cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).


Eligibility Criteria:
Inclusion Criteria:

1. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease
2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-child-bearing potential.
3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight \>50 kg (110 lbs.). This inclusion criterion will be assessed only at the first screening visit.
4. Hemoglobin ≥12.0g/ld.

Exclusion Criteria:

1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor \[Human\], Berinert \[C1 Estrace Inhibitor (Human)\] and C1 estrace \[recombinant\]
2. Known history of alcohol or other substance abuse within the last year.
3. Donation of blood or blood products within 60 days prior to receiving investigational product.
4. Current use of any medication except hormonal replacement therapy, hormonal contraceptives and occasional use of any over-the-counter non-steroidal anti-inflammatory drug (NSAID) or acetaminophen.
5. Have a history of hypercoagulability or other predisposition to thrombotic events.
Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

This is an investigator initiated registry aimed at assembling a blood/serum and genomic resource (bank) of human blood samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. Funding is from institutional/divisional research funds.

This study is aimed at assembling a blood/serum and genomic resource (bank) of human samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. These samples will be analyzed at UC Davis Medical Center for determination of biomarker levels, and concomitantly analyzed at UC San Francisco in an IRB-approved protocol at that institution for genetic analysis (UCSF IRB approval # for this study is H711-15138-03; protocol name is "Discovery of Gene Mutations and Polymorphisms that Contribute to the Risk of Atherosclerosis"; principal investigator is John P. Kane, MD). All samples sent to UCSF will be de-identified and catalogued using an alphanumeric code. A number of candidate genes will be studied to detect mutations and polymorphisms that could contribute to the risk of atherosclerosis. The technique of hybridization sequencing will be employed for this. The techniques of classical statistical genetics will be employed for both cosegregation analysis and for the genome search approach. Clinical follow-up may be obtained at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Any individual cared for in the UC Davis Health System
* disorders of lipoproteins or arteriosclerosis

Exclusion Criteria:

* Subjects will be excluded only if they refuse to be in the study
Interventional Bronchoscopy Under Noninvasive Ventilation

To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.

With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.


Eligibility Criteria:
Inclusion Criteria:

* (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;

Exclusion Criteria:

* (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
The Variations of Macular Thickness in Juvenile Subjects

It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. However, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. Similarly macular retinal structure may develop with age. It is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. However, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. Similarly macular retinal structure may develop with age. It is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

Optical Coherence Tomography (OCT) is an imaging technique widely used in clinic in last twenty years. According to the base theory of dim coherent light interference machine, OCT detect the back-reflection or scattering signal of biological tissue to the incident dim coherent light, and acquire the two-dimension or three- dimension image of biological tissue by scan. It enables the characteristic of tissue's microstructure in vivo and makes it possible to observe dynamically developing process of diseases so that it has become an essential test for macular and optic nerve diseases with unmatched measurement reproducibility. It also enables high-resolution and noninvasive imaging of the retinal lamina, the organizational structure of macular. It is most often used clinically to demonstrate the macular morphology, treatment response and disease progression clinically. However, who researchers studyed in through OCT were mostly patients with retinal disease and adults. There was few study focused on OCT's application to children.

In this study, the investigators aims to measure macular thickness (MT) using spectral-domain optical coherence tomography (SD-OCT) and to investigate MT variations with sex, age, laterality, refraction error (RE) and axial length (AL).

Eligibility Criteria:
Inclusion Criteria:

* age from 4 to 17 years
* children with the mild-to-moderate refraction error(from 0 to -6.00D)

Exclusion Criteria:

* children with visual complaints
The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy

The aim of the study is to compare the conventional rehabilitation program and derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity.

Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
* Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
* Understanding simple commands and signing the consent form

Exclusion Criteria:

* Presence of a static cause of femoral internal rotation deformity
* Situations that may prevent assessments or communication
* Lack of cooperation during work
* Presence of surgery that may affect assessments, such as joint freezing
* Presence of botulinum toxin administration in the last 6 months
* Development of an allergic reaction on the skin to the tape
Ultrasound Index Fat Fraction

The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years old.
* Subject is able to understand and sign the Informed Consent Form.
* Subject is able to stand and walk independently.
* Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites.
* Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination
* Subject is affiliated to National Social Insurance or a Health Insurance Regimen

Exclusion Criteria:

* Subject is unable or unwilling to adhere to Study procedures
* Subject is unable to understand the Informed Consent
* Subject is unable to express its consent
* Subject is under legal protection
* Subject is deprived of liberty by judicial or administrative decision
* Subject undergoes psychiatric treatment under constraint
* Subject is pregnant or breastfeeding
* Subject has latex allergy
* Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

The aims of this study are to evaluate the usefulness of various methods of quantifying right ventricular (RV) function using perioperative transoesophageal echocardiographic (TOE), compared with simultaneous transthoracic echocardiographic (TTE) findings.

The hypothesis of this study that perioperative TOE is useful in quantifying RV function, and that the quantification methods used will correlate well to commonly used, well-studied TTE parameters obtained simultaneously, under the same loading conditions.

Assessment of RV function is of particular importance in the perioperative period. RV dysfunction can be due to a myriad of causes - myocardial ischemia, pulmonary embolism, pulmonary hypertension, congenital heart disease, or cardiomyopathy. The presence of RV failure can lead to difficulty in separation from cardiopulmonary bypass in cardiac surgical patients, and has been shown to be an independent predictor of mortality in high-risk cardiac surgery patients. Additionally, correct identification of RV dysfunction is crucial in order for the correct treatment to be administered. RV failure can lead to underfilling of the left ventricle, and mimic hypovolaemia with hypotension and an exaggerated stroke volume variation. In such a case, failure to diagnose RV dysfunction can wrongly lead to fluid loading and further worsening of right ventricular failure.

