cyrilzakka/clinical-trials huggingface dataset:
Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files

The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.


Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy patients (ASA I or II)
2. Lower permanent molar teeth with:

Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Patients with two or more adjacent teeth requiring endodontic treatment.
4. TMJ problems, bruxism, clenching or traumatic occlusion.
5. Inability to perceive the given instructions.
6. Teeth with:

Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients

Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.


Eligibility Criteria:
Inclusion Criteria:

* aged 10 to 80
* treatment naive symptomatic PAH
* 6-MWD of 100-425 m
* resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 dyn.s.cm-5 or greater.

Exclusion Criteria:

* Patients with thromboembolic disease,
* untreated obstructive sleep apnea,
* portal hypertension,
* chronic liver disease or renal insufficiency,
* left-sided or unrepaired congenital heart disease,
* substantial obstructive (FEV1/FVC\<50% predicted) or restrictive (total lung capacity\<60% predicted) lung disease
* Patients receiving phosphodiesterase inhibitors or other prostanoids and endothelin receptor antagonists
Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms

In this study, it is planned to investigate the effect of connective tissue massage on symptom severity, autonomic functions, psychological state and quality of life in individuals with erectile dysfunction symptoms.

The most common sexual dysfunctions in men include erectile dysfunction and premature ejaculation. Erectile dysfunction (ED) is defined as the inability to achieve and maintain the penile erection necessary for sexual intercourse for at least 6 months.The prevalence of ED generally varies between 37.2%-48.6%.

There are various treatment methods used in individuals with ED symptoms. While urologists use oral phosphodiesterase-5 inhibitor drugs (such as sildenafil and vardenafil) as the first step, intracavernosal papaverine or alprostadil injections and vacuum devices may be preferred afterwards. When these treatments are inadequate, penile prostheses can be used. In addition, various physiotherapy techniques such as pelvic floor muscle training, electrical stimulation, massage and aerobic exercises are also recommended for these individuals.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 20-65 years with ED complaints for at least 6 months will be included in the study. In addition, sexually active individuals will be included in the study

Exclusion Criteria:

* Patients with diabetes and renal diseases, uncontrolled hypertension, priapism, pacemaker users, history of psychiatric or psychological illness, skin lesions/ulcer in the penis or lumbosacral region, and patients who are unable to cooperate will be excluded.
Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents

The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.


Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition present except for third molars
* No history of previous orthodontic treatment.
* Class I or II malocclusion with minimal or no lower anterior crowding (\<3 mm)
* Excessive overbite (\>3 mm).

Exclusion Criteria:

* Syndromic patients as well as individuals with skeletal asymmetry
* Endodontically treated or periodontally involved loweranterior teeth.
* Need for tooth extraction in the lower arch.
* Agenesis (except for third molars)
* Any kind of tooth/root shape anomaly
Detection of Hypovolemia Using Pleth Variability Index (PVI)

The purpose with the planned study is to study Pleth Variability Index (PVI) as a non invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects. Lower body negative pressure (LBNP), a well established technique is used to create defined levels of hypovolemia.

Primary hypothesis: By applying a breathing resistance (positive end expiratory pressure PEEP) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter signal (PVI) is enhanced and enables PVI to detect and grade the level of mild hypovolemia.

Secondary hypothesis: 1) When tidal volume is increased, the respiratory synchronous variation in the pulse oximeter signal (PVI) will also increase. 2) The earlobe is superior to the finger in detecting PVI 3) Hemoglobin (Hb), detected non invasively by pulse oximetry, is not affected by hypovolemia created by LBNP

The subjects are placed supine on a bed. Non invasive equipment for recording pulse and blood pressure is placed on a finger on the right hand. From this equipment total peripheral resistance and cardiac output are recorded. A pulse oximeter for saturation, perfusion index and PVI is placed on a finger and on the ear lobe. Data are recorded in parallel from the finger and the ear lobe. In addition non invasive haemoglobin (Hb) is recorded from the pulse oximeter on the finger. The subjects breathe through a mask connected to a simple Y-connector with an inspiratory valve on one side and an expiratory valve on the other. A positive pressure valve is applied on the expiratory side. Tidal volume is measured on-line by a connector connected to a spirometer and the tidal volume is displayed to the subjects. Stroke volume, total peripheral resistance and cardiac output is measured using ultra sound via the jugular fossa.

