cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease

The purpose of this study is to determine whether Lingzhi (Ganoderma), a widely used traditional Chinese Medicine is effective and safe in the treatment of Parkinson's disease when combined use with L-dopa.

This study is to focus on the effects of Lingzhi on non-motor symptoms of Parkinson's diseases as the primary outcome and on delaying the disease progression using the delay start design as the secondary outcome measurement. Two dosage groups and one placebo control group with total 360 subjects will be recruited. The treatment is one year.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to give informed consent
* age 30 years or older at time of diagnosis of Parkinson's disease
* have idiopathic Parkinson's disease, defined as:

  * having at least 2 of the following 4 signs: resting tremor, bradykinesia, rigidity, or postural reflex impairment, at least one of which must be resting tremor or bradykinesia
  * no secondary or atypical parkinsonism
  * asymmetric features (current signs or history of asymmetric onset)
  * response to L-dopa, by patient self-report
* Parkinson's disease duration of no more than 5 years
* receiving stable therapy of L-dopa/DCI for at least 3 months; acceptable dose range: 250 mg - 1000 mg L-dopa/DCI daily
* Hoehn and Yahr stage \< 4 on stable L-dopa/DCI treatment

Exclusion Criteria:

* have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
* have any other known medical or psychiatric condition that may compromise their participation in the study
* have taken another investigational drug within 90 days of baseline
* have a change in dosage of any other antiparkinsonian drug (eg, pramipexole, ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or amantadine) during the study or within 90 days prior to baseline
* have received treatment with dopamine blocking agents (including neuroleptic agents, antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine) within 90 days prior to baseline
* do not consent to participate
Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

The primary purpose of this study is to investigate medication utilization pattern and risk of adverse outcomes among commonly used antidepressants by using nationwide claims database, in order to assess overall clinical benefit of antidepressant therapy in real-world practice.

While there are many antidepressants from which physicians can select based on efficacy and tolerability profile, evidence on effectiveness and safety outcomes of new antidepressants in real clinical practice among Korean MDD population is limited.

Hence, this study will explore the following primary, secondary objectives using national health insurance database :

1. Explore baseline characteristics and drug utilization patterns of 11 commonly used antidepressant therapy during 90 days of acute treatment phase
2. Explore drug utilization patterns such as therapy changes, medication compliance and recurrence relationship, and risk of adverse outcomes during maintenance phase
3. Choice of antidepressants and drug utilization patterns in patients with various comorbidities
4. The relationship of non-pharmacologic treatment and discontinuation, medication compliance
5. Choice of antidepressants by non-psychiatric specialty

Eligibility Criteria:
Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients aged 18 years or older on the index date
2. Patients who had at least one inpatient claim or two outpatient claims in the intake period with any of the following diagnosis codes F06.3 Organic mood \[affective\] disorders F32\* Depressive episode F33\* Recurrent depressive disorder F34.1 Neurotic depression F38.1 Other recurrent mood \[affective\] disorder F41.2 Mixed anxiety and depressive disorder
3. Patients prescribed any of the following antidepressant during intake period (from January 1, 2017 to June 30, 2018)

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients with a claim of diagnosis codes in Table 1 during the 12 month pre-index period
2. Patients with a claim of prescription in Table 2 during the 12 month pre-index period
3. Patient who had a claim as a beneficiary of Medical Aid program (Korean Medicaid program with free or minimum copay)
4. Patients who are hospitalized at the index date
5. Patients who are under hospice care (procedure codes WG\*-WO\*)
NMES in HF Patients to Improve Functional Recovery Following Hospitalization

The goal of this research study is to understand whether an at-home exercise program started after hospitalization for HFpEF, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.

Heart failure is the leading cause of hospitalization among adults in the US with patients with preserved ejection fraction (HFpEF) comprising half of those admissions. Many patients exhibit chronic fatigue, exercise intolerance and an inability to perform activities of daily living, which is exacerbated by hospitalization. The goal of this research study is to understand whether an at-home exercise program started soon after hospitalization and continuing for 4 weeks following discharge can improve functional recovery in HFpEF patients. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated during hospitalization and 4 weeks following discharge. Assessments will include measurements of physical function by 6 minute walk test and the Short Physical Performance Battery, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36 and Kansas City Cardiomyopathy questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 50-90 years of age
* clinical diagnosis of HF being actively managed during hospitalization
* live within 30 miles of the medical center
* able to perform informed consent

