cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium)

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3.

The device under investigation (Micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery
* Patients who do not give informed consent
New Technique to Assess Correct Positioning of the Right-sided Double Lumen Tube

A technique not yet described in the literature and allowing anesthesiologists who do not regularly practice fibroscopy or who do not routinely have this type of apparatus for their procedures, to install straight double-lumen tubes without compromising the ventilation of the patient. The aim is to introduce a central venous catheter wire guide into the bronchial arm of the right double-lumen tube and insert it into the right upper lobe bronchus orifice under fluoroscopic control. Then, to validate the new technique, we will carry out a fibroscopic control.

Right-sided double lumen tube (Mallinckrodt - Endobronchial tube) is introduced into the glottis via direct laryngoscopy. After the endotracheal lumen tube has passed the vocal cords, the stylet is removed, and the tube is rotated 90° toward the right and advanced slightly until resistance is encountered. Auscultation is then performed to check the proper side the endobronchial tube was inserted to.

Then, the anatomy of the carina and the origins of the right and left upper bronchus are identified with the video-bronchoscopy.

After a mild plication of the distal extremity of an adult central venous catheter wire guide (0.53mm diameter, 45cm length, one straight soft tip on one end and one "J" tip on other), the J-shaped extremity of this guide is introduced through the endobronchial lumen under direct video-bronchoscope. The wire guide is then slowly removed in order that proper alignment between the wire extremity and the right upper lobe occurs. The wire is removed again until its J-shaped extremity appears through the right-upper lobe ventilation orifice. In order to align the orifice of the tube with the upper lobe bronchus, a rotational movement of the double-lumen tube may be necessary. When the location of the orifice of the right upper lobe is identified, the guide is moved forward through the orifice into the upper lobe bronchus.

Once satisfactory initial placement is achieved, the bronchial cuff is left inflated, the wire guide of the central venous catheter is kept in place in the upper lobe bronchus, and the patient is turned to the right lateral decubitus position. The proper positioning of the tube is once again checked by another video-bronchoscopy.

To confirm the exact placement of the tube, a fiberoptic bronchoscopy is performed through the endobronchial lumen to find the right upper lobe ventilation orifice and confirm alignment. Then, it is placed distally to the endobronchial lumen to confirm a clear view showing the bronchus intermedius.

After passing the fiberoptic bronchoscope through the tracheal lumen, the blue bronchial cuff is visualized at the origin of the right main stem bronchus below the level of the carina.

Eligibility Criteria:
Inclusion Criteria:

* all patients \> 18 years old who have to undergo a left thoracic surgery with a one lung ventilation technique

Exclusion Criteria:

* emergency surgical procedures, patients with predictable difficulties of insertion of a double-lumen endotracheal tube, hemodynamically unstable patients
Management of Patent Ductus in Premature Infants

To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.

BACKGROUND:

The incidence of patent ductus arteriosus is higher in premature infants than in full-term infants and is highest in premature infants who have respiratory distress syndrome. It is generally agreed that intervention in an asymptomatic infant with a small left-to-right shunt is unnecessary, since the patent ductus almost invariably closes spontaneously and thus does not require surgery. A few infants will demonstrate signs of a large shunt during the course of respiratory distress syndrome. Many of these infants will improve with medical management of congestive heart failure, but others require surgical closure. A third group of babies with respiratory distress have severe progressive pulmonary disease requiring ventilatory support. There was disagreement as to whether elimination of the patent ductus in these infants resulted in decreased mortality. A variety of therapeutic approaches was being used, and there was no convincing evidence of the superiority of one treatment over another.

DESIGN NARRATIVE:

Trial A was a randomized, double-blind trial in which indomethacin plus usual medical therapy was compared with a placebo plus medical therapy. Where this regimen was unsuccessful, the code was broken, and infants who received indomethacin were treated surgically. Infants who had received placebo in Trial A were entered, if there were no contraindications to indomethacin, into Trial B. In Trial B, infants were randomized to surgery or indomethacin therapy. Those in whom indomethacin treatment was unsuccessful were treated surgically. The Recruitment and Intervention Phase began in April 1979. All patients were enrolled by March 31, 1981, and followed for one year after enrollment.

