cyrilzakka/clinical-trials huggingface dataset:
Prediction of the Development of Heart Failure With Preserved Ejection Fraction

The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Patients that were initially included in another prospective cohort study (LIFE-Heart study) and did not show evident heart failure at that timepoint, will be followed-up approximately 7-years after their initial inclusion in the LIFE-Heart study. Patients will be screened for the development of HFpEF and characterized with thorough clinical as well as laboratory assessment. Patients will be classified according to the presence of absence of heart failure and predictors for the development will be identified by using measurements taken at their initial inclusion in the LIFE-Heart study.

Heart failure with preserved ejection fraction (HFpEF) is associated with severe morbidtiy and mortality. Yet, little is known about factors leading to the development of HFpEF investigated in a longitudinal fashion. The PREDICT-HFpEF study aims to adress this open question. Patients that were initially included in a large cohort study (LIFE-Heart study) approximately 7-years ago, that underwent thorough clinical, laboratory and echocardiographic assessment, and did not show evidence of heart failure at the present time point will be included in the current study.

Patients will be screened for the development of HFpEF or other forms of heart failure (e.g. heart failure with reduced ejection fraction) and will again undergo thorough clinical, laboratory and echocardiographic assessment. Initially measured biomarkers (including clinical data, lab-charts, ECG recordings and echocardiography) will be used to predict the development of HFpEF in this cohort at cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* At timepoint of inclusion in the LIFE-Heart study normal left ventricular ejection fraction (≥ 50%)
* At timepoint of inclusion in the LIFE-Heart study normal NT-proBNP (\< 125 ng/l)

Exclusion Criteria:

* At timepoint of inclusion in the LIFE-Heart study acute coronary syndrom

  1. Troponine elevation above 14 pg/ml as well as coronary intervention, or isolated troponine elevation above 50 pg/ml in the absence of a coronary intervention
  2. No troponine elevation but coronary intervention
  3. Creatine kinase \> 0.41 µmol/l\*s and Creatine kinase to Creatine kinase-MB ration \>6% or Creatine kinase-MB \> 0.82 µmol/l\*s
* At timepoint of inclusion in the LIFE-Heart study missing data on left ventricular ejection fraction
* At timepoint of inclusion in the LIFE-Heart study missing NT-proBNP measurement
* At timepoint of inclusion in the LIFE-Heart study missing data on echocardiographic diastolic function and structural alterations of the left ventricle
* At timepoint of inclusion in the LIFE-Heart study relevant valvular heart disease (including relevant aortic stenosis, mitral- and/or tricuspid regurgitation, congenital heart disease, mitral stenosis)
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction

This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.


Eligibility Criteria:
Inclusion Criteria:

* Meibomian gland dysfunction in both eyes
* Best-corrected visual acuity of 20/40 or better in each eye

Exclusion Criteria:

* Known or suspected prostate cancer
* History of breast cancer
* Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
* Contact lens wear in either eye during any portion of the study
* Unable to instill eye drops correctly
* History of corneal refractive surgery in either eye within 1 year
Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.

However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics:

* plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness;
* anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution.

The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.

The purpose of this study is to collect and publish data from several centers, several users.


Eligibility Criteria:
Inclusion Criteria:

* Subject of either gender who needs a fixation of osteotomy of the basis of the first metatarsal for whose surgeon has recommended that a B-BOP® Lock plate from INTEGRA be implanted can be enrolled in this study.
* Age ≥ 18 years
* Have willingness to give his/her data transfer authorisation

Exclusion Criteria:

* Contraindication of the implantation of the B-BOP Lock plate
* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.


Eligibility Criteria:
Inclusion Criteria:

* Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
* No allergic reactions recorded in patient history
* Having primary molar teeth in one jaw, having deep caries and vital pulp.
* No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
* Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

  * Radiographic criteria:
* No sign of radiolucency in periapical or furcation area
* No widening of PDL space or loss of lamina dura continuity
* No evidence of internal/external pathologic root resorption

Exclusion Criteria:

* Lack of informed consent by the child patient's parent
* Lack of informed consent by the child patient's parent
* Unable to attend follow-up visits.
* Refusal of participation.
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients

The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 50 yrs;
* ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
* Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
* body mass index \<35 kg/m 2 ;
* resting systolic blood pressure (BP) \<160 mmHg and diastolic BP \<105 mmHg;
* ability to walk at least 2 min at 2.0 mph;
* ability to undertake an incremental treadmill test;
* decrease of at least 15% in ABI after a maximal treadmill test;
* not currently engaging in any regular exercise program.

