cyrilzakka/clinical-trials huggingface dataset:
Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients

Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. The present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.

Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS, PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will be done. After the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. The sleep data will be scored manually for staging based on Rechtschaffen and Kales criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia
2. Aged 18-50 Yrs
3. Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months)
4. Consenting

Exclusion Criteria:

1. Any comorbid psychiatric illness
2. Significant medical or neurological illness
3. History of significant head injury, epilepsy
4. Substance use in the past 4 months excluding nicotine and caffeine
5. Presence of a primary sleep disorder
Study of the Effect of the Supine Position at Brain Velocities in Noncerebro - Injured Patient

To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years old, maximum 45 years old for men and 55 years old for women.
* surgery with supine position.

Exclusion Criteria:

* refusal to participate
* failure of measurement brain velocity
* Penthotal or de kétamine before measurment
* Cardiac or pulmonary desease
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age 18 or older
* Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion Criteria:

* Patient has another infection, other than abdominal
* Female patient is pregnant or planning to become pregnant
A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From Abdominal Aorta Surgery

Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. The patients were randomly divided into three subgroups and three various models of physiotherapy were applied. Control group has only routine physiotherapy since therapeutic group I and II have also walking exercises forward in group I and backward in group II respectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with abdominal aortic aneurysm
* Age 65-75 years
* Male sex
* Stable cardiologic status
* Absence of neurological disorders
* Non-symptomatic aneurysm - non-ruptured
* No pain complaints
* No motion system impairments

Exclusion Criteria:

* Patients with neurological disorders
* Unstable coronary heart disease symptomatic aortic aneurysm - dissecans aneurysm
* Having difficulty in locomotion
* Having contradiction for starting physical training during the first or second day after surgery
* Patients with psychiatric disease
* Lack of patient's compliance with physiotherapist; AND
* Other medical contraindications
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 years
* Veterans enrolled in a VHA facility
* Hospitalized ( 24 hours) with new HF or worsening chronic HF
* Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed)
* Able and willing to provide informed consent and perform study activities

Exclusion Criteria:

* Food allergies or intolerances that cannot be accommodated by study diet
* On dialysis or estimated glomerular filtration rate \<30 at randomization
* Serum potassium (non-hemolyzed) \>6.0 mmol/L during index hospitalization
* Heart transplant or active transplant listing
* Left ventricular assist device present or anticipated \<6 months
* Malignancy or other non-cardiac condition limiting life expectancy to \<12 months
* Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet
* Lack of space to store food for a week or equipment to prepare food
* Severe cognitive impairment (SLUMS score \<20, or \<19 if less than high school education completed)
* Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)
* Body mass index \>50 kg/m2
* Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study
Ethical Activity Profile of Nurse Managers -Testing Ethics Quarter as an Intervention

The aim of this study is:

1. to test a new ethics educational intervention for nurse mangers, Ethics Quarter (EQ) and
2. to measure the feasibility and the usability of the EQ

The detailed research questions and hypothesis of this study are as follows:

1. Is EQ effective in increasing NMs' ethics knowledge?
2. Is EQ effective in increasing NMs' influencing ethics issues?
3. Is EQ effective in increasing NMs' ethics research implementing?
4. Is EQ effective in increasing NMs' ethics problem identifying?
5. Is EQ effective in increasing NMs' ethics problem solving?

   H 1-5: It is hypothesized that participating into EQ promotes NM's ethics knowledge, influencing ethics issues, ethics research implementing, ethics problem identifying and ethics problem solving compared to comparisons.
6. What are NM's perceptions of feasibility and usability of the EQ?

The ultimate goal is to strengthen nurse managers' ethical activity profile and create a new, modern way to promote ethical management of nursing.

A new educational intervention, EQ, for nurse managers has developed. Intervention development has evaluated by using criteria for complex interventions in health care (CReDECI)- guideline (Möhler et al. 2012). EQ intervention is based on distance learning method and it consists of 12 educational packages included in the virtual learning environment www.etiikanvartti.fi.

Effectiveness of EQ intervention will be tested by using an individually randomized controlled trial with baseline-, post- and follow-up-measurements.The intervention group will participate in the educational EQ intervention and the control group will not participate.

