cyrilzakka/clinical-trials huggingface dataset:
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.

Eligibility Criteria:
Main Inclusion Criteria:

* Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
* Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, including the left main artery, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:

  * Second prior AMI,
  * Diabetes mellitus defined by ongoing glucose lowering treatment,
  * Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
  * Peripheral artery disease at any time prior to randomization,
  * Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
* Successful self-administered placebo according to the autoinjector instruction for use training during screening.

Main Exclusion Criteria:

* Increased risk of serious bleeding including any of the following:

  * History of intracranial bleed at any time.
  * Known uncorrected intracranial vascular abnormality.
  * Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
  * Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
  * Known liver impairment significantly affecting the hepatic function.
  * Current dialysis.
  * Ischemic stroke or transient ischemic attack within 3 months of screening.
* Chronic anemia with hemoglobin \< 10 g/dL.
* Chronic thrombocytopenia with platelet count \< 100,000/mm3.
* Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
* Previous exposure to an investigational drug within 3 months prior to randomization.
* Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.
Comparison of the Visual Performance After Implantation of Multifocal Lens

This is a prospective, consecutive, nonrandomized,comparative study. Comparison of the Visual Performance After Implantation of a Trifocal Intraocular Lens and Two Bifocal Intraocular Lenses

Multifocal intraocular lenses were introduced in the 1980s and have the benefit of promoting near and far vision simultaneous. However, these multifocal lenses have the disadvantages, including lower contrast sensitivity(CS) and visual discomfort, such as halos, glares and starburst, et al. Therefore, careful patient selection is crucial to achieve good postoperative results. The purpose of this study was to compare the visual outcomes and subjective visual quality between bifocal intraocular Lens(ReSTOR +2.5/+ 3.0D and Diff-aay) and trifocal intraocular Lens(AT Lisa tri 839MP). This prospective, nonrandomized, consecutive, comparative study included the assessment of 60 patients implanted with multifocal intraocular lens. visual acuity was tested in all cases. Ophthalmological evaluation included the measurement of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and uncorrected intermediate visual acuity (UIVA), the analysis of contrast sensitivity (CS), visual defocus curve, spectacle independence, patient satisfaction, residual sphere, spherical equivalent (SE), cylinder and complications.

Eligibility Criteria:
Inclusion Criteria:

* cataract

Exclusion Criteria:

* existence of any corneal disease;
* previous eye surgery;
* illiteracy;
* previous refractive surgery;
* expected postoperative corneal astigmatism more than 1.00D;
* higer-order aberration more than 0.3;
* spherical aberration more than 0.3μm;
* intraoperative or postoperative complications.
Effect of Electronic Cigarettes on Platelets, Endothelium and Inflammation

The primary purpose of this study is to evaluate the acute effects of electronic cigarette (e-cigarette) smoking on measurable biomarkers of platelet function, vascular endothelial function and inflammation in healthy active smokers. 10 healthy subjects, smokers, with no other medical conditions will be included in this study and measurements will be obtained at baseline and after smoking an e-cigarette. The study will contribute to the understanding of the effects of e-cigarettes on cardiovascular physiology, specifically establishing if the use of e-cigarettes increases platelet aggregation and platelet activation when compared to baseline in healthy active smokers, if the use of e-cigarettes decreases brachial artery flow-mediated dilation compared to baseline in healthy active smokers, and to determine the association between biomarkers of inflammation, platelet function, and vascular endothelial function before and after use of e-cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Adult English speaking subjects able and willing to provide written informed consent
* Active tobacco cigarette smoker
* History of active smoking tobacco cigarettes for 3-10 years (at least 10 cigarettes per day). The rational for inclusion of active smokers is based on prior data showing that most e-cigarette users have smoked moderate to high amount of tobacco cigarettes in the past
* No other use of alternative tobacco or nicotine products
* No history of hypertension, diabetes, cardiovascular disease, stroke, peripheral arterial disease, asthma or other chronic lung disease.

