cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Combined Music on Sleep Disorder

The results of this study will provide an affordable, safe and scientific treatment for patients with sleep disorders, so that patients can improve their sleep quality at home.

The population suffered from sleep disorders is raising year by year, it has increased much social costs and medical burdens, especially the spread of the COVID-19 epidemic has made it even worse recently. Although many studies in the past few years have found that the use of non-invasive music therapy (such as five-element music, music combined with binaural beats) can effectively improve sleep quality, however, there is a lack of rigorous study design and measurement tools (scientific instrument examination).

To explore the effects of short-term sleep quality in patients with sleep disorders after receiving five-element music therapy or binaural beats, and further explore the combination of the above two music therapies to verify its effectiveness in improving long-term sleep quality.

The first year study was a randomized single-blind trial. 60 patients with sleep disorders were randomly assigned to the five-element music group and binaural beats group for two consecutive nights treatment to verify their short-term effects and assess the differences between them; the second year study was a randomized controlled trial , 60 patients with sleep disorders were randomly assigned to the five-element music combined with binaural beats group and the control group for four-week follow-up treatment to verify their long-term results and evaluate the feasibility of home treatment. The main results were measured with meridian energy examination and polysomnography. Other secondary results include sleep-related questionnaires (including Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Berlin Questionnaire, Hospital Anxiety and Depression Scale).

Eligibility Criteria:
Inclusion Criteria:

* sleep disorder
* PSQI score \> 5

Exclusion Criteria:

* Using tranquilizers or taking drugs or foods (such as coffee or refreshing drinks)
* Severe cardiopulmonary disease (heart failure or cardiopulmonary failure) or cancer
* Kidney dialysis patients
* Patients with cardiac rhythm regulators or built-in hearing aids
* Pregnant women and women who are still breastfeeding
Impact of DHA/Oat on Metabolic Health in Gestational Diabetes Mellitus

The randomized controlled trial (RCT) recruits pregnant women with de novo diagnosis of gestational diabetes. Women bearing a singleton pregnancy are randomized into four arms: DHA, oat, oat plus DHA, and placebo. The primary outcomes are cord blood leptin concentration in the newborns and maternal fasting glucose levels at 8 weeks post-intervention.

DHA is a long-chain fatty acid that has been shown to increase insulin sensitivity in basic science studies. Some studies have reported that oat (β-glucan) intake in patients with type 2 diabetes may improve glycaemic control. Evidence is emerging that gut microbiota may play an important role in energy homeostasis and glucose metabolism. This RCT aims to test the hypothesis that DHA and/or oat intake may improve glycemic control in women with gestational diabetes mellitus (GDM), and may impact metabolic health in fetuses/infants as indicated by cord blood leptin level. Changes in microbiota may be linked to these effects.

Growing evidence suggests that epigenetic changes may occur during fetal development in response to an adverse in utero environment, and this may "program" the risk of metabolic syndrome and type 2 diabetes in adulthood. GDM's offspring are programmed to be at substantially elevated risk of metabolic syndrome and type 2 diabetes in adulthood. We will explore whether the intervention may affect epigenetic profile in placental DNA in GDM.

Pregnant women bearing a singleton fetus without any evidence of malformation and with a de novo diagnosis of GDM at 22-28 weeks of gestation will be randomized into four arms: DHA, oat, oat plus DHA, and placebo. We will collect maternal blood and stool specimens on recruitment and 8-weeks post-intervention, cord blood and placenta specimens at delivery. The primary outcomes are cord blood leptin concentration in the baby, and fasting blood glucose at the 8 weeks post-intervention in the mother.

Eligibility Criteria:
Inclusion Criteria:

1. Han nationality
2. 20-45 years old
3. singleton pregnancy
4. natural conception
5. the pregnant women with de novo diagnosis of gestational diabetes mellitus during 22-28 weeks of pregnancy

Exclusion Criteria:

1. Pregnant woman or the biological father has diabetes mellitus (Type I or II)
2. the woman has severe diseases or life threatening conditions such as HIV, cancer, renal failure
3. the fetus has known congenital malformation or genetic defects
4. in-vitro fertilization
5. active hepatitis
6. tuberculosis
7. syphilis
8. drug abuser
9. multiple pregnancy
Pharmacokinetics of Inhaled Levosimendan

Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.


