cyrilzakka/clinical-trials huggingface dataset:
The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block

Generally it is accepted that infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of devitalized mandibular molars.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. Lidocaine with epinephrine is used for all injections. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. Teeth were extracted as usual. The pain felt during extraction will be compared.

It has been taught in dental curricula that using only infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. However, it is also well-known that dental implants can be inserted into mandibular posterior region using only IA.

It can be claimed that there is no difference regarding the need for anesthesia between extracting a devitalized tooth and placing an implant in the same area. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of mandibular molars that had previously undergone root canal treatment.

The study is as a prospective, randomized, and non blinded clinical trial. All procedures are carried out at Necmettin Erbakan University, Faculty of Dentistry. The inclusion criteria are: age \> 18 years, the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment. The patients allergic to local anesthetics, those with severely mobile teeth, those had severe pain due to an acute infection, and the patients using psychotropic drugs are excluded.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. An anesthetic solution containing 20 mg/mL of lidocaine and 0.0125 mg/mL of epinephrine was used in all subjects. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. The teeth will be extracted as usual. Using a visual analog scale (VAS), the pain felt during extraction will be separately recorded. Mann-Whitney U test will be used for statistical analysis. Statistical significance is defined as p\<.05.

Eligibility Criteria:
Inclusion Criteria:

* the patient is older than 18 years
* the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment

Exclusion Criteria:

* The patients allergic to local anesthetics
* Those with severely mobile teeth
* Those had severe pain due to an acute infection
* The patients using psychotropic drugs
Psoriatic Arthritis D2P Screening

The overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in patients with psoriasis. Previously developed screening questionnaires were intended for use in the setting of a doctor's office to assist providers with referral decisions. However, these screening questionnaires are infrequently used in routine practice because of limitations with time and resources. The study will aim to develop a practical screening strategy that does not require involvement from dermatologists (or other non-rheumatology providers) and can systematically reach a broad range of psoriasis patients, including patients not attending dermatology clinics. The researchers hypothesize that disseminating questionnaires directly to patients outside of a clinic setting (direct-to-patient approach) will educate patients about their PsA risk and improve early PsA diagnoses.

Electronic medical record (EMR) systems will be used to identify psoriasis patients without a PsA diagnosis. Patients will be randomized to receive a PsA screening questionnaire (intervention group) or not receive a questionnaire (control group). Rates of rheumatologic evaluations and new PsA diagnoses will be compared between the groups, using EMRs to longitudinally track outcomes.

Intervention group patients who through the completion of the PsA Screening questionnaire positively self-screen for an elevated PsA risk will either be randomly invited to directly access a rheumatology appointment or instructed to talk with their doctor about a rheumatology referral. We will compare rates of rheumatologic evaluations and new PsA diagnoses between these groups to identify the best method for accessing rheumatology appointments.

To determine if PsA patients diagnosed after receiving a screening questionnaire differ from patients diagnosed via usual care; investigators will examine disease duration, severity, and comorbidities in patients receiving and not receiving the screening questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Have an International Classification of Diseases (ICD) code diagnosis of psoriasis but without a confirmed diagnosis of Psoriatic Arthritis prior to study initiation
* Be age 18 or older
* Be geographically located within a reasonable proximity to the Rheumatology study site

Exclusion Criteria:

* Have psoriasis and a confirmed diagnosis of psoriatic arthritis made or confirmed by a rheumatologist
Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

Body Dysmorphic Disorder (BDD) affects 2.3% of the population and is characterized by excessive concerns with imagined or minor defects in physical appearance. Retrospective outcome studies suggest patients affected by BDD don't typically benefit from surgical treatments while cognitive behaviour therapy (CBT) appears to provide symptom - reducing and distress - reducing benefits. Two different 8-week online CBT approaches to assisting individuals with this disorder are compared: one approach will integrate mindfulness meditation methods (in combination with CBT) and one approach will employ CBT methods without reference to mindfulness meditation.

Body Dysmorphic Disorder (BDD) affects 2.3% of the population and is characterized by excessive concerns with imagined or minor defects in physical appearance. Retrospective outcome studies suggest patients affected by BDD typically do not benefit from surgical treatments while cognitive behaviour therapy (CBT) appears to provide symptom - reducing and distress - reducing benefits. In this study two different 8-week online CBT approaches to assist individuals with this disorder are compared: one approach will integrate mindfulness meditation methods (in combination with CBT) and one approach will employ CBT methods without reference to mindfulness meditation.

The purpose of this comparison is to ascertain whether the inclusions of the two additional intervention modalities, demonstrated effective in other studies, adds to positive outcome effects in this disorder. A primary hypothesis is that the 8 week post-intervention outcomes associated with the CBT-mindfulness approach will show significantly more benefit than the comparison group.

