cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome

Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic parameters during the night : heart rate, arterial blood pressure, cardiac output. This is due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to frequent micro-arousals. These disorders have several consequences : hypertension, NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance and other cardiovascular impairments.

Objective of the study is to characterize the cardiovascular phenotype of patients with obstructive sleep apnea syndrome, relative to the presence of hypertension or not. Hypertension should not have been previously treated. 2 groups of apneic patients (SAS+HTA+ and SAS+HTA-) will be compared together, referred to group of non apneic but hypertensive patients (SAS-HTA+) and non apneic / non hypertensive patients (SAS-HTA-).

Apneic and hypertensive patients may have a sympathetic nervous system activation and a much more important vascular and baroreceptor reflex impairment, than non apneic but hypertensive patients.

During the study, a second visit as control will be done for apneic patients only, 3 to 6 months after SAS treatment setting.

Eligibility Criteria:
Inclusion Criteria:

* patients with or without obstructive sleep apnea syndrome (AHI \> 15)
* patients with or without hypertension

Exclusion Criteria:

* known or expected secondary hypertension
* pathologies with consequences on arterial blood pressure regulation: Parkinson's disease, patients with renal or cardiac graft, severe heart failure
* drugs with consequences on arterial blood pressure regulation : vasoconstrictors, vasodilatators, béta-agonists, antagonists, nitrites, theophylline, dipyridamol, sildenafil, immunosuppressors, IMAO, neuroleptics, tricyclic antidepressants, corticoids or long-term oral (\>10 days) non steroidal anti-inflammatory drugs, oestroprogestative treatments
* atrial fibrillation, frequent extrasystoles (\> or = to 10/minute)
* bedridden patients
* night shift workers
* surgical or carotid stenting history
* subjects unwilling or unable to provide written, signed and dated informed consent
* patient previously treated for obstructive sleep apnea syndrome (positive airway pressure, forward mandible prosthesis, maxillofacial surgery
Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness

The PATHway system is designed to help patients remain physically active and maintain a good cardiovascular health. It proposes a novel approach that aims to empower patients to self-manage their CVD, set within a collaborative care context with health professionals. This will be achieved via a patient-centric holistic approach that specifically addresses the above barriers. It involves an internet-enabled and sensor-based home exercise platform. It is represented by several modules with an exercise module as the core component which will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general.

The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle and health related physical fitness and cost-effectiveness of the PATHway intervention in patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* Men and women with documented CVD
* age 40-80 yrs
* patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
* patients must have completed the ambulatory CR program and received clinical approval from their treating physician to continue exercising outside the hospital program
* internet access at home

Exclusion Criteria:

* significant illness during the last 6 weeks
* known severe ventricular arrhythmia with functional or prognostic significance
* significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
* cardiac disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
* co-morbidity that may significantly influence one-year prognosis
* functional or mental disability that may limit exercise
* acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
* GFR \<25ml/min/1.73m2
* hemoglobin \< 10g/dl
* severe chronic obstructive pulmonary disease (FEV1 \< 50%)
* NYHA class 4
* participation in another clinical trial
Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.

Study groups:

Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cesarean section under spinal anesthesia.
* age : (20-45) years old.
* American Society of Anesthesia (ASA) physical status I, II.

Exclusion Criteria:

* Patient refusal.
* Contraindication to spinal anesthesia.
* BMI \> 35 kg/m².
* Impaired renal, hepatic and cardiac function.
* Thyroid disease.
* Body temperature \>38 °C or \< 36.5 °C.
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.


Eligibility Criteria:
Inclusion Criteria:

* supported on ECMO
* receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management

Exclusion Criteria:

-none
Confirmation Bias Towards Treatments of Depressive Disorders in Social Tagging

The study examines whether people primarily want to confirm their prior attitudes in health-related information search, in an online environment using social tags for navigation. Participants were looking for information on the treatment of depression with antidepressants and psychotherapy. They were randomly assigned to two groups with either high or low credibility of the community who provides social tags, and two groups where participants' confidence in prior attitudes was heightened or lowered, and to two groups where either antidepressant tags were more popular or psychotherapy was more popular. The investigators measured attitude change toward the treatments and also navigation behavior.

In health-related, Web-based information searches, people should select information in line with expert (vs nonexpert) information, independent of their prior attitudes and consequent confirmation bias.

This study aimed to investigate confirmation bias in mental health-related information searches, particularly (1) if high confidence worsens confirmation bias, (2) if social tags eliminate the influence of prior attitudes, and (3) if people successfully distinguish high and low source credibility.