Data will be collected via the membership register of the Union of Health and Social Care Professionals in Finland (Tehy) trade union. This union is a national interest group for nurses, nurse managers and advanced consultants/specialists in the social and health-care sector having a Master's degree (nursing science or related) or registered nurses degree.

Based on statistical power analysis, the required sample size for the study will be 87 NMs at both groups, at 80%, 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse manager
* Finnish-speaking

Exclusion Criteria:

* Unwilling to provide consent
Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers 45-75 years of age
* Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
* Physically able to participate in the BDJ and stretching control education programs
* Willing to complete the 12-week study
* Can participate in MRI scan
* Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures

Exclusion Criteria:

* Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
* Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
* Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
* Patient Mini-Mental Status Examination score below 24 \[293\]
* Unable to walk without a cane or other assistive device
* The intent to undergo surgery during the time of involvement in the study
* Plan to permanently relocate from the region during the trial period
Study of the Neurobiology of Tourette Syndrome and Related Disorders

OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.

II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies.

III. Establish the neurochemical and neuropeptide profile associated with the range of expression of the putative Tourette gene expression in adult and adolescent patients.

PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and a semi-structured interview. Patients then receive a comprehensive assessment of systemic disease. Patients and first-degree family members also participate in a genetic study.

Any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnostic and Statistical Manual of Mental Disorders IV lifetime diagnosis of 1 or more of the following:

* Tourette syndrome (TS)
* Obsessive compulsive disorder
* Chronic tics

Severely affected adolescents with a score of 3 or greater on the TS-Clinical Global Impression Scale eligible

--Prior/Concurrent Therapy--

At least 1 month since any medication

--Patient Characteristics--

Other:

* In good physical health
* No alcohol or substance abuse
* No Intelligence Quotient below 80
* Negative pregnancy test required of fertile women
Natural Cycle, Minimal Stimulation and Conventional IVF: a Registry-based Study

International prospective registry-based study of different types of In Vitro Fertilisation (IVF) and their outcome.

One year of prospective collection of descriptive In-Vitro-Fertilisation data. The data will be collected in 13 In-Vitro-Fertilisation-centres

Eligibility Criteria:
Inclusion criteria: In Vitro Fertilisation and signed informed consent

Exclusion criteria:

* Medical freezing
* Social freezing
* thawed cycles
Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions

The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* aortic dissection type A

Exclusion Criteria:

* age limits
CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis

This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 12 - 70 years.
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
* Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.
* Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study

The prevalence of anxiety and depression in our OSA population is more than in COPD and the general population of North West Adelaide. (principal hypothesis).

CPAP therapy in OSA population produces a positive effect on the anxiety and depression scale.

The Investigators intend to study the prevalence of anxiety and depression in patients with sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP has a role in controlling anxiety and depression in depressed and anxious patients with sleep apnoea.

This is a two phase study, in first phase; investigator will assess the prevalence of anxiety and depression, in a population with sleep disorders to check whether it is different to the prevalence in the COPD population. The prevalence of depression in Sleep Disorder population will also be compared with the Adelaide North Western general population, which was reported in The North West Adelaide Health Study. According to this epidemiological survey, which was conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general population was 20%.During the second phase of the study investigator will evaluate the effect of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a well-documented tool for assessing symptoms of anxiety and depression in patients with somatic diseases.

AIM (S) / OBJECTIVE OF STUDY

1. To compare the prevalence of anxiety and depression in patients with sleep disorders (OSA), COPD and the general population of North West Adelaide.
2. To study the effect of CPAP on depression and anxiety in patients with sleep apnoea who also have anxiety and depression.

STUDY DESIGN/ SETTING/LOCATION/POPULATION

This is a multicenter Prospective Cohort study run at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH), among patients attending the Respiratory and Sleep Outpatient Clinics at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH). These both sites are teaching tertiary hospital.

STUDY OUTCOMES

1. Primary Outcome To establish the prevalence of anxiety and depression in patients with sleep disorders and compare how this prevalence differs from its prevalence in COPD and in the general population.
2. Secondary Outcome To evaluate whether treatment with CPAP improves anxiety and depression symptoms (HAD scale) at 3 and 12 months in OSA patients with anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Respiratory and Sleep Outpatient Clinics at LMH and TQEH with OSA or COPD
* Aged over 18 years

Exclusion Criteria:

* Unwilling or unable to give informed written consent
Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer

Breast cancer has a high impact, affecting 2.3 million women worldwide in 2022. In Spain, there were 40,203 new cases in 2023. In addition to the economic and social costs, patients suffer genitourinary dysfunctions due to cancer treatments. Genitourinary Menopausal Syndrome (GUS) affects 50% of menopausal women, with a higher prevalence in women with breast cancer.