Exclusion Criteria:

* rheumatoid arthritis or other inflammatory/autoimmune disease
* cancer, excluding non-melanoma skin cancer or low-grade prostate cancer
* severe dementia/alzheimer's disease
* exercise limiting peripheral vascular disease
* neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
* body mass index ≥40 kg/m2
* lower extremity blood clot or implantable cardioverter-defibrillator or pacemaker
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)

This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
* Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:

  * Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
  * Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:

  1. Metformin
  2. Dipeptidyl peptidase-4 (DPP-4) inhibitor
  3. sodium glucose cotransporter 2 (SGLT2) inhibitor
  4. oral glucagon-like peptide 1 (GLP-1) agonist
* Doses of OAMs are required to have been stable for at least 90 days prior to screening.
* Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
* Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.

Exclusion Criteria:

* Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
* Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
* Have hypoglycemia unawareness as judged by the investigator.
A Cohort of Acute, Ischemic and Rare Neuropathies

Neuropathies are defined as the clinical, electrical, biological and histological manifestations of peripheral neuron damage. They represent a heterogeneous group of disorders and are responsible for disabling sensory and motor disorders. Their diagnosis is based on a set of clinical arguments confirmed by the electromyogram. This allows to specify the site of the damage, its severity, and to follow the evolution of the disease.

To date, the diagnosis of peripheral nerve injury secondary to occlusion of arterial trunks is rarely evoked; its clinical, electromyographic and prognostic characteristics are poorly known. Indeed, the rare cases reported in the literature are from vascular specialties, with little data on neurological symptoms, neurophysiological diagnostic elements and prognosis.

However, these unrecognized and underdiagnosed neuropathies are sometimes indicative of severe vascular damage for which urgent management is necessary. Neurological symptoms should then be treated as warning signs and the correct recognition of the early ischemic vascular etiology may lead to an optimized medical management.

The objectives of this study will be to describe the clinical presentation of these neuropathies, to discuss their electrophysiological diagnostic characteristics, to compare the demographic data with those from the literature, and to evaluate the functional prognosis of these attacks. A better knowledge of this rare etiology of neuropathy would allow to better inform the patients and to optimize the diagnostic and therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient hospitalized or seen in neurophysiological consultation/exploration in the Neurology Department within the Groupe Hospitalier Paris Saint-Joseph
* Diagnosis of acute or subacute peripheral nerve ischemia
* French speaking patient

Exclusion Criteria:

* Patient with impaired comprehension making it impossible to understand the protocol
* Patient under guardianship or curatorship
* Patient under court protection
* Patient deprived of liberty
* Patient or relative who objects to the use of his/her data
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.

IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.

The study was powered to detect 10% difference in 3 year OS.


Eligibility Criteria:
Inclusion Criteria:

* age \> 6 months and \< 18 years
* no distant metastases
* diagnosis within previous 8 weeks without prior treatment except surgery
* pathology available for central review
* written consent according to institutional requirement

Exclusion Criteria:

* stage III (node positive)
* stage I or II non alveolar orbital tumours
* patients with parameningeal disease aged \< 3 years
Ramelteon Prevention of Delirium - RCT

Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been unsatisfactory and prevention is the preferred goal. Based on limited experimental research, ramelteon appears to have promise for prevention. This study will evaluate ramelteon in prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.

Delirium is a very common condition that is associated with significant complications in hospitalized adults.

