cyrilzakka/clinical-trials huggingface dataset:
Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing

The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen; 2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST) (patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and ecchymosis. HBOT will be applied as a single pre-operative and a single post-operative treatment for patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21, 30 \& 90 days after surgery. Edema and ecchymosis will be assessed in a time series to determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to test will be that no differences in scores will exist between treatment and control at day 3, 10 \& 21 post-surgery. A secondary null hypothesis to test is the time required to change a score will be no different between the two groups.

HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients that are able to undergo surgery at the Allure Clinic are capable of undergoing exposure to HBOT, as the contraindications of HBOT are similar to eyelid surgery, with few exceptions.

Exclusion Criteria:

* The investigators will exclude active smokers and those who have quit smoking in the last 12 months, those with known lung disease, seizure disorder, congestive heart failure, known active cancer, previous treatment with specific chemotherapy agents (Doxorubicin, Bleomycin, Disulfiram, Cis-platinum, Mafenide acetate), those who cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety.
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

This observational study aims to analyze the time of correction of hyponatremia in patients within an internal medicine ward. The researchers will assess volume status using both clinical evaluation and point-of-care ultrasound. Patients will be categorized based on whether they have the same volume status determined clinically and by ultrasound or a different status between the two methods. By tracking sodium levels daily until normalization, the study will compare the time of hyponatremia correction between the two groups.

The main question it aims to answer are What is the time of correction of hyponatremia by assessing the volume status clinically or by point of care of ultrasound?.

Participants will be asked to participate in the study and they will be receive a volume status by a portable ultrasound. If they have the same volume status clinically and by point of care ultrasound they will be referred as group 1. If they have a different volume status clinically or by point of care ultrasound they will be referred as group 2.

Researchers will follow the patients by measuring the sodium levels daily until they reach normal sodium levels ( \>135mEq/L) and will compare group 1 and group 2 with a survival analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18 years
* Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18)

Exclusion Criteria:

* Patients who are critically ill with ventilatory support.
* Patients with clinical signs suggestive of hypovolemia and have a documented history of aortic insufficiency or show mitral insufficiency during POCUS (Point-of-Care Ultrasound).
Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects

The aims of this study are in four experimental sessions. The aims are:

* to characterize the excitability of the cortical pharyngeal area with pharyngeal pressure and electromyograms (EMGs), at rest, in awake healthy subjects;
* to study its facilitation by inspiration and deglutition; and
* to study its plasticity by respiration and swallowing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Pregnant women
A Comparative Clinical Study of Different Caries Removal Techniques in Pediatric Patients

The aim of this study is to evaluate the acceptance of pediatric patiens using Er: YAG laser in comparison with the conventional techniques for caries removal.

The study was carried out on 100 children between the ages of 9-12, who had class 1 occlusal caries in one of their permanent first molars. The patients were divided into two groups; conventional technical group and laser group. Rotary handpieces was used in conventional technique group, Er:YAG laser was used in the laser group for caries removal. The heart rate of each patient was measured during the caries removal procedure at 30 seconds intervals. The pain during the procedure was determined by VAS. CFSS-DS scale was used to determine the anxiety level of the patients before and after the procedure. FIS was used to determine how patients are disturbed from the smell, taste, sound, vibration and sight of the devices after the procedure. The video segments were collected from the patients during the caries removal and the procedural pain were evaluated by the FLACC scale.

Based our results, ın the laser group, the patients were found to experience less pain and discomfort compared to conventional technique according to the VAS and FLACC scores. The rate of patients with dental anxiety decreased significantly in the laser group compared with the conventional group according to CFSS-DS performed after the procedure. According to the sensory survey, the laser group had good acceptability compared to the conventional technique group in terms of vibration and sight. The laser group showed a lower percentage increase in heart rate comparsion between beginning and end of procedure. It was observed that the cavity preparation time was longer in the laser group.

Eligibility Criteria:
Inclusion Criteria:

* patients age between 9-12 years old
* Having no systemic condition and ASA 1 healty status
* Having lower permanent first molar teeth with occlusal caries (class 1)
* having no laser treatment before

Exclusion Criteria:

* having spontaneous tooth pain
* having high dental anxiety
* having no restorative treatment before
* teeth with periapical pathology, a root filling or non-vital teeth.
Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain

A randomized controlled trial of the efficacy of classification based cognitive functional physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual therapy and exercise in patients with non specific chronic low back pain.

The investigators hypothesis was that treatment targeted at the mechanism behind the problem from a multidimensional perspective would be superior to traditional treatment.

NSCLBP is widely viewed as a multifactorial biopsychosocial pain syndrome. It has been proposed by several authors that NSCLBP represents a vicious cycle associated with different combinations of maladaptive; cognitive (negative beliefs, fear avoidance behaviours, catastrophising, depression, stress, lack of pacing and coping), physical (pain provocative postures, movement patterns and pain behaviours) and lifestyle (inactivity, rest) behaviours that act to promote pain and disability. However a recent systematic review suggests that this change in paradigm and our new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. line with this shift in paradigm a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation of. with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Eligibility Criteria:
Inclusion Criteria:

* all patients with non-specific LBP for more that 8 weeks duration
* mechanical provocation of pain with postures, movement and activities
* localised pain in the area from T12 to gluteal folds
* moderate ongoing LBP with a VAS \> 2/10
* disability had to be higher than 14% on Oswestry Disability Index

Exclusion Criteria:

* sick listed for more than 4 months continuous duration
* acute exacerbation of LBP
* radicular pain with positive neural tissue provocation test
* any low limb surgery on the last 3 months
* surgery involving the lumbar spine (fusion)
* pregnancy
* psychiatric disorders - somatisation
* dominant psycho-social problems
* widespread non-specific pain disorder (no primary LBP focus)
* specific diagnoses: active rheumatologic disease, progressive neurological disease, serious cardiac or other internal medical condition, malignant basic diseases, acute traumas, infections, or acute vascular catastrophies
Study Evaluating Occupational Exposure to Antineoplastic Drugs

The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).

The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics.

The study will be proposed to all workers exposed to cytotoxic agents who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol. Participation of workers in the study is voluntary.

The control group will be recruited from administrative staff and/or individuals not exposed to chemotherapy who have an employment contract or similar arrangement and who are affiliated with the hospital facilities participating in the protocol.

A subject is considered enrolled after signing the informed consent and will be considered evaluable if:

They have completed the exposure diary (only for the exposed group). They have responded to the medical history questionnaire. They have undergone sampling of oral mucosa exfoliated cells and blood collection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Capacity to understand and consent
* Personnel with an employment contract or similar arrangement
* Ability to comply with the procedures outlined in the protocol
* Signing of the informed consent

Exclusion Criteria:

* Age \< 18 years old
* Any ongoing chemotherapy or radiation treatment for neoplasms of any kind
* Planned diagnostic exams involving radiation within three weeks following the signing of the Informed Consent
* Inability to comply with the procedures outlined in the protocol
Management of Obstructive Colon Tumors in Istanbul

The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
* Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT

Exclusion Criteria:

* Benign diseases
* Emergency surgery due to bleeding, perforation and other non-obstructive situations
* Recurrent colon tumors
* Rectal cancer
Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals with Type 2 Diabetes

Type 2 diabetes mellitus (DM2) is characterized by chronic hyperglycemia, which is a risk factor for comorbidities and death. Although conventional pharmacotherapy is effective, some individuals do not reach the glycemic targets, requiring adjuvant therapies. Taurine is a semi-essential amino acid with antioxidant and osmoregulatory properties, commonly used as a nutritional supplement. Pre-clinical studies show its effectiveness in reducing blood glucose and cholesterol, but there are no well-conducted clinical studies evaluating the effect of taurine on glycated hemoglobin. Additionally, animal models showed that taurine had a protective effect from diabetic nephropathy. The hypothesize of this study is that taurine administration improves the glycemic, lipid, inflammatory, and anthropometric parameters in DM2 individuals.

A randomized, double-blind, placebo-controlled clinical trial will be conducted at Hospital de Clínicas de Porto Alegre (HCPA), Brazil. A total of 94 participants with DM2 will be recruited and randomized on a 1:1 ratio to receive 3 g taurine as a powder for oral suspension, twice per day, for 12 weeks or packets containing placebo. Blood will be collected prior to the treatment and after 12 weeks for glycated hemoglobin, fasting glucose, insulinemia, total cholesterol and fractions, triglycerides, C-reactive protein, creatinine, urea, tumor necrosis factor-alpha (TNF-α), interleukin 1 and 6 (IL-1 and IL-6) measures. Urine will be collected at baseline and after 12 weeks for creatine, protein, and albumin measured. Anthropometric parameters and a 24-h dietary recall will be monthly investigated. Fourteen days before the end of the trial, participants will be connected to a continuous glucose monitoring system for glucose monitoring system for glucose variability evaluation. Participants will be contacted by phone weekly to report adverse effects.

Eligibility Criteria:
Inclusion criteria

* Female and male individuals, with clinical diagnosis of DM2 for at least 6 months;
* Age over 30 years;
* BMC equal to or above 18.5 kg/m2, without weight change in the last 3 months;
* HbA1c between 7.5% and 10.5%.

Exclusion criteria

* Use of herbal supplements, antioxidants, and multivitamins in the last 3 months;
* Pregnancy or lactation;
* Chronic renal failure with glomerular filtration rate calculated by MDRD \< 30 mL/h;
* Myocardial infarction in the last than 6 months
* Current neoplasia;
* Chronic use of glucocorticoids;
* Bariatric surgery.
Integrated Intervention for Substance Abusers With Depressive Disorders

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment.

Eligibility Criteria:
Inclusion Criteria:

Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included.

Exclusion Criteria:

Psychotic disorders
Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis

Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin. Although myocardial involvement is predominant, other locations are possible: the atrioventricular conduction system, coronary arteries and valve leaflets. In systematic histological analyzes, deposits of amyloidosis infiltrating the aortic valve have been reported with a frequency of up to 74% for degenerative RA. The nature of these deposits has never been established because the immunostaining carried out all remained negative, probably due to decalcification prior to cutting. Currently, these deposits are considered to be local degenerative phenomena without clinical repercussions. However, the use of bone scintigraphy has shown a high prevalence, between 14 and 16%, of ATTR cardiac amyloidosis in patients with severe RA. The diagnosis of ATTR amyloidosis has been proven histologically in a few patients. Sequencing of the TTR gene has shown that they are mainly wild forms. In fact, the prevalence of transthyretin mutations in our local cohort is 20%.

The objective of this study is to determine by proteomic analysis based on mass spectrometry, the prevalence of ATTR aortic valve amyloidosis in patients undergoing surgical valve replacement for degenerative aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Degenerative aortic stenosis
* Aortic valve replacement surgery
* Signature of the informed consent form

Exclusion Criteria:

* Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
* Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
* Pregnant women
Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery

The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* congenital cardiac surgery
* \< 6 years old
* who were required the evaluation by transesophageal echocardiography

Exclusion Criteria:

* right heart failure
* supported by more than 2 inotropic agents
* reduced kidney function
* any valvar stenosis
* moderate or severe tricuspid regurgitation
* single ventricle
Clinical on the Safety and Efficacy of Fosaprepitant Dimeglumine for Injection in the Prevention of CINV.

To evaluate the safety of Fosaprepitant Dimeglumine Injection for the prevention of nausea and vomiting caused by tumor chemotherapy drugs, analyze the characteristics of the applicable population and clinical medication of Fosaprepitant Dimeglumine, evaluate the risk factors that may affect the efficacy of drug use, and compare the clinical benefits of different drug use modes.

This is a prospective, one arm, open, non-interference, multi center, observational, real world clinical study.

Study drug: Fosaprepitant Dimeglumine for injection. White or almost white lump or powder, containing 150mg (calculated as C23H22F7N4O6P). This product is a NK-1 receptor antagonist, which is administered jointly with other antiemetic drugs. It is suitable for adult patients to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetic chemotherapy drugs (HEC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with nausea and vomiting caused by chemotherapy
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Hypersensitive to any component in this product
* Patients taking pimozide, terfenadine, astemizole and cisapride
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)

This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
* Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study

Exclusion Criteria:

* Patient must undergo CEA less than 4 weeks after entering study
* Patient has recent history of acute coronary syndrome
* Patient has has coronary artery bypass graft surgery within 30 days of study start
* Patient has thyroid disease that has not been treated for more than 6 weeks
* Patient has donated blood within 8 weeks of study start
* Patient has poorly controlled diabetes mellitis
* Patient has human immunodeficiency virus (HIV) or Hepatitis B or C
* Patient is taking warfarin or other anticoagulants
* Patient is taking hormone replacement therapy
Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells

This study aims to characterize the neurological basis of obesity and response to surgical and medical treatment by inducing adult pluripotent stem cells into neuronal cells from subjects that have demonstrated extreme response to bariatric surgery or pharmacological treatment for obesity.

The investigators will consent subjects who have achieved extreme response to either bariatric surgery or pharmacologic treatment for obesity and harvest fibroblasts from skin biopsies, which will be reprogrammed to induced pluripotent stem cells (iPSC). These iPSC's will then be differentiated into neural progenitor cells, neurons, astrocytes, and microglia to identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells of the brain.

Eligibility Criteria:
Inclusion Criteria:

* History of obesity
* Treatment with bariatric surgery
* Treatment with anti obesity medications
* Greater than 70% excess weight loss at least 6 months after surgery
* Greater than 15% weight loss on anti obesity medications

Exclusion Criteria:

* Active cancer, not including non-melanoma skin cancer
* Active eating disorder
* Use of anti obesity medications in subjects with a history of bariatric surgery
* Active complication of the upper GI tract in patients with a history of bariatric surgery
Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars

The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are:

• Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal.

Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgical correction of facial deformities involving BSSO or bimaxillary surgery with bilateral asymptomatic impacted mandibular third molars
* Age between 18 and 75 years

Exclusion Criteria:

* Fully erupted and well-functioning mandibular third molar
* Unilateral impacted mandibular third molar
* Pathology associated with the impacted mandibular third molar
* BSSO combined with genioplasty
* Previous mandibular fractures
* Present neurosensory disturbances of the inferior alveolar nerve
* Systemic bone disease or arthritis
* Physical status classification system, ASA Class III or IV, specified patients with severe systemic disease ore patients with severe systemic disease that is constant threat to life
* Failure to attend the entire observation period