Exclusion Criteria:

* Use of aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, statins, colchicine, nitrates, steroids, fish oil, omega-3 fatty acids, or any other anti-inflammatory, antithrombotic or anticoagulant agent in the last week
* History of adverse reactions to e-cigarettes
Comparison of the Effectiveness of Different Myofascial Release Techniques for the Pectoralis Minor Muscle

The aim of this study was to compare the effects of self-myofascial release, myofascial release with a physiotherapist and instrument assisted soft tissue mobilization (IASTM) techniques for the pectoralis minor muscle on pectoralis minor muscle length, rounded shoulder posture, glenohumeral joint total rotation range of motion (ROM) and skin temperature in asymptomatic individuals.

In the literature, the effects of myofascial release and instrument assisted soft tissue mobilization (IASTM) applications on individuals with pectoralis minor muscle are investigated, but the available evidence is insufficient. In a study conducted in asymptomatic individuals, self-myofascial release was found to be more effective than placebo application in increasing glenohumeral flexion joint range of motion (ROM), improving pectoralis minor length and advanced scapular posture. However, there was one study comparing the short-term effectiveness of the self-myofascial release method and IASTM methods on pectoralis minor length, glenohumeral total arch movement and skin temperature in individuals with short pectoralis minor, and the results of both applications were found to be similar. Despite these studies in the current literature, the amount of evidence examining the effectiveness of myofascial release technique performed under the guidance of a physiotherapist in individuals with short pectoralis minor is insufficient. However, the number of studies comparing the immediate and short-term effects of different myofascial release methods on the pectoralis minor muscle lengthening is few. Given the limited evidence available, different myofascial release methods may produce different short-term responses on the pectoralis minor muscle, with different results on muscle length, scapular position, glenohumeral total arch motion, and superficial skin temperature. Therefore, the aim of this study was to compare the effects of 3 different myofascial release techniques on pectoralis minor muscle length, rounded shoulder posture, glenohumeral joint total rotation ROM and skin temperature in asymptomatic individuals.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-35
* Presence of pectoralis minor shortness
* Not having any upper extremity injury in the last 6 months

Exclusion Criteria:

* Presence of upper extremity surgery in the last 12 months
* Presence of neurological disorder in the upper extremity
* Any sensory problems or open wounds around the shoulder
The Clinical Effect of Different Lateral Retinaculum Relaxation Methods in the Treatment of LPCS

To observe the comparison of the clinical effects of two different ways of loosening the lateral support band under arthroscopy to treat lateral patella excessive compression syndrome.

To analyze the surgical conditions of 64 patients with lateral patella excessive compression syndrome who were surgically treated by Deputy Chief Physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital from September 2004 to January 2019. Among them, 24 early cases used the traditional proximal release of the lateral retinaculum (traditional surgical group), and recently 40 cases, after learning from the surgical experience of the early cases, switched to the lateral release of the lateral retinaculum, that is, "L" type Release (new surgery group). The visual analog scale (VAS), Lysholm score, and IKDC knee function subjective evaluation scale (IKDC) score were performed before and after the operation. By analyzing the knee movement scores of patients before and after surgery, the efficacy of the above two operations was judged, and the two groups of postoperative scores were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* From September 2004 to January 2019, patients with lateral patella overcrowding syndrome treated by deputy chief physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital

Exclusion Criteria:

* From September 2004 to January 2019, patients with lateral patella overcrowding syndrome treated by deputy chief physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital
Hormonal Replacement Therapy and Small Artery Function

Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease

We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.

Eligibility Criteria:
Inclusion Criteria:

* All women had been amenorrheic for at least 1.5 year.
* Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH \> 34 IU/ml) and estradiol (E2 \<50 pmol/l).

Exclusion Criteria:

* Cigarette smokers and women with:

  * Hypertension
  * Diabetes mellitus
  * Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease)
  * Venous thromboembolic disease
  * Liver disorders
  * Unexplained vaginal bleeding; and
  * Personal or family history of breast cancer were excluded.
Effect of Oculomotor Exercise on Writing Capabilities on Autism

Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). In addition to these core deficits, ASD is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. It is therefore not surprising that handwriting difficulties are frequently reported in children with ASD.