Eligibility Criteria:
Inclusion Criteria:

* Subject \>18 years of age
* Scheduled for elective coronary artery bypass grafting (CABG)
* Provided written informed consent
* Impaired left ventricular function (LVEF \<40%)

Exclusion Criteria:

* Known allergy for levosimendan or solutes
* Persistent angina, defined as Canadian Cardiovascular Society score \> I
* History of valvular intervention or uncorrected primary stenotic valve disease
* Uncorrected thyroid disease
* Infiltrative, hypertrophic or restrictive cardiomyopathy
* Pericardial disease
* Active myocarditis
* Chronic obstructive pulmonary disease requiring long-term treatment with β-agonists, Theophylline, or corticosteroids (FEV1 \< 80%; Tiffeneau-index \<0.7)
* History of serious arrhythmias, defined as a history of ventricular tachycardia or fibrillation other than that occurring within 24 hours after acute myocardial infarction (MI)
* resting heart rate \> 115 bpm for at least 10 minutes on repeated measurements
* Supine systolic blood pressure \< 85 mm Hg or \>200 mm Hg
* patients with implanted pacemaker/defibrillator or cardiac resynchronisation therapy (CRT-device)
* primary renal or hepatic impairment (creatinine \> 2.5 mg/dL or aspartate aminotransferase/alanine aminotransferase \>2 times upper limit of normal and/or increased level of bilirubin (\> 2 times the upper limit of normal and increase of international normalised ratio (INR) above the upper limit of normal, respectively)
* Uncorrected hypokalemia or hyperkalemia (potassium \<3.5 mmol/L or \>5.5 mmol/L)
* Uncorrected hypomagnesemia (magnesium \<0.65mmol/L)
* Treatment with another investigational agent within 30 days before study entry
* Intubated and mechanically ventilated at the time of study entry
A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors

The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion Criteria:

Part 1:

* Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and BTC that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with KRAS G12C inhibitors.
* For NSCLC and CRC: Individuals must have a documented KRAS G12C mutation status from NYS or FDA approved/cleared or CE marked test or, when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory in blood sample collected at the time of screening.
* For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS or FDA-approved/cleared, or CE-marked test and blood samples will be collected only for retrospective testing.
* Are relapsed or refractory to available standard of care treatments.

Part 2:

* Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A) or CRC (Part 2B) that has spread to other parts of the body and cannot be removed surgically and have not received previous treatment with KRAS inhibitors.
* Individuals must have a documented KRAS G12C mutation from FDA or NYS approved/ cleared or CE marked test or, when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory in blood sample and /or tumor samples collected at the time of screening or from archival biopsies (less than 1 year old).
* Have failed or disease recurrence or are not able to tolerate after at least 1 pervious line of therapy.

Key Exclusion Criteria:

* Have tumors with known BARF V600X, PTPN11 or KRASQ61X mutations.
* Have or any significant heart disease or condition.
* Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors

Note: Other protocol-defined inclusion/exclusion criteria apply.
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery

Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery

Metamorphopsia is a visual symptom in which straight lines appear distorted, for example a vertical window blind may appear wavy which can affect quality of vision. Metamorphopsia is a common symptom in retinal conditions such as epiretinal membranes (ERM) and macular holes. There is a lack of studies analysing the prevalence of ERM in the UK and Europe.

Both of the conditions have shown to be a higher risk factor with age. With an aging population it is likely these numbers will increase. Currently the only treatment option is surgery (vitrectomy) or conservative management to monitor the condition. It would therefore be beneficial to find a tool that would inform the surgeon of a patient's quality of vision and how this impacts their life. A patient's severity of metamorphopsia reveals more precise information on the progression of the disease than visual acuity alone (Nomoto et al. 2013) therefore gaining a better understanding can help aid clinical decisions.

Current clinical practice is to monitor metamorphopsia with an Amsler chart, a grid with lines; the patient is then asked to draw where they can see distortion. They are used to detect metamorphopsia but are unable to quantify and provide an accurate measurement of the severity of metamorphopsia and quality of vision

The Quality of Vision questionnaire (QoV) (McAlinden et al. 2010) is a modern tool developed to specifically measure subjective quality of vision. The Metamorphopsia questionnaire (Arimura et al. 2011) has been developed to provide a measurement of subjective metamorphopsia in macular disease. Both have been psychometrically validated and are in use in a number of clinical trials worldwide.

It would be valuable to investigate the role of each questionnaire in identifying quality of vison and metamorphopsia pre- and post-surgery for ERM and macular holes to establish if there are changes to patient responses. We would compare this to visual acuity and optical coherence tomography (OCT) images pre- and post-surgery to see if changes correspond to the questionnaire responses. If a questionnaire can measure metamorphopsia and its impact on quality of vision in ERM and macular holes, this would assist in clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent
* \>18 years old
* Patients listed for epi retinal and macular hole surgery
* Patient is able to perform study procedures

Exclusion Criteria:

* Patients who are diagnosed with a condition other than epiretinal membrane or macular hole

  * Patients not undergoing epiretinal or macular hole surgery
  * Patients will be excluded if there are any complications within surgery, or undergo any procedures that is not an epiretinal or macular hole surgery (i.e vitrectomy, phacoemulsification (lens extraction) as this can affect visual outcomes.
A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome

To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.


Eligibility Criteria:
Inclusion Criteria:

* Were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening.
* Experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening.
* Had a normal upper GI endoscopy within the past year.

Exclusion Criteria:

* Heartburn that occurs \>3 times per week
* Current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening
* Any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening
* At screening, a QT interval corrected for heart rate using Bazett's correction formula (QTcB) \>440 msec as determined by the Investigator.
Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis: PAFIP

Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal studies that have addressed this issue rigorously. Most studies that have established the poor prognosis of the disease have followed a cross-sectional design and are based on samples of patients undergoing treatment in healthcare devices and therefore represents an important bias. Based on clinical, cognitive, functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can establish that the particular idea of poor prognosis should be reconsidered. The development of longitudinal studies of first-episode patients in representative samples of a population and long-term it is of high value to shed light on the clinical course of the disease. The belief that there are factors determining the disease progression beyond the initial three years brings us to publish this study.

Given this background, our project's main objective is to know the evolution at 10 years of patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is that a higher percentage of expected patients have a favorable outcome of the disease. Factors such as enhancing treatment completion, abstinence from drug use, return to work, the reduction of expressed emotion in families during the early years of the disease (at least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution of patients on long-term (10 years). Our hypothesis defends the existence of certain factors as independent risk factors for poor clinical and functional outcome of patients who should be known for establishing intervention strategies that attempt to mitigate their impact on the quality of life of patients and their families.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.

Exclusion Criteria:

* Meeting DSM-IV criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma

Exclusion Criteria:

* Metastatic disease
* under 18y patient
* woman of childbearing age
Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS （progression-free survival） , the OS （ overall survival） is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions

Exclusion Criteria:

-
Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease

Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of dopaminergic neurons that can cause some mobility limitations and it has association with quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of these patients Objective: Evaluate the functional capacity and QOL of individuals with PD using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3, aged 50-75 years. They were divided by lot into two groups (control and experimental) with ten patients in each. The group (CG) treated with exercises (conventional therapy) during five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG) spent half the time with conventional physical therapy and other half of time in virtual rehabilitation (VR). Subjects were evaluated before and after treatment using the following scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of idiopathic Parkinson's disease
* Male and female
* Stage 1-3 of the Hoehn and Yahr scale.

Exclusion Criteria:

* Have other neurological diseases
* They have decompensated systemic diseases
* Musculoskeletal changes that prevent the achievement of movements
* With lowering of the cognitive level assessed using the MiniMental State examination with cutoff point according to education
* With respiratory impairment
* With medical restrictions for performing exercises
* In physical therapy, occupational therapy service for 3 months or more;
Irritable Bowel Syndrome and Lactibiane Tolerance

The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).

The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).

The secondary purposes are to evaluate the effects of the intervention on:

* quality of life
* severity of fatigue, anxiety and depression
* levels of inflammatory markers in blood and tools

Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome according to the Rome II criteria
* 150\< Francis Score \< 300
* HAD score inferior or egal to 25

Exclusion Criteria:

* History of hypersensitivity to one of the composant of the product
* Use of probiotics or antibiotics last four weeks
* use of prohibited drugs
* bowel preparation for morphological examination last month
* pregnancy or lactation
* immundepressed or co-existing other serious illness or evolutive
Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients

This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year.
* Age ≥18 years old.
* No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.

Exclusion Criteria:

* Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration.
* Previous use of other biological treatments for any reason
Surgical Site Infection Study

The purpose of this study is to investigate the pharmacokinetics of cefazolin using both plasma and microdialysate sampling methods in children with single ventricle physiology undergoing their second palliation procedure. This will provide data to determine if the current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue concentrations greater than the minimum inhibitory concentrations (MIC) for common post-surgical pathogens that cause Surgical Site Infections (SSIs).

This study aims to sample interstitial fluid (IF) of infants undergoing superior cava-pulmonary anastomosis (either Glenn or Hemi-Fontan) cardiac surgical procedures who receive cefazolin as their surgical prophylactic antibiotic. Cefazolin concentrations will then be determined in both microdialysate and plasma samples and used to define the pharmacokinetics of cefazolin at the tissue level and compare that to plasma pharmacokinetics. In addition, the data gathered will be used to assess how cardiopulmonary bypass (CPB), deep hypothermic cardiac arrest (DHCA), and modified ultrafiltration (MUF) affect tissue penetration of the prophylactically administered cefazolin.

The study involves the use of microdialysis (MD) and plasma sampling methods to determine the pharmacokinetic properties of cefazolin when used as a prophylactic antibiotic during the second palliation procedure (superior vena cava-pulmonary anastomosis) for infants with single ventricle physiology. This requires the use of microdialysis (MD) catheters inserted into the left deltoid muscle in eligible subjects after the induction of general anesthesia as well as collection of microdialysate and blood samples throughout the duration of the procedure. Cefazolin will be administered as standard of care. Cefazolin concentrations in the collected samples will be measured via a validated high-performance liquid chromatography (HPLC) and mass spectrometry assay. Pharmacokinetic analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
* Use of cefazolin as the prophylactic antibiotic during the operation
* Written informed consent provided by the parent or legal guardian

Exclusion Criteria:

* Use of prophylactic antibiotic other than cefazolin during the operation
* Anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter
* Known renal or hepatic function