cyrilzakka/clinical-trials huggingface dataset:
Tubular Markers in Response to Saxagliptin Therapy

the study aims to investigate whether treatment with saxagliptin would induce beneficial changes in renal NGAL and L-FABP biomarkers and if they would be used as a tool to identify patients' categories with a particular renal response to DPP-4inhibition. Secondly, to find an association between NGAL and L-FABP, and the relevant renal parameters for both baseline values and rate of changes across defined time points.

Diabetic kidney disease (DKD) is considered a substantial cause of end-stage kidney disease (ESKD) worldwide. Incorporation of renoprotective options during interventions to prevent the development of DKD and attenuation of its progression; is of the utmost importance. Incretin-based therapies, specifically dipeptidyl peptidase 4 (DPP-4) inhibitors exhibited albuminuria lowering potential beyond their antihyperglycemic effects. Saxagliptin, a potent selective DPP-4 inhibitor which has been used as monotherapy or in combination with antidiabetics, has demonstrated great renal efficiency on both experimental and clinical scale .

Although albumin excretion rate (AER) is a powerful predictor of kidney function deterioration and progressive renal dysfunction, it is primarily a marker of glomerular damage and it has some drawbacks. For example; some patients may follow a non-albuminuric pathway to kidney impairment, others do not progress to macroalbuminuria but remain at microalbuminuria or even regress to normoalbuminuria. Thus, more sensitive and specific renal biomarkers than AER will be valuable in predicting early kidney injury and the progression of diabetic renal damage.

Besides glomerular damage, tubulointerstitial dysfunction largely contributes to the pathology of diabetic nephropathy. Neutrophil gelatinase-associated lipocalin (NGAL) and liver type fatty acid binding protein (L-FABP) are apparent as excellent biomarkers of tubular damage and are earlier predictors of acute kidney injury relative to microalbuminuria. NGAL is produced by neutrophils, highly expressed in tubular epithelium and released from tubular cells following damage . L-FABP is expressed in the proximal tubules and secreted into urine upon tubulointerstitial damage. Clinical significance of these biomarkers lies in their emergence in normoalbuminuric patients and their association with increased albuminuria and progression to ESRD with sustained high urinary markers' levels.

Eligibility Criteria:
Inclusion Criteria:

* T2 DM,
* prevalent albuminuria (30-3000mg/g),
* controlled hypertension (defined as blood pressure \<140/90 mm Hg) on a selected angiotensin receptor blocker, olmesartan 20mg/day for at least 4 weeks before intervention.

Exclusion Criteria:

* type 1 diabetes,
* poorly controlled hypertension (140-160/90-100 mm Hg),
* pancreatitis,
* malignancies
* albuminuria more than 3000mg/g.
* cardiovascular diseases (acute myocardial infarction, cerebrovascular disease in the past 6months,
* End Stage Renal Disease (ESRD) on chronic dialysis, renal transplant, a serum creatinine \>6.0 mg/dL, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)

The goal of this study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Trained research staff will document the number of neuraxial attempts before the operation, and compare this with the attempts recorded in the patient's chart. The definition of a neuraxial attempt will be determined before the study begins through a thorough literature review.


Eligibility Criteria:
Inclusion Criteria:

* Healthy parturients receiving any neuraxial procedure

Exclusion Criteria:

* Patient refusal of observation
* Provider refusal of observation
Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically

Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.

This study will follow a digital cohort via the REMAIN App. The REMAIN App is adapted from the HealthMPowerment (HMP) platform and tailored to our focus population's unique needs. Digital cohorts, or eCohorts, utilize the flexibility and capacity of the internet to complement traditional approaches to epidemiological research, helping address some of the limitations and challenges associated with conventional cohort studies.

Aim 1 of this study is to recruit and retain a geographically and demographically diverse cohort of PLWH who are sub optimally engaged in care and with a history of, at high risk for, or not currently virally suppressed. Outcomes for this are levels of recruitment and retention to hit the study objectives to enroll 1,000 PLWH at risk for or experiencing VNS and follow them for up to 48 months. Aim 2 is to evaluate longitudinal patterns of care engagement within the cohort by modeling and advanced epidemiologic methods utilizing remote collection of biomarkers of HIV disease (e.g., viral load), online surveys, and brief, frequent app-based "check-ins". Outcomes include both those related to VS and engagement in care as well as engagement in the digital cohort.

Eligibility Criteria:
Inclusion Criteria:

* Have access to a personal smartphone device;
* Over 18 years of age;
* Speak English or Spanish;
* Living with HIV
* Are either 1) not currently virally suppressed, 2) not currently engaged in care, or 3) have one or more factors associated with viral non suppression including a history of missed appointments or viral non suppression;
* Active substance use or mental health disorder;
* Willing and able to provide written informed consent to take part in the study.

