cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients

A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province, Thailand. Sixty participants were randomized to music listening group and control group. The music listening group was assigned to listen to 30-minute instrumental folk music everyday for one month. Home BP and office BP were monitored and recorded.


Eligibility Criteria:
Inclusion Criteria:

* 40-80 years old
* Diagnosed stage-2 hypertension (HT) (defined by office systolic blood pressure \>= 140mm Hg and/or diastolic blood pressure \>= 90 mm Hg at first hospital visit)

Exclusion Criteria:

* Pregnant women, white-coat HT, secondary HT and hearing loss or blind.
Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study

This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

Age over 18, with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma, or after a first-line chemotherapy with at least a residual mass or after induction chemotherapy or at progression.

Stem cell transplantation would be programmed. Patients were required to give their written informed consent.

Exclusion Criteria:

Progressive cancer or diagnosed less than 5 years, except cancer in situ of the cervix and basocell skin carcinoma, kidney insufficiency or diabetes. Patients would not be pregnant or lactating
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

Eligibility Criteria:
Inclusion Criteria:

* chronic phase CML not received treatment
* Pts with no heart disease
* Pts with no abnormal cholesterol level

Exclusion Criteria:

* Any pts treated before with diff. Treatment
* Pts. With past history of heart problems
* Pts. With abnormal cholesterol level
Effect of Acute Bout of Exercise on Levels of PAHSA

Exercise represents an important tool in the prevention and treatment of metabolic disorders associated with obesity and aging, such as type 2 diabetes and cardiovascular disease. Besides skeletal muscle and its myokinins, the metabolic effects of exercise also rely on the induction of favorable changes in adipose tissue function. For example, adipose tissue is a source of lipokinins from the family of palmitic acid esters of hydroxy fatty acids (PAHSA), which have anti-inflammatory and insulin-sensitizing properties. We have recently shown that 4 months of exercise training increases PAHSA levels in adipose tissue and circulation. However, the mechanisms involved in the induction of PAHSA levels in response to exercise are unknown. The aim of the Effect of Acute Bout of Exercise on Levels of PAHSA (ETAPA) project is therefore to investigate the regulation of PAHSA metabolism in response to both acute and chronic exercise. To achieve this goal, we will employ state-of-the-art analytical methods to measure PAHSA levels in both adipose tissue and circulation of subjects of various ages and adiposity status. The main output of the ETAPA project will be the proof of principle regarding the important role of PAHSA lipokinins in exercise-induced enhancement of insulin sensitivity and the identification of potential drug targets that could be used to further improve PAHSA metabolism for the treatment of metabolic disorders associated with aging or obesity.


Eligibility Criteria:
Inclusion Criteria:

* healthy young lean, young obese and elderly omnivorous men and women as defined by BMI, self-reported activity, self-reported medical history and self-reported diet assessment
* must be able to withstand repeated blood draws
* must be able to undergo abdominal fat biopsy

Exclusion Criteria:

* use of betablockers
* use of glucocorticoids
* use of non-steroidal anti-inflammatory drugs
* use of metformin in prediabetes
* use of psychiatric drugs such as selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, anticonvulsants and others
* oncologic malignancy
* chronic inflammatory or autoimmune diseases
* diabetes mellitus
* chronic ischemic heart disease
* cardiovascular and pulmonary disease
* renal and hepatological disease as assessed per biochemistry
* musculo-skeletal deviations limiting physical performance
* substance abuse
* other than omnivorous diet
Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by activation of immune cells, which results in vascular dysfunction (vasculopathy) and subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military. On a national level there are 5,766 SSc patients (ICD-9 710.1) presently cared for in the Veterans Health Administration (VHA). While there is no cure for SSc, studies of therapeutics that can help slow disease progression are valuable to our Veterans. This proposal addresses the solicitation for projects with attention to SSc requested by President Obama after reviewing potential contamination of water at Camp Lejeune. This proposal is a patient-centered outreach for our Veterans with SSc to inform and prevent catastrophic endstage vascular abnormalities, including digital ulcers, pulmonary arterial hypertension (PAH) and scleroderma renal crisis in SSc. The study proposes a novel application of a therapeutic for this disease. A better understanding of the initiating insult and natural progression of SSc vasculopathy is needed in order to develop therapeutics with a goal of curing/treating the underlying disease. This project has the potential to impact not only Veterans with SSc, but also those with vascular abnormalities including digital ulcers, PAH, and renal crisis. This proposal represents a potential major therapeutic advance for our Veterans with SSc.

