cyrilzakka/clinical-trials huggingface dataset:
Study of the Telomere-telomerase System and the Expression of Candidate Genes in the Leukocytes of Patients With Depressive Disorder: Search for Peripheral Markers of Somatic Stress

The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular senescence and are reflected by alterations in systemic gene expression detectable in leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically significant markers. The identification of new genetic markers will make it possible to improve evaluations of the severity and somatic consequences of depressive syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have given their written informed consent
* absence of a diagnosis of major depressive disorder throughout the study and no history of psychiatric disorders
* diagnosis of a first episode of a major depressive disorder
* diagnosis of a recurrent major depressive disorder (at least three episodes) with or without resistance to therapy

Remarks:

* the diagnosis of major depressive disorder with characteristics of melancholy must be clearly mentioned in the case report form but is not a reason for not being included in the study
* the presence of a recent or older attempted suicide must lead to a careful clinical assessment of the diagnosis of depressive disorder and must be clearly mentioned in the case report form.

Exclusion Criteria:

* Persons not covered by the national Health Insurance Agency
* Psychotic or bipolar disorders
* Severe personality disorders
* cardiovascular disease, proven inflammatory disease and cancer
* persons unable to give their consent personally,
* persons in emergency situations,
* pregnant women,
* breast-feeding women
Assessing Symptomatic Clinical Episodes in Depression

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Eligibility Criteria:
Inclusion Criteria:

* Currently meets DSM-5 criteria for MDD
* Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Suicide risk
* History of treatment resistance in current depressive episode
* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply
Metatarsophalangeal Arthrodesis of the Hallux

The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.

The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.

Patients will be divided into two groups:

* patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
* patient undergoing arthrodesis of the hallux by plate (group B)

This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
* Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
* Patient able to understand information related to the study and complete quality of life questionnaires;
* Patient accepting study follow-up visits;
* Patient having been informed and agreeing to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Patient undergoing lateral ray surgery;
* Patient undergoing revision arthrodesis;
* Patient with a loss of bone substance requiring a graft;
* Patient suffering from chronic inflammatory disease;
* Patient treated with long-term immunosuppressive or corticosteroid treatments;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)

There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions.

Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm. and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months after PCI.

Eligibility Criteria:
Inclusion criteria

* Age 19-85 years
* Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
* Complex coronary stenotic lesions (\>50% based on visual estimate) considered for coronary revascularization with DES
* Definition of complex lesions (at least one):

  * Acute myocardial infarction
  * Chronic total occlusion
  * Long lesion: expected stent length ≥28mm based on angiographic estimation
  * Calcified lesion
  * Bifurcation (including all techniques, one- or two-stent)
  * Unprotected left main disease
  * Small vessel diseases with reference vessel diameter less than 2.5 mm
  * Intracoronary thrombus visible on the angiography
  * Stent thrombosis
  * In-stent restenosis
  * Bypass graft lesion
* Patients who provide signed informed consent

Exclusion criteria

* Severe hepatic dysfunction (≥3 times normal reference values)
* Significant renal dysfunction (Serum creatinine \>2.0 mg/dL)
* Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a white blood cell count of \<3,000 cells/mm3, hemoglobin \<8.0 g/dL, or other known bleeding diathesis
* Hemodynamically unstable during procedures or cardiogenic shock
* Pregnant women or women who might be pregnant
* Life expectancy; less than 1 year
* Inability to understand or read the informed content
A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery

The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.

This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
* American Society of Anaesthesiologists (ASA) Physical Status I-III

Exclusion Criteria:

* Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
* Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction

This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* diagnosed as aortic valve disease

Exclusion Criteria:

* aortic valve replacement at baseline
Effect of Dexamethasone on Migraine Headache

Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is never evaluate and not correlate with the effect of popular anti migraine medication such as dihydroergotamine. The investigators proposal is to compare its effect with dihydroergotamine.


Eligibility Criteria:
Inclusion Criteria:

1. Migraine attack according to international headache society criteria
2. Migraine without aura; at least 5 attack with mean duration of 4 to 72 hours and 2 of following:

   * Unilateral
   * Pulsatile
   * Severe enough to impair daily activity
   * Aggravate with walking and climbing, also 1 of following:

     * Nausea and or vomiting
     * Photophobia and phonophobia, and not contributed to other headache.
3. Migraine with aura; at least 2 attacks with 3 of following:

   * One reversible aura
   * Aura became apparent at least in 4 minutes
   * Aura not lasting more than 60 minutes
   * Headache develops in less than 60 minutes after aura

Exclusion Criteria:

1. Hypertension
2. Ischemic heart disease
3. Basilar migraine with sign and symptoms such as:

   * Diplopia
   * Ataxia
   * Dysarthria
   * Dysphagia
   * Weakness
   * Sensory disorder
   * Drowsiness
4. Peripheral vascular disease
5. Sepsis
6. Age more than 40 and less than 15 year old
7. Pregnancy
8. Use of triptans and ergots derivatives in past 24 hours
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* A documented history of seasonal allergic rhinitis to mountain cedar pollen

Exclusion Criteria:

* Significant medical condition
* Cardiovascular abnormality
* Have a significant physical obstruction in the nose
* Started or had a change in immunotherapy within the 30 days prior to

screening

* Have nasal ulceration(s) or any active nasal bleeding
* Require use of allergy medications during the study
* Require use of asthma medications other than as needed albuterol
A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient with Type 2 Diabetes

The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent in accordance with GCP and local legislation
* Adults (≥18 years) with the diagnosis of T2D
* BMI of \<=45 kg/m2 at the time of presentation/screening
* T2D mellitus inadequately controlled on therapy (HbA1c ≥7.0 and ≤10.0% \[53-86 mmol/mol\] at the time of initial presentation for screening and with the need for therapy escalation \[dose increase of existing therapy or additional prescription of insulin and/or OADs or change of therapy regimen\]) to achieve the therapeutic HbA1c target defined by the physician
* Treatment with oral and/or injectable glucose lowering medications and/or long-acting insulin therapy

Exclusion Criteria:

-
Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis

Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis.

Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis.

For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific Professional and environmental questionnary.

Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year, smoking more than 10 pack-year)


Eligibility Criteria:
Inclusion Criteria:

* Absence of respiratory and cardiac illness (healthy volunteers)
* Normal spirometry and chest x-ray (healthy volunteers)
* Absence of viral infection (B and C hepatitis, HIV) (healthy volunteers)
* Confirmation of sarcoidosis (endoscopic exam with bronchoalveolar lavage) (patients suffering from sarcoidosis)

Exclusion Criteria:

* Pregnant women
* Lack of bronchoalveolar lavage (volume less than 20 ml)
Clinical and Biochemical Evaluation of Dental and Periodontal Conditions in Children With Juvenile Idiopathic Arthritis

Aimed to be done in the planned thesis to evaluate the dental and periodontal health of patients with newly diagnosed JIA and healthy-periodontal problems with cytokines from saliva and oxidative stress markers non-invasively, and thus, to determine the markers' evaluability in terms of markers in determining the state of inflammation among individuals with and without the disease.

Periodontal diseases and inflammatory diseases such as arthritis show similar clinical pathologies such as connective tissue deterioration and bone destruction. They carry the risk of being seen together and the possibility of mutual influence. It is important whether these patients have a difference in cytokine profile from individuals who do not have the disease. In the literature, it has been determined that pro and anti-inflammatory cytokines, which are involved in the pathogenesis of periodontitis, are also involved in the pathogenesis of juvenile idiopathic arthritis (JIA). Cytokines play an undeniable role in the pathogenesis of both diseases. The cytokine profile in periodontal disease is distinctly similar to that of rheumatoid arthritis (RA). As in RA, the level of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α) increase in periodontal disease. Again, it is stated that oxidative stress assessment is an important factor in evaluating the development of the disease. Saliva evaluation can be made with new oxidative stress markers that can be used in this sense.

On the subject of the proposed thesis; It is to determine the profile of dental and periodontal health in a specific group in terms of biochemical and microbiology using different body fluids together with clinical findings and has an interdisciplinary character. Aimed to be done in the planned thesis;

It was aimed to evaluate the dental and periodontal health of patients with newly diagnosed JIA and healthy-periodontal problems with cytokines from saliva and oxidative stress markers non-invasively, and thus, to determine the markers' evaluability in terms of markers in determining the state of inflammation among individuals with and without the disease.

Eligibility Criteria:
Inclusion Criteria:

* healty patients

Exclusion Criteria:

* used antibiotics within the last 3 months
Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.

Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Otosclerosis where surgery is planned
* Air / bone gap larger than 20 dB
* Normal middle ear status

Exclusion Criteria:

* Hypersensitivity to acetylcysteine
* Deafness on the other ear
* Stapedotomy previously performed on the ear
* Pregnancy
* Asthma
The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery

We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.

Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Single missing teeth with adjacent and opposing healthy natural teeth;
2. Healthy patients;
3. Sufficient alveolar bone available for implant placement.

Exclusion Criteria:

1. Pregnancy or intention to become pregnant at any point during the study duration
2. With any systemic diseases/conditions that are contraindications to dental implant...
Alternate-Day Buprenorphine Administration. Phase VII - 8

The purpose of this study is to determine if four times a subjects daily maintenance dose will hold for 96 hours without changes in agonist and antagonist effects under open dosing conditions.


Eligibility Criteria:
Please contact site for information.
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)

1. To identify biological sex differences in baseline RV function in CTEPH
2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).

Eligibility Criteria:
Inclusion criteria

* Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42
* Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis
* Subject must have a right heart catheterization (RHC) at the time of diagnosis
* To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis

Exclusion criteria

* Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
* Any subjects \<18 years of age
* Patients diagnosed during pregnancy
* Patients without a TTE and RHC at time of diagnosis
Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have been aged 18 to 79 years, inclusive.
* Participants must have understood and executed an Informed Consent Form (ICF).
* Participants (if female) must have been willing to take a urine pregnancy test prior to the initiation and at the completion of the trial.
* Participants must have been capable of understanding and following directions.
* Participants must have been considered reliable.

Exclusion Criteria:

* Participants who were in ill health or taking medication, other than birth control, which could have influenced the purpose, integrity or outcome of the trial.
* Participants who had any visible skin disease that might have been confused with a skin reaction to the test material.
* Participants who were participating in another clinical trial at this facility or any other facility.
* Participants who were using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial.
* Participants who had a history of adverse reaction to adhesive tape, cosmetics, over-the-counter (OTC) drugs or other personal care products.
* Participants judged by the principal investigator (PI) to be inappropriate for the trial.
* Female participants who were pregnant as evidenced by a positive urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.