Exclusion Criteria:

* Unwilling or unable to provide reliable contact information;
* Unwilling to provide blood sample for HIV virology testing;
* Living with HIV and virally suppressed and not at risk of becoming unsuppressed in the near future.
Airway Resistance Measurement in Children 3 to 6 Years of Age

In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.


Eligibility Criteria:
Inclusion Criteria:

* Child 3 to 6 years aged

Exclusion Criteria:

* Height below 90 centimeters
* Opposition to participation
An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit / Hyperactivity Disorder (AD/HD).

The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the AD/HD patients.

If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate, it can contribute to development of the medical treatment of AD/HD.


Eligibility Criteria:
\[Inclusion Criteria\]

1. Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
2. Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
3. Patients are stable for 4-weeks for medication.

\[Exclusion Criteria\]

1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2. Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
3. Pregnant or breast-feeding women
Biomarkers of Common Eye Diseases

To identify biomarkers of common eye diseases based on single-cell sequencing technologies using PBMC samples. These diseases include uveitis, diabetic retinopathy, age-related macular degeneration and polypoid choroidal vasculopathy. Our study may provide new insight into the underlying mechanisms, and reveal novel predictors and intervention targets for the diagnosis, prognosis and treatment of these diseases.

The pathogenesis of common eye diseases such as uveitis (including Behcet's disease (BD) and Vogt-Koyanagi-Harada disease (VKH)), diabetic retinopathy (DR), age-related macular degeneration (AMD) and polypoid choroidal vasculopathy (PCV) remains unknown. Although immunosuppressants, anti-vascular endothelial growth factor (VEGF) agents, and pars plana vitrectomy (PPV) have been widely used for treatment, the current therapeutic options are limited. In addition, there is a lack of biomarkers to indicate the prognosis and treatment response of these diseases. The aim of this study is to identify biomarkers and to provide a new target for individualized diagnosis and treatment of common eye diseases based on single cell sequencing technology.

Eligibility Criteria:
Inclusion Criteria for patients:

1. Age over 18 (including 18 years old);
2. Clinically diagnosed as diabetic retinopathy (DR), uveitis (VKH or BD) , age-related macular degeneration (AMD) , or polypoid choroidal vasculopathy (PCV)

Exclusion Criteria for patients with retinal diseases:

1. Have received more than 2 intravitreal injections of anti-VEGF drugs because of retinal or choroidal neovascularization and macular edema;
2. Patients with stable condition after having undergone panretinal laser photocoagulation and pars plana vitrectomy (PPV);
3. There are other serious systemic diseases of the body, such as history of chronic kidney disease requiring dialysis or a kidney transplant, unstable blood pressure, cardiovascular disease, tumors, etc;
4. Patients who are pregnant or nursing
Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis

The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be correlated to performance in the manual dexterity 'nine holes peg' test, within a control group and a group of patients with multiple sclerosis.

TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis: magnetic stimulation and electroneuromyography. It is based on the principle of two collisions between the descending central stimulation (magnetic stimulation) and the ascending peripheric stimulation. TST allows to better quantify central nervous system diseases. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise than with the magnetic stimulation technique alone.

The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs.

The nine hole peg will be realized first, and the triple stimulation examination performed after. The acquired data will be analyzed in order to find a correlation between the impairment level given by these two tests.


Eligibility Criteria:
Inclusion Criteria:

Control group:

* No history of neurological disease
* No medicines intake that could disturb performance within the tests (psychotropic medications, sedatives, anti spastic and drugs acting on neuromuscular transmission).

Multiple sclerosis group

* Multiple sclerosis diagnose. Patients followed by Dr Dachy, within the CHU Brugmann Hospital.

Exclusion Criteria:

* Persons carrying ferromagnetic material (implants, pacemaker).
* Epilepsy history.
* Patients who have had a head trauma with loss of consciousness and/or brain injury.
* Pregnant woman.
The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse

The purpose of this study is to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.

Purpose: to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.

Design: A randomized controlled trial with patients blinded of study hypotheses. Randomization will be stratified on centers and the sex

Interventions:

Patients randomized in the experimental group will participate in an interactive computer program with video, questionnaires and information related to alcohol misuse. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.

Patients randomized in the control group will participate in an interactive computer program with questionnaires and information related to healthy diet. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.

Participants: all patients consulting in an emergency department will be screened regarding their alcohol consumption and misuse. All patients screened as having alcohol misuse will be invited to participate in the trial.

Outcomes: the main outcome is the declared alcohol consumption at 12 months. Patients will be evaluated by phone at 3, 6 and 12 months by an independent outcome assessor.

