cyrilzakka/clinical-trials huggingface dataset:
A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata

This study includes a dose escalation part(phase I) and a dose extension part(phase II).

In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers.

In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.

Eligibility Criteria:
Inclusion Criteria:

* 18 \~ 65 years old (including boundary value), regardless of gender;
* Diagnosis of Alopecia Areata;
* Hair loss accounts for 5% \~ 49% of the total scalp area;
* The duration of hair loss is at least 6 months, the longest is not more than 5 years;
* Patients can complete treatment for at least 6 months;
* About Fertility needs meet the following criteria: The results of serum pregnancy tests performed by fertile women during screening visits must be negative, and the results of human chorionic gonadotropin tests performed before the initiation of the study drug must be negative;Women who were fertile and men who had not received vasectomies were required to use effective contraception throughout the study period beginning with the informed consent and up to six months after the last administration;
* Subjects will voluntarily participate in the study after learning about the content and potential adverse drug reactions and must sign an IRC-approved informed consent prior to beginning any examination required by the study;
* Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.

Exclusion Criteria:

* The following causes of hair loss should be excluded: hair loss caused by androgenic alopecia,syphilis, thyroid diseases, etc.
* Acute Diffuse and Total Alopecia of the Female Scalp;
* Prior history of serious chronic diseases, such as thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor and mental illness, etc;
* Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus infection;
* Participated in a trial for a topical or oral JAK inhibitor;
* Allergic reactions to active ingredients or excipients are known or determined by the investigator;
* Receipt of treatment known to potentially affect the course of AA within last 3 month;
* In the opinion of the investigator , the subject is inappropriate for entry into this study.
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects age 18 years or older;
2. Diagnosed with EGPA for at least 6 months;
3. History of relapsing or refractory EGPA；
4. Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization;
5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.

Exclusion Criteria:

1. Subjects with other eosinophilic-related diseases;
2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
3. Life-threatening EGPA within 3 months prior to randomization;
4. Malignancy history within 5 years prior to randomization;
5. Immunodeficiency;
6. Uncontrolled hypertension；
7. Uncontrolled cerebrovascular and cardiovascular disease;
8. parasitic infection within 6 months prior to randomization;
9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
10. Subjects with a dose of oral prednisone of \>50 mg/day within 4 weeks prior to randomization;
11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
14. Rituximab or alemtuzumab used within 12 months prior to randomization；
15. Surgical plans that might affect the evaluation;
16. Significant laboratory abnormalities；
17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
20. Subjects is pregnant, lactating, or planning to be pregnant;
21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
22. Other conditions unsuitable for participation in the study per investigator judgement.
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes

The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.

This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.

Exclusion Criteria:

1. Type1 diabetes or ketoacidosis
2. End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
3. Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
4. Any stage of heart failure
5. Previous history of pancreatitis
6. Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
7. Pregnant or lactating females
A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects
2. 18-30 years-old

Exclusion Criteria:

1. Pregnancy
2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum

The hypothesis is that in patients with emphysema, a high MMP12 sputum and/or blood level correlates with airspace enlargement and with increased sputum Th2 immune biomarkers.

Since MMP-12 apparently has a preponderant role in the genesis of emphysema and probably in airspace enlargement, its inhibition may result in an interesting targeting point in view to find specific therapies in obstructive diseases. There is abundant evidence in animal models that shows how MMP-12 blockade inhibits the development of emphysema and airway remodeling. Unfortunately, the results have not been conclusive in human models.

In the last years, pulmonary imaging biomarkers that measure airspace enlargement have been developed. In particular, the apparent diffusion coefficient (ADC), quantified by inhaled hyperpolarized gas MRI, reflects alveolar airspace size. ADC provides information consistent with histopathological findings that may be used to estimate lung disease progression and treatment response.

Eligibility Criteria:
Inclusion Criteria (COPD):

* ≥40 years of age
* Current or ex-smokers with a \>10 pack year smoking history
* Have a post-bronchodilator forced expired volume in 1 second (FEV1)/forced expired vital capacity (FVC) ratio of \<70% and a post-bronchodilator FEV1 value from ≥30% predicted (GOLD 1, 2 and 3), (Global Initiative for Obstructive Lung disease)
* Have a radiologist confirmed pulmonary emphysema diagnosis based on CT

Inclusion criteria for normal controls:

* No clinically significant medical condition or a history of asthma, COPD, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.
* No current or past smoking history
* Have a post-bronchodilator FEV1/FVC ratio of \>70%

Exclusion Criteria:

Any potential subject who meets any of the following criteria will be excluded from participating in the study:

