cyrilzakka/clinical-trials huggingface dataset:
Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery

Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III
* Elective coronary artery bypass graft surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV
* Emergency surgery and redo surgery
* Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
* Allergy to any study drugs, local infection at the block site
* Opioid abuse
Risk Factors In Heart Failure Patients With Preserved Ejection Fraction

This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.

This study sought to determine the independent risk factors linked to endpoint events (which include all-cause mortality or readmission for heart failure, cardiovascular death) among hospitalized patients with heart failure and preserved ejection fraction (HFpEF) at Xiangtan Central Hospital during the period from May 1, 2014, to January 31, 2023. The clinical follow up ended on January 31, 2024. The study examined the risk factors associated with the endpoint outcome (cardiovascular death and death from any cause and readmission due to heart failure) to provide clinical evidence for intervening discharged HFpEF patients, with the objective of improving patient outcomes in future clinical practice.

The clinical features of hospitalized heart failure with preserved ejection fraction (HFpEF, EF≥50%) are analyzed retrospectively by reviewing the patient's demographic, clinical data, including patient medical history, initial clinical evaluations, and therapeutic interventions, as well as echocardiographic data in the hospital's electronic health records and relevant databases. The clinical outcome of enrolled patients are obtained through a team of three experienced cardiologists and twelve nursing professionals through outpatient consultations, telephone follow-ups, and community visit. The primary endpoint events are all-cause mortality, the second endpoints are the composite cardiovascular death and heart failure readmission.

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged with diagnosis of heart failure were screened and met definition of heart failure with preserved ejection fraction (HFpEF) according to the 2021 European Society of Cardiology (ESC) guidelines at final analysis.
* 1）Heart failure signs and symptoms; 2）LVEF\>50%;

Exclusion Criteria:

* 1) age under 18 years; 2) life expectancy of less than one year due to non-cardiac conditions.
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)

This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.


Eligibility Criteria:
Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
2. Females between 18 and 29 (inclusive) years of age at the time of screening
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report
5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report
6. The subject must be willing to be photographed and/or video-taped
7. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye
8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating
2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)
5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)
8. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion)
9. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment

The aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a Chiari type I malformation and healthy volunteers.

Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type I malformation is responsive in perturbation of the cerebro spinal fluid flow at the cranio-cervical junction. Those perturbations caused headaches, and various otological symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis...). The surgical treatment consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological perturbations especially alteration of the vestibular test.

In the literature, hearing performance could be normalized after posterior fossa decompression. Furthermore, the multifrequency tympanometry measurement and particularly the width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid pressure have consequences on the pressure of the perilymph.

Investigator's hypothesis is that tympanometry (conductance) could be an effective test to show the variation of the cerebro spinal fluid pressure.

Eligibility Criteria:
Inclusion criteria:

* Chiari type I malformation proved at MRI or CT-scan with an indication of cranio cervical decompression.
* Patients between 18 and 60 years old.
* Patient should benefit of the national health care system
* Agreement of the patient

Inclusion criteria for healthy volunteers:

* Between 18 and 60 years old.
* Free of otologic pathology
* Benefit of the national health care system
* Agreement of the volunteers

Exclusion criteria:

* Acute hydrocephaly
* Other type of Chiari disease (induced...)
* Medical history of neurosurgery
* Contraindication for MRI
* Cophosis
* Chronic otitis
* Medical history of ontological surgery
* Tympanic perforation
* Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with abolition of stapedial reflex
* Pregnant women or nursing women
* Protected adults by French laws

Exclusion criteria for healthy volunteers:

* Medical history of neurosurgery
* Cophosis
* Chronic otitis
* Medical history of ontological surgery
* Tympanic perforation
* Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with abolition of stapedial reflex
* Pregnant women or nursing women
* Medical history of Chiari malformation
* Chronic headaches or neck pain
* Protected adults by French laws
Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control

This study is a randomized controlled trial comparing two ADR repair methods: nylon suturing and nylon suture with mesh enforcement. The ADR correction is performed simultaneously with abdominoplasty/ modified skin reduction abdominoplasty.

