cyrilzakka/clinical-trials huggingface dataset:
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

The aim of this study is to test whether aspirin improves endothelial function in alpha-1 antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.

Emphysema is a common type of lung disease in patients with alpha-1 antitrypsin deficiency (AATD). Emphysema refers to destruction of the fine network of air spaces and blood vessels in the lung, and results in what looks like "holes" in the lung. Emphysema is associated with an increased risk of death but currently no medications, except for replacement of alpha-1 antitrypsin (AAT), have been shown to treat emphysema.

The study plans to enroll subjects with alpha-1 antitrypsin deficiency-associated lung disease (PiZZ phenotype) to perform a cross-over randomized controlled trial (RCT) of aspirin compared to placebo to test the hypotheses that aspirin is effective in improving blood flow in the lungs and reducing damage to the endothelial cells. Subjects will be randomized to receive aspirin or placebo for 2 weeks. There will be a 2-week washout period, then the participant will be crossed over to receive the other treatment (those who received aspirin first will receive the placebo and those who received the placebo first will receive aspirin).

Participants who are on alpha-1 replacement therapy who have had fewer than 2 exacerbations in the last year will be asked whether they are interested in a withdrawal study. For this second part of the study, eligible and willing participants will be asked to stop their alpha-1 replacement therapy for 5 weeks and come in for a 4th study visit. This will allow AAT levels to drop briefly to those seen in the absence of AAT augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Alpha-1 antitrypsin deficiency (PiZZ genotype)
* 40 years of age or older
* Evidence of emphysema on CT scan as read by a Radiologist

Exclusion Criteria:

* Platelet count \< 150,000/dL, history of intracranial hemorrhage or severe GI bleed, use of systemic anticoagulant, physician prescribed use of antiplatelet drug (including aspirin and P2Y12 receptor inhibitors), or known severe liver disease
* Immunosuppression by use of medications (including oral prednisone), or those with immunomodulatory disease (organ transplantation, autoimmune conditions or actively-treated malignancy)
* Known atrial fibrillation or left ventricular (LV) systolic heart failure
* Contraindication to MRI, including pregnancy, weight \> 300 lbs (due to weight limits of the machine), those with pacemakers, aneurysm clips, cochlear implants or other implanted electronic devices, or severe claustrophobia;
* Chronic renal insufficiency (estimated GFR \< 45 L/min/1.73 m2 or self report) due to slightly increased risk of nephrogenic systemic fibrosis from gadolinium administration and aspirin-related renal insufficiency
* Exacerbation of respiratory symptoms within the previous 6 weeks, such as that requiring hospitalization, oral prednisone or antibiotics to control symptoms.
Simplified Medical Abortion Screening: A Pilot Demonstration Project

This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.


Eligibility Criteria:
Inclusion criteria:

* Women having medical abortion
The Effect of BIS-guided Propofol Induction on Hemodynamic Response in Patients With Cardiac Risk.

Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. The patients were divided into 2 groups: Group P; Propofol 2 mg / kg bolus (in 10 seconds), Group B; Propofol will be started as an infusion dose of 0,25 mg / kg / min and will be discontinued when the BIS reaches a minimum value of 60. Noninvasive arterial blood pressure and heart rate will be measured at 2-minute intervals during the first 10 minutes of induction and then at 15th , 20th ,30th and 60th minutes peroperatively. Hypotension; mean arterial pressure (MAP) \<60 mmHg, bradycardia heart rate \<60 / min, hypertension MAP\> 120 mmHg and tachycardia heart rate\> 100 / min were defined. The difference of changes, their duration, the difference between the maximal value and the baseline value, and the number of occurrences of hypotension, hypertension, and arrhythmias during the entire induction and perioperative period will be recorded. Noninvasive arterial blood pressure and heart rate measurements of the patients will be made in the postoperative period at 5th , 15th , 30th minutes and at 1st , 2nd , 4th , and 24th hours. At the end of the 1st month, it will be questioned whether the patients encounter a cardiovascular problem that will require treatment or hospitalization in the period following the surgery. All patients will be started with 5 ml / kg / hour IV crystalloid infusion. When the MAP falls below 60 mmHg during induction, the patient will be given the Trendelenburg position and the crystalloid infusion will be increased to 10 ml / kg / hour, and vasoconstrictor drug will be added if the hypotension does not improve within the following 10 minutes.

surgeries performed on patients participating in the study

minor elective ear nose throat surgery (microlaryngeal surgery, biyopsy for ENT malignancy, myringoplasty)

exclusion criteria;history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females

Eligibility Criteria:
Inclusion Criteria:

The patients with a cardiovascular problem requiring ENT surgery lasting less than 2 hours

Exclusion Criteria:

Patients having history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females were excluded from the study.
Investigating Musculoskeletal Health and Wellbeing

Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations.

Methods A prospective cohort of 10000 people aged \> 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale).

Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.


