cyrilzakka/clinical-trials huggingface dataset:
Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.

Primary sclerosing cholangitis (PSC) is characterised by inflammation and fibrosis of the biliary tree and the condition can lead to end-stage liver disease. PSC is strongly associated with inflammatory bowel disease (IBD), with a prevalence of IBD in PSC as high as 60-84 % in Northern Europe and North America. The majority of patients with IBD and PSC have ulcerative colitis (UC).

Considering all patients with UC, around 30% will ultimately require surgery; the most common indications are acute colitis, chronic refractory disease or colorectal dysplasia. The standard procedure is proctocolectomy and ileal pouch-anal anastomosis (IPAA). However, ileo-rectal anastomosis (IRA) or conventional ileostomy are options. The prognosis after surgery is generally considered good.

Previous studies have shown that the course of colitis in patients with UC/PSC is different from that of patients with UC-only.

In a patient with UC, several aspects have to be considered at counselling before surgery. However, in many aspects, the literature is substantial for patients with UC-only (for example function and quality of life after IPAA) and key information can be safely provided. Conversely, patients with UC/PSC that require colectomy are rare and as a consequence, data on most aspects is sparse (18-20).

The aim of the study was to assess outcome after surgery (IPAA or IRA) in patients with UC/PSC. Focus was on pouch/rectal function, pouchitis, surgical complications and failure. Patients with UC-only were employed as controls.

Eligibility Criteria:
Inclusion Criteria:

* UC
* PSC
* IPAA
* IRA

Exclusion Criteria:

* non-UC
* non-PSC
* no consent
Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage

Brain bleed in premature infants damages the brain and survivors suffer from cerebral palsy (weakness in the extremities), cognitive deficits, and neurobehavioral disorders. In this clinical trial, investigators will test whether thyroxine (hormone from thyroid gland) treatment in premature infants with moderate-to-large brain bleeds show recovery in the brain structure on MRI evaluation at the time of discharge (44+/-1 weeks) and neurodevelopmental improvement at 2 years of age.

Intraventricular hemorrhage (IVH) remains a major complication of prematurely born infants. Survivors of IVH suffer from cerebral palsy, cognitive deficits and neurobehavioral disorders. In the proposed study We hypothesize that T4 treatment in preterm (230/7-276/7 weeks) infants with grade II-IV IVH will: a) improve MRI biomarkers, including total myelinated white matter volume, Kidokoro scoring, functional connectivity between motor brain regions, and fractional anisotropy in the corpus callosum of preterm infants with grade II-IV IVH at 36 weeks postmenstrual age, and b) better composite outcome of disability and death. The composite outcome will be derived by integrating scores for Bayley Scales of Infant and Toddler Development (BSID-IV) Motor subscale at 22-26 months in survivors and BSID IV value of 46 assigned to deceased infants. To test these hypotheses, we will perform a randomized double-blinded placebo-controlled trial to determine the effect of T4 treatment on preterm infants with grade II-IV IVH. Ten participating neonatal intensive care units will enroll 346 premature infants (230/7-276/7 weeks gestational age. 173 in each arm) with unilateral or bilateral grade II-IV IVH over a period of 3 years. The treatment will consist of T4 administration (8 µg/kg/day divided into two doses) up to 34 weeks of postmenstrual age, which will be initiated at 2-5 days of postnatal age in all cases. The infants will undergo MRI with DTI at 36 weeks and neurobehavioral evaluation at 22-26 months of corrected age. We have assumed a 7.5 point mean difference (SD=15) in BSID-IV motor subscale between T4 and placebo groups, an overall mortality rate of 25%, and 5% reduction in mortality for each SD change in outcome. Based on these, we expect an increase in the induced composite outcome by ≥5.6 points in T4 treated group compared to placebo controls. The study will conclusively determine whether the proposed clinical trial of T4 treatment enhances motor outcome and diminishes composite endpoint of death or disability in preterm infants with grade II-IV IVH.

Eligibility Criteria:
Inclusion Criteria

* NICU inpatients born between 23-0/7 and 27-6/7 weeks of gestation
* Postnatal age 3-6days (≥3 d ≤ 6 d)
* Unilateral or bilateral Grade 3 or 4 IVH
* Parental consent

Exclusion criteria:

* Major malformations, including surgical, cardiac, cerebral, chromosomal, or genetic syndromes, identifiable at or before birth;
* Congenital bacterial infection proven by culture at birth or viral syndrome known prior to delivery (e.g. chicken pox, rubella, etc.)
Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis

This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).

PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.

HFNC allows the administration of a heated and humidified mixture of air and oxygen at high flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for interhospital transport of critically ill children, as the system is easily set up and is well tolerated by patients. In the context of AVB, retrospective audits and observational studies have suggested promising outcomes on both physiological and clinical variables. However, in less than 6 months old infants with moderate to severe AVB, the failure rate with this device - defined as worsening of respiratory failure or the occurrence of discomfort or severe apnea - remains high, from 30% to 50% in key studies.

HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential explanation for this high failure rate is that the flow usually used is lower than the patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow (PTIF) values in infants up to 6 months old with moderate to severe AVB.

PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of spontaneous ventilation. The measurements will be performed within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de Villeneuve University Hospital at Montpellier (France).

Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be expressed with parametric and non-parametric correlation coefficients according to the distribution of the data.