Exclusion Criteria:

* exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
* no access to laptop or internet;
* no medical clearance for exercise
The Clinical Effects of Modified TRS Treatment

Objective Tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. Many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. This study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control.

Methods and analysis A randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Distress Scale (HADS), and visual analogue scale (VAS) for tinnitus; the secondary outcome measures will be Athens Insomnia Scale (AIS), tinnitus loudness matched by sensation level (LM, SL), and minimum masking level (MML). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 18 to 80 years old;
2. Diagnosed with subjective tinnitus;
3. Chronic tinnitus: tinnitus course ≥3 months;
4. Be able to understand and communicate with Mandarin；
5. The average pure tone threshold (0.5, 1, 2kHz) ≤ 55dB HL of the worse ear;
6. Subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent.

Exclusion Criteria:

1. Pulsatile tinnitus and objective tinnitus；
2. Having significant health issues that affect or prevent participation or continue with the follow-up;
3. Diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss);
4. People with severe hyperacusis, severe anxiety, depression and other psychiatric disorders；
5. Currently participating in other research projects that may affect tinnitus；
6. Subjects who are not considered suitable for this clinical trial by the researchers.
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female participants with normal liver function. The side effects and tolerability of Imlunestrant will also be evaluated. The study may last up to 46 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal
* Are between the body mass index (BMI) of 18.0 and 42.0 kilograms per meter squared (kg/m²), inclusive, at screening

Healthy Participants:

- Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function

Participants with Impaired Liver Function:

* Females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring
* Have diagnosis of chronic hepatic impairment (\>6 months), with no clinically significant changes within 90 days prior to study drug administration.

Exclusion Criteria:

* Women of childbearing potential are excluded from the study.
* Have known allergies to imlunestrant or related compounds
* Have a history of alcoholism or drug/chemical abuse within 2 years prior to check-in
* Have received blood products within 2 months prior to check-in
* Have evidence of HIV infection and/or positive human HIV antibodies
* Have used or intend to use medications that are strong inhibiters or inducers of cytochrome P450 (CYP)3A4
* Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine) per day.
* Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of \<60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.

In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.

The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.


Eligibility Criteria:
Inclusion Criteria:

- uncontrolled mild or moderate persistent asthma;

Exclusion Criteria:

* acute upper respiratory infections;
* immunological or metabolic systemic disease;
* major malformations of the upper airways;
* active smokers.
Acute Kidney Injury in Poly Trauma Patients

The aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients

Trauma causes significant morbidity and mortality in all age groups but particularly for those below 60 years and is one of the top 5 causes of death (1,2).Most deaths occur in adults who are between 15 and 44 years(3).Polytrauma originates from the Greek words poly which means multiple and trauma which means wounds. The term polytrauma, which was defined using the new Berlin definition, as cases with an Abbreviated Injury Scale (AIS)≥3 for two or more different body regions and one or more additional variables from five physiologic parameters (hypotension\[systolic blood pressure≤90 mmHg\], unconsciousness\[Glasgow Coma Scale score≤8\], acidosis \[base excess≤ -6.0\], coagulopathy \[partial thromboplastin time≥40 s or international normalized ratio≥1.4\], and age \[≥70 years\]) \[4\].There are complex pathophysiological changes that happen in a polyrauma patient which requires effective treatment for improving morbidity and mortality outcomes. Hemorrhage, systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are some of the complications of trauma whose effects are not only local but also systemic. There are mechanisms and triggers which result in cardio-vascular shock, hemostasis, apoptosis, organ dysfunctions and immune suppression (CHAOS) \[5\]. These local and systemic pathophysiological changes that occur in polytrauma (CHAOS) eventually lead to Acute Kidney Injury (AKI) which further worsens their outcomes \[6,7\].

Eligibility Criteria:
Inclusion Criteria:

* The present study will be conducted on patients with multiple trauma of both genders "without intently selected certain gender" who have no previous history of kidney disease or chronic illness.

Exclusion Criteria:

* • Patients who are less than 16 years old.

  * Patients with preexisting kidney disease or localized individual trauma.
  * patients with diabetes and hypertension.
  * Patients Post cardiac arrest
  * patients leaving the hospital on the same day or transferred to a different hospital will be excluded from this study.
  * patients refusing study will be excluded.
Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height

The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Access through this membrane to provide oxygen and ventilation is critical in emergency situations where other traditional means to access the airway (e.g. through endotracheal ventilation, supraglottic airway devices or face mask ventilation) have failed. It is known, from previous studies, that due to the physiological changes that occur in labour, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult, specifically during the period of labor, delivery, and just after delivery. Ultrasound is becoming increasingly popular due to its ability both to identify the cricothyroid membrane and to improve success in accessing the airway through the cricothyroid membrane. What is not known, and has not been studied to date, is specifically how the anatomy (i.e. its height and its depth) specifically changes during the period of labour, delivery and just after delivery.