Eligibility Criteria:
Inclusion Criteria:

- Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability

Exclusion Criteria:

- Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia.
Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit

An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of of idiopathic Parkinsons disease
* Motor fluctuations despite optimised per oral treatment

Exclusion Criteria:

* Severe dementia, confusion, psychosis or depression
* Patients with contraindications against levodopa treatment
Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression

To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group was administered the Jiedu Tongluo granules, while the control group was administered the placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke, with neurological deficits symptoms;
* Clinical diagnosis of depression, according to the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3), the score is between 7 to 24 by 17-item Hamilton Depression;
* Age of 45 to 80 years old;
* The patient is conscious, cooperation, without aphasia and severe cognitive impairment after acute phase of stroke;
* Without psychiatric disease history or family history of psychosis before stroke;
* No hormones and psychotropic drugs were used within 1 month before enrollment;
* capacity to provide written consent.

Exclusion Criteria:

* With brain organic disease such as brain tumors;
* Had a history of psychiatric illness or depression before stroke;
* Combined with severe liver, kidney, hematopoietic system disorder;
* Poor glycemic control and insulin-dependent diabetes;
* Participate in any clinical trial or taking antidepressant treatment 1 month prior to baseline;
* Pregnant or breast feeding;
* History of sensitivity to Chinese medicine ingredients.
AMG 745 in Subjects With Age-associated Muscle Loss

Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss


Eligibility Criteria:
Inclusion Criteria:

* Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3
* Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg
* Walk speed ≤ 0.8 m/s (based on a 4 meter walk)

Exclusion Criteria:

* Subject weight \> 137 kg (300 lbs), or Body Mass Index (BMI) \> 32 kg/m2
* Primary muscle disease or myopathy
* Recent immobilization, or major trauma to the legs within 6 months
* Knee or hip replacement within 12 months or lower extremity amputation
* Significant laboratory abnormalities
* Significant comorbidities or medical history
* Weight loss (intentional or unintentional) of \> 5 kg in 12 weeks
* Unable to complete an MRI scan
The Study of Mesenchymal Stem Cells Treat Autoimmune Pulmonary Alveolar Proteinosis in Vitro

Autoimmune pulmonary alveolar proteinosis (aPAP) is a respiratory disease characterized by massive deposition of pulmonary surfactant in the alveoli, involving a variety of immune cells and factor disorders. However, there are certain limits in treatment at present. MSCs can improve the microenvironment in the alveoli by regulating immunity, thereby achieving a good therapeutic effect. The purpose of this study is to use the lavage fluid obtained after whole lung lavage with aPAP to isolate alveolar macrophages, and to use MSC to complete the verification of the efficacy of aPAP primary alveolar macrophages in vitro. A series of protocols including multi-factor detection, cell phenotype analysis and phagocytosis assay were used to evaluate the efficacy of MSCs on alveolar macrophages.


Eligibility Criteria:
Inclusion Criteria:

1. Sign an informed consent form before any research-related activities;
2. No gender restrictions, age ≥18 years old, and ≤75 years old;
3. Patients who need to receive whole lung lavage due to the needs of the disease, and the patient agrees to perform whole lung lavage. The standards are as follows:

   1. The diagnosis of aPAP is clear, and the anti-GM-CSF antibody in serum is greater than 5 μg/ml;
   2. PaO2 \<65 mmHg;
   3. P(A-a)O2\>40 mmHg;
   4. Intrapulmonary shunt \>10%-12%.

Exclusion Criteria:

1. Suffering from multiple chronic respiratory diseases at the same time, including but not limited to chronic obstructive pulmonary disease, pulmonary fibrosis, and asthma;
2. Various malignant tumors or a history of malignant tumors;
3. Uncontrolled pulmonary or systemic infection;
4. Severe other systemic diseases: acute myocardial infarction, unstable angina pectoris, liver cirrhosis, acute glomerulonephritis, etc.;
5. Syphilis, HIV, HCV antibody positive;
6. Patients with coagulation disorders who cannot perform bronchoscopy, such as hemophilia, giant platelet syndrome, thrombocytopenia, etc.;
7. Severe renal impairment, serum creatinine \> 1.5 times the upper limit of normal;
8. Liver disease or liver function damage: ALT, AST, total bilirubin \> 2 times the upper limit of normal;
9. Have any coexisting medical conditions or diseases that the investigators judge may impair the development of this trial;
10. Social and mental disability, no legal capacity/limited capacity;
11. Refuse to sign the informed consent.

    -
Efficacy of a Brown Seaweed Powder for Glycemic Control

The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.