Although SSc is heterogeneous in the extent of organ involvement and prognosis, it is accepted that all SSc cases have a progressive and usually devastating course. Since vasculopathy precedes fibrosis in this disease, a focus on understanding its natural history and preventative measures for vascular dysfunction has profound implications. This pilot work suggests that measurement of endothelial dysfunction with flow mediated dilatation (FMD) holds promise as novel method to assess disease progression as well as the therapeutic efficacy of the pharmacologic compound tetrahydrobiopterin (BH4) in SSc. The investigators believe that BH4, which targets the endothelium, has great promise to reduce SSc-related tissue hypoxia, end organ damage, and potentially may impact underlying disease progression. The first aim will adopt an integrative approach and validate a novel, non-invasive technique, FMD to define vasculopathy in SSc. The second aim and third aim (which is reported in this PRS report) will examine if BH4 is effective in ameliorating vascular dysfunction in patients with SSc and determine the role of oxidative stress in BH4-mediated improvements in vascular function in patients with SSc. The overarching goal of these aims is to improve vasculopathy detection and management in Veterans with SSc.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic sclerosis (SSc, scleroderma) by ACR/EULAR 2013 criteria.

Exclusion Criteria:

* Age \< 18
* Pregnant or breast feeding
* Unwillingness to consent
Iodine Supplement Strategies Between Routine Iodine Supplementation and Selective Iodine Supplementation

Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive routine iodine supplementation. The other will receive iodinated pill or only iron supplementation base on their urine iodine status.


Eligibility Criteria:
Inclusion Criteria:

* first visit for antenatal care in the first trimester
* singleton pregnancy
* delivered at Maharaj Nakorn Chiangmai Hospital

Exclusion Criteria:

* thyroid disease which diagnosed before pregnancy or currently
* history of thyroid gland surgery or iodine ablation therapy
* received iodine supplement before pregnancy
* received any medication for thyroid disease treatment, within 6 weeks postpartum women or breast feeding period
* family history of thyroid disease
* having underlying disease or contraindication which cannot received iodine supplement
* loss follow-up or incomplete data.
Voice Analysis in Asthmatic Patients with Machine Learning Models

Asthma can lead to various factors that impair voice production, including airway restriction, inflammation, and mucus production, resulting in changes in voice frequency and amplitude. Therefore, voice analysis may serve as an indicator of respiratory diseases.

A national, observational, case-control study is planned in Türkiye to analyze differences in voice between healthy subjects and asthmatic patients and to assess voice analysis techniques for determining an effective biomarker for asthma control using a machine learning model.

Asthma is a disease characterized by chronic inflammation. Based on the frequency of symptoms and the use of reliever medications, the disease can be classified as either 'controlled' or 'uncontrolled'. Currently, GINA criteria and Asthma Control Test can be used to evaluate asthma control.

The relationship between respiratory functions and speech has been previously studied, revealing that voice changes can occur in asthmatic patients due to symptom presence. Asthma can lead to various factors that impair voice production, including airway restriction, inflammation, and mucus production, resulting in changes in voice frequency and amplitude. Therefore, voice analysis may serve as an indicator of respiratory diseases. Understanding the alterations in phonation/voice due to the underlying disease is crucial.

This study seeks to analyze differences in voice between healthy subjects and asthmatic patients and to assess voice analysis techniques for determining an effective biomarker for asthma control using a machine learning model.

