cyrilzakka/clinical-trials huggingface dataset:
Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery

To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.

A retrospective case-control study was conducted. Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified. Patients were divided into two groups according to the severity of burns, the patients with a 20%\<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA\>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group. The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* TBSA≥ 20% （TBSA，the total burn area.）
* Admitted to hospital within 24 hours after injury.

Exclusion Criteria:

* STB ≥ 33 μ mol/L
* Cr ≥ 171 μ
* Urine output l\< 500 ml / 24 h
* Pregnant and lactating women
* Severe combined injury
* Glucocorticoids users
* Immunosuppressants users
* Patients survived less than 48 hours
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)


Eligibility Criteria:
Inclusion Criteria:

* B-ALL blast cells expressing CD22
* Diagnosed with R/R B-ALL
* Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

Exclusion Criteria:

-Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment
Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS.

III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis.

OUTLINE: This is a phase I dose-escalation study followed by a phase II study.

Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI).

After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing SRS for brain metastases
* Lesions to be treated under this protocol must be \> 2 cm, but =\< 4.0 cm in diameter
* Patients may have had prior therapy including:

  * Whole brain radiation therapy (WBRT) \> 3 months ago
  * SRS to other brain metastases
* Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
* Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
* Patient must be able to provide written informed consent

Exclusion Criteria:

* Patients receiving SRS to resection bed
* Planned concurrent WBRT
* Leptomeningeal metastases
* Small cell lung cancer, lymphoma, and germ cell histologies
* Inability to participate in study activities due to physical or mental limitations
* Inability or unwillingness to return for all the required follow-up visits
* Conformality index 2.0 or less cannot be achieved, or homogeneity index is \> 2.0
* Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
* Brainstem location is excluded from this study
The Effect of Axio Scapular Muscle Stretching Exercises in Office Workers

The aim of this study is to examine the effects of stretching exercises applied to the axioscapular muscles on posture, periscapular muscle strength and symptoms in office workers.

Individuals who work at a desk for a long time often take a kyphotic or loose sitting position, resulting in tension in some of the axioscapular muscles and weakness in others. Because, as a result of wrong working posture at the desk, scapular downward rotation formation, increased activation in trapezius and levator scapula muscles, pain, decrease in normal joint range of motion (ROM) may result in impaired proprioception and this situation may create a vicious circle. In addition, incorrect sitting posture was found to be associated with changes in scapula position, kinematics and muscle activity.

It is considered a clinical feature that a change in scapular alignment can cause neck pain and dysfunction. The scapula shares common muscle connections with the neck, and altered axioscapular muscle function is claimed to potentially cause neck pain through abnormal loading of the cervical spine or the formation of myofascial trigger points.

Stretching the shortened upper trapezius, sternocleidomastoid, and levator scapula muscles and strengthening the deep cervical flexor muscles are effective in correcting the anterior tilt posture of the head.

Stretching exercises applied to the tension and shortness of the axioscapular muscles can have a positive effect on middle and lower trapezius muscle and serratus anterior muscle weakness, as they contribute to the change of scapular position. It may also contribute to cervical motion and/or symptom relief.

For this reason, the aim of the study is to examine the effects of axioscapular muscle stretching exercises on posture, periscapular muscle strength and symptoms in office workers. In addition, information about the effect of isolated stretching exercises on muscle strength and symptoms will be obtained and a contribution will be made about the weekly dosage.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer office workers who work at a desk more than 4 hours a day for at least 1 year

Exclusion Criteria:

* Those who have undergone surgery on the upper extremity and/or neck,
* Patients that had been diagnosed for Diabetes, Rheumatoid Arthritis, Ankylosing Spondylitis,
* Those who have received a physiotherapy program for the neck and/or upper extremity in the last 3 months,
* People who are actively involved in sports (at least 3 days a week / 150 minutes).
Pelvic Floor Muscle Training for Incontinence in Older Women.

To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are:

1. That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life.
2. That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.

Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way.

Comparisons: pelvic floor muscle training group and bladder training.

Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5).

Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling women aged over 65 years
* urodynamically proven stress incontinence
* Medically stable

Exclusion Criteria:

* Already receiving physiotherapy intervention
* Neurogenic incontinence
* Cannot comply with training program
A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

This trial will recruit 500 hopitalized patients with AECOPD. The eligible participants will be randomly assigned to either PCT group or guideline group.The investigators aim to compare the efficacy and safety between PCT-gudied antibiotic therapy and guideline-guided antibiotic recommendations. The primary hypothesis is that PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with AECOPD
* ≥40 years of age
* Able to understand and communicate to ensure the completion of the trial
* Voluntary participation and provide written informed consent

Exclusion Criteria:

* Fever, Axillary temperature≥38°C
* Pneumonia identified by X-Ray or CT of the chest
* Severe respiratory failure requiring admittance to ICU
* Concurrent infection at another site (e.g. urinary tract infection)
* Immunosuppression secondary to chemotherapy, AIDS or malignant tumor of blood system
* Comorbidities requiring corticosteroids (prednisone 30mg/d or equivalent more than 30 days )
* Invasive mechanical ventilation
* Patients with malignant tumors receiving chemotherapy or radiotherapy
* Pregnancy
* Participation in another clinical trial
* Previously enrollment into the study
* Refuse to attend
French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Implantable cardioverter-defibrillators (ICDs) are widely recognized for their efficacy in reducing the risk of sudden cardiac death in high-risk patients. Nonetheless, there remains significant scope for improving outcomes through advancements in device technology and design. The extravascular cardioverter-defibrillator (EV-ICD) represents such an innovation, offering key advantages over other ICD systems. It incorporates a lead positioned in the substernal space, enabling the delivery of pause-prevention security pacing, antitachycardia pacing, and defibrillation energy similar to that provided by conventional transvenous ICDs.

Previous studies have demonstrated that EV-ICDs can be implanted safely and are capable of terminating majority of induced ventricular arrhythmias during implantation; however, follow-up data are limited to highly experienced selected centers and over a relatively small follow-up period (6-month follow-up). The FOREVER cohort study, initiated by the French Institute of Health and Medical Research, aims to evaluate the EV-ICD use in France.

This nationwide evaluation will provide an exhaustive collection of all EV-ICD implantations in France, offering valuable real-world evidence on the long-term safety and efficacy of the device.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing EV-ICD implantation

Exclusion Criteria:

* Refusal of consent
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers

To assess in healthy adult subjects:

* The tolerability and safety of ascending repeated oral doses of Genz-682452.
* The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.
* The pharmacodynamics of Genz-682452 after ascending repeated oral doses.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive.
* Certified as healthy by a comprehensive clinical assessment.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
* Blood donation, any volume, within 2 months before inclusion.
* Symptomatic postural hypotension.
* History or presence of drug or alcohol abuse.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen.
Epidemiology of Pain in the Delivery Room

The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy. During the delivery the baby is exposed to multiple exterior factors and he is capable to memorize the pain .Recent epidemiologic studies showed that the coverage of pain was insuffcient and also an increase of analgesic means. Normally the pain coverage have to be managed and group every painful gesture. In fact all these recommandations are not followed by medical team.

The aim of the study is to evaluate the prevalence of this type of pain as to set up an adequate coverage.


Eligibility Criteria:
Inclusion Criteria:

* Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery room

Exclusion Criteria:

* Newborn child been born in palliative care
* non francophone parents
Short-term Immunomodulatory Effects of Lactobacillus Casei DN-114001: Impacts on Gut Microbiota Composition and Systemic Immune Biomarkers in Healthy Adults

The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at \>0.90 for males and \>0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if \<30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 29.99;
* Waist-to-Hip Ratio with thresholds set at \>0.90 for males and \>0.85 for females for individuals with normal weight (eutrophic)
* Percentage of body fat: Considered within normal range if \<30% for individuals with normal weight.
Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development

This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).


Eligibility Criteria:
Inclusion Criteria:

* Women who desire to use the ENG implant as a contraceptive method and desire to breastfeed her newborn for ate least 3 months;
* With no contraindication to breastfeeding, whose newborn is healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability

Exclusion Criteria:

* Tobacco smokers, drug addicts or alcoholics;
* Women with educational levels lower than 5 years;
* Women with clinical conditions considered category 3 and 4 for implant use by the WHO;
* Women with histories of psychiatric illness;
* Women using medications that could alter the concentration of ENG,
* Women with known allergies to the local anesthetic lidocaine (used to place the implant);
* Women who wanted to keep their cyclic menstrual bleeding
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).

The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
3. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Inability to sign written informed consent.
2. Abnormal Apical dysfunction at baseline
3. LVEF \< 20%
4. Pregnancy or breast feeding.
5. Need for emergency surgery for any reason.
6. Any case in which the practicing physician asserts that enrollment in the protocol will
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

Comparison of two Dry Eye products


Eligibility Criteria:
Inclusion:

* Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
* Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
* Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.

Exclusion:

* Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
* Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1.
* Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
* Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
* Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
* Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
VA106483 Dose Response Study in Elderly Males

The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.

VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night.

The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration.

Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.

Eligibility Criteria:
Inclusion Criteria:

* Male, Age: 65 years and above
* Using adequate contraception
* Medical history without clinically significant pathologies; no evidence of serious pathology or disease
* Physical examination parameters without signs of serious disease
* No clinically significant ECG and lab safety tests (sodium must be within normal range)
* Willing and able to participate and provides written informed consent

Exclusion Criteria:

* Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
* Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg
* Presence of poorly controlled endocrine disorders
* Renal insufficiency, active hepatic and/or biliary disease
* Hyponatraemia. Serum sodium level must be within normal limits
* Syndrome of inappropriate antidiuretic hormone (ADH) secretion
* Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus
* Known hypersensitivity to the IP or any constituent of the IP
* Use of any non-prescription preparation within 72 hours prior to study entry, with the exception of defined pain killers
* A history of alcohol abuse or drug addiction within the last 2 years
* Positive screen for HIV, hepatitis B or C
* Currently taking any diuretics or any concomitant medication known to be a cytochrome 3A4 inhibitor
* Other protocol defined eligibility criteria may apply.