The manifestations of delirium are the result of a disturbance of brain functioning, the causes of which include a very wide array of illnesses, intoxications, and stresses. Delirium has been estimated to affect 20-50% of hospitalized patients, and to be associated with longer hospital stay (2x), greater likelihood of discharge to nursing home (2x), and higher rate of death (2x). 20% have delirium on admission. Patients who experience delirium may have persistent confusion (cognitive impairment). In 20%, this confusion appears to be permanent. Treatment of delirium has been unsatisfactory. Once it develops, no therapy or intervention has demonstrated a meaningful reduction of delirium associated complications. Prevention is clearly the preferred goal. Based on limited reports, ramelteon appears to have the most promise for prevention. Ramelteon, FDA approved (2005) as a nonscheduled prescription hypnotic agent, is generally considered safe and effective with no serious associated side effects, and no limitation of duration of use. It is related to melatonin in action and shares sleep promoting effects (reduced sleep latency) and improvement in coordination of circadian cycles. A recent randomized placebo-controlled single blinded trial of ramelteon treated 33 patients with ramelteon 8 mg/d. The researchers reported that ramelteon was associated with a dramatically lower risk of delirium (3% vs 32%; P = .003), with a relative risk of 0.09. Estimates of time to develop delirium were delayed for ramelteon compared to placebo, and the frequency of delirium was significantly lower in ramelteon compared to placebo (P = .002). There were significant limitations of this study, however, including a very high exclusion rate (1059 of 1126 \[94%\] patients assessed were excluded), a 24+ hour delay in initiation of study agent, a small sample size, and unclear sampling bias. The investigators propose a clinical trial of ramelteon to prevent delirium in patients admitted to Hartford Hospital. Hartford Hospital is in a unique position to conduct this study having established the ADAPT program to systematically apply best practices to the assessment and management of delirium. A registry of patients screened contains all of the screening results (over 1.5 million CAM screens on nearly 91,000 patients). Our study will permit us to evaluate the recent limited research findings regarding ramelteon in a larger general adult hospitalized population, and evaluate the potential benefit of treatment started earlier in the course of a hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* from designated nursing units

Exclusion Criteria:

-
Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer.

PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.

OBJECTIVES:

* Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer.
* Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA) in these patients.
* Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients.
* Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients.
* Determine the relationship between the presence of OM and disease-free survival in these patients.
* Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients.

OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction.

Patients are followed every 6 months for 5 years.

Eligibility Criteria:
* Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2 primary N1 or N2 lymph nodes \<1cm on CT or negative mediastinoscopy
* ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT.
* ≥ 18 years of age
* No history of previous lung cancer or concomitant malignancy
Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients with NAFLD

This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Eligibility Criteria:
Inclusion Criteria:

* NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
* Patient without known heart disease
* Patient agreeing to participate and who has given his non opposition

Exclusion Criteria:

* Association with another cause of liver disease
* Already known coronary artery disease
* Pregnancy or breastfeeding in progress
Study of the Prevalence of Fabry Disease in French Dialysis Patients

Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked mutation and characterized by an alpha-galactosidase A (GLA) deficiency. It causes globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency. Due to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other organs irreversible lesions, and to enhance the familial screening.

We aim to conduct a multicentric cross-sectional prevalence study in 5 areas (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving biologic collection and genetic diagnosis test. Our objective is to measure the prevalence of FD among dialysis patients. Eligible patients will be included after signing the informed consent.

In the five participating areas, all of the dialysis centers will be asked for involvement. Nominative data of the French renal epidemiology and information network (REIN) registry will enable first patients screening for eligibility among prevalent dialysis patients. If needed (insufficient or absent data in the REIN registry), data will be completed with medical files.

A blood drop will be collected during a hemodialysis session (or the monthly test for peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas screening in women will be established on the association of alpha-galactosidase activity and lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in order to confirm the diagnosis for women, and, for all, to offer familial testing. Results will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed with FD will be managed in accordance with the guidelines of the French National Authority for Health (F.N.A.H.).


Eligibility Criteria:
Inclusion Criteria:

* Woman or men
* Age between 18 to 70 years
* Patient undergoing chronic renal dialysis with a confirmed diagnosis of FD or a diagnosis of nephropathy according to the French renal epidemiology and information network (REIN) registry classification :
* Primitive glomerulonephritis
* Hypertension
* Diabetic nephropathy with non type 1 diabetes
* Vascular nephropathy
* Pyelonephritis
* Unknown or other
* Informed consent signed

Exclusion Criteria:

* IgA nephropathy confirmed by renal biopsy
* Diabetic nephropathy with type 1 diabetes
* Autosomal dominant polycystic kidney disease
* Law-protected patient
* Patient who doesn't belong to the national social security system, or similar system
* Pregnant or lactating woman
Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator

Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.

The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.


Eligibility Criteria:
Inclusion criteria:

* Requiring a lumbar puncture as part of their routine care
* Male or female of legal age with no upper age limit
* French speaking
* Subject affiliated to a social health insurance scheme
* Not having expressed his or her opposition to the re-use of his or her data in the context of this research

Exclusion criteria:

* Previously undergone a lumbar puncture
* BMI \> 35 kg/m².
* Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
* Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under court protection
* Subject under guardianship or curatorship
* Contraindication to the use of Emlapatch