The aim of this study would be to scan (using ultrasound) pregnant women's necks once at the very start of their labour, and once within 4 hours of delivery of their baby, to identify how the size and depth of the cricothyroid membrane changes. This information would improve the understanding of how to best approach accessing this membrane in laboring pregnant women.

The investigators hypothesize that in labouring third trimester patient, that the depth to the cricothyroid membrane will increase, and there will be no change in the cricothyroid membrane height.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* Pregnant patients in third trimester (\>28/40 weeks)
* Ability to understand the rationale of the study assessments and to provide signed consent.

Exclusion Criteria:

* Neck arthritis
* Cervical stenosis
* Known cervical degenerative disc disease
* Rheumatoid Arthritis
* Any restriction of neck movement
* Upper limb neurology
* Patient refusal
* Patients not in established labour.
* Patients undergoing cesarean section
* Known distorted airway anatomy
Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children

Pre - operative anxiety and emergence agitation are common issues among pediatric patients, which have various influences on the recovery progress and prognosis of children. Nasal administration of dexmedetomidine is a convenient and non - invasive sedation technique for children. This technique can reduce the incidences of pre - operative anxiety and emergence agitation. However, there are few studies on the effect of dexmedetomidine on intraoperative electroencephalographic activities.

In view of this, the investigators elaborately designed a prospective, multi - center, large - sample - sized, double - blind, randomized - controlled clinical trial. This trial aims to provide a basis for drug selection in pediatric anesthesia, ensuring the safety and comfort of pediatric anesthesia.

The investigators plan to select 627 participants who will undergo minor surgeries under general anesthesia. Thirty minutes before the surgery, dexmedetomidine or normal saline will be administered nasally to these participants. Before the surgery, the anxiety degree and sedation score of the participants will be assessed; during the surgery, the cooperation degree of patients during anesthesia induction will be evaluated and electroencephalographic monitoring will be carried out; after the surgery, the incidence of emergence agitation, the recovery time and the analgesic score of the participants will be assessed. Throughout the whole process, the occurrence of adverse reactions of participants will be fully monitored, and the adverse reactions will be timely recorded and treated.


Eligibility Criteria:
Inclusion Criteria:

* 2≤ age ≤6 years old, gender is not limited;

  * ASA anesthesia grade I \~ II; ③ For children who intend to undergo minor surgery under general anesthesia (including but not limited to minor surgery such as ENT surgery and hernia surgery), the operation duration is expected to be no more than 2 hours; ④ Family members agree to participate in the study and voluntarily sign informed consent;

Exclusion Criteria:

* Respiratory tract infection occurs within 4 weeks before surgery;

  * Potential or other contraindications to general anesthesia;

    * There are nasal diseases, nasal bleeding, sinusitis, nasal polyps and other conditions that affect nasal absorption; ④ Heart, liver, kidney and other vital organ dysfunction or blood system diseases;

      * Allergy or intolerance to dexmedetomidine or other α2-adrenergic receptor agonists;

        * Patients with mental illness or neurological diseases;

          * Unable to complete the test, the child's guardian refused to participate; ⑧ Have participated in other clinical trials or need to participate in other clinical trials during the study period; ⑨ Other reasons that the researchers consider inappropriate to participate in this study.
Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3

Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load.

The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery.

60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* HIV infection
* Patients receiving HAART treatment for at least one year with a sustained viral load equal or below 200 copies/ml
* Viral load equal or below 200 copies/ml at the screening visit
* Discordant patients: patients without an increment over 50 copies /ml of CD4 lymphocytes during the last year
* Patients with an expected adherence to HIV treatment over 90% according to their physician.
* Signed informed consent form

Exclusion Criteria:

* Pregnancy or breast feeding or women planning pregnancy during the study duration
* Any contraindication to treatment with Maraviroc
* X4 tropism at inclusion
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy

The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

1. Patients planned for elective lobectomy or pneumonectomy
2. 18 years or more on the day of the operation
3. Danish skills appropriate for fulfilling preoperative questionnaires

Exclusion Criteria:

1. Known contralateral paresis of the Phrenic nerve
2. Allergy to Ropivacaine or Sodium Chloride
3. Preoperative ipsilateral shoulder pain
4. Infection or eczema on the intervention site. Clinical decision
5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
6. Pregnancy
7. Acute porphyria