In total, 520 participants of a representative sample of the German Web-based population were recruited via a panel company. Among them, 48.1% (250/520) participants completed the fully automated study. Participants provided prior attitudes about antidepressants and psychotherapy. The investigators manipulated (1) confidence in prior attitudes when participants searched for blog posts about the treatment of depression, (2) tag popularity -either psychotherapy or antidepressant tags were more popular, and (3) source credibility with banners indicating high or low expertise of the tagging community. The investigators measured tag and blog post selection, and treatment efficacy ratings after navigation.

Eligibility Criteria:
Inclusion Criteria:

Online Population - Internet Browser, Representative Sample of Germans with respect to age and region

Exclusion Criteria:

No Internet Browser
Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:

* What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?
* What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?
* What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?
* What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.

  1. Experimental group 1 will receive suctionings using automated robotic suctioning device.
  2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
  3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.
  4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18 years or older
* those who received a tracheostomy during their hospital stay
* those who were admitted to the hospital with a tracheostomy

Exclusion Criteria:

* none
A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain

The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.

This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm \[no pain\] to 100 mm \[worst possible pain\]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants planned to receive a tooth extraction of one mandibular impacted wisdom tooth
* Participants who require bone removal and separation of the crown at tooth extraction
* Participants whose intensity of pain associated with tooth extraction within 2 hours after tooth extraction is greater than or equal to 50.0 millimeter on the visual analog scale (VAS)
* Participants who did not undergo general anesthesia or sedation at tooth extraction
* Participants without an abnormality (including laboratory test values) corresponding to Grade 3 in the "Criteria for severity classification of adverse drug reactions" during the pretreatment observation period

Exclusion Criteria:

* Participants with conditions for which tramadol is contraindicated
* Participants with conditions for which acetaminophen is contraindicated
* Participants with history of convulsions or the possibility of convulsive seizures
* Pregnant participants or those who may be pregnant, lactating mothers, and those who wish pregnancy during the study period
* Participants with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction
Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits
* In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool.
* Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts

Exclusion Criteria:

* IBS-D
* not reporting any constipation and diarrhea criteria
* evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
* history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
* evidence of cathartic colon or history of laxative abuse

Other protocol-defined inclusion/exclusion criteria may apply.
Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.

Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV

Secondary outcomes

• Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.
Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment

Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.

Exclusion Criteria:

* Presence of a posterior vitreous detachment in the study eye
* History of vitrectomy in the study eye
* Proliferative diabetic retinopathy in the study eye
* Presence of media opacity that precludes quality examination of the vitreous and fundus.
Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer

Visualise peritoneal lesions of epithelial ovarian cancer (EOC) in both primary and interval debulking surgery by using intravascular indocyanine green (ICG) and near-infrared (NIR) light. This Trial wants to investigate whether ICG can increase the visibility of peritoneal lesions and can differentiate between peritoneal implants and fibrosis.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. At least 18 years of age.
3. Advanced stage epithelial ovarian cancer: FIGO stage IIIb, IIIc or IV. (For FIGO staging classification, please refer to Appendix 7).
4. A biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma
5. Preoperative imaging (CT and/or MRI), describing metastatic implants, as standard of care.

Exclusion Criteria:

1. Participant has a history of following diseases:

   1. Hyperthyroidism
   2. Autonomously functioning thyroid adenoma
2. Participant has an allergy or hypersensitivity for one or more of the following components:

   1. Iodine (including potassium iodine)
   2. Indocyanine green
3. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
4. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.
6. Participant has a severe renal impairment (classified as renal function\<30 ml/min/1,73m2 according to CKD-EPI).
7. Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:

   1. Danaparoid (Orgaran®)
   2. Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion.
8. Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.
9. A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.
10. Participants utilises one of the interacting drugs listed in the protocol
The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.

There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).

The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.

The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.

Immediate implants are implants inserted immediately after surgical extraction of the teeth to be replaced. Creation of an anatomically correct emergence profile is one of the most important aspects in providing an esthetically pleasing implant-supported restoration. Dentists understand the risks involved when restored prostheses are subjected to non-axial loading. It has always been recommended to direct occlusal loads as close to the long axis of the fixture as possible. However, it is known that the loading on angled abutments is mostly off-axis, which raises the concern of how angled abutments generally perform with such an unfavourable loading regimen.

There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).

The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.

The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with immediate implants in the anterior region
2. Patient with preoperative and postoperative CBCT
3. Provide informed consent.

Exclusion Criteria:

1. patients without a preoperative CBCT.
2. 2- patients without an informed consent.