Eligibility Criteria:
Inclusion Criteria: On the Body Dysmorphic Disorder Questionnaire, responses indicating current BDD status; -

Exclusion Criteria: Individuals who are currently receiving weekly structured psychotherapy or who meet DSM-V criteria for severe alcohol/substance use disorder in the past 3 months or demonstrated clinically significant suicidal ideation defined as imminent intent, or attempted suicide in the past 6 months. Individuals of co-morbid diagnoses of borderline personality, schizophrenia, bipolar disorder and/or obsessive compulsive disorder are excluded.

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Increasing Patient Comfort in Palliative Radiotherapy With a Newly Developed Mattress - A Prospective Clinical Study

The goal of this research is to determine if a new radiotherapy mattress is more comfortable for patients than the standard mattress. The table of the CT scanner and the radiation machine is flat and hard. To increase comfort during the CT scan and radiation dose delivery, the investigators have recently developed a new mattress (RTComfort). This research aims to find out if the new mattress is more comfortable for patients than the standard matt and to learn how radiotherapy mattresses can be further improved.

Patients who participate in the research, will be asked to try both the standard mattress and the new mattress during the CT scan appointment. This will take about 5 minutes (one minute each). Patients will then be asked which mattress was most comfortable and if they experience any pain while lying on the mattress. Patients can choose which mattress will be used for the CT scan and treatment. Both mattresses are approved and safe for treatment. If patients participate in the research, it means the investigators will collect and use some of their (medical) data.

Patients will not have any direct benefits from participating in this research, except that they can choose which mattress they want to lie on. Additionally, participation can help us gain more knowledge to make radiotherapy treatment more comfortable. Participation in the research will not affect the treatment. Participants will receive the normal treatment and check-ups for their condition. The drawback of participating is that the investigators will ask patients to try both mattresses, which will take about 5 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 16
* Patients treated for bone metastasis in thoracic, abdominal and pelvic region
* Patients have read, understood and signed the informed consent of the COMFORT study (in Dutch).

Exclusion Criteria:

* Patients not willing or able to test two mattresses (RT-Comfort Mattress and standard thin foam matt)
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Body mass index (BMI) between 18.5 and 27.0 kg/m\^2 (both inclusive)
* Body weight between 60 and 90 kg (both inclusive)

Exclusion Criteria:

* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
* History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
* Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial
* Drug or alcohol abuse
Different Intra-abdominal Pressures and Optic Nerve Size

In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.

In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. This situation creates ischemia in the abdominal organs in the patient, decreases venous return as a result of inferior vena cava compression and leads to a decrease in cardiac output. In addition, intracranial pressure frequently increases as a result of the venous circulation being affected. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.

Eligibility Criteria:
Inclusion Criteria:

Having had major abdominal surgery

Exclusion Criteria:

1. pregnant patients
2. Patients whose bladder catheter cannot be inserted
3. Patients with diagnosed or suspected brain death
Haematologic Predictors and Clinical Outcome in Cardiac Surgery

The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective, on-pump cardiac surgery

Exclusion Criteria:

* emergent cases
* pediatric cases
* congenital surgery
* heart transplantation
Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.

The specific objectives are:

1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.

The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 70 years old.
2. BMI ranges between 27 and 40 kg/ m2.
3. Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
4. Signature of the informed consent for participation in the study.

Exclusion Criteria:

1. Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
2. Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).
3. Pregnancy and lactation.
4. Vegetarians or subjects subjected to an irregular diet.
5. Patients with severe eating disorders.
6. Patients with clinical symptoms and signs of infection in the previous month.
7. Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
8. Recent antibiotic treatment.
9. Uncontrolled alcoholism or drug abuse.
10. Rotating or nocturnal shift workers.
The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia

Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia, referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be involved in the development of IAH. A recent study indicated increased brain lactate utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to patients with NAH has been shown to attenuate counterregulatory hormone responses to and symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has, however, not been demonstrated whether the excess of lactate is actually taken up or metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic conditions or both.

This project consists of two related studies. The objective of part 1 is to investigate the effect of elevated plasma lactate levels that are sufficient to impair awareness of hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH.

Furthermore, this study aims to determine the effect of acute hypoglycemia on the inflammatory function and composition of peripheral blood mononuclear cells.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: 0-1 or \>=3
* Blood pressure: \<160/90 mmHg

Exclusion Criteria:

* Inability to provide informed consent
* Use medication other than insulin, except for oral contraceptives or stable thyroxin supplementation therapy
* Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, known liver disease, anxiety disorders or a history of panic attacks.
* Microvascular complications of T1DM: Proliferative retinopathy, Symptomatic diabetic neuropathy (including autonomic neuropathy), Nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate \<60ml/min/1.73m2
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Virtual Reality for Post Operative Pain

Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.

While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., \& Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patient with varicose vein, hernia repair or gallbladder surgery
* Patient in the acute care units, 1-3 days following surgery.
* Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.

Exclusion Criteria:

* Non-Romanian speaking patients.
* Age \> 18 years and \< 65 years.
* Patients with neoplastic pathologies.
* Patients with history of motion sickness.
* Patients with visual impairment.
* Patients with severe/profound cognitive impairments measured with Six-item Cognitive Impairment Test (6CIT).