cyrilzakka/clinical-trials huggingface dataset:
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)

The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.


Eligibility Criteria:
Inclusion Criteria:

1. LVEF \</= 35% as assessed by echocardiography.
2. New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
3. QRS duration of \>/= 120 ms.
4. Ability to provide written, informed consent.
5. Age \> 18 years.
6. Successful implant of a biventricular/ICD pacemaker device.

Exclusion Criteria:

1. Documented Chronic Atrial Fibrillation
2. Life expectancy less that 6 months due to non-cardiac causes
3. Inability to place a coronary sinus left ventricular pacing lead
4. Pregnancy
5. Scheduled cardiac surgery within the next 6 months
6. Prosthetic Tricuspid Valve
Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia

Hypothesis

That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection

Tuberculosis (TB) will be the world's largest single cause of death from infection for the 30-year period between 1990 and 2020. More than 95% of TB cases, and deaths due to TB, occur in developing countries. Mongolia is one of the countries with the highest tuberculosis burdens in the Western Pacific region. In addition, vitamin D deficiency is endemic in Mongolia. We propose to determine the efficacy of vitamin D supplements, as an adjunct to multidrug therapy, in enhancing the anti-microbial immune response to TB, a finding that could lead to the development of shorter drug regimens, and thus more efficient and effective TB treatment protocols.

We propose to conduct a double blind, placebo controlled, randomized clinical trial to test the effect of a daily vitamin D supplementation on the ability of subjects to control TB infection.

The Primary Endpoint: The primary endpoint will be: time to sputum culture conversion from positive to negative. The number of days to sputum conversion will be measured, in both the intervention and control groups, starting on the date that treatment is begun. Sputum samples will be collected and cultured every two weeks thereafter. The date of conversion from positive to negative, for each subject, will be the date halfway between the date of the last culture-positive sputum and the first culture-negative one.

Secondary Endpoints:

Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Sputum positive TB patients

Exclusion Criteria:

* We will exclude those with abnormal LFTs at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis
White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI

Cerebral small vessel diseases (SVD) are a very frequent group of disorders all characterized by alterations of the structure and/or function of small arteries, veins and capillaries. In these disorders, brain tissue lesions accumulate years before the occurrence of clinical symptoms which can be devastating such as stroke, cognitive disturbances and gait disorders. So far, chronic hypoperfusion was considered to be responsible for the accumulation of such lesions. However, recent results have suggested that the lesions underlying white matter hyperintensities (WMH), the most common MRI marker of SVD visible on conventional MRI in quite every subject with SVD long before the occurrence of clinical events, may depend on the considered brain area and may correspond to various mechanisms. Some WMH may even be associated with less severe clinical manifestations.The aim of the present study is to identify different types of WMH by studying 100 patients with different forms of SVD with the most advanced MRI (including ultra-high-resolution imaging at 7 Tesla, new diffusion protocol, sodium MRI, contrast-enhanced angiography and relaxometry and post-processing techniques), and post-processing techniques (machine learning, deep learning, artificial intelligence).


Eligibility Criteria:
Inclusion Criteria:

* Subjects or patients with MRI defined cerebral small vessel disease including different extents of white matter hyperintensities, presumably related to hypertension (30 patients), cerebral amyloid angiopathy (30 patients), CADASIL (30 patients) or any other monogenic form of cerebral small vessel disease (HTRA1 AD, COLIVA1... 10 patients)
* Age ≥ 18 years
* No dementia (MMSE \> 24 and absence of dependence in daily activities)
* No disability (modified Rankin's scale \< 2)
* No history of severe allergic reaction, in particular to gadolinium infusion
* No history of severe asthma
* No renal insufficiency (clearance \< 60 ml/mn/1.73 m2)

Exclusion Criteria:

* Contraindications to MRI
* Standard MRI of bad quality due to movement artefacts
* Dementia or disability
* Patient without affiliation to the French social security
Emergent Stenting In Acute Vertebrobasilar Occlusions

In the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. However, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. The investigators investigated whether the improvement of clinical outcome was achieved in postprocedural 3-month.

Acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (LVOs) occur 0.8% - 5.7%. Although mechanical thrombectomy (MT) has recently been the gold standard in LVOs treatment, the futile recanalization (defined as unfavorable outcome despite early successful recanalization of target artery) rate was showed in posterior circulation higher than in anterior one. Multiple randomized controlled trials (BEST, BASICS, BAOCHE, ATTENTION) have recently reported the benefit of endovascular treatment better than of standard medical treatment for acute vertebrobasilar occlusions stroke. Besides, up to 36% LVOs with underlying intracranial stenosis and 64% with tandem lesions occured in the acute vertebrobasilar stroke. This was a reason why emergent stenting was considered to support the successful recanalization in the setting of failure of mechanical thrombectomy. Moreover, the successful recanalization is one of the independent predictors of good outcomes. However, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. Therefore, we aimed to investigate whether the impact of emergent stenting on the improved clinical outcome in vertebrobasilar occlusions.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Onset to treatment time \< 24 hours
* NIHSS ≥ 10
* pc-ASPECTS ≥ 5 on MRI

Exclusion Criteria:

* Premorbid mRS \> 2
* Extensive, bilateral brain-stem infarction on neuroimaging
* Cerebellar mass effect on neuroimaging
Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency

This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL Deficiency and was designed to examine 3 doses of sebelipase alfa. The targeted number for this study was 9 evaluable participants.

The study was composed of a screening period, a treatment period, and a post-treatment follow-up period (including an End of Study visit). Participants who successfully completed screening assessments to determine study eligibility were allocated to 3 sequential cohorts (0.35, 1, or 3 milligrams/kilogram \[mg/kg\]). Within each cohort, one participant was initially dosed and, if sebelipase alfa was deemed safe and well tolerated in this participant (based on at least 24 hours of monitoring), dosing was allowed to be initiated for the remaining participants in the cohort. Initiation of dosing in the next cohort occurred only after all participants in the preceding cohort had been monitored for at least 5 days after the second infusion, without any evidence of significant safety signals, and an independent Safety Committee had reviewed the cumulative safety data and provided their recommendation on the acceptability of beginning dosing in the next cohort.

Cholesteryl Ester Storage Disease (CESD) is the late onset phenotype for LAL Deficiency, a lysosomal storage disorder, which also has an early onset phenotype known as Wolman disease that primarily affects infants. CESD can present in childhood but often goes unrecognized until adulthood when the underlying pathology is advanced. Many of the signs and symptoms are common to participants with other liver conditions.

CESD is an autosomal recessive genetic condition and is characterized by hepatomegaly, persistently abnormal liver function tests and type II hyperlipidemia. Splenomegaly and evidence of mild hypersplenism may affect some participants. Untreated, CESD may lead to fibrosis, cirrhosis, liver failure and death.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥ 18 and ≤ 65 years of age
* Documented decreased LAL activity
* Evidence of liver involvement

Exclusion Criteria:

* Clinically significant concurrent disease, serious inter-current illness, concomitant medications or other extenuating circumstances
* Clinically significant abnormal values on laboratory screening tests, other than liver function or lipid panel tests
* Aspartate aminotransferase and/or alanine aminotransferase persistently elevated \> 3x upper limit of normal at screening
* Previous hemopoietic bone marrow or liver transplant
* Current history of alcohol abuse
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of AMI, either with or without ST segment elevation
2. Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)

Exclusion Criteria:

1. Age under 18 years old
2. History of DM
3. Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
4. Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
5. Platelet aggregation or coagulation disorders
6. Severe conditions with an estimated short (under 1 year) life expectancy
7. Participation in other trials
8. Patient refusal to participate in the study
Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)

The main objective of this study is to determine the prevalence of sarcopenia in patients hospitalized in the follow-up care and rehabilitation units of the geriatrics department of the Mulhouse French hospital.

Secondary objectives

1. To assess the performance of the SARC-F questionnaire to screen for sarcopenia ;
2. To describe the characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization);
3. To identify predictive factors of sarcopenia;
4. To determine, in the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of sarcopenia between admission and discharge of the following variables :

   1. muscle strength,
   2. muscle mass,
   3. functional ability,
   4. dependency.

Conduct of research

After receiving the written consent of the study participant, all of the following tests and questionnaires will be performed :

* SARC-F questionnaire,
* measurement of muscle strengh by a grip test,
* measurement of muscle mass by impedancemetry (ASM/size2),
* 4-meter walking speed test,
* Timed-Up and Go (TUG) test,
* ADL (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) questionnaires.

For patients in day hospital care, the study will end upon completion of these tests.

For patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), a follow-up visit will be scheduled within 72 hours prior to the patient's discharge from the service, or at 3 months of hospitalization. The following tests and questionnaires will be performed during this visit:

* measurement of muscle strengh by a grip test,
* measurement of muscle mass by impedancemetry,
* 4-meter walking speed test,
* Timed Up and Go (TUG) test,
* ADL and IADL questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patient 60 years of age or older
* Patients hospitalized in the follow-up care and rehabilitation units (i.e. day hospital, full hospitalization) of the geriatrics department of the Mulhouse French hospital
* Patient who gave consent to participate in the study
* Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Patient admitted for palliative care
* Bedridden patient
* Patient with major neurocognitive disorders preventing impedancemetry or grip test from being performed, or any other medical condition preventing impedancemtery or grip test from being performed
* Patient under legal protection
* Patient with an unstable psychiatric disorder
* Patient under guardianship or curatorship
* Patient already included in the study during a previous hospitalization

Secondary exclusion criteria :

- For patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), impedancemtry or grip test not performed within 7 days of admission.

Patients excluded secondarily will not be replaced.
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment

The study will be performed in patients with NASH. The primary endpoint will be the assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).

Eligibility Criteria:
Inclusion Criteria:

* Patients have given written informed consent
* Body mass index (BMI) ≤ 50 kg/m²
* For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
* Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²
* Liver fat content ≥ 8% on MRI-PDFF
* Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3
* Effective contraception for women of child bearing potential

Exclusion Criteria:

* Evidence of another form of liver disease
* Evidence of liver cirrhosis
* Evidence of hepatic impairment
* Positive serologic evidence of current infectious liver disease
* History of excessive alcohol intake
* Acute cardiovascular disease within 6 months prior to Randomization
* Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
* Use of non-permitted concomitant medication
* Pregnancy or lactation
Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances

Patients who have severe crowding that required four premolars extraction will be treated in this study. The effects of clear aligners therapy on oral health related quality of life (OHRQoL) in comparison with vestibular fixed appliances using the validated OHIP-14 tool during orthodontic treatment. So the aim of the study was to compare the changes in OHRQoL between patients receiving clear aligners or fixed appliances during the first year of the orthodontic treatment.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consists of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
* Good oral hygiene and periodontal health.
* No congenitally missing or extracted teeth (except for the third molars).
* No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

* Previous orthodontic treatment.
* Subject with psychological abnormalities.
* Subject with systemic diseases.
* Subject has known allergy to latex and plastic
Individualization of Music-based Cueing During Gait in Parkinson's Disease.

Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach.

The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Idiopathic Parkinson's disease based on UKPDSBB criteria
* 10-meter walking comfortable speed between 0,30 and 1,10 m/s
* Capacities to walk with shoes during at least 20 minutes without assistance
* Signature of informed consent

Exclusion Criteria:

* Non-affiliation to Social Security
* Person under protection (e.g. under protection of justice)
* Auditory disorders without treatment
* Cognitive disorders that limit the understanding of the study according to the medical investigator
* Other neurological or orthoêdic disorders that addect walking
* Participating in another Category 1 or 2 interventional clinical study for the duration of the trial
Walnut Consumption and Gut Microbiota

Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. There is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. Since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. The purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. The investigators intention is to identify how these walnut-derived molecules influence Faecalibacterium spp., a butyrate producing microbe. Increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.


Eligibility Criteria:
Inclusion Criteria:

Participants will include adults ages 25-75 years BMI of \> 30 kg/m2 Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion Criteria:

* Walnut allergy or intolerance
* Food allergies or intolerances
* Prior diagnosis of metabolic or gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
* Women that are pregnant, had a baby within the last 12 months, or lactating
* Individuals that smoke, use tobacco, abuse drugs, or consume \> 2 alcoholic beverages per day.
* \> 5% weight change in the past month or \> 10% change in the past year
* Oral antibiotics during the previous 6 weeks
* Fasting blood glucose \>126 mg/dL, blood pressure \>160/100 mm Hg, elevation in serum transaminases (i.e. \>3 times the upper limit of normal) or with evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation, are currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or certain medications (laxatives, bile acid sequestrants, and opiates)
* History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.
* Are unable to consume the experimental meals/snacks.
* Participants who have donated blood within the last 8 weeks
* Recent diagnosis of anemia
* Concurrent enrollment in another dietary, exercise, or medication study
SBRT With Atezo/Bev for HCC

A phase I dose escalation and pharmacodynamic study of repeated dose stereotactic body radiotherapy (SBRT) administered with concurrent atezolizumab and bevacizumab for patients with advanced hepatocellular carcinoma (HCC)


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have hepatocellular carcinoma (HCC) that is not amenable to curative-intent surgical or ablation (where surgery or ablation are not indicated due to disease extent, co-morbidities, or other technical reasons) and systemic therapy is indicated.

Exclusion Criteria:

-