The primary endpoint is incremental area under the curve (iAUC, mmol\*min/L) for blood glucose.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged between 18-45 y
* Normoglycemic (fasting blood glucose \<5.6 mmol/L)
* Body mass index (BMI) 18.5-29.9 kg/m2
* Able to consume bread products

Exclusion Criteria

* Fasting blood glucose \> 5.6 mmol/L
* Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
* Presence of a gastrointestinal disorder within the past year
* Presence of major gastrointestinal surgeries
* Thyroid problems
* Smokers
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement
* Women that are currently pregnant or lactating, or not using an appropriate contraception method
* Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
* Allergic to shellfish (crab) or molluscs
* Weight gain or loss of at least 10lbs in previous three months
Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)

CLET is a published treatment for the management of corneal failure due to extensive LSCD. Due to our previous studies on this novel treatment, the regulatory agency of Spain "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" authorized our institution (IOBA-University of Valladolid) to perform this kind of therapy (CLET) in a case-by-case base following the Special Situation Medicines Policy Procedure in Spain. Upon approval of the permanent authorization patients will be included as specified by AEMPS.The objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.


Eligibility Criteria:
Total and/or severe LSCD of any etiology in one or both eyes.
Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years of age
* Right hand dominate
* Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
* Baseline doppler study with a peak systolic velocity of 400cm/sec
* Patient is deemed candidate for carotid artery stenting
* TIMI flow of 1,2 or 3
* 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
* Subjects are able to give informed consent
* Subjects are willing/able to complete follow-up visits

Exclusion Criteria:

* History of major stroke: within the past 6 months
* History of Alzheimers disease or Dementia
* Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
* Planned intervention opposite carotid artery within 2 months
* Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
* Any individual identified with cognitive impairment which would affect their performance during cognitive testing.
Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline

The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants \< 32 weeks hospitalized between 2016 -2017 were retrospectively analysed, especially all the events related to monitoring of hemoglobin level and RBC transfusions during the first month of life. The criteria (postnatal age, rate of haemoglobin, type of breathing assistance, oxygen needing, medullary regeneration) on which rely the decision process in the HAS algorithm for the RBC transfusion were also considered, as well as the final decision actually adopted for each case (transfused/ not transfused). All this made it possible to determine the kappa coefficient for evaluation of agreement with HAS new guidelines in the investigator's medical staff.


Eligibility Criteria:
Inclusion Criteria:

* preterm infant hospitalized in Amiens School hospital (CHU Amiens-Picardie) between October 2016 and April 2017 during the first month of life, with allowed access on data recorded in medical files concerning the evolution of clinical characteristics (body weight,...) and the results of laboratory analyses performed during this initial hospital stay.

Exclusion Criteria:

* less than 25 weeks or more than 32 weeks at birth
* any hemoglobin dosage during the hospital stay
* serious congenital malformation
* known or documented neonatal red blood cell disease (inherited hemolysis, enzymopathy of red blood cell membrane,...)
Mallet Finger Splinting Study

Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting?

Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?


Eligibility Criteria:
Inclusion Criteria:

* All adult, English-speaking patients in the practice of Dr. Jesse Jupiter, Dr. Chaitanya Mudgal, or Dr. David Ring electing splint treatment for mallet deformity will be invited to enroll on their follow-up visit 6-8 weeks after initiating splint treatment.

Exclusion Criteria:

1. Open lesions
2. Mallet fracture more than 2 weeks old
3. Mallet fracture with subluxation of the distal interphalangeal joint.
Volumetric Impedance to Guide Stroke Response

Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry


Eligibility Criteria:
Inclusion Criteria:

* Being evaluated as a suspected stroke

Exclusion Criteria:

-
Evaluation of APAP With SensAwake in OSA and Insomnia Patients

The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.

Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age.
* Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 with no more than 20% of central respiratory events)
* Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
* Fluent in spoken and written French

Exclusion Criteria:

* Significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or Left Ventricular Ejection Fraction (LVEF) \< 45%
* Co-existing lung disease, as per the principal investigator's discretion
* Co-existing sleep disorder, such as predominant central sleep apnea
* Previous or current diagnosis of sleep phase delay
* Pregnancy
* Participants that are unable or unwilling to give informed consent
* Receiving cognitive behavioral therapy or other intervention to treat insomnia. Subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study.
* Diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months.
* Hospital Anxiety OR Depression score \> 11
* Participating in another research study for the duration of participation in this study. Participation in an observational study or genetic study is permitted at the discretion of the investigator.
* Patient protected by the Law, under guardianship or curators, as defined in Public Health Code in articles from L1121-5 to L1121-8.
* Patient not covered by a health insurance
A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia

The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years
* Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
* Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity \[TRV\] \>2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation \<90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to \<88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).

Exclusion Criteria:

* Daily supplemental oxygen use
* Inability to provide informed consent
Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer

This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.

Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each)

\[Group A\] Pregabalin+ Polmacoxib. \[Group B\] Polmacoxib \[Group C\] Pregabalin

Eligibility Criteria:
Key Inclusion Criteria:

* Adequate Biochemistry, Urinalysis, Serology and so on.
* Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation.
* Negative pregnancy test (hCG) and agree to contraception during the trial.

Key Exclusion Criteria:

* History of hypersensitivity to investigational products.
* History of hypersensitivity or allergic reaction to sulfonamide.
* Patients with a history of asthma, acute rhinitis, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors)
* Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.