Baseline data are recorded with the subjects in the supine position breathing with normal tidal volume without PEEP and without LBNP applied. Data are then recorded with LBNP applied in two steps (40 and 15 mmHg). Recordings are continued 5 minutes after releasing the negative pressure. Data are collected in total in four different series; normal tidal volume without PEEP; normal tidal volume with PEEP 5cm H2O; three doubled tidal volume without PEEP; three doubled tidal volume with PEEP 5 cm H20. Respiratory rate is not controlled. The order of the four series is randomized. Between the series a 20 minute period of rest is allowed to the subjects. This period is also necessary to restore steady state between provocations.

Eligibility Criteria:
Inclusion Criteria:

* Subjects without any heart or lung disease

Exclusion Criteria:

* Smoking
* Drugs affecting circulatory or respiratory system
A Just-in-Time Adaptive Intervention for Child and Family Mental Health

The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.

The following study tests the efficacy of an app-based program designed to improve child and family mental health and well-being. The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app, as well as a just-in-time adaptive intervention (JITAI) component where AI analysis for family interactions will be used to provide real-time, dynamic feedback to families. Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention. The study will assess caregiver and child functioning in a variety of domains, such as mental health symptoms, attachment style, and family conflict through a series of baseline and follow-up questionnaires. Caregivers may use their own smartphones, or they will be lent smartphones for the study. Caregivers and children will also be lent Fitbits/Apple Watches. The intervention will last 8 weeks. Data will include daily surveys, daily audio recordings, 15-minute surveys every 2 weeks about their experiences using the app, bi-weekly check-ins, psychoeducational modules, homework activities, JITAI sessions, and passively sensed data. The intervention will be administered through the smartphone app and will include daily 5-15-minute psychoeducation modules and practice sessions and daily JITAI sessions.

Eligibility Criteria:
Inclusion criteria:

* A family income less than or equal to the 33rd percentile for their county of residence OR
* At least one participating family member identifies as belonging to an ethnic/racial minoritized group AND
* Child mental health symptoms at or above the 70th percentile based on any subscale of the Strengths and Difficulties Questionnaire AND
* Participants speak English and/or Spanish AND
* Have a child 6-9 years old at the time of enrollment AND
* Families must be located in Texas or Florida

Exclusion Criteria:

* Active suicidal ideation OR
* Active homicidal ideation OR
* Current child abuse OR
* Current violence in the home

Families meeting these exclusion criteria will undergo a clinical risk assessment and be referred for alternative treatment services.
Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* BMI:19-24 kg/m2, weight \> 50 kg.
* Age:18-45

Exclusion Criteria:

* History of clinically significant laboratory results or disease.
* History of alcohol or drug abuse.
Early Multimodal Therapy and Mechanical Ventilation

To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.

This study compares the impact of early multimodal therapy on mechanical ventilation duration in ICU patients. It is an open-label, randomized controlled clinical trial. Patients will be assigned to either early multimodal therapy or standard therapy (control) in a 1:1 ratio. Blinding is not possible due to the study design. The analysis will follow an intention-to-treat approach. The hypothesis is that early multimodal therapy reduces mechanical ventilation duration

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria are as follows:

Patients hospitalized in the adult intensive care unit of the Fundación Santa Fe de Bogotá.

Requirement of invasive mechanical ventilation through an endotracheal tube for a period exceeding 72 hours with an expected continuation of at least 24 hours.

Barthel Index equal to or greater than 70

Exclusion Criteria:

Exclusion criteria:

* Patients requiring invasive mechanical ventilation through a tracheostomy tube or nasotracheal tube.
* Patients who have undergone any type of head and neck surgery.
* Cardiac arrest.
* Airway burn.
* Burns with an extent greater than 50% of the body surface area.
* Patients with chronic obstructive pulmonary disease.
* Patients referred from another institution.
* Demyelinating or neuromuscular junction diseases.
* Patients requiring neuromuscular blockade.
* Patients with a life expectancy of less than 180 days.
* Patients deemed by medical criteria not to benefit from multimodal treatment.
* Patients not entering the ICU for the first time.
* Patients participating in other clinical rehabilitation trials
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures

There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution.

While advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined.

The primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip fracture fixation with a Gamma Nail by one of four orthopaedic trauma surgeons at William Beaumont Hospital Royal Oak
* Diagnosis of an intertrochanteric femur fracture (AO Classification 31-A1,A2)
* Low energy mechanism of injury (i.e. fall, twist)

Exclusion Criteria:

* Minors (less than 18 years)
* Pregnant
* Have a high energy mechanism of injury (e.g. motor vehicle accident, fall from height)
* Have an open fracture (i.e. the skin is broken at the fracture site), or
* Present with multiple injuries to the ipsilateral lower extremity
Structured Information During the Intensive Care Unit Stay

The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.

The trial is designed as a prospective multicenter randomized controlled trial including an intervention and a control group. The control group receives an unspecific conversation. The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU. Anxiety will be measured with a VAS during ICU stay and with a questionnaire after ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Elective open heart or abdominal surgery including scheduled ICU stay
* Heart or abdominal surgery or internal patients with non-scheduled ICU stay
* Informed consent

Exclusion Criteria:

* Reduced sensual perception
* Cognitive impairment
* Not able to answer a questionnaire (e.g. illiterate)
* Lying in the same room with another patient already included
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO

The research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). The question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 4 years;
* Weight ≥ 11 kg;
* with ongoing symptoms compatible with a clinical diagnosis of leptospirosis.
* AND having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by Polymerase Chain Reaction (PCR) (blood or urine) or, failing that, serology indicating a recent infection (positive Immunoglobulin M (IgM) or Microscopic Agglutination Test (MAT) technique with titer \>1/400 for a pathogenic serogroup)
* AND affiliated to a Social Security scheme

Exclusion Criteria:

* Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).
* Not affiliated with social security
* Immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease
* Patient under legal protection (Guardianship, Curators)
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795

The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.


Eligibility Criteria:
Inclusion Criteria:

* Participants with certain genetic predisposition to non-alcoholic fatty liver disease (NAFLD) determined at screening
* Presence of liver steatosis at screening
* Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening
* Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its excipients
* History of hepatitis B surface antigen (HbsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Biomarkers Correlation With Volemia

The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.


Eligibility Criteria:
Inclusion Criteria:

* 20 Cerebral Hemorrhage
* 20 Head Injury
* 20 post surgery non traumatic non neuro
* 20 Polytrauma patients

Exclusion Criteria:

* Heart failure NYHA III or IV
* Renal insufficiency creatinin clearance \< 30 ml/mn
* age \< 18 Y
* Pregnancy
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.

For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 16 years or older on the day of the first vaccination
* No history of hepatitis A or having hepatitis A vaccination
* Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
* Determined by the investigator to be able to be followed up during the study period

Exclusion Criteria:

* A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
* Positive hepatitis type B antigen at the time of screening
* The following blood test results at the time of screening

  * ALT: More than 1.5 times the upper limit of normal
  * AST: More than 1.5 times the upper limit of normal
  * Total bilirubin: More than 1.5 times the upper limit of normal
* Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination
* Moderate to severe acute or chronic infectious disease on the day of vaccination
* History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
* Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
* Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
* uncontrolled epilepsy or neurological disorders
* Administered with other vaccine within 4 weeks prior to the screening
* Planned with other vaccine within 4 weeks after the vaccination date
* Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
* Participated in another clinical study within 12 weeks prior to the screening, or currently participating
* Pregnant women or breast-feeding women
* Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study