This study aims to compare the effectiveness of radiofrequency (RF) and pelvic floor muscle exercise (PFMT) in the treatment of pelvic dysfunction associated with GUS in breast cancer patients. A randomised, double-blind clinical trial will be conducted in collaboration with the Association of Women Affected by Breast Cancer of Elche and Region) and the CEU Cardenal Herrera University. Women diagnosed with breast cancer and pelvic dysfunction will participate, divided into three groups: one will receive PFMT, one will receive RF and one will receive PFMT+RF therapy.

Both techniques are expected to improve the quality of life of patients, where RF could offer additional benefits due to its proven effectiveness in the treatment of vaginal dryness and dyspareunia. The expected results will contribute to more effective and less invasive treatment protocols. The project presented has the potential to positively impact the health and well-being of women with breast cancer, reducing the symptoms associated with the disease and its treatment, and improving their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* women of legal age with a clinical history of breast cancer, who agree to participate in the study and who present pelvic dysfunction assessed by the Pelvic Floor Distress Inventory (PFDI20) ≥ 100
* women survivors of stage 1 and 2 breast cancer
* A medical discharge was granted more than one year ago
* A diagnosis of another type of cancer has not been made.

Exclusion Criteria:

* Having performed PMFT or received RF in the last 12 months
* Use of vaginal oestrogens in the last 6 months
* Systemic hormone therapy in the last 6 months
* Laser therapy in the last 6 months
* Absence of pelvic floor contraction according to the Modified Oxford Scale
* Use of pacemaker
* Use of heart pacemaker, decompensated heart or metabolic diseases, cognitive deficits, peripheral or central neurological disorders, previous surgeries in the pelvic region, skin pathologies or wounds in the treatment area or presence of an active urinary tract and/or vaginal infection.
Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

The proposal seeks to establish:

* A comprehensive compilation (database) of clinical information comprising clinical, histopathological, treatment and follow-up characteristics of past and future gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators. The characteristics will include clinical (eg age, sex, stage), histopathological (eg. grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival, toxicity) from medical records.
* A collection (bank) of corresponding frozen and fixed tissue, blood and processed samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in Singapore that can be shared by the investigators.
* A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists researching prognostic and predictive markers in GIC, which will benefit from the multi-disciplinary knowledge, information and samples of its members.
* To characterise genetic polymorphisms related to Gastrointestinal cancer chemotherapy treatment in controls (healthy volunteers)


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal)

Exclusion Criteria:

* None
Primary Care Obesity Prevention and Treatment

The overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting.

Specifically, the investigators aim to answer the following questions:

Can the investigators recruit and retain patients using the methods proposed, and how easy or difficult will this process be?

Can physicians deliver the proposed intervention messages in the time the investigators have proposed?

Can the phone counselor reach participants and accomplish the goals outlined for these calls?

Can the investigators obtain the data proposed and within the proposed time frame?


Eligibility Criteria:
Inclusion Criteria:

* child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
* child scheduled for an upcoming well child visit
Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion

To compare the effect of intravitreal-Bevacizumab and Triamcinolone with intravitreal-Bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender, age 40-80 years, having macular edema secondary to CRVO, Best-corrected visual acuity (BCVA) of less than or equal to 0.3 on Log MAR chart (Snellen equivalent of 6/12), Central foveal thickness CFT greater than or equal to 250 microns on Heidelberg Spectralis Spectral Domain Optical coherence tomography (SD-OCT) and clinical diagnosis of CRVO.

Exclusion Criteria:

* previously received laser treatment and/or intravitreal injection of any Anti-VEGF agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for CRVO before presenting to us.
Reverberation Effects on MED-EL Recipients

The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.

Eligibility Criteria:
Inclusion Criteria:

* MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
* Minimum of 6 months experience with their cochlear implant
* Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
* Patient at the University of Miami

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)