cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Tests Performance on a New Digital Orthoptic Platform

This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.

The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time.

It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision.

The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital.

Exclusion Criteria:

* monophthalmic
* Medium and deep amblyopic patients
* Patients with not normal ocular motility
* Patient who underwent surgery at the head and neck during the previous three months
* Children under 7 years old.
PAtophysiological, Nodal-based Approach for Crohn's Disease Excision

Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence.

The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence.

Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease).

Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled.
* Informed consent

Exclusion Criteria:

* Crohn's Disease with a different localisation
* Recurrent disease
* Extensive jejunitis
* \<18 years of age
* Cancer as primary indication for surgery
* Followed by gastroenterologists outside our centre, due to loss of follow up
* Ileostomy. If a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported
Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder

This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Obsessive-Compulsive Disorder (OCD)
* Resident of state of Wisconsin
* Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI
* Ability to communicate effectively using written and spoken English

Exclusion Criteria:

* Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
* Currently taking medication that reduces seizure threshold (e.g., clomipramine)
* Cranial pathologies (e.g., holes, plates)
* History of seizure or black-out concussion
* Pregnancy
* Previous treatment at Rogers Behavioral Health
Treatment of Prostate Cancer With Firmagon®

How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.

Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended

Exclusion Criteria:

* contraindication for Degarelix
Ambulatory Surgery for Urogenital Prolapse : a Pilot Study

Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.

Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.

This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.

A randomized control study will follow PCAP study.

The prolapse surgery will be performed in 13% of women. Improved surgical and anesthetic techniques available makes this surgery to ambulatory care, while the latter is only slightly conducted in France.

Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.

Secondary objectives are AS rate in the overall population and reasons for ineligibility or failure of ambulatory surgery.

This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.

A randomized control study will follow PCAP study.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Planned POP surgery
* Valid social insurance
* French spoken and written
* Informed consent signed
* No exclusion criteria

Exclusion Criteria:

* Refuse participation to study
* Pregnant or lactating woman
* Vulnerable people (Article L 1121-6 of the french code of public health)
* Major subject to legal protection or unable to consent (Article 1121-8 of the french code of public health )
* Participation in another protocol for less than 3 months
* Patient not presenting all the inclusion criteria.
AI Assisted the Diagnosis of Pancreatic Solid Lesions

Solid lesions of the pancreas mainly include tumor and non tumor lesions. More than 90% of pancreatic tumor lesions are pancreatic cancer, which is characterized by high mortality and poor prognosis and requires surgical treatment; Non-tumor lesions of the pancreas are mainly inflammatory lesions, which usually do not require surgical treatment, but can be treated with drugs. The common ones are chronic pancreatitis and autoimmune pancreatitis, with a good prognosis. Clinically, the differential diagnosis between them is very difficult. Multi-disciplinary diagnosis and treatment of MDT makes our understanding of pancreatic diseases increasingly rich and in-depth. From disease diagnosis to preoperative evaluation and curative effect evaluation, non-invasive imaging involves almost every link under MDT mode. In view of this, improving the differential diagnosis of pancreatic solid space-occupying lesions on imaging will be more conducive to the diagnosis and treatment under MDT mode, so new technologies such as artificial intelligence should be considered. Our goal is to develop a clinically applicable artificial intelligence system, which uses multiple modes to simulate the routine clinical workflow and assist in the diagnosis of benign and malignant pancreatic solid space-occupying lesions.

The diagnosis of solid pancreatic lesions is challenging, MDT is a very effective method, but it has a certain misdiagnosis rate. This is a multi-center, prospective and observational clinical study. Our goal is to develop a clinically applicable artificial intelligence system. On the one hand, our artificial intelligence based on clinical data+CT imaging images can assist MDT doctors to diagnose the nature of pancreatic space-occupying lesions and reduce misdiagnosis; On the other hand, if a patient needs EUS-FNA puncture, the multimodal artificial intelligence system based on clinical data+CT+EUS developed by us can help MDT doctors understand the nature of pancreatic space-occupying lesions and reduce the probability of misdiagnosis or secondary puncture.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic solid mass in CT and EUS

Exclusion Criteria:

* insufficient imaging quality of CT or EUS
* endoscopic ultrasound non accessible lesions
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?

Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bronchiectasis

Exclusion Criteria:

* Hospitalization history during past month
* Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
ATT Compared With ATE in OSAS Children

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention).

Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography.

The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest.

Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA.

To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years.

To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and ATT.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-6 years
* Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
* Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
* Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)

Exclusion Criteria:

* Clinical signs of craniofacial anomalies or neuromuscular disorders
* Obesity
* Earlier having had surgery of tonsils or adenoid
* Bleeding disorder
* Cardiopulmonary disorder
Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any study assessment is performed.
* Males and females of non-childbearing potential ≥ 18 years of age.
* Subjects with mild to moderate essential hypertension,

  * Untreated subjects must have a mean seated SBP (msSBP) ≥ 130 mmHg and \< 180 mmHg at screening.
  * Pre-treated subjects must have a msSBP ≤ 160 mmHg at screening and \< 180 mmHg at the end of the washout period.
* Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women);

Exclusion criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
* History of angioedema, drug-related or otherwise
* History of hypersensitivity to LCZ696, amlodipine, or drugs of similar chemical classes.
* Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
* Type 1 or Type 2 diabetes mellitus.
* Dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid.
* Concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on glucose or lipid metabolism for the duration of the study.

Other protocol defined inclusion/exclusion criteria may apply
Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury, brain injury or acquired muscle weakness
* Managed chronic diseases
* No contraindications to the practice of physical exercise
* Ability to communicate in oral and written Portuguese

Exclusion Criteria:

* Amputation of lower limbs at any level
* Unstable or acute fractures of lower limbs
* Contraindication for the practice of physical activity
* Open wounds in the lower limbs
* Consent withdraw
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants

This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

Retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (IVH) in extremely premature infants of mothers given magnesium sulfate (MgSO4) may be reduced. The purpose of this study was to examine the effects of MgSO4 exposure on adverse outcomes in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database, data were prospectively collected on maternal/infant conditions and MgSO4 exposure (including indications, timing and duration of exposure).

Eligibility Criteria:
Inclusion Criteria:

* Infants born in NRN Centers with a birth weight of 401-1,500g

Exclusion Criteria:

* None
Training Cognitive Control Processes in Older Adults

Control processes are classes of brain activity that initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults.

The proposed research investigates whether exposure to a computer-based training protocol designed to enhance cognitive control processes will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into three experimental groups: 1) Video game play with training strategy; 2) Video game play without training strategy (Active Control); 3) Minimal contact (Passive Control). Subjects in Groups 1 and 2 will be instructed to play the complex, high-demand video game, Space Fortress, for 36 one-hour sessions over 12 weeks. Subjects in Group 3 will receive all assessments but will not play the computer game.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-75
* Willingness to adhere to training protocol
* Adequate English proficiency

Exclusion Criteria:

* Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance
* Taking medications known to influence cognitive performance
* Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
* Enrolled in a concurrent study that could affect the outcome of this study
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.

This trial includes a dose-escalation part (Part 1) in which the MTD and RDE will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

BYON3521 is an ADC comprising a humanized IgG1 monoclonal antibody (mAb) directed against the c-MET receptor covalently and site-specifically conjugated to a duocarmycin-containing linkerdrug.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:
* Part 1 (dose-escalation): solid tumours of any origin;
* Part 2 (expansion):

  * Cohort A: Non-squamous non small cell lung cancer (non-squamous NSCLC);
  * Cohort B: Gynaecological cancers: ovarian cancer, endometrial cancer, cervical cancer;
  * Cohort C: Pancreatic adenocarcinoma (PA);
  * Cohort D: Uveal melanoma (UM).
* c-MET prevalence confirmed by:
* Part 1: Tumour c-MET positive membrane staining by immunohistochemistry (IHC) and/or MET amplification by dual In Situ Hybridization (dISH) and/or known MET-mutation;
* Part 2: Tumour c-MET membrane expression by immunohistochemistry (IHC score ≥ 2+) as determined by the central laboratory on most recent available/obtained tumour material from a site not previously irradiated;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
* Adequate organ function

Exclusion Criteria:

* Having been treated with:
* Trastuzumab duocarmazine (SYD985) at any time;
* Other anticancer therapy within 4 weeks or as defined in the protocol;
* History or presence of keratitis, glomerulonephritis, idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
* History (within 6 months prior to start IMP) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
* Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks