cyrilzakka/clinical-trials huggingface dataset:
Phase Ib of Recombinant Human Albumin Injection

A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis

This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The study design consists of two phases: Screening and treatment phase(dose increasing stage).Following the Screening phase, all eligible subjects will be randomized to receive recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose increasing stage (including 3 dose groups with increasing dose, and each group was set with HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years of age;
2. No less than 45 kg.
3. Diagnosed with ascites due to cirrhosis.

Exclusion Criteria:

1. Allergy to biological products;
2. West-Haven HE ≥ III ;
3. Uncontrolled severe infections;
4. HRS. Serum creatinine (Cr)\>2×ULN, or Cr increase\>50% during the screening period;
5. Combined with other serious underlying diseases.
6. Organ transplant recipients;
7. Child-bearing females. Pregnancy test positive. Refusing to take contraceptive measures; (8) Participation in other clinical trials. Using study drugs within three month; (9) With the following laboratory test abnormality:

   1. PLT\<30×109/L, HGB\<70 g/L;
   2. ALT and (or) AST\> 5×ULN, TBIL\>3×ULN;
   3. Prothrombin activity \<40%, PT prolonged\>5s;
   4. LVEF \<50%;
   5. The 24h urine volume exceeds 1500 mL/day ;

10) Other subjects by investigator's opinion.
Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease

To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.

This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.

Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.

Exclusion Criteria:

* Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.
Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

Coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. The spread of coronavirus (COVID-19) has posed significant challenges for occupational health services. However, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates

This is an observational study by REDCap questionnaire® via an internet link, which will be distributed to occupational health workers by any means The self-survey will assess stress, working conditions and changes in practices related to the coronavirus outbreak. This questionnaire includes 39 questions.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers who are screened

Exclusion Criteria:

* None
The Resilience Alliance

The Resilience Alliance is a skill-based staff development intervention for child protective staff that focuses on improving job satisfaction, resilience, optimism and social support, while decreasing attrition, stress reactivity and burnout. The investigators believe that the intervention will enhance the capacity of child welfare workers to care for themselves, which will result in them providing better care for the children and families involved with the child welfare system.

The Resiliance Alliance will be implemented in two child protective offices, Manhattan Zone C and Brooklyn Zone B. Staff from two additional offices (Staten Island Zone A and Brooklyn Zone C) will serve as a control group. A web-based survey will be administered in the group receiving the Resiliance Alliance intervention prior to intervention, at completion of the intervention, and 3 months post completion. The control group will be given a two-part training (3 hours in total) on secondary traumatic stress. The control group will then be asked to complete the same survey as the intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Administration for Children's Services (ACS) employees working at one of four offices: Manhattan Zone C, Brooklyn Zone B, Staten Island Zone A and Brooklyn Zone C
* Adults aged 18 years or older
* English-speaking

Exclusion Criteria:

* None
In-hospital Physiotherapy for Patients Undergoing Thoracic Surgery - a Randomized Controlled Trial

Lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year. About one fifth of the patients are eligible for surgery.

Patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery.

In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. The treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. Reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. Breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery.

The purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

Lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year. About one fifth of the patients are eligible for surgery.

Patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery.

In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. The treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. Reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. Breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery.

The purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic surgery

Exclusion Criteria:

* Previous lung volume reducing surgery
Increased Blood Glucose Levels After Steroid Injection

a sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Our study compared the differences in blood glucose changes between HbA1c \>7% and HbA1c ≤7% groups and those between insulin and non-insulin treated groups.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years, patients with knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) Criteria (17), and grade1-3 in Kallgren-Laurence radiographic scale (18), whom failed to response to medical treatment including paracetamol and nonsteroidal anti-inflammatory medication, and to physical therapy, checking their blood glucose values daily.

Exclusion Criteria:

Patients who were unable to provide consent, patients had any contraindications to corticosteroids, patients who had received oral corticosteroid in the past 6 months or corticosteroid injection in the previous 3 months, patients who had no monitoring HbA1c level before injection or also whom had not monitor blood glucose levels before or after injection.
Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.

Alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. It is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. The neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death.

Perturbations in calcium homeostasis in the central nervous system, such as those associated with Alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to cellular dysregulation and cell death. The role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss.

MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.

Eligibility Criteria:
Inclusion Criteria:

* standardized MMSE Score of 10 to 24 points
* diagnosis of probable Alzheimer's disease
* magnetic resonance imaging or computed tomography examination compatible with AD
* modified Hachinski Ischemia Score of less than or equal to 4
* currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine

Exclusion criteria:

* head injury associated with cognitive impairment
* history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
* treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
* treatment with calcium channel blockers or any investigational medications within the prior 30 days
Repair of Subscapularis Tear :Clinical Results and MRI Analysis

This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of arthroscopic repair of subscapularis tears

ROM UCLA Constant ASES VAS MRI Goutallier

Eligibility Criteria:
Inclusion Criteria:

- Patients suffering from rotator cuff injury scheduled for an arthroscopic procedure. A partial- or full-thickness subscapu-laris tendon tear

Exclusion Criteria:

- revision repairs or open repairs.
The Incidence of Subclinical High-altitude Pulmonary Oedema at High Altitude

The aim of this investigation is to determine the incidence of silent interstitial pulmonary edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a suspected association with acute mountain sickness (AMS), co-morbidities and endothelial dysfunction (marker of hypoxia responses, endothelial damage and inflammation).

