cyrilzakka/clinical-trials huggingface dataset:
The Effect of Stress on the Residual Gastric Volume

In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.

In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
* American Society of Anesthesiologists physical status classification 1, 2, and 3
* Body mass index \< 35 kg/cm2
* Patients administered carbohydrate-containing fluid 2 hours prior to surgery

Exclusion Criteria:

* Previous surgery of the upper gastrointestinal tract
* Achalasia
* Diabetes
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.


Eligibility Criteria:
Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick test

Main Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
* Use of any prohibited concomitant medications as defined by the study protocol
Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and isotretinoin. Sebum overproduction is fundamental to the pathogenesis of acne with associated disordered keratinization and subsequent microbial colonization and inflammation resulting in the clinical manifestations of acne. Given the influence of hormones on sebum production, therapies that address these underlying hormonal factors such as spironolactone and oral contraceptive pills represent an underutilized treatment option for women with acne and could help decrease the use of long-term oral antibiotics in this patient population. The purpose of this trial is to evaluate the comparative effectiveness of spironolactone versus doxycycline hyclate (tetracycline class antibiotic) for women with acne.


Eligibility Criteria:
Inclusion Criteria:

* Female sex assigned at birth
* Age 16-40 years old
* Acne defined as at least 10 inflammatory papules or pustules and an Investigator's Global Assessment (IGA) score of at least 2 as measured by the Comprehensive Acne Severity Scale
* Not currently pregnant or planning to become pregnant

Exclusion Criteria:

* Pregnancy
* Heart disease
* Renal disease
* Liver disease
* Orthostatic hypotension
* Addison's disease
* History of hyperkalemia
* Allergy to tetracycline-class antibiotic
* Allergy to spironolactone
* Concomitant use of medications known to interact with spironolactone or doxycycline or that may increase the risk for hyperkalemia, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, eplerenone, nonsteroidal anti-inflammatory drugs, and digoxin.
* Treatment with spironolactone, an oral antibiotic, laser, photodynamic therapy, or chemical peel within the past 4 weeks
* Treatment with isotretinoin within the past 3 months
* Sebacia laser treatment within the past 12 months
Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility

Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). Women with confirmed idiopathic infertility, in whom infertility factors have been excluded during full diagnostics, will be included in the study


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45
2. No pregnancy for a minimum of 12 months prior to screening.
3. Diagnosed with idiopathic infertility.
4. No use of hormone therapy 30 days before screening.
5. No use of any methods of contraception 30 days before screening and during the examination.
6. BMI between 18.5 - 30 kg/m2.

Exclusion Criteria:

1. Positive pregnancy test result.
2. Patients diagnosed with another factor of infertility.
3. Patients with type I or II diabetes.
4. Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks before screening.
5. Patients with hepatic impairment and abnormal liver function tests (alanine aminotransferase and/or aspartate aminotransferase (above 3x ULN).
6. Patients with an eGFR less than 45 mL/min/1.73m2.
7. Accompanying chronic diseases with poor prognosis.
8. Patients with a history of lactic acidosis or other metabolic acidosis.
9. Patients with a history of congestive heart failure III/IV NYHA degree.
10. Patients with acute myocardial ischemia.
11. Patients with sepsis or severe infection.
12. Diseases which, in the opinion of the investigator, constitute an exclusion criterion and prevent the patient from participating in the study.
13. Patients with predictable problems with cooperation with the research team.
Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women

The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.

The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. Preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the intervention for delivery in India, clinic nurses will be trained to deliver the intervention, and the feasibility, fidelity and preliminary efficacy of the novel application of the intervention will be evaluated in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ women starting ART
* Willing to be contacted by mobile phone
* Speaks English or Hindi or Kannada
* Screens positive for depressive symptoms or psychosocial risk factors
* Able to provide informed consent

Exclusion Criteria:

* Unable to participate in study visits
* Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate
The Efficacy of the Caregiver Psychoeducational Consultation Program

Aim:

To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.

This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.

To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.

This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.

Eligibility Criteria:
Inclusion Criteria:

* Spouse caregivers of patients with resectable colorectal cancer,
* Those who are willing to participate in the research,
* Aged above 18.

Exclusion Criteria:

* Who refuses to participate in this study.
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study

Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial

Assessment of the discontinuation rate of tamsulosin and tadalafil after 12 months follow up either and evaluate the changes in urinary parameters and sexual parameters in patients with lower urinary tract symptoms due to BPH concomitant with erectile dysfunction. We tried to overcome the limitations of the previous studies by designing a prospective randomized controlled trial as the present study is the first randomized controlled trial that evaluate the safety, discontinuation rate and efficacy of tadalafil compared with tamsulosin for long term follow up (12 months).

Eligibility Criteria:
Inclusion Criteria:

* patients with Lower Urinary Tract Symptoms
* married and sexually active
* age more than 50 years
* IPSS more than 12
* Q max less than 15 ml/s
* Post voiding residual less than 150 ml

Exclusion Criteria:

* prostatic adenocarcinoma
* cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
* vesical stones
* active Urinary Tract Infection
* patient refused participation in the study
Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes

Seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. Healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. The athletes were randomly assigned to vaccination within 2 hours after the last training session ("2h") vs. vaccination after a resting period of at least 26 hours ("26h"). All participants documented side effects and training restrictions. Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.


Eligibility Criteria:
Inclusion Criteria:

* performance-oriented training on at least five days a week, healthy athletes

Exclusion Criteria:

* current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases
Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer.

Exclusion Criteria:

* Subjects less than 18 years of age
* Subjects unable to give informed consent
Metabolic Responses to Breakfast in Adolescent Girls

Breakfast consumption (BC) is frequently associated with a healthy lifestyle, healthy body weight and favourable cardiometabolic health. Research from studies in adults suggests that breakfast skipping causes elevated plasma glucose and insulin concentrations after lunch. However, there is currently no evidence to suggest a similar metabolic response in adolescent girls, a population that frequently skips breakfast. The primary purpose of this study is to examine the effects of BC versus breakfast omission (BO) on metabolic responses after lunch in healthy adolescent girls.

Breakfast consumption (BC) is habitually associated with a healthy lifestyle (e.g., diet and physical activity), reduced adiposity and favourable cardiometabolic health profiles in children, adolescents and adults. Experimental research in adults has shown that breakfast consumption reduces the glycaemic and insulinemic response to lunch when compared with breakfast omission; this has been termed 'the second meal effect'. Further, breakfast consumption may improve exercise performance and increase free-living physical activity energy expenditure in adults. Understanding the postprandial metabolic responses to BC and breakfast omission (BO) in adolescent girls is particularly important, as this population frequently skips breakfast and have low physical activity levels. Yet, adolescent girls may respond differently to adults due to their distinct metabolic profiles, and past research has not targeted this population. The primary aim of this research is to examine whether BC versus BO affects postprandial glycaemic and insulinemic responses to lunch in adolescent girls. Secondly, it aims to examine the lipaemic and substrate oxidation responses during rest, substrate oxidation during an exercise bout performed later in the day, and physical activity enjoyment during the exercise bout.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 11 to 14 years old
2. Female
3. Healthy weight Body Mass Index centile (between the 3rd and 91st centile - Cole et al 2000)

Exclusion Criteria:

1. Allergies to the breakfast and lunch ingredients
2. Fitted with a pacemaker
3. Unable to walk
4. Health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride

The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).

Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.

This study will Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia.

Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18 and 75;
2. Weighs between 40 \~ 100 kg, and BMI ≥ 18 kg/m2;
3. Must have a clinical diagnosis of CAP
4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates
5. Patients with PORT/PSI score II, III or IV.
6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
7. The patient is able to receive an intravenous infusion of the drug .

Exclusion Criteria:

1. Patients with PORT/PSI score I or VI.
2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
3. Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease \[COPD\] is not exclusionary)
4. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
5. Potassium is \< 3.5 mmol/L
6. Any known disease that seriously affect the immune system
7. Active hepatitis or decompensated cirrhosis;
8. Have used quinolones or fluoroquinolones within 14 days before enrollment
9. Patients who are being or will be on a long-term medication of steroids
Global Posture Reeducation (GPR) Compared To Isostretching in Chronic Low Back Pain Patients

The aim of this study was to investigate the changes in posture, flexibility, muscle strength, functional capacity, heart rate(HR), peripheral oxygen saturation, systolic blood pressure, diastolic blood pressure and intensity of pain in chronic low back pain underwent to Isostretching and GPR.

It was selected 40 patients, from 40 to 59 years old, with chronic low back pain from CESUMAR Physiotherapy Clinic-Schoo. These were evaluated before and after treatment regarding posture by SAPO computer program; flexibility for lumbar Schober testing, sit and reach; muscle strength by dynamometry for trunk extensors and the maximum repetition test in a minute to abdominal and trunk extensors; functional capacity by Rolland-Morris Questionnaire; pain by visual analog scale; heart rate(HR) by polar frequencymetric; peripheral oxygen saturation by Finger Pulse Oximeter; and systolic and diastolic blood pressure with a Sphygmomanometer. The sample was divided in two groups (1-GPR with 11 patients, 2-Isostretching with 10 patients). All patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week. It was considered statistically significant p values \<0.05 obtained from the Student's t test.

Eligibility Criteria:
Inclusion Criteria:

* patients with non-specific LBP in its chronic phase (pain lasting more than 12 weeks), from 40 to 60 years old.

Exclusion Criteria:

* scheduling conflicts
* lack of transportation
* disease that compromises their health during the treatment
* uncontrolled hypertension
* fibromyalgia
* history of spinal surgery in the last six months
* patients with neurological diseases
* individuals who demonstrate inability to understand or physical restraint for the exercises.