While evaluation of right heart function is well described in TTE studies, there is insufficient data at present to recommend a reliable method to quantify RV function using TTE.

In addition to traditional measurements of RV function, we hope to study the usefulness of speckle tracking and strain imaging in assessment of RV function, modalities of echocardiographic image analysis which have garnered increasing interest in recent years.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Undergoing elective cardiac surgery
* Planned for intraoperative TOE

Exclusion Criteria:

* Patient refusal
* Emergency surgery
* Haemodynamic instability
* Previous tricuspid valve surgery
* Severe tricuspid regurgitation
* Rhythm other than sinus
* Previous oesophageal / gastric surgery
* Oesophageal stricture / tumour
* Oesophageal diverticulum / fistula
* Active upper GI haemorrhage
* Oesophageal varices
Assessment of Different Rehabilitation Treatments After a Partial Removal of the Meniscus

To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness.

It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the current isotonic protocol.

Longitudinal randomized single-blind study, 81 patients (27 per group; 3 groups), 18 to 60 years, underwent surgery meniscus and performing rehabilitation at the University Hospital Sant Joan de Reus. The first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy). From Session 10, will be randomized into 3 groups: group 1 protocol added isotonic exercises, group 2 isokinetic exercises and group 3 isotonic and isokinetic exercises.

The principal variable will be the maximum force peak of the muscle. An evaluation of other parameters such as knee function (Lysholm Test) and the degree of pain (VAS) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of between 18 and 60 years
* Surgical Intervention: partial meniscectomy of the internal meniscus
* Informed consent

Exclusion Criteria:

* Re-meniscectomy
* Associate injury of crossed ligaments
* Degenerative osteoarthritis of knee degree the II, III or IV
* Morbid obesity
* Infectious diseases in the skin, cutaneous injuries and / or zones of hypoesthesia
* Participants with malignant tumors
* Participants with cognitive or sensory alterations
* Volunteers who have taken part in a study in the last 3 months
* Lack of collaboration of the patient
Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Eligibility Criteria:
Inclusion Criteria:

* aortic valve replacement

Exclusion Criteria:

* contraindication to undergo MRI
Continuous Infraclavicular Nerve Blocks: Needle Versus Catheter Local Anesthetic Bolus

The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.

Specific Aim: The investigators propose to test the hypothesis that when placing a perineural catheter for a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the insertion needle results in a faster-onset sensory block than injecting the initial bolus via the perineural catheter. The study results will help define the optimal local anesthetic bolus introduction technique-needle versus catheter-for peripheral nerve blocks when placing a perineural catheter.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* willing to have bilateral infraclavicular blocks/catheters placed

Exclusion Criteria:

* current daily analgesic use
* opioid use within the previous 4 weeks
* any neuro-muscular deficit of either upper extremity
* body mass index \> 30 kg/m2
* weight \< 50 kg \[100 lbs\]
* pregnancy
* incarceration
Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers

Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive properties in isolated ocular blood vessels. A variety of animal experiments indicate that endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood flow. There is also evidence that the prostaglandin pathway is involved in the activation of NO production in humans, however, the mechanisms for interactions between PG and NO in ocular vasculature are still unclear.

Animal studies suggest that retinal and choroidal blood flow decrease after administration of indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2 reactivity. This is probably the result of decreased blood flow through vasoconstriction of vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral, renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of this study is to investigate the effect of indomethacin on ocular blood flow in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropy less than 3 dpt
Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Chinese T2D patients who are inadequate controlled (6.5 %\< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),

Exclusion Criteria:

* Type 1 diabetes and secondary diabetes
* Acute metabolic diabetic complications within the past 3 months.
* Acute infections which may influence glucose level.
* Evidence of significant chronic diabetic complications,
* Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
* FPG \> 270 mg/dl (15 mmol/l)
* Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)

Other protocol-defined inclusion/exclusion criteria may apply
Addressing Gender Based Violence in HIV Testing and Counseling

The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.


Eligibility Criteria:
Inclusion Criteria:

* Lived in the community for at least one year
* Aged 15-49 years
* Satisfy gender requirement

Exclusion Criteria:

* Lack of informed consent
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)

In ASCVD patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (LDL-C\>1.8mmol/L) is usually higher than that in population with normal thyroid function. The present study aims to randomly compare two lipid-lowering therapeutic strategies (statins only vs. statins combined with thyroid hormone supplement).


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female;
2. Stable or unstable angina with evidence of myocardial ischemia; coronary angiography reveals stenosis lesions;
3. Subclinical hypothyroidism defined as mild TSH elevation within 5-10mIU/L and normal serum thyroid hormone levels within reference ranges;
4. Level of LDL-C is more than 1.8mmol/L before randomization.
5. Participate in the trial voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography);
3. Pregnant or lactating women;
4. Complicated with severe organ dysfunction: large number of pericardial effusion; acute myocardial infarction; acute myocarditis; acute left heart failure; cardiogenic shock; severe arrhythmia, such as ventricular tachycardia, ventricular fibrillation, frequent atrial / ventricular premature beat, poor control of fast ventricular fibrillation, and bradycardia requiring pacemaker therapy, etc.
5. Patients who are unable to withstand lipid-lowering therapy or thyroid hormone replacement due to allergy to statins or levothyroxine;
6. Serum AST/ALT is three times higher than the upper limits of normal.
7. Patient's life expectancy is less than 12 months;
8. Those waiting for heart transplantation;
9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.