Abdominal diastasis recti (ADR) persists after pregnancies in one third of women. Traditionally plain ADR has been managed conservatively. There is some evidence that ADR reduces abdominal integrity and functional strength, contributing to pelvic instability and back pain. However, patients are referred to a surgeon mainly because of some other primary concern and ADR is an additional condition: in the case of excess skin-subcutis, the person is referred to a plastic and reconstructive surgeon for abdominoplasty and in the case of midline hernia, to a general surgeon.

In combination with abdominoplasty the plication of the superficial aponeurosis of recti muscles is the most commonly used reconstructive technique. There is a wide variety of different plication procedures available. Convincing data of the long-term results of ADR repair are lacking especially when ADR is severe. Some studies have reported large recurrence rates. Polypropylene mesh repair is an evidence-based technique to ensure a strong and reliable abdominal wall repair in ventral hernias or in high risk laparotomy wounds. Large retromuscular or intraperitoneal meshes have been used also in ARD repair.

This study reports a novel surgical technique aimed at reliable and mini-invasive open repair of ADR with or without midline hernia combined by abdominoplasty for symptomatic ADR patients. In RmB (roll mesh in between) method the investigators bury a narrow piece of self-gripping mesh inside the plicated linea alba to give tensile strength to plication. Patients are randomized to a suture plication group or RmB group.

Outcome evaluation is performed by clinical examination with video recorded movement control tests and with structured questionnaires for Quality of Life (RAND36) and for low back pain (LBP) (Oswestry 2.0). Evaluation is done three times: when recruiting the patient, after a conservative 3-6 months therapy with written instructions and one year after the intervention. Complications and recurrences are recorded as well.

Outcomes The effect of ADR repair on LBP and movement control problems Patient satisfaction and complications of ADR repair after the two techniques

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic diastasis recti (\> 3 cm) after pregnancies, with or without a midline hernia

Exclusion Criteria:

* BMI \> 28,
* smoking
* less than a year since the previous pregnancy or still breast feeding
* planning further pregnancies
ARON-2 Study-Multicentric International Retrospective Study

The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18y
* Histologically confirmed diagnosis of UC of upper and/or lower urinary tract
* Histologically or radiologically confirmed metastatic disease
* Patients treated with at least one of the following:
* Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021
* Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023

Exclusion Criteria:

* Patients without histologically confirmed diagnosis of UC
* Patients without histologically or radiologically confirmed metastatic disease
Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis

A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 year
* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
* Active lupus nephritis (both new and flare patients can be included) defined as:

  * Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV \[exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and
  * At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day

Exclusion Criteria:

* Pregnancy or breast feeding
* Child-bearing age women who refuse to use effective birth-control
* Poor compliance
* Estimated-GFR \< 20 mL/min/1.73 m2
* Crescentic glomeruli more than 30 percent
* Severe extra-renal involvement of SLE
* History of severe allergic reactions or adverse effects to MMF
* Uncontrolled concomitant disease
* Known active, clinically significant infection of any kind
* History of serious recurrent or chronic infection
* History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
* Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening
* Treatment with more than 1 g cyclophosphamide within the past 24 weeks
* Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks
* Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks
* Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks
* On treatment with Tacrolimus or Cyclosporine on the day of screening
* Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks
* Receiving concomitant medication interfering PK of MPA

  * Cholestyramine
  * Rifampin
Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns

The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.

It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.

Eligibility Criteria:
Inclusion Criteria:

* CVM stage 5 on lateral teleradiography (end of growth)
* Angle Class II
* Treatments with rubber bands for inter-arch traction
* End of treatment in class I

Exclusion Criteria:

* Incomplete data
* Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
* Dental agenesis (excluding wisdom teeth)
* Cranial-facial syndromes
Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefit tremendously from better BP control and a corresponding decrease in heart damage. HTN occurs early in life and more often in African-Americans, reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to play an important role in cardiovascular health. Vitamin D replacement in those who are deficient has been thought to reduce the cardiovascular disease, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease.

The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which, if shown to be effective could improve the existing approach to a widely accessible, cost-effective option.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with known HTN
* African-American race (self reported)
* Repeat SBP ≥ 160 mmHg within 1 hour of arrival
* Age 30-74 years
* Asymptomatic state (class I as defined by Goldman Specific Activity Scale)

Exclusion Criteria:

* Dyspnea (exertional, rest or nocturnal) or chest pain as a primary or secondary chief complaint
* Prior history of HF, coronary artery disease, myocardial infarction, cardiomyopathy (any), valvular heart disease (any) or renal failure with current, previous, or planned future dialysis
* Acute illness or injury which necessitates hospital admission
* Acute alcohol or cocaine intoxication or history of chronic alcohol (determined using the CAGE screening questions) or cocaine (self-reported) abuse
* Acute or decompensated psychiatric disorder or any underlying psychiatric disorder or cognitive deficit which precludes effective on-going communication or ability to follow-up as required
* Cancer (other than skin), HIV, or any other medical condition that might limit life expectancy
* Hepatitis or liver enzyme (ALT, AST) elevations \> 1.5x normal
* Planned move \> 50 miles in the next 9 months
* History of kidney stones
* GFR \<30
* Serum calcium \> 10.5 mg/dl or known history of hypercalcemia
* History of or known primary hyperparathyroidism
* Sarcoidosis or other granulomatous disease
* Pregnant or planning to become pregnant
* Allergy or known hypersensitivity to gadolinium contrast
* Severe claustrophobia
Impact of Pharmacist in Cardiology Service

The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment.

Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.

By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2 patient hospitalized in cardiology service
* Hospitalization more than 24 hours
* with insuline or/and oral anti diabetic

Exclusion Criteria:

* diabètes type 1
* iatrogenic hyperglycaemia
* hospitalization for cardia angiography
Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

The purpose of this study is to test a liquid levothyroxine formula and examine if it will lead to improvement in management of thyroid function and if it improves hypothyroid symptoms that patients experience.

Patients who require enteral nutrition through an enteral feeding tube and have hypothyroidism often struggle with the management of hypothyroidism. Hypothyroidism usually requires lifelong treatment except in some cases. It has been clinically observed the traditional management of hypothyroidism is to crush the tablet and administer the medical through the enteral nutrition tube and hold the feeds for one hour. However, management of the hormonal profile has been noted to have variable results with this method. Limited data is available about the effectiveness of levothyroxine liquid formulation in outpatients' dependent on enteral feeding tubes for administration.

Therefore, we propose a study to assess if daily treatment of, Tirosint-SOL (liquid levothyroxine, IBSA pharma Inc.), will improve thyroid function tests in individuals requiring enteral nutrition and are hypothyroid in a prospective, randomized study in a population requiring enteral nutrition. We hypothesize that Tirosint-SOL will lead to improvement in management in their thyroid function tests resulting in possible improvement in hypothyroid symptoms experienced by the patients.

This will be a randomized controlled trial. The study will be conducted in patients who have uncontrolled hypothyroidism on levothyroxine therapy. These patients will also be dependent on enteral nutrition and medication administration through the gastrostomy tube. The participants will be followed at UCLA Enteral Nutrition Clinic. Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine. At baseline (week 0) and week 6-8, TSH and thyroid function tests will be performed. In addition, medical history and physical, body weight, HR, blood pressure, nutritional intake by a registered dietitian will be done at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years old or older
* G-tube/G-J tube dependent for medication administration
* Hypothyroid patients on levothyroxine tablet
* TSH\>5 on levothyroxine

Exclusion Criteria:

* J-tube
* Unstable cardiac condition
* Unstable gastrointestinal condition
* Unable to reliably administer medication
* Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
* In the opinion of the study investigator, any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials.