positive Men

This study aims to enhance syphilis testing among HIV-positive men who have sex with men (MSM), so that more men will undergo testing, they will test more often, and more cases will be treated early. The intervention will combine syphilis tests with the standard HIV blood tests that are routinely done every 3-6 months for persons in care at hospital-based HIV clinics in Toronto and Ottawa, Canada.

A clinic-based intervention to incorporate syphilis testing with routine HIV bloodwork among HIV-positive men who have sex with men (MSM) attending 4 hospital-based HIV clinics in Toronto and Ottawa will be conducted. The objectives are to determine to what degree the intervention: (1) increases the detection rate of untreated syphilis; (2) increases the proportion of men who undergo syphilis testing at least annually (increased screening coverage); (3) reduces the interval between syphilis tests (increased screening frequency); and (4) reaches men at highest risk according to sexual behaviours. The main hypotheses are that the intervention will increase screening coverage to a minimum of 85% of men undergoing syphilis testing annually, increase screening frequency to a median of 3 tests per person per year, and increase the case detection rate by 75% or more.

The design of this study is a cluster-randomized controlled trial with stepped wedge design that will gradually introduce the intervention across clinics. This pragmatic approach incorporates a concurrent comparison group, allows for assessment of time trends, will be well-powered, and will generate more generalizable results due to its inclusion of multiple clinics. The intervention will be operationalized as standing orders for syphilis serology when there is an order for HIV viral load and/or CD4 cell count. Data sources include (1) syphilis tests submitted to the Public Health Ontario Laboratory; (2) a standardized clinical worksheet and medical chart review to validate diagnoses for screen test positives; and (3) data collected from a subset of patients via their participation in the ongoing Ontario HIV Treatment Network (OHTN) Cohort Study. The latter follows adults in HIV care and collects data using chart reviews and annual face-to-face interviews including measures of sexual behaviour.

Eligibility Criteria:
Inclusion Criteria:

* Male HIV patients
* Must be attending at least one of the four participating hospital-based HIV outpatient clinics

Exclusion Criteria:

* Women
Replication of the EINSTEIN-PE Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Inclusion Criteria:

* Confirmed acute symptomatic proximal PE with or without symptomatic DVT

Exclusion Criteria:

* Legal lower age limitations \[Day 0, Day 0\]
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE \[Day -14, Day 0\]
* Other indications for VKA than DVT and/or PE \[Day -180, Day 0\]
* Creatinine clearance \<30 ml/min \[Day -180, Day 0\]
* Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3x ULN \[Day -180, Day 0\]
* Bacterial endocarditis \[Day -180, Day 0\]
* Life expectancy \<3 months \[Day -365, Day 0\]
* Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA \[Day -180, Day 0\]
* Systolic blood pressure \>180 mgHg or diastolic blood pressure \>110mgHg \[Day -180, Day 0\]
* Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding \[Day -180, Day 0\]
* Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers rifampin \[Day -14, Day 0\]
Acupressure Wristbands for GLP-1RA Related Nausea

Nausea is a common side effect of GLP-1RA medications used for treatment of Type 2 diabetes mellitus and obesity. Current recommendations for nausea relief include the use of dietary changes and prescription anti-emetics. Acupressure wristbands Sea-Band are FDA cleared for nausea relief in other indications such as motion sickness, morning sickness in pregnancy, post-operative nausea, chemotherapy associated nausea. We hypothesized that acupressure wristbands could alleviate nausea in persons taking GLP-1RA.

Nausea is the most commonly reported side effect of the class of drugs collectively known as glucagon like peptide-1 receptor agonists (GLP-1RA). GLP-1RAs are FDA approved to treat Type 2 diabetes mellitus (T2DM) and Obesity. Sea-Band is an FDA-cleared set of drug-free elastic wristbands used for nausea relief in several indications including motion sickness, morning sickness in pregnancy, post-operative nausea, chemotherapy associated nausea in persons ages 3 years old and up. The elastic wristbands have a plastic skin facing knob that apples pressure to an acupressure point called pericardium 6 (P6) located below the crease of the wrist. We hypothesize that Sea-Band can alleviate nausea in persons taking GLP-1RA. Participants on GLP-1RA medication with nausea were offered a set of Acupressure wristbands, and followed for four weeks. Weekly touch points assessed the response to nausea relief of the bands. Eligibility for the study included Adults taking GLP-1RA experiencing nausea.

Eligibility Criteria:
Inclusion Criteria:

* Adults taking GLp-1RA with nausea

Exclusion Criteria:

* Adults on GLP-1RA without nausea
* Uncontrolled GERD
* Hx of Gastroparesis
* Other nausea related conditions such as vertigo
* History of chronic use of antiemetic medication for other reasons
Cooperative Study of Factor VIII Inhibitors

To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.

BACKGROUND:

Despite major advances in the treatment of patients with hemophilia, a serious remaining challenge was presented by the occurrence of circulating inhibitors to Factor VIII. Because of lack of information on the natural course of patients with Factor VIII inhibitors, the relative efficacy of various modes of therapy was not established. The Division of Blood Diseases and Resources decided to sponsor a clinical investigation which would evaluate populations of hemophilia patients for Factor VIII inhibitors, follow up these patients to provide information on the natural history of the inhibitor in the hemophilia patients, and make available a reference center to monitor results and attain uniformity.

Treatment of a patient with a severe inhibitor and consequent bleeding remained a problem. Management included protracted treatment with Factor VIII, use of immunosuppressive agents and prothrombin complex (or Factor IX) concentrates. The rationale for Factor IX was that it bypassed the defect in Factor VIII caused by the inhibitor. This method of therapy attracted wide popularity, but the success was greatly debated. It was intended at the very outset of the Factor VIII study that therapeutic trials involving patients with inhibitors would not be a prime function, but that such studies would be monitored if necessary. A controlled trial of Factor IX concentrates therapy was strongly advised by the DBDR Advisory Committee. Accordingly, during fiscal year 1978, a protocol for a double-blind control study was developed by the Factor VIII inhibitor group. The trial began in the spring of 1978, and the intervention terminated about one year later.

DESIGN NARRATIVE:

Double-blind study; patients served as their own controls. A total of 51 patients each received a single large dose of Konyne, Proplex, or diluted albumin (as a control). Joint bleeding of the elbow, knee, and ankle was evaluated six hours after each dose.

Eligibility Criteria:
Males with hemophilia, not stratified as to ethnic group.
Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse

Girl Empower (GE) is a program designed to equip girls with the skills and experiences necessary to make healthy, strategic life choices and to stay safe from sexual exploitation and abuse.

The GE program is unique in its approach because it addresses girls' needs holistically. The girls' activities will take place in girl-only safe spaces located in their communities and contains the following components: Mentorship: girls have access to older female mentors. Mentors both provide weekly group-based and one-to-one interaction with girls as well as teach them critical skills; Asset building: Girls will have access to life skills and financial literacy training. This includes setting up savings accounts so girls practice their financial literacy skills, Monthly caregiver discussion groups among guardians of program girls, Capacity building and training of local health and psychosocial service providers to provide quality services to survivors of gender-based violence Intervention communities will either receive the GE program alone or the GE program with the plus small cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).

Eligibility Criteria:
Inclusion Criteria:

* Healthy, eligible girls aged 13 to 14 years of age.

Exclusion Criteria:

-
COr Loco-regional Advanced Lung Cancer Treated With Chemo-radiotherapy (COLA)

Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.

Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years
* Inoperable and histologically/cytologically verified NSCLC.
* Planned treatment with curative intent.
* Capable of completing study procedures ECG and Cardiac MR.
* Able of giving written and informed consent before study procedures are initiated.

Exclusion Criteria:

* Vulnerable patients.
* Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
* Claustrophobia.