Analyses: An intention to treat analyses will be performed Number of patients: 600 patients will be included Number of centers:3 centres (university hospital) will participate

Eligibility Criteria:
Inclusion Criteria:

* age \>=18
* patients consulting in an emergency department
* screened for alcohol misuse or dependence (i.e. for women: AUDIT score\>5 or consumption of more than 14 alcohol drinks per week For men: AUDIT score\>8 or consumption of more than 7 alcohol drinks per week)
* informed and signed consent form
* clinical exam performed
* having social protection

Exclusion Criteria:

* vital risk
* patients having mental disorder,
* patient unable to answer the questions and to participate in the computer program because of their clinical condition
* patients no understanding French languages
* patient already being treated for alcohol disorder
* patients asking for a specific treatment for their alcohol disorder
* patients unable to answer to the follow-up visits
Reliability and Validity of the DIPS (Structured Interview) in a Community Sample

The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been studied in clinical samples. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance.

The DIPS (Diagnostisches Interview bei psychischen Störungen) is a structured interview to assess a variety of the most frequent psychological disorders. Its reliability and validity has been demonstrated in clinical samples. Also, studies have tested patients' and therapist's acceptance of the interview. Since structured interviews are also used in non-clinical samples like epidemiological research the investigators would like to conduct a study in a community sample to test the interview's reliability, validity and acceptance in this population (study aim 1). The investigators also plan to compare positive mental health and affective styles of the subsample of participants with no current or lifetime mental health illness to patients from the local outpatient treatment center at the Ruhr-University Bochum, who all reported at least one current mental illness (study aim 2). If the researchers obtain enough participants with no current mental health problem, but a history of at least one mental health illness, they will be included in the analysis for study aim 2 as well.

Since the data collection takes place during the Corona pandemic, participants will also be asked to give information about how they are affected, about their living situation and their media use over the course of half a year to describe the sample and to determine the impact of these factors on the incidence and course of mental illness (study aim 3).

Eligibility Criteria:
Inclusion Criteria:

* sufficient knowledge of the German language

Exclusion Criteria:

* none
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy.

In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years old.
2. Histologically or cytologically confirmed, previously untreated, HNSCC of the oropharynx, hypopharynx, larynx or oral cavity without distant metastases and aimed for treatment with radiotherapy (with or without concomitant chemotherapy) with curative intent.
3. The primary tumour must fulfil the following high-risk criteria:

   1. For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc.
   2. For all other subsites and for p16- oropharyngeal cancer: Radiographic measurement of three orthogonal diameters must render a tumour estimate of ≥20 cc.
4. The treatment may be followed but not preceded by surgery, either as a salvage procedure or a neck dissection. An excision of a lymph node or tonsillectomy for diagnostic purposes, does not exclude the patient from participation.
5. WHO/ECOG performance status 0-2
6. The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.

Exclusion Criteria:

1. Previous radiotherapy in the head and neck region.
2. Concomitant or previous malignancies, except uncomplicated basal cell carcinoma, early (T1-2 N0) squamous cell carcinoma of the skin with follow-up time of at least one year for squamous cell carcinomas, and except other cancer with a disease-free follow-up of at least three years
3. Two or more synchronous primary HNSCC at time of diagnosis
4. Nasopharyngeal cancer
5. Sinonasal cancer
6. Co-existing disease prejudicing survival (expected survival \< three years).
7. Pregnancy or lactation
8. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Tonsillitis

A multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute tonsillitis

The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group and control group. Experimental group: On the basis of conventional therapy,combined with xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: Xiyanping injection simulation(0.9% normal saline) 10-20ml/d,the treatment method is the same as the experimental group. Treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped treatment).

Eligibility Criteria:
Inclusion Criteria:

* 1.18-65 years, males or females;
* 2.patients met the acute tonsillitis diagnosis;
* 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial
* 4.patients compliance is good, written informed consent was obtained from all participants before the study.

Exclusion Criteria:

* 1.Patients had a history of andrographolide sulfonate or andrographolide allergy.
* 2.Pregnancy, lactation, and absence of contraception in women of fertile age.
* 3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases.
* 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases
* 5.Patients using systemic steroids or other immunosuppressive therapy
* 6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases.
* 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
* 8.Patients were participated in any study of drug trials in the last 30 days.
* 9.According to the researchers' judgment, anyone who are not suitable for the study.
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants

This is a multi-site study of 272 premature infants \>32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.


Eligibility Criteria:
Inclusion Criteria:

Premature infants diagnosed with SGA, RDS and/or Sepsis \>32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing

Exclusion Criteria:

Infants with diagnoses other than the above