Eligibility Criteria:
Boy and girl premature infants with patent ductus arteriosus. Birth weight of 1,750 grams or less. Admitted to participating institution within first 24 hours of life.
Parent Telehealth Intervention for Children With Autism

As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.


Eligibility Criteria:
Inclusion Criteria:

Child inclusion criteria include:

* diagnosis of ASD or showing signs of ASD based on autism screening
* chronological age of less than 48 months
* a parent who is willing to learn intervention strategies
* English as the primary language spoken in the home

Parent inclusion criteria include:

- Biological Mother

Exclusion Criteria:

* Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
* Fathers or caregivers other than the child's Mother will be excluded from the study.
Effect of Talar Mobilization With Movement Versus Acupuncture on Knee Pain and Function in the Postmenopausal Women

The purpose of this study is to determine the effect of talar mobilization with movement versus acupuncture on knee pain and function in the postmenopausal women

A sample of forty postmenopausal women were selected from Department of Gynecology and Obstetrics, Participants were assigned into two groups (group A) postmenopausal women who receive the talar mobilization with movement technique for knee joint , their age raged from 50-60 years (n= 20) and (group B) postmenopausal women who receive acupuncture for knee joint (n= 20), their age ranged from 50-60 years and body mass index (BMI) for both groups were less than 30 kg/m2. All participants were evaluated through measuring knee range of motion by using goniometer and the degree of knee pain by using numeric rating scale and pressure algometer

Eligibility Criteria:
Inclusion Criteria:

* ) Females patients refered from orthopedic surgeon diagnosed with knee OA (2) Their age ranged from 50 _60 years old 3) Their BMI less than 30 kg/m2. 5) knee pain in the previous week with an intensity of at least 3 points on a numeric pain rating scale (NPRS ) (5) Patients limited ankle dorsiflexion ROM 6) All Patients had 3 points on NPS (7) Presence of knee pain for at least 3 moonths 8) All patients were given the arabic version of KOOS questionnaire

Exclusion Criteria:

* 1) Patients with Rheumatoid arthritis 2) Their BMI more than 30 kg/m2. 3) Unrelated to any traumatic knee event 4) Patients with Previous tibial fracture 5) Patients with Ankle instability 6) Patients with previous meniscal degeneration 7) Patients with hyper laxity 8) Patients with neurological disorders
An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices.
* Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care.
* Participants prescribed risankizumab in accordance with the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing and able to provide authorization to use and disclose personal health information.
* Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).

Exclusion Criteria:

* Females who are pregnant or breast feeding at baseline.
* Participants with any contraindication to risankizumab.
* Participants previously exposed to risankizumab.
* Participants currently participating in an interventional clinical trial.
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.


Eligibility Criteria:
Inclusion Criteria:

* Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia
* Adequate renal and hepatic function
* Negative for HIV
* Negative serum pregnancy test, if applicable
* ECOG 0-2

Exclusion Criteria:

* Active CNS involvement by ALL
* Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)
* Contraindication to receive intrathecal methotrexate
* Prior treatment with blinatumomab
* Active malignancy other than ALL
* Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
Carvedilol PAH A Pilot Study of Efficacy and Safety

Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV function in patients with PAH.

Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH

This is a prospective, open label, uncontrolled, pilot study examining the safety and efficacy of beta-blocker therapy with carvedilol on RV function in stable PAH Patients with World Health Organization (WHO) functional class II or III symptoms and RV ejection fraction (EF) \< 40%. Twenty-five evaluable patients will be enrolled at the University of Minnesota.

Specific Aims:

1.1 Primary Efficacy Endpoint: Adult males and females on a stable dose of an approved PAH medication will undergo cardiac magnetic resonance imaging (MRI), right heart catheterization (RHC), echocardiogram, 6-minute walk test (6-MWT), measurement of plasma NT-ProBNP and serum catecholamine, and quality of life assessment. Patients will receive carvedilol (3.25 mg/kg bid escalating to 25 mg/kg bid over 3 months). Testing is repeated at the end of the study (month 6). RVEF measured by cardiac MRI is the primary efficacy endpoint. We define a 5% increase in RVEF as a meaningful change.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be eligible to participate in the study if all of the following conditions exist:
2. Age \> 18 years
3. WHO category 1 pulmonary arterial hypertension (Dana Point 2008)
4. WHO functional class II-III
5. RVEF by cardiac MRI \< 40%
6. Mean pulmonary artery pressure \> 40 mm Hg
7. Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and functional class in the past 3 months. Patient can be on either mono or combination PAH-specific therapy

Exclusion Criteria:

* 1. Subjects will be excluded from participation in the study if any of the following conditions exist: 2. Significant persistent bradycardia (resting heart rate \< 60 bpm) without a permanent pacemaker 3. Second or third degree AV block without a permanent pacemaker 4. Significant sinus tachycardia (resting heart rate \> 100 bpm) 5. Use of anti-arrhythmic drugs 6. Hypotension defined as systolic blood pressure \< 100 mmHg at the time of enrollment 7. Significant illness in the past 30 days requiring hospitalization 8. Acute decompensated right heart failure within past 30 days 9. Known allergy or intolerance to carvedilol or other β blockers 10. Cardiac index \< 2 l/min/m2 or right atrial pressure \> 15 mm Hg 11. Asthma
The Effects of Probiotics in Atopic Dermatitis

The purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. We propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the T Regulatory cell--which can suppress the activity of allergic disease.

The central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of T Regulatory (Treg) cells. We specifically hypothesize that the probiotic mixture that induces Treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing Treg activity in vivo.

1. We will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. We will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the SCORing Atopic Dermatitis (SCORAD) index. We specifically hypothesize that probiotics will clinically improve the disease.
2. We will assess whether probiotic mixtures induce the development of T regulatory cells in patients with atopic dermatitis.

A. We will measure the relative levels of Tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter Treg development in vivo, and whether these changes correlate with improvement in clinical scores. Primary outcomes will be measurements of gene expression and absolute increases in cell population. We specifically hypothesize that probiotics will increase Treg activity.

B. We will also determine if all patients' Tregs have in vitro responses to probiotics. This data will be used to correlate whether clinical responders in the study also have strong in vitro responses.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 months to 3 years
* Physician diagnosis of moderate to severe atopic dermatitis as defined by the Hanifin and Rajka criteria
* Ability to take enterally commercially available probiotics by powder form added to food or drink
* Ability to undergo venipuncture or dermal puncture (if less than 1 year old)

Exclusion Criteria:

* Prior exposure to probiotics
* Current antibiotic administration
* Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
* Absence of T regulatory cell induction by probiotic bacteria on initial laboratory assessment
* Any other condition in which the Investigators involved in the study determine potential subject is unsuitable for the study
Placenta Accreta Spectrum Protocol

Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS

Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death

* The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate
* Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS

However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy

* Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited
* There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women diagnosed with PAS, aged between 18 to 48 years.
* Women should be delivered by the corresponding center.

Exclusion Criteria:

* Inadequate follow-up
* Authorization to use anonymous patient data for research purposes.
Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia

During sepsis and septic shock the immune response can be overwhelming leading to excessive tissue damage, organ failure and death. Ideally, the inflammatory response is modulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant immune response. In the last years, experimental evidence has been accumulating that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves organ integrity in several inflammatory models. The current study investigates the immune-modulating potential of enriched enteral nutrition in a human setting of experimental endotoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 35 yrs
* Male
* Written informed consent
* non-smoking

Exclusion Criteria:

* Use of any medication (e.g. NSAID's, antibiotics, gastrointestinal motility altering medicine, corticosteroids)
* Smoking in the past year
* History, signs or symptoms of cardiovascular disease
* (Family; first degree) history of cerebrovascular disease
* Previous vagal collapse
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90)
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50)
* Renal impairment (defined as plasma creatinin \>120 μmol/l)
* Liver enzyme abnormalities ( ASAT \> 60 U/L, ALAT \> 75 U/L, Gamma-GT \> 60 U/L)
* Positive hepatitis serology
* Positive HIV test
* Allergy to milk and/or soy proteins