This is a national, observational, cross-sectional study that will be conducted in Türkiye. The study consists of two stages: in the first stage, a machine learning (ML) model will be developed using voice data collected from both healthy individuals and patients diagnosed with asthma. In the second stage, this ML model will be tested to detect voice differences among patients at different levels of asthma control.

Eligibility Criteria:
Asthmatic Group

Inclusion Criteria:

* Patients diagnosed with asthma according to GINA criteria and Pulmonary Function Test, and followed for at least three months
* 18-65 years of age.
* Sign an informed consent document
* Able to comply with the study protocol during the study period.

Exclusion Criteria:

* None

Healthy Group

Inclusion Criteria:

* Healthy participants between 18-65 years of age
* Good general health
* No history of chronic respiratory disorders
* No history of chronic systemic disorders
* No history of upper respiratory tract infections within five days prior voice recording.

Exclusion Criteria:

* None
Impact of Reconstruction Method (ASIR, FBP) Used in CT on Bone SPECT/CT Image Quality

The main objective of this study is to demonstrate the non-inferiority of SPECT image quality (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT acquisitions versus the quality of those obtained by filtered back projection (FBP) of low-dose CT acquisitions.

The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP expected is between 5 and 6.

The secondary objectives of this study are:

A. Demonstrate the non-inferiority of image quality (as assessed by a Likert scale) obtained by ASIR-reconstruction-SPECT versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.5); B. Verify the non-inferiority of image quality (as measured by the signal / noise ratio)of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.2); C. Verify the non-inferiority of image quality (as assessed by the Likert scale) of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower limit of non-inferiority is set at -0.5); D. Check that the irradiation dose received by the patient is lower for the acquisition of images reconstructed with ASIR than for the acquisition of images reconstructed with FBP.

E. Check the concordance of two evaluations of image quality (Likert scale) made by nuclear medicine physicians (blinded to each other).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* A SPECT-CT exam is scheduled for the patient
* The patient is able to withstand an extended position with the arms behind the head for 15 minutes (i.e. patient is able to undergo a SPECT-CT exam)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or any kind of guardianship
* The patient refuses to sign the consent
* The patient has a contra-indication for a treatment necessary for this study (patient is not able to withstand an extended position with the arms behind the head for 15 minutes)
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Emergency situations
* Presence of osteosynthesis material (or any other material that would generate an artifact during SPECT-CT) in the spine
* Patient behaviour hampers image acquisition
Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.

NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.

Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.

The study will enable real-life Heath Economics and Outcome Research (HEOR).

Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed locally advanced or metastatic NSCLC
* Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
* Planned first or second-line treatment with crizotinib
* Signed and dated IRB-approved informed consent document
* Ability to read and understand English or French
* 18 years of age or older
Anatomical and Physiological Characterisation of the Gut Endocrine Cells in Healthy and in Patients With Type 2 Diabetes

Investigation of the anatomical distribution of enteroendocrine cells by a systematic approach along the entire human intestinal tract in healthy individuals and patients with type 2 diabetes.

Enteroendocrine K and L cells are pivotal in regulating appetite and glucose homeostasis, but knowledge of their distribution in man is sparse and it is unknown whether alterations occur in type 2 diabetes. Twelve patients with type 2 diabetes and 12 age and BMI-matched healthy individuals underwent upper and lower double-balloon enteroscopy with mucosal biopsy retrieval from every \~30 cm of the small intestine and specific locations in the large intestine. The investigators evaluated the distribution of enteroendocrine cells (using IHC staining for their specific hormonal products) and evaluated mRNA expression of the corresponding genes along the entire intestinal tract in patients with type 2 diabetes and in healthy individuals.

Eligibility Criteria:
Inclusion criteria:

Type 2 diabetes patients

* Diagnosis of type 2 diabetes (at least 3 months prior to study inclusion)
* Treatment with diet counseling alone or combined with an glucose-lowering drugs: metformin or sulphonylurea
* Caucasian ethnicity
* Age \>25 and \<70 years
* Normal hemoglobin
* Negative for autoantibodies to glutamic acid decarboxylase (GAD-65) and islet cell autoantibodies (ICA).

Healthy individuals

* Fasting plasma glucose \<6.0 mM
* Plasma glucose 2 hours after a 75 g-oral glucose tolerance test \<7.8 mM
* Negative for GAD-65 antibodies and ICA
* Caucasian ethnicity
* Age \>25 and \<70 years
* Normal hemoglobin

Exclusion criteria:

Type 2 diabetes patients

* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
* Previous hysterectomy, appendectomy, cholecystectomy or caesarean
* Sleep apnea
* American Society of Anesthesiologists class \>3
* Allergy to soy protein or eggs
* BMI \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy.

Healthy individuals

* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
* Previous hysterectomy, appendectomy, cholecystectomy or caesarean
* Sleep apnea
* American Society of Anesthesiologists class \>3
* Allergy to soy protein or eggs
* BMI \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy
* First-degree relative(s) with type 1 or type 2 diabetes.
Validation of the Gugging Swallowing Screen for the Intensive Care Unit

Aetiology of dysphagia after extubation is unknown and considered to be multifactorial. Use of a standardized dysphagia- screening permits an early diagnosis. This study is to evaluate a new GUSS (gugging swallowing Screen) tool with multi-consistency check for intensive care patients (GUSS-ICU) with dysphagia. The concurrent validity (in terms of sensitivity and specificity) of the GUSS-ICU is analyzed in comparison to the flexible endoscopic evaluation of swallowing (FEES).

Aetiology of dysphagia after extubation is unknown and considered to be multifactorial. Use of a standardized dysphagia- screening permits an early diagnosis. This study is to evaluate a new GUSS (gugging swallowing Screen) tool with multi-consistency check for intensive care patients (GUSS-ICU) with dysphagia. The concurrent validity (in terms of sensitivity and specificity) of the GUSS-ICU is analyzed in comparison to the flexible endoscopic evaluation of swallowing (FEES).

The GUSS-ICU with multi-consistency check includes an indirect and a direct swallowing attempt. In indirect swallowing, the vigilance is first assessed on the basis of the RASS score (Richmond agitation-sedation scale), the presence of a stridor, the effectiveness of coughing and screeting, the possibility of swallowing saliva, drooling (saliva) and the change of voice after swallowing. If six points are reached, one can immediately proceed to the direct swallowing attempt. Unlike the original GUSS, the new GUSS-ICU direct swallowing test consists of 4 subtests with pulpy, liquid, solid and mixed solid-liquid consistency. The mixed solid-liquid consistency has been supplemented, as mixed consistencies require a more complex swallowing function with increased tongue- and lip coordination.

Eligibility Criteria:
Inclusion Criteria:

* patients treated in ICU with intubation time of at least 24 hours
* Richmond Agitation-Sedation Scale (RASS)-Score of 0 (alert and calm) to 2 (agitated)
* Inclusion in study not earlier than 1 hour after extubation
* Mini-Mental-State (MMS) Score \>/=24
* signed informed consent

Exclusion Criteria:

* not capable to follow study procedures (language problems, mental disorder)
* end of life- patients
An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
* Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines

Exclusion Criteria:

* N/A
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection at screening defined as: positive anti-HCV antibodies (Ab) at screening and HCV RNA \> 1,000 IU/mL at screening.
* Plasma HIV-1 RNA \< 40 copies/mL during screening using Abbott RealTime HIV-1 assay.
* On a stable qualifying HIV-1 antiretroviral therapy regimen.

Exclusion Criteria:

* Positive test result at screening for hepatitis B surface antigen.
* Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.
* Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.
* Chronic human immunodeficiency virus, type 2 (HIV-2) infection.