cyrilzakka/clinical-trials huggingface dataset:
Comparison Between the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation for Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.

Tracheal intubation is a common procedure in the operating room to secure the airway in patients receiving muscle relaxants .

Two devices are currently used for this purpose with various indications: the French Society of Anesthesia and Resuscitation (SFAR) recommends a direct laryngoscopy with MacIntosh blade in first intention for patients with less than 2 criteria of difficult intubation (ID). The SFAR recommends first-line video laryngoscopy in patients with two or more criteria of difficult intubation. Video laryngoscopy improves glottic vision, difficult intubation score, and intubation success rate at the first attempt, compared to the direct laryngoscopy with a Macintosh blade.

Currently, it is estimated that 15% of direct laryngoscopies with a MacIntosh blade result in failure of orotracheal intubation (IOT) on first attempt, whereas tracheal intubation with a video laryngoscopy is a better solution to secure the airway.

Our hypothesis in this study is that the MacGrath MAC videolaryngoscope allows to intubate at the first laryngoscopy 91% of patients with less than 2 difficult intubation criteria, against the expected 85% with the MacIntosh blade.

Eligibility Criteria:
Inclusion Criteria:

less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent

Exclusion Criteria:

* pregnancy
* age \< 18
* contraindication to oro-tracheal intubation
* emergency surgery
* thoracic surgery
* naso-tracheal intubation
* patient protected by law
* patient not affiliated to french social security
* BMI\> 45kg / m²
* Predicted patient with difficult intubation

Patients considered to be predisposed to difficult intubation are those with a history of difficult intubation, or with 2 criteria among:

* Mallampati 3 or 4
* Thyroid-chin distance \<65mm
* Mouth opening \<35mm
* Spinal extension less than 90 °
* Retrognathism with Negative Lip Test
* Morbid obesity with BMI\> 35kg / m²
* Obstructive Sleep Apnea Syndrome with choker\> 45cm
* Diabetic with sign of the positive prior
* Head and Neck Pathology
An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM

Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

Eligibility Criteria:
Major Inclusion Criteria:

1. Age 22 or greater
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:

   1. One ADHF hospitalization in the last 12 months
   2. One unplanned IV/SC diuretic administration in the last 6 months
   3. Two unplanned IV/SC diuretic administrations in the last 12 months
   4. NTProBNP \>500 pg/ml
4. Clinically stable HF according to investigator discretion
5. Willing to participate as evidenced by signing the written informed consent.

Major Exclusion Criteria:

1. Unable to comply with daily use of the App,
2. Has had a major cardiovascular event within 3 months prior to enrolment.
3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
6. Was treated for a significant COPD
Topical Timolol for Superficial Infantile Hemangioma

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. The characteristic natural history of this tumor is rapid growth in the first year of life and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early intervention in superficial IH may help to minimize the risk of residual aesthetic problems. Topical timolol, a non selective beta-blocker, is an emerging treatment which has been reported in efficacy and safety for the treatment of IH. However, the reported studies were case-series or small study. This study is a prospective double-blind,randomized-controlled study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in superficial IH. The patient will be treated with topical timolol for at least 6 months and instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the entire lesion with a finger. Photographs of the lesion will be taken at the baseline and every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2 investigators independently to determine the change in lesion size and visual analogue scale of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is less than 2 years
* Patient who has been diagnosed with superficial infantile hemangioma
* The tumor which has been in proliferative or plateau phase
* There is no indication for systemic treatment
* Informed consent is obtained from the parent of the patient

Exclusion Criteria:

* Patient who has the indication for systemic therapy
* Patient who is treated by the other modality such as laser treatment
* Patient who has underlying disease treated by beta blocker, corticosteroids, interferon, cyclophosphamide or vincristine
* Patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac condition prove to heart block
Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along With Laser Therapy

Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along with Laser Therapy in Non-Specific Low Back Ache

Comparison of Spinal Stabilization Exercises Vs Maitland Mobilization Along with Laser Therapy for finding the better method for the treatment of Non-Specific Low Back Ache

Eligibility Criteria:
Inclusion Criteria:

* Both male and female within the age range of 18-60 years.
* Visual analogue scale that scores 3 and higher.
* Non radiating low back pain

Exclusion Criteria:

* Patients with a history of spinal diseases and injury
* Spinal stenosis
* Degenerative changes
* Neuropathy
* Intervertebral disc collapse.
* Spinal discectomy
* Spinal laminectomy
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron.

To evaluate the safety of IV low molecular weight iron dextran in pregnant women.

To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester.

Exclusion Criteria:

* known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(\>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.
Superb Microvascular Imaging Ultrasonography of Lacrimal Gland in Patients With Sjögren Syndrome

A prospective study will be conducted to evaluate inflammatory activity in lacrimal glands due to Sjögren's syndrome on Superb Microvascular Imaging (SMI), gray scale ultrasound (US), color Doppler US and Power Doppler US.

In the disease activity index recommended by EULAR, the European Rheumatology Association, to evaluate the disease activity of patients with Sjögren's syndrome, it is recommended to measure the swelling in the gland by performing a clinical examination for glandular activity. However, it is not practical to measure the size of these glands due to their location.

In studies in which lacrimal glands were evaluated by ultrasonographic methods, parameters such as gland size measurement, gland heterogeneity and Doppler activity were reported to be very successful in differentiating patients from healthy controls.

Determining the presence and characteristics of vascular flow is an important part of ultrasonographic examinations. However, small vessels and low velocities are not always possible to detect with conventional color and power Doppler ultrasound. Sonographic examination will be inconclusive, especially if the presence of vascular flow or activity needs to be addressed as a basis for diagnosis and follow-up. Superb Microvascular Imaging (SMI) is a new vascular imaging mode that provides low speed and visualization of microvascular flow. SMI uses an algorithm that can suppress parasitic reverberations to extract flow signals and displays this information as a color overlay image or a monochromatic or color flow map.There are studies that report that Superb Microvascular Imaging (SMI), a new and up-to-date Ultrasonography technology, is more sensitive in detecting the activity of Rheumatic diseases. In this respect, there are no studies evaluating the inflammatory activity of lacrimal glands with SMI method.

Therefore, a prospective study will be conducted to evaluate the inflammation detecting performance of SMI, gray scale US, color Doppler US and Power Doppler US. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased inflammatory activity in Sjögren's syndrome patients.

Eligibility Criteria:
For the first group:

Inclusion Criteria:

* Patients diagnosed with Sjögren's syndrome
* Age between 18-65

Exclusion Criteria:

* History of eye or face trauma or surgery
* Diabetes mellitus
* Pregnancy

For the second group:

Inclusion Criteria:

* asymptomatic eye (no dry eye or dry mouth),
* no previous trauma or surgery on face or eye,
* no history of systemic inflammatory disorders.

Exclusion Criteria:

* History of eye or face trauma or surgery
* Diabetes mellitus
* Pregnancy
* Rheumatological diseases
Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Measurable or evaluable disease
* Females \> 18 years
* Able to perform activities of daily living with minimal assistance
* Life expectancy \> 3 months
* Adequate bone marrow, liver and kidney function
* All patients must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Women who are pregnant or lactating.
* Received more than 3 prior chemotherapy regimens in the metastatic setting.
* Received continuous infusion 5-fluorouracil lasting \> 120 hours.
* Received thalidomide or capecitabine as their last prior regimen.
* Preexisting moderate to severe neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on the Birth Process and Care

This study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care.

The research is a randomized controlled trial. The research was conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group were given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group received only the standard intrapartum care in the hospital. Data were collected using the personal information form, labor and postpartum follow-up form, Visual Analog Scale (VAS), Labor Comfort Scale (DKS), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Childbirth Scale. VAS, DKS, and Fear of Childbirth scale were applied to women in both groups when cervical dilation was 5 cm and 9 cm. After birth, the Women's Perception of Supportive Care Given During Childbirth scale was applied.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older,
* History of term pregnancy (38-42 weeks),
* Having a primiparous,
* Single, healthy, vertex positioned fetus,
* Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
* Birth canal dystocia, dystocia related to the mother's psychology),
* Having a partner/husband,
* History of cervical dilatation of 5 cm or more,
* Being able to speak and understand Turkish

Exclusion Criteria:

* Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, etc.),
* Those with any complications that prevent vaginal delivery,
* Elective caesarean section, those who became pregnant with assisted reproductive techniques,
* Those who are multiparous,
* Those who have chronic diseases (such as hypertension, diabetes, heart disease).
Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 - 80 years.
* Patients diagnosed with gallstones.
* Patients diagnosed with common bile duct stone by one of the three exam (MRI、MRCP and CT).
* Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
* Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).

Exclusion Criteria:

* Combined with Mirizzi syndrome and intrahepatic bile duct stones
* Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
* History of upper abdominal surgery.
* Serious heart,brain,lung, metabolic diseases history.
* Pregnant women
* Unwillingness or inability to consent for the study.
eMotiph: E-mental Health Solution for Patients With Schizophrenia

Although the main objective of current schizophrenia intervention programs is the reduction of symptoms, its rates are around 36%, and recovery rates are 16.5%. Between 30 and 50% of people with schizophrenia obtain little benefit with conventional therapy. They are considered resistant to treatment. Therefore, the development of innovative evidence-based interventions adjunctive to pharmacological and psychological treatment are necessary for improving results in patients with treatment-resistant schizophrenia (TRS). Studies with digital solutions have shown feasibility, acceptability and even preliminary efficacy data. But no earlier published study has focused on TRS.

The eMOTIPH is an innovative solution addressed to TRS and born from the outcomes of the previous study eMOTIPH Part 1 (study of beliefs, needs, and limitations associated with current intervention in TRS patients).

A prospective non-randomised feasibility trial will be performed. People with a diagnosis of treatment-resistant schizophrenia and their informal caregivers will test the digital mental health solution eMOTIPH for 6 months. Psychiatric treatment and psychological intervention (based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Farchione et al., 2012) will be delivered to patients.

The aim of the study is to evaluate the feasibility, acceptability, usability, satisfaction and perceived quality of life after using the eMOTIPH digital solution.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-55 years old.
* Diagnosis of schizophrenia following the Diagnostic and Statistical Manual of Mental Disorders-5 criteria.
* Meet criteria for treatment-resistant schizophrenia.
* Used to information and communication technology and with the physical capability to use them.

Exclusion Criteria:

* Meet criteria for remission according to the Remission of Schizophrenia Working Group (Andreasen et al., 2005).
* The presence of delusions mainly related to their therapists or with new technologies.
* Hearing, vision or motor impairment that makes it impossible to operate a smartphone.
* Intellectual Developmental Disability.
Determination of Lymphocyte JAM-C Expression in Patients With Psoriasis Vulgaris

The stepwise process of leukocyte extravasation to inflamed tissues depends on the expression of a variety of cytokines and adhesion molecules. Recently much attention has focused on the Junctional Adhesion Molecules (JAM). The three members of this adhesion molecule family, namely, JAM-A, -B and -C, have been shown to govern the last step of leukocyte extravasation (transmigration) - the process of leukocytes passing between endothelial cells. In addition to transmigration, some members of this family seem to support additional steps in the leukocyte extravasation cascade. The investigators recently showed, that antibody-mediated inhibition of JAM-C significantly reduced hapten induced skin inflammation (J Invest Dermatol;125(5):969).

Recent unpublished work from our laboratory showed, that JAM-C expression of lymphocytes can be up-regulated through specific activators. Hence, the investigators hypothesize, that JAM-C expression is elevated in patients with psoriasis. As it is currently not know, which factors may influence the expression of JAM-C, the investigators intend to analyse JAM-C expression on CD3+CD41- cells at several time-points during the treatment of psoriatic patients. Expression of JAM-C will then be correlated to disease activity (PASI).

The stepwise process of leukocyte extravasation to inflamed tissues depends on the expression of a variety of cytokines and adhesion molecules. Recently much attention has focused on the Junctional Adhesion Molecules (JAM). The three members of this adhesion molecule family, namely, JAM-A, -B and -C, have been shown to govern the last step of leukocyte extravasation (transmigration) - the process of leukocytes passing between endothelial cells. In addition to transmigration, some members of this family seem to support additional steps in the leukocyte extravasation cascade. We recently showed, that antibody-mediated inhibition of JAM-C significantly reduced hapten induced skin inflammation (J Invest Dermatol;125(5):969).

Recent unpublished work from our laboratory showed, that JAM-C expression of lymphocytes can be up-regulated through specific activators. Hence, we hypothesize, that JAM-C expression is elevated in patients with psoriasis. As it is currently not know, which factors may influence the expression of JAM-C, we intend to analyse JAM-C expression on CD3+CD41- cells at several time-points during the treatment of psoriatic patients. Expression of JAM-C will then be correlated to disease activity (PASI).

Detailed in- and exclusion criteria are outlined below.

Eligibility Criteria:
Inclusion Criteria:

* Psoriasis vulgaris
* PASI \>/= 10 at inclusion

Exclusion Criteria:

* Psoriasis arthritis
* Psoriasis pustulosa
* Psoriasis palmoplantaris
* Pregnancy
* current infectious disease
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS \<4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian countries)

Key Exclusion Criteria:

* Chronic liver diseases other than MASH/NASH
* Evidence of cirrhosis on screening liver biopsy
* Have type 1 diabetes or poorly controlled type 2 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to screening

Other inclusion and exclusion criteria may apply.