Handwriting is a functional skill that profoundly affects children's academic and psychosocial development. Difficulties in acquiring and applying these skills subsequently lead to problems such as slow writing and illegible written .Such difficulties may have implications on the child's successful participation in school and play activities, potentially leading to problems in academic performance and lowered self-esteem .Therefore, students with handwriting difficulties are especially prone to frustration, disappointment, and under achievement. The aim of our study is to improve handwriting quality of children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
* Intelligence quotient (IQ) score 70-100.
* Writing difficulties

Exclusion Criteria:

* Middle ear disorders
* Physical or mental conditions that may affect handwriting (e.g., seizures)
* Uncorrected visual or hearing impairments.
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet.

A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce.

To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.


Eligibility Criteria:
Inclusion Criteria:

1. 65 or older, as older women will show a particular genitourinary profile compared with younger women, notably due to menopause. This age cut-off was used in other studies in UI;
2. Ambulatory (able to walk, move about safely and autonomously without any mobility device);
3. Describe a pattern of stress/mixed UI, confirmed using the Questionnaire for Incontinence Diagnosis (QUID);
4. Have at least three urinary leakage per week, persisting for 3 months or more;
5. Understand French or English instructions;
6. Report no important cognitive deficit (determined with a Mini-Mental State Evaluation (MMSE) score of 24/30 or more);
7. Have an internet access; and
8. Able to give informed consent and complete a gynecological examination and fill 7-day bladder diaries and questionnaires.

Exclusion Criteria:

1. Present risk factors known to interfere with the effects of PFMT or with the PFM evaluation, including chronic constipation (as defined by the International Working Committee for Chronic Constipation), important pelvic organ prolapse (Baden-Walker score \> stage 2), or any other comorbidities with a potential impact on the treatment (i.e. cognitive impairment, diabetes, active cancer, respiratory or cardiovascular conditions, etc);
2. Currently taking medication for UI or medications affecting skeletal muscles;
3. Considered obese with a body mass index (BMI) over 35;
4. Had an active urinary or vaginal infection in the past 3 months;
5. Underwent a change in hormonal replacement therapy in the past 6 months;
6. Received pelvic floor physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.

We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.

GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.


Eligibility Criteria:
Inclusion Criteria:

* T2-T3 operable infiltrating breast carcinoma
* No allergy to Patent Blue
* Pre-operative diagnosis of unifocal infiltrating breast carcinoma.
* Patient planned to be treated by NAC.
* Informed consent.
* Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)

Exclusion Criteria:

* pT4d (inflammatory breast cancer)
* Locally advanced or metastatic breast cancer
* Any previous chemotherapy of contra-lateral breast cancer.
* Breast cancer local relapse
* Previous surgical removal of breast Cancer.
* Inadequate biopsy for pathological analysis.
* Dementia or altered mental disorder
* Pregnant woman or breast feeding or without efficacious contraceptive method.
* Contra-indication to NAC NAC interrupted due to progressive disease.
* Neoadjuvant radiotherapy.
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI

This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.

With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation.

In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients.

This trial was designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after PCI in the era of the newer generation DES era.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent percutaneous coronary intervention with drug-eluting stent;

Exclusion Criteria:

* Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;
* Serum creatinine level \> 2.0 mg/dL
* Serum aspartate transaminase \> 3 times upper limit of normal
* Serum alanine transaminase \> 3 times upper limit of normal
* Having anaphylactic reaction for Rosuvastatin;
* Having the other contraindications for Rosuvastatin;
* Having plan to be pregnant;
* Having life expectancy less than 1 year
Restorelle® Mesh Versus Native Tissue Repair for Prolapse

The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years of age
* Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
* Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
* Subject is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

* Subject is pregnant or intends to become pregnant during the study
* Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
* Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
* Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Subject has uncontrolled diabetes mellitus (DM)
* Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
* Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
* Subject is not able to conform to the modified dorsal lithotomy position
* Subject is currently participating in or plans to participate in another device or drug study during this study
* Subject has a known sensitivity to polypropylene
* Subject has had previous prolapse repair with mesh in the target compartment(s)
* Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair