cyrilzakka/clinical-trials huggingface dataset:
Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.

Literature reveals that there occurs masticatory dysfunction in patients with Stage III and IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state.

Patients of Stage III and Stage IV Periodontitis with the following criteria will be included :

1. Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.

Exclusion Criteria: Patients with

1. Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
2. Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
3. History of periodontal treatment within the 6 months
4. Patients wearing orthodontic appliances
5. Diagnosed psychiatric disorder
6. History of antibiotic use within the previous 3 months
7. History of use of Steroid, immunosuppressive and psychiatric drugs
8. Pregnant and lactating women
9. Smoking or substance abuse
10. History of Menopause

Periodontal clinical parameters:

Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum.

The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory performance and psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
* Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.

Exclusion Criteria:

* Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
* Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
* Periodontal treatment within the 6 months
* Patients wearing orthodontic appliances
* Any diagnosed psychiatric disorder
* Antibiotic use within the previous 3 months
* Steroid, immunosuppressive and psychiatric drug use
* Pregnant and lactating women
* History of menopause
* Smoking or substance abuse
REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE)

The RECONNECTIVE Registry is an observational single center study, focused on the subgroup of precapillary pulmonary hypertension related to connective tissue diseases. All patients will have hemodynamic confirmation by right heart catheterization and will be follow-up for at least 5 years from admission. All patients diagnosed with Group I Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) and Group IV Pulmonary Hypertension (PH) with CTD will be included. The purpose of the registry is to learn and understand the clinical outcomes and natural history of the pulmonary arterial hypertension in this subgroup of patients to improve the medical care and treatment.

Connective tissue diseases represents an important risk factor for pulmonary hypertension, either due to vasculopathy or chronic pulmonary thromboembolism. These chronic conditions are characterized by being disabling, progressive and fatal in a short time and are caused by multiple mechanisms that results in remodeling of the pulmonary microvasculature and right heart failure.

In recent years, due to international registries, we have acquired a better understanding of high-risk subpopulations, their poor prognostic factors, and the results of specific combination therapies. In Mexico, the National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) is a referral center for connective tissue diseases and pathologies of the pulmonary circulation. The RECONNECTIVE registry is a five years follow-up cohort that offers the possibility to obtain data regarding to the clinical characteristics and hemodynamic assesment of pulmonary circulation. The main objective is to evaluate the clinical course of the PAH in this subgroup of patients and their specific therapy for PAH.

Eligibility Criteria:
Inclusion Criteria:

* Incident and prevalent patients diagnosed with Group I associated with Connective Tissue Diseases (CTD)
* Incident and prevalent patients diagnosed with Group IV Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) with evidence of a chronic thromboembolic pulmonary disease by ventilation/perfusion pulmonary gammagraph or computed tomography pulmonary angiogram with at least three months of total anticoagulation therapy.
* Patient diagnosed with a connective tissue disease according to the classification criteria of the American College of Rheumatology.
* Precapillary pulmonary hypertension confirmed by right heart catheterization (RHC): Mean pulmonary arterial pressure (mPAP) \>20 mm Hg with a pulmonary arterial wedge pressure ≤ 15 mm Hg and Pulmonary vascular resistance (PVR) ≥ 2.0 Wood units

Exclusion Criteria:

* Patients who meet the criteria for another group of pulmonary hypertension (Groups II, III or V).
Capnography in the Post-Anesthesia Care Unit (PACU)

To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are heralding respiratory difficulties before desaturation measured from capnography in obstructive sleep apnea patients, with the use of nasal prongs, transcutaneous monitors, Capnostream, and Massimo technologies.

Background and Significance Carbon dioxide (CO2) levels can be monitored throughout the respiratory cycle via capnography. In this way, capnography allows healthcare professionals to follow a number of respiratory factors (i.e., depression, apnea, and hypercapnia) in real-time. Earlier detection of alterations to ventilation status will better enable providers to more accurately dose medications during procedures, especially in at-risk patient populations such as patients with obstructive sleep apnea (OSA) \[1, 2\].

In a recent study of bariatric patients, approximately 15% experience postoperative pulmonary complications. These patients could benefit significantly from capnography monitoring as this measure can very accurately estimate the prevalence of respiratory complications.

Through this study we seek to understand how end-tidal CO2 (ETCO2) levels of patients with obstructive sleep apnea vary when patients are in the post-anesthesia care unit (PACU). By collecting information on patient outcomes, we hope to better understand the value of this monitoring technique in an at-risk patient population. Though capnography in the PACU has not previously been demonstrated to improve patient safety or satisfaction, capnography has never been studied in a population of patients who are at risk of obstructive sleep apnea.

Study Design This is a prospective, blinded observational pilot study to monitor if changes in end-tidal CO2 levels provide incremental value over pulse oximetry when detecting respiratory difficulties (i.e., hypercapnia).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Patients who have are at TGH for bariatric surgery
* BMI \> 30
* At risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire

Exclusion Criteria:

* \<18 years of age
* Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire
Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise

Qigong exercise is beneficial for older adults with co-occurring chronic physical illness and depression in terms of psychological and physical outcomes. However, the effects on functional independence, sleep quality, and mobility of depressive older adults remain unclear. It is also important to replicate its benefits for subjective well-being and muscle strength. A randomized clinical trial was conducted among older adults who were aged 60 or above and with chronic medical conditions for one year. After random assignment, intervention group (n = 25) went through qigong exercise twice a week and for 12 weeks,whereas control group (n = 22) was involved in cognitive training activities with mobilization elements. The psychosocial and physical outcomes of the two groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 or above
* have been suffering from chronic medical conditions for more than one year
* have depressive symptoms as indicated by Geriatric Depression Scale (GDS ≥ 6)

Exclusion Criteria:

* have practiced or received training of any form of mind-body exercises (including tai chi, yoga, and qigong) during the 6 months prior to intervention.
* have changed medication or the dosage prior to or during intervention
* have obvious cognitive and language impairment or score less than 20 in Mini-Mental State Examination (MMSE)
* undergo electroconvulsive therapy, psychotherapy, or psychoeducation
* cannot demonstrate satisfactory sitting balance
Hydration Dynamics and Influence of Beverage Composition

The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.

Using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. Comparisons will be made between beverages for indices of the rate of appearance of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster absorption (D2O appearance rate), and better overall hydration (expanded PV and higher modified BHI) will occur for beverages containing glucose and sodium compared to water. Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.

Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of 18.5 to 29.9 kg/m2.
* Be normotensive (\<120/80 mm Hg).
* Must be able to speak and read English.
* Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial.
* Fast for at least 8 hours prior to and through the study trial.
* Be able to abstain from alcohol for 48 h prior to each study.
* Be able to abstain from caffeine for 24 h prior to each study.
* If female, must have regular menstrual cycles, that are \> 27 days and \< 35 days in length.

Exclusion Criteria:

* Under 18 y of age or over 45 y of age.
* Have a BMI \<18.5 or \>30.
* Being pregnant.
* Lactating.
* Tobacco user.
* Have hypotension or hypertension.
* Have any type of kidney disease or dysfunction.
* Have diabetes.
* Have any type of cardiovascular disease.
* Have been diagnosed with galactosemia.
* Females with irregular menstrual cycles.
* Females with polycystic ovary disease.
Differential Adaptation of Renal Function in Intense Physical Exercise

In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. The injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise.

Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury.

The aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Able to understand the objectives of the study and to provide informed consent.
* Body mass index between 18.5 and 24.9 kg / m2
* Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).

Exclusion Criteria:

* History of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or HbA1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease.
* Use of NSAIDs in the 72h prior to the test.
* Consumption of statins or anabolic steroids.
* Some kind of major physical injury in the four months prior to the tests.
The Effect of Resilience Psychoeducation Program Based on Positive Psychotherapy on Nurses

The Effect of Resilience Psychoeducation Program Based on Positive Psychotherapy on Nurses

Based on the principles of positive psychology, Positive Psychotherapy integrates symptoms with strengths, resources with risks, weaknesses with values, and hopes with regret to understand the natural complexities of human experiences in a balanced way. This includes cognitive restructuring of the individual, reviewing expectations, and acquiring new goals.

Resilience is a person's process of adapting, resilience, or the ability to successfully cope with change/disaster against major stressors such as a trauma, a threat, a tragedy, or familial and relational distress, serious health problems, workplace and financial problems. It is stated that people with high psychological resilience are more successful in adapting to change and struggling against obstacles, and people with high psychological resilience experience less emotional exhaustion.10 Possible risky situations that individuals encounter in their work life and the protective factors they have also affect their psychological resilience. It is also stated that psychological resilience is an important concept for nurses who are faced with many risk factors, especially in business life, and who have to provide professional care to patients who are in difficult situations and in need, and who have to comfort the patient.1 The effectiveness of developing and strengthening psychological resilience in coping with the stressful environment of nursing has been proven. It is stated that among the coping resources of nurses, adequate rest, self-care and social support are of great importance and that these resources are positively related to the quality of life.

The aim of this research is to determine the effect of the Psychological Resilience Psychoeducation Program Based on Positive Psychotherapy on the resilience of nurses and to determine their balanced life skills.

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse at Düzce University Health Application and Research Center
* Individuals who voluntarily agree to participate in the research will be included.

Exclusion Criteria:

* The acute phase of a psychiatric illness
Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain

Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.

Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects.

The present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical low back pain

Exclusion Criteria:

* Under 18 years old
* Over 65 years old
* Pain less than 40 mm in visual analogue scale
* Allergy to the study drug
* Drug or alcohol addiction
* Pregnancy and lactation
CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.

The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea.

Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for and treated with the study drug according to the approved label in South Korea
* Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative.

Exclusion Criteria:

* Participation in any interventional trial during the treatment of the study drug
* Other off-label indications according to the approved label in South Korea
Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.

120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre.

Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
* Use of subarachnoid anesthesia with lidocaine

Exclusion Criteria:

* Allergy or Hypersensitivity to lidocaine or other local anesthesics.
* Patients not accepting subarachnoid anesthesia
* Patients with general anesthesia
* Hypersensitivity or contraindication to acetylsalicylic acid.
* History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use
* Active or relapsing peptic ulcer/gastrointestinal hemorrhage
* Serious heart failure.
* Active Crohn disease
* Active ulcerative colitis
* Moderate or sever renal failure
* Severe liver disfunction
* Coagulation disorders requiring treatment with anticoagulant drugs
* Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases
* Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids
* Pregnancy
Resistance Training and Sex Hormone Concentrations During the Menstrual Cycle

Although there are numerous studies showing effects of aerobic training on sex hormone concentrations, research analyzing the fluctuation of sex hormones in response to resistance training (RT) is lacking. The objective of this project is to analyze estradiol (E2) and progesterone (P4) responses to an acute resistance training session throughout different phases of the menstrual cycle. This proposed research has strong implications for exercise prescription and for women in general, but more importantly will allow exercise physiologists, coaches, personal trainers, or nutritionists optimize exercise programming around women's menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* Eumenorrheic females
* Age 18-45 years old
* BMI of 18.5-34.99 kg/m2

Exclusion Criteria:

* Practice exercise more than 2 days/week in the last 3 months.
* Cardiovascular, metabolic, pulmonary or muscular-skeletal condition
* Taking medications that affect metabolism (e.g. oral contraceptives)
* Irregular menstrual cycles