* Patients with other non-COPD airway diseases
* Patients with very severe COPD (FEV1\<30% predicted)
* Patients with an intercurrent exacerbation
* Patients with life expectancy less than 3 months
* Pregnant or breastfeeding
* Undergoing immunomodulatory or biologic treatment
* Use of systemic steroids in the last month
* Hospitalization in the last 12 months due to exacerbation
* Known cardiovascular comorbidity under treatment or with hospitalizations of this cause in the last year
* That they cannot perform spirometry
* Active malignancy
* Realization of lung surgery during the study period
* History of alcohol and drug abuse that prevents compliance with follow-up
* History of bronchial thermoplasty
* Participating in another study concomitantly
* MRI Related: patients who have implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, artificial limb, metallic fragments of foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).
Prognostic Biomarkers for Pulpotomy Outcome

This study will recruit 180 molars diagnosed with irreversible pulpitis. Full pulpotomy will be performed on 120 teeth, while RCT (root canal treatment) will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes. Additionally, 12 blood samples and pulp tissues from healthy teeth receiving elective RCT will be collected as the controls. The first pulpal blood sample will be collected after caries removal and pulp exposure. Subsequently, the entire coronal pulp tissue will be removed and collected for histological examination, image-based spatial and scRNA-seq analyses. A second pulpal blood sample will be collected from the radicular pulp tissue. Both blood samples will be used to profile the inflammation-related biomarkers through multiplex immunoassays. The remaining pulp tissue will be covered by Biodentine and restored with resin-based composite. Pulpotomy treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months. The biomarkers identified in the pulpal blood and histology and the single-cell transcriptomes of the coronal pulp will be compared with the treatment "success" and "failure" groups upon one year. The outcome of RCT will be compared with that of full pulpotomy at 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Permanent molars showing clinical and radiographic evidence of a deep carious lesion (extend to the three-quarters thickness of dentine radiographically) extending close to the pulp chamber
* Clinical diagnosis of irreversible pulpitis, including spontaneous pain, lingering pain with cold stimulation, no or mild tenderness to percussion, normal apical tissue or widening of the periodontal ligament space but with no signs of periapical periodontitis (i.e., PAI score 1 or 2)
* Positive response to cold and electric pulp test.

Exclusion Criteria:

* Tooth with no response to the cold and electric tests, presence of apical radiolucency (greater than periodontal widening), signs of canal calcification and resorption, history of trauma, unrestorable or nonfunctional teeth, and evidence of perio-endo lesion
* Intraoperative bleeding time is more than 10 minutes or less than 10 μL pulpal blood can be obtained
* Patients with a compromised immune status (such as HIV or organ transplant) or with any history of taking analgesics/antibiotics in the past one week.
PAthwAy of Dyspneic patIent in Emergency in France

This observational retrospective multi-center study focuses on patients treated for acute dyspnea by emergency medical teams. The primary objective is to identify factors associated with the risk of mortality and rehospitalization in these patients. This evaluation will be conducted both overall and within specific subgroups of interest, including gender (men/women), age categories, mode of admission, and comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Man or women aged 18 years and older.
* Patients with acute dyspnea managed by a medical emergency team at the investigator centers between 2010 and 2021.

Exclusion Criteria:

- Cardiorespiratory arrest before emergency department management.
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.


Eligibility Criteria:
Inclusion Criteria:

* Less than 10 kg
* Subjects less than or equal to 28 days old

Exclusion Criteria:

* Underdeveloped skin at sites of sensor placement
* Jaundice or bilirubin levels out of normal range
* Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study
* Subject deemed not eligible based on Principal Investigator's judgment
Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.

Stroke is a leading cause of mobility disability for adults. Selfit is an advanced practice system that enables a wide range of exercises to improve patient mobility in the sub-acute stage after a stroke. The system collects, measures and analyzes the patient's activity in practice.

Objectives of the study: An evaluation of the improvement of mobility after a stroke using the Selfit system.

Type of study: Case Control Study. Study population: 30 patients, after stroke (men and women aged 18-85). Criteria for Inclusion: Stroke patients who are capable to walk with a little help or no help at all, with or without any assitive device, for a distance of 10 meters.

Intervention: Random distribution of the study participants into two groups - Case: stroke patients (15 patients) - evaluation of patients using Selfit for 2 sessions per week, for a period of at least 30 minutes per session, during 3 weeks.

Control: Stroke patients (15 patients) - continuing with current therapy with no use of the Selfit system.

Measurement tools and outcome measures:

Duration of each treatment session, the duration of the actual treatment, the number of technical failures in the system during the exercise and the duration of each session will be recorded. At the end of the intervention, questionnaires describing the experience of using the system will be completed with a rating of the degree of satisfaction, convenience and simplicity of using the Selfit system. The following tests will be carried out : 10 meter walk test, Timed up and go test, Dynamic Gait Index (DGI).

Analysis of the data: For each patient's treatment, a personal activity profile will be established that includes the timing and speed of walking, the number of steps, the length and width of each step, the elevation of the leg at each step and the accuracy of the patient's performance. Statistical analysis will examine the various levels of activity throughout the intervention period for each patient and for the entire study population before and after the intervention. At the same time, the correlation between the level of activity in the treatment and the scores on the neurological tests will be examined. The data will be presented descriptively for the therapist and patient. For statistical analysis, the SPPS version 21 (IBM) will be used.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Stroke .Must walk with little or no help at all, with or without an assistive device, for a distance of at least 10 meters.

Exclusion Criteria:

- .Patients suffering from significant lower back pain and / or previous orthopedic impairment and / or cognitive impairment (grade 18 and below according to the MOCA test).

.Patients who are unable to move with little or no help at all, with or without an assistive device, for a distance of 10 meters.
Weight Loss Among Adults in Beijing, China

The purpose of this study is to test the effect of a mobile phone-assisted lifestyle intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared to a control group.

The rapid gains in China's economic development during the past two decades have been accompanied by similar gains in the population's waistline. Over 25% of Chinese adult females and more than a third of males are overweight or obese and rates are highest in urban areas such as Beijing. By 2015, overweight/obesity prevalence in China may reach 50% , thus imposing a heavy toll on chronic disease rates and health care costs. Despite these pressing public health challenges, very few obesity intervention studies have been conducted among Chinese adults.

Duke University and Peking University have partnered to implement an intervention to address these rapid changes in weight. 124 participants in Beijing will be randomly assigned to either: (1) usual care (UC), or; (2) a 6-month weight loss (WL) intervention condition. The primary outcome is weight change (kg) at 6 months post-baseline. Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline.

Participants randomized to the intervention arm will receive a series of components, delivered over 6 months: personalized behavior change goals to be self-monitored via text messaging, group "starter" counseling sessions, and personalized individual counseling. Each participant will also receive a pedometer to facilitate self-monitoring. These are evidence-based approaches, drawn from the investigators' collective research experience.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 24,
* age 30-55 years
* current use of a mobile phone
* interest in losing weight.

Exclusion Criteria:

* Pregnancy or plans to become pregnant within 10 months of recruitment
* current lactation
* occurrence of a major cardiovascular disease (e.g., myocardial infarction or stroke in the past 6 months)
* other serious medical conditions that contraindicate weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment in past 2 years)
* blood pressure ≥ 160/100 mm Hg
* type 2 diabetes or controlled by lifestyle only
* use of medications known to increase body weight
* substance abuse; psychiatric illness, including major depression, which could interfere with study adherence
* prior or planned bariatric surgery
* use of weight loss medications or weight loss ≥ 5% of initial weight in past 6 months
* plans to relocate in next 10 months
Neurological Soft Signs in Neurodegenerative Dementias

The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:

* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?
* Are NSS associated with neuropsychiatric alterations in dementia patients?
* Do NSS correlate with cognitive screening tools?
* Do NSS increase over time in patients with neurodegenerative dementias?

Participants will undergo assessments including:

* Evaluation of NSS using the Heidelberg scale
* Neuropsychiatric assessments
* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)

Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or probable Lewy Body Dementia (LBD) according to established clinical criteria.
* MMSE score greater than 10.
* Age and gender-matched controls without a history of neurological or psychiatric conditions.

Exclusion Criteria:

* Mixed dementia or vascular etiology.
* History of neurological or psychiatric conditions predating the dementia diagnosis.
* Substance or alcohol abuse history.
* Known comorbidities affecting neurological or psychiatric function.
* MMSE score less than or equal to 10.
* Inability to provide informed consent.
Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection

The objective of the present study is to analyze the overall tubular function, and in particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in comparison with seronegative controls, by applying a validated tubular physiological test known as "Low sodium infusion test".

Hypothesis is that patients with HIV infection and normal renal function will show subclinical tubular abnormalities compared with seronegative controls

Renal disease is a well recognized complication among patients with HIV infection. Either viral infection itself and the use of some antiretroviral drugs contribute to this serious non AIDS-defining condition that may affect both the glomeruli and the renal tubules.

The thick ascending loop of Henle constitutes the main location for free-water clearance determining kidney´s ability to concentrate and dilute urine in a direct and indirect fashion, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are as follows: adult patients (≥18 years old) with confirmed chronic HIV-1 infection who agreed to provide written informed consent. Patients under antiretroviral treatment must had a stable regimen for over six months and undetectable (\<50 copies/ml) viral load for at least three months. At study entry all selected patients were confirmed as having normal physical examination, routine clinical laboratory including urinalysis, as well as renal and cardiac ultrasound.

Exclusion Criteria:

* Exclusion criteria include patients with acute HIV infection (\< 6 months of disease), personal history of nephropathy, plasma creatinine ≥1.3 mg/dl, Glomerular filtration rate ≤60ml/min/1.73 m² (as determined by Modification of Diet in renal Disease formula), presence of glucosuria/proteinuria (measured in spot urine sample), prior heart failure, concurrent opportunistic infection, chronic active hepatitis B or C, and use of potentially nephrotoxic agents in the prior week before the test (e.g diuretics, angiotensin converting enzyme antagonists, Angiotensin II receptor antagonists or non-steroidal anti-inflammatory agents).