cyrilzakka/clinical-trials huggingface dataset:
Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort

The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 21 years of age and older
* Able and willing to make the required study visit
* Able and willing to provide consent and follow study instructions
* Patients must have understood and signed the informed consent

Exclusion Criteria:

* Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
* Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
* Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
* Known Pregnancy
Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease

The purpose of this study is to investigate the prevalence and degree of coronary arterial microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with type 2 diabetes. Furthermore, the risk factors of coronary arterial microcirulation would be screened and identified.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis non- obstructive coronary artery disease;
* Positive Treadmill exercise test;
* Positive Cardiac ECT test;
* Positive Holter test

Exclusion Criteria:

* Diagnosis of myocardial infarction;
* Diagnosis heart failure;
* Diagnosis of chronic kidney disease;
* Diagnosis of heart valvular disease;
* Diagnosis of malignant tumor;
* Positive heart transplant history;
* Pregnant and lactating women
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)

The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.

Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.

Eligibility Criteria:
Inclusion Criteria:

* calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray);
* pain and loss of function in the shoulder;
* not currently receiving physiotherapy or ESWT.

Exclusion Criteria:

* previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.);
* other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability);
* known allergy to any of the pharmacological products used in the study;
* taking oral anticoagulants
* taking oral steroid within the six months prior to participation in the study;
* cancer, systemic disease, pregnancy or infection;
* neck pain.
The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency

Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing.

The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. The objective of the present study is to evaluate the effect of RV pacing on both global and regional oxidative metabolism and perfusion, and myocardial efficiency. In addition, the effect of RV pacing induced LV dyssynchrony on myocardial oxidative metabolism and efficiency will be studied.

Our hypothesis is that LV dyssynchrony during RV pacing results in regional abnormalities in LV perfusion and oxidative metabolism. LV dyssynchrony will also result in altered myocardial efficiency.

Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. Several clinical trials have demonstrated an association between RV pacing and an increased risk of heart failure and death. In addition, RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing.

The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. Importantly, the relation between the presence of LV dyssynchrony during RV pacing and changes in myocardial perfusion, oxidative metabolism and cardiac efficiency has not been studied.

Ten patients with normal LV ejection fraction and VVI/DDD pacemaker will be studied during AAI-pacing/sinus rhythm without RV pacing (pacing-OFF) and with RV-pacing (pacing-ON) at the same heart rate. Dynamic \[15O\]water and \[11C\]acetate positron emission tomography is used to measure perfusion and oxidative metabolism (kmono) of the LV. An echocardiographic examination is used to assess LV stroke volume (SV) and LV dyssynchrony.

The PET data will be first analyzed based on RV pacing mode only, comparing the two pacing conditions (pacing-ON vs. pacing-OFF). Thereafter, the study population will be divided into two groups, according to the presence of LV dyssynchrony during RV pacing.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age over 18 years
* Previously implanted permanent pacemaker (DDD or VVI)
* Normal left ventricular function

Exclusion Criteria:

* Pacemaker dependency
* Symptomatic coronary artery disease
* Pregnancy
Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection

All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm

Eligibility Criteria:
Inclusion Criteria:

18 years and older Willing and able to provide written informed consent

Exclusion Criteria:

* women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease

The purpose of this study is to determine if high doses of vitamin D3 administered orally as adjunct therapy to children with Crohn's disease could improve the outcome of the disease.

Background : Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive tract from the mouth to the anus. This condition is associated with an increased risk of relapses throughout the course of the disease. Nearly 25% of patients with Crohn's disease are in the pediatric age range. Many epidemiological data are in favor of an increase incidence of pediatric Crohn's disease. Environmental factors could explain this increased incidence. Among them sunlight exposure and vitamin D deficiency have been suggested by many authors.

Vitamin D, in addition to its action on bone metabolism, exerts an anti-inflammatory effect by modulating the innate and acquired immune system. The biological effect of high doses of vitamin D administered orally have not been extensively studied in children with Crohn's disease. In these patients, the absorption and bioavailability of vitamin D may be altered in relation with mucosal lesions.

Objective :

Thus our aim is to investigate the effect of high doses of vitamin D3 administered orally as an adjunct therapy to children with newly diagnosed pediatric Crohn diseases or children in remission.

Methods : In this Prospective study 40 children will be enrolled and followed up for a duration of one month. The administration of vitamin D 3000 IU or 4000 IU per day will be considered as an adjunct to conventional therapy (steroids or enteral nutrition for patients at diagnosis or immunosuppressants for patients in remission).

Analysis:

1. Tolerance will be assessed during weekly visits by a brief questionnaire and blood tests.
2. Efficacy will be assessed by monitoring the change in fecal and blood inflammatory markers.
3. Change in the immunological status will be assessed by measuring the following parameters :

   * T lymphocyte count CD3, CD4, CD8, and invariant Natural Killer T cell, Treg.
   * Proliferation and activation of CD4 and CD8 T lymphocytes induced by anti-CD3 antibody activator (OKT3). The activation will be evaluated by dosing CD25 and the proliferation by the study of cell cycle after 3 days of culture of total blood culture.
   * The culture supernatants will be collected and frozen for subsequent analysis of cytokines Th1 and Th2 (IFN, IL2, IL4, IL13) with Affymetrix method that allows simultaneous determination of multiples cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Age between 10 and 18 years
* Crohn's disease diagnosed by usual clinical and endoscopic criteria
* Recent (less than one week) blood test with results of : Albumin, sedimentation rate, hematocrit

Exclusion Criteria:

* Known renal or cardiac malformation
* Disorders of phospho-calcic metabolism and vitamin D
* Intake of vitamin D supplementation in the last three months prior to enrollment
* Current intake of medications known to interfere with the metabolism of calcium, phosphate and vitamin D \*
Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.

Eligibility Criteria:
Inclusion criteria:

* Age between 2 and 12 years
* child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

Exclusion criteria:

- over 12 years old
Endocrine Disrupting Monomer Release in Clear Aligner Systems and Fixed Orthodontic Treatment: a Randomized Controlled Clinical Study

The aim of this study is to evaluate the release of endocrine disrupting monomers from clear aligners as a result of exposure to intraoral factors by measuring their concentration in saliva and to evaluate their reliability of use in terms of general health by comparing them with the fixed orthodontic treatment group. It is also aimed to compare the groups in terms of total treatment duration, treatment effectiveness and white spot lesion formation.

The aim of our study is to evaluate the saliva concentration of endocrine-disrupting monomers released from attachments used and clear aligners produced directly by the orthodontist in the clinic and indirectly produced by companies. Accordingly comparing them with the fixed orthodontic treatment group and assessing clear aligner's safety for general health. It is also aimed to compare the groups in terms of treatment time spent, treatment effectiveness and white spot lesion formation. Endocrine-disrupting chemicals are substances that interfere with the synthesis, metabolism, or effects of hormones, causing deviation from normal reproduction and homeostatic control in organisms. Bisphenol A (BPA), a monomer, is also included in the chemicals listed as endocrine disruptors by the World Health Organization. Different studies have suggested that Bisphenol A may cause adverse health effects by acting as an endocrine disruptor. While previous research has been conducted on BPA release or monomer leakage related to orthodontic materials, there is limited evidence regarding the safety aspects of thermoplastic aligners or retainers. The concentrations of endocrine-disrupting monomers in the saliva of patients undergoing treatment with directly produced aligners by orthodontists and indirectly produced aligners by companies will be examined in comparison to patients undergoing fixed orthodontic treatment. Patients will not receive any treatment other than routine orthodontic care.

Eligibility Criteria:
Inclusion Criteria:

* Absence of primary teeth in the oral cavity, with permanent teeth fully erupted,
* Presence of a non-extraction orthodontic treatment plan,
* Age range of 15 to 24 years,
* Presence of mild to moderate dental crowding (0-6 mm of crowding),
* Classification as skeletal Class I (ANB: 2±2°),
* Absence of any craniofacial anomalies,
* Normal vertical growth pattern (Sn-GoGn: 32±6°),
* No congenital tooth agenesis (excluding third molars),
* Absence of atypical tooth morphology,
* No extracted permanent teeth,
* Absence of dental caries,
* Good level of oral hygiene,
* Healthy periodontal tissues.

Exclusion Criteria:

* Presence of any systemic disease,
* History of previous fixed orthodontic treatment,
* History of allergy to any dental material,
* Use of medications containing estrogen analogs,
* Patients with a history of xerostomia and a salivary flow rate of less than 0.1 ml per minute,
* Patients with more than five composite restorations.
Diagnostic Validation of Rapid Detection of the COVID-19 Causative Virus (SARS-CoV-2) in Saliva Samples by Mass Spectrometry

In order to control the COVID-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with SARS-CoV-2 has been established The reference diagnostic test is RT-PCR on nasopharyngeal swab. Nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. RT-PCR is efficient, but time-consuming. It is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. Tandem mass spectrometry on saliva samples is a promising option. A combined "mass spectrometry/saliva test" should provide faster results.


Eligibility Criteria:
Inclusion Criteria:

* The patient must not have opposed their inclusion in the study
* Patient presenting to the Walk-in Center for Emerging Biological Risks for SARS-CoV-2 screening by nasopharyngeal swab OR hospitalized in the Infectious and Tropical Diseases Department for severe SARS-CoV-2 infection, diagnosed by RT-PCR on nasopharyngeal sample, taken at Nîmes University Hospital, in the previous 24 hours.

Exclusion Criteria:

* Patient already included in the study
* The subject is in a period of exclusion determined by a previous study
* It is impossible to give the subject clear information
* The patient is under safeguard of justice or state guardianship
* Patient unable to give consent
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer
* Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

Exclusion Criteria:

* Age \> 75 yrs
* No metastatic disease (M1).
* No presence of gynaecomastia and/or mastalgia at screening
* No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens

An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens

This is a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of tildacerfont in approximately 39 women with PCOS and elevated adrenal androgens assessed by elevated DHEAS levels. Subjects will be randomized 2:1 (tildacerfont:placebo) at baseline. The study will consist of 3 consecutive 4-week treatment periods at each dose level. Duration of participation is approximately 25 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 18 to 40 years old at Screening visit
* Diagnosis of PCOS (either historical or during Screening) according to NIH (1990) criteria
* DHEAS level \> age-matched upper limit of normal (ULN) at Screening visit
* Agree to follow industry standard contraception guidelines within protocol

Exclusion Criteria:

* Evidence of:

  1. History of congenital adrenal hyperplasia (CAH), Cushing's syndrome, pituitary or adrenal disease
  2. Clinically significant hyperprolactinemia
  3. Thyroid stimulating hormone (TSH) \<0.1 mU/mL or \>4.5mU/mL at Screening
  4. Cortisol levels concerning for adrenal insufficiency
  5. Other findings suggestive of secondary cause for anovulation and/or hyperandrogenemia
* Total testosterone levels \>140 ng/dL, DHEAS \>650 mcg/dL, virilization or other signs or symptoms concerning for ovarian hyperthecosis or androgen-secreting tumors
* Medical conditions that require glucocorticoid treatment within 30 days of screening and throughout the duration of the study
* Clinically significant unstable medical conditions, illness, or chronic diseases
* Prior hysterectomy or bilateral oophorectomy
* Females who are pregnant or nursing
Decreased Consumption of Blood Components During Cardiac Surgery Procedures: Causes and Effects.

There is a decrease in the amount of blood components used during cardiac surgery in the last four years. As the hemovigilance team of the investigators' Hospital the investigators want to find out the causes and effects of this decrease.


Eligibility Criteria:
Inclusion Criteria:

* patient underwent cardiac surgery between 2010 and 2014 in UZ Leuven

Exclusion Criteria:

* patient without cardiac surgery
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatient at a psychiatric unit at MGH
2. Male and female, 18-70 years of age
3. Diagnosis of Major Depressive Disorder, single or recurrent, based on DSM-5 criteria, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening
4. Current suicidal ideation
5. In good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and/or ECG
6. A status of non-childbearing potential or use of an acceptable form of birth control
7. Access to a mobile phone or computer with internet connection
8. Ability to read, understand, and provide written and dated informed consent prior to screening
9. Has a treating psychiatrist, either prior to admission or at discharge from the inpatient unit

Exclusion Criteria:

1. Any history of previous treatment with IV ketamine
2. Pregnant or breastfeeding
3. A status of childbearing potential and is not willing to use birth control during the study
4. Unstable medical illness
5. Current diagnosis of a moderate to severe substance use disorder, within the last six months prior to screening based on DSM-5 criteria
6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes
7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD)
8. Currently receiving ECT treatment
9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications
10. Has dementia, delirium, amnestic, or any other primary cognitive disorder
11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
12. Inability to consent to or comply with the study procedures.
13. Other medical issues that might affect safety, study participation, or confound interpretation of study results
14. Inability to comply with study safety procedures, including having reliable escorts to and from visits