Eligibility Criteria:
Inclusion Criteria:

* Infants up to 6 months old, with AVB according to conventional clinical criteria;
* Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de Villeneuve University Hospital in Montpellier (France);
* Supported with HFNC, according to the department's protocol (2 \< m-WCAS \< 5);
* Not requiring immediate intubation for invasive ventilation;
* Signed parental consent.

Exclusion Criteria:

* Infant with heart disease, cystic fibrosis or neuromuscular disorder;
* Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP) or with HFNC and without possibility of weaning, including for a few minutes;
* Intolerance of the spirometry mask.
Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.

Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.


Eligibility Criteria:
Inclusion Criteria:

Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.

Exclusion Criteria:

Age \<18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.

The proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. For the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the Scientific institute Eugenio Medea.

The primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety.

The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. Ease of use, safety and usability of the device will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
* Spastic syndrome (ankle joint Modified Ashworth Scale \> 1).

Exclusion Criteria:

* Pace maker or other contraindication to Magnetic Resonance Imaging scans.
* Other serious comorbidity.
* Behaviour and psychiatric disorders.
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization

The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization

Exclusion Criteria:

* infection over the puncture site
* history of prior clavicular fracture
* anatomical anomaly of subclavian vein
Vitamin D Status in Children With Sickle Cell Disease Living in Lyon, France

Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.


Eligibility Criteria:
Inclusion Criteria:

* Children: under 18 years old
* Sickle cell any genetic type homozygous or composite heterozygous
* To receive an assessment independently of the study, during a presentation to the emergency ward and/or a follow-up consultation by the hematologist
* no parental opposition signed by at least one parent/legal representative and no child opposition
* social security beneficiary

Exclusion Criteria:

* History of hematologic grafting
A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.

This study is seeking participants who:

* Are healthy as determined by medical evaluation.
* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)

Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.

This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.

Eligibility Criteria:
This study is seeking participants who:

* Are overtly healthy as determined by medical evaluation.
* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Have a body mass index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb).

This study is not seeking participants who have:

* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
* Any of the following acute or chronic infections or infection history
* Any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
* Have undergone significant trauma or major surgery within 1 month of the first dose of study drug.
Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial

This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.

60 therapists in underserved areas will treat children with anxiety disorders in one of three conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach with minimal direct contact) to determine the feasibility of using of Anxiety Coach to increase the frequency of exposure and improve outcomes with varying degrees of face-to-face contact (N = 60 patients).

Eligibility Criteria:
Inclusion Criteria:

1. Age 7 to 17
2. Primary diagnosis of:

   1. social phobia,
   2. separation anxiety disorder,
   3. panic disorder with and without agoraphobia,
   4. specific phobia, or
   5. obsessive compulsive disorder
3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities
4. Estimated average intelligence
5. English speaking

Exclusion Criteria:

1. History of and/or current diagnosis of:

   1. psychosis,
   2. autism,
   3. bipolar disorder,
   4. mental retardation,
   5. oppositional defiant disorder,
   6. PTSD,
   7. selective mutism, or
   8. major depressive disorder
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last two months
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).

After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).

Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).

After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.

At the time of surgery, re-assessment of the tumor will be done.

Blood work will be performed on day one of each chemotherapy cycle.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have Stage II or III histologically diagnosed breast cancer
* Primary invasive breast cancers that overexpress the HER2/neu oncogene
* Age older than 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 1
* White blood cell (WBC) \> 4000/mm3
* Platelet count \> 100,000/mm3
* Bilirubin \< 1 x upper limit of normal (ULN)
* SGOT \< 1 x ULN
* Creatinine \< 1.5mg/dl
* Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy

Exclusion Criteria:

* Excisional biopsy, sentinel node dissection or axillary node dissection.
* Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
* Pregnant or breast-feeding women
* Uncontrolled infection
* Active or severe cardiovascular or pulmonary disease
* Peripheral neuropathy of any etiology that exceeds grade 1
* Prior history of malignancy treated without curative intent
* Uncontrolled diabetes
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma

This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression

The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed diagnosis of extremities high grade osteosarcoma
* Age ≤ 40 years
* Localized disease or presence of skip metastasis
* Hepatic, renal and bone marrow normal function
* LVEF \> 50%
* No previous surgery and/ or chemotheraputic osteosarcoma treatments,
* No more than 4 weeks interval between histological diagnosis and start of chemotherapy
* Informed consent to the study participation obtained.

Exclusion Criteria:

* Presence of metastases other than skip metastases
* Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma,
* Medical contra-indication to the drugs foreseen in the protocol,
* Subject is pregnant or breast feeding
* Mental or social conditions that can compromise a correct adherence to the protocol and its procedures
Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube

No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.

* Trial with medical device

In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.

The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.

The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.

The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.

Eligibility Criteria:
Inclusion criteria:

* Elective thoracic surgery with anticipated use of a DLT
* Anticipated extubation in the operating room;
* American Society of Anesthesiologist Physical Status 1-3;
* Age 18- 90.
* Written consent (signature from patient)

Exclusion criteria:

* Tracheal pathology, including tracheostomy;
* Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
* BMI higher exceeding 40 kg/m2;
* Known or suspected difficult airway.
* Pregnancy
* Breast feeding
* The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension and dyslipidemia

Exclusion Criteria:

* The subject not meet the specified msBP and LDL-C level