The high-altitude pulmonary edema (HAPE) is the leading cause of death from high altitude sickness. At moderate altitude (2500-4500m) the incidence (0.2-6%) may be underestimated because only clinical HAPE leads to symptoms and motivates the patient to seek medical advice. Cremona et al. \[Cremona et al. Pulmonary extravascular fluid accumulation in recreational climbers: a prospective study. Lancet 2002;359:303-09\] suggested that a silent interstitial pulmonary edema arises in most recreational climbers at moderate altitude. Recently, chest sonography has been shown to effectively detect pulmonary edema and quantify extravascular lung water through the sign of "ultrasound lung comets" (ULCs) originating from water-thickened interlobular septa \[Lichtenstein D et al. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med;156:1640-46\]. The technique requires only basic twodimensional technology and has been applied in extreme, out-of-hospital setting, showing in recreational climbers a high prevalence of clinically silent interstitial pulmonary edema at high-altitude \[Pratali L et al. Frequent subclinical high-altitude pulmonary edema detected by chest sonography as ultrasound lung comets in recreational climbers. Crit Care Med 2010;38:1818-23\]. However, data for moderate altitude remain scarce, despite that mountaineers are increasing in age and comorbidities and could be more prone to high altitude emergencies.

Prospective, non-randomised, observational study. Study participants are recruited from a scientific research group lead by the Ohio State University during a glaciology study on the Ortles Glacier in South Tyrol (3905m).

Patients are tested for a baseline measure, during a permanent stay on the glacier camp (3h, 9h, 24h, 48h, 72h, 7d ). Parameters include chest ultrasound, Lake Louise score, cerebral sensitive score, non-invasive haemodynamic parameters (i.e. US) and markers of hypoxia responses, endothelial damage and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* healthy of age \>18y

Exclusion Criteria:

* cardiac failure
* chronic kidney disease
* chronic pulmonary disease
* acute lung/heart/kidney/brain conditions
* neoplastic disease
* lack of consent
Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

Social communication makes use of predictable, rhythmic behaviors and children are sensitive to the rhythm of social interaction from infancy. The goal of the current study is to investigate if social rhythm sensitivity, measured via children' entrained eye-looking when viewing videos of infant-directed singing, predicts autistic toddlers' response to naturalistic developmental behavioral intervention (NDBI). Following eligibility testing and baseline assessments, children are randomized to receive either 30 sessions of Reciprocal Imitation Training (RIT), an NDBI that uses evidence-based strategies to support children's imitation and social communication development, or a music-enhanced version of RIT that embeds music and rhythm within the RIT platform (meRIT). Children's imitation skills are assessed before and after the intervention programs. Children's rhythm sensitivity is assessed via repeated eye-tracking sessions throughout baseline, intervention, and two-weeks after the intervention ends.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autism / autism spectrum disorder
* 18-36 months of age

Exclusion Criteria:

* Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age \<=34 weeks.
Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:

A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

The current clinical trial is designed to provide posaconazole (SCH 56592 to subjects with invasive fungal infections a) which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH 56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH 56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of invasive fungal infections. Approximately 320 subjects have been enrolled at 160 clinical study centers in the US and worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Proven or probable invasive fungal infections according to EORTC/MSG criteria.
* IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.
* Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria:

* History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
* Concurrent progressive neurological disease (except if due to invasive fungal infection)
* Use of medications that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine.
* Females pregnant or nursing.
Urokinase Therapy in Diabetic Foot Syndrome

The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.

Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.

Eligibility Criteria:
Inclusion Criteria:

* angiopathic or angioneuropathic diabetic foot lesions
* critical limb ischemia
* no surgical or interventional treatment option

Exclusion Criteria:

* feasibility of vascular surgery or angioplasty
* prior treatment of the current ulceration with urokinase
* need for dialysis
* creatinine \> 180µmol/l
* any kind of cerebral event less than three months before inclusion into the study
* proliferative retinopathy (not remediated)
* uncontrolled hypertension
* hemorrhagic diathesis
* gastrointestinal bleeding
* need for oral anticoagulation
* mental disorders
* pregnancy
* participation in another study
D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
* Patient informed of the study

Exclusion Criteria:

* Age \<18 years.
* Patients under guardianship
* Pregnant woman
* Contraindication to transesophageal echocardiography
* transesophageal echocardiography made in another center as the center of ablation
* Refusal of the patient to participate in the study
* Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography