cyrilzakka/clinical-trials huggingface dataset:
Thoracolumbar Fascia Release on Pulmonary Function in Stroke

This study looks at how thoracolumbar fascia release affects breathing in people who had a stroke. After a stroke, many people have trouble breathing well because their muscles become stiff. We want to see if releasing the thoracolumbar fascia (a big sheet of tissue in the lower back) can help improve lung function.

Participants will be divided into three groups:

Control group - Receives standard stroke rehabilitation. Breathing exercise group - Gets standard rehabilitation plus breathing exercises.

Thoracolumbar fascia release group - Gets standard rehabilitation plus thoracolumbar fascia release therapy.

We will measure lung function right after a single session to see if this therapy makes breathing easier.

Our primary outcome is to check if thoracolumbar fascia release improves lung function compared to the other groups.

This study hopes to find new ways to help stroke survivors breathe better and feel more comfortable.

This randomized controlled study investigates the immediate effects of thoracolumbar fascia (TLF) release on pulmonary function in stroke patients. Post-stroke impairments often lead to respiratory dysfunction due to musculoskeletal restrictions and altered neuromuscular control. Given the biomechanical connections between the thoracolumbar fascia and the respiratory system, we hypothesize that TLF release may enhance pulmonary mechanics by improving respiratory functions, in single session.

Participants randomly assigned into three groups:

Control group - Receives standard post-stroke rehabilitation. Respiratory exercise group - Undergoes standard rehabilitation combined with structured breathing exercises.

TLF release group - Receives standard rehabilitation along with thoracolumbar fascia release.

The primary outcome measure is the immediate change in spirometric parameters, including forced vital capacity (FVC%), forced expiratory volume in one second (FEV₁%), FEV₁/FVC (tiffeneu index) and peak expiratory flow (PEF%).

By evaluating the acute effects of thoracolumbar fascial release on respiratory function, this study aims to explore a potential adjunct therapy for post-stroke pulmonary rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants were male patients aged 18-65 years, diagnosed with monohemispheric ischemic stroke above the brainstem, confirmed through computed tomography or magnetic resonance imaging and a stroke diagnosis at least six months prior to the study.

Exclusion Criteria:

Severe cardiorespiratory or neuromuscular disease, tracheostomy, obesity (BMI ≥30 kg/m²), rib cage deformity, cognitive impairment (Mini-Mental State Examination score ≤ 20), and severe dysphagia, aphasia or confusion.
Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus

Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* No regular medications
* No known significant medical conditions

Exclusion Criteria:

* Inability to consent
* Renal failure (eGFR \<30 mL/min/1.73 m2)
* Standard MRI contraindications
* Pregnancy or breast feeding
Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Aged 18 years or older at the time of enrollment.
* Able to read in either French or English.
* Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc.

are permitted)

For patients only:

* Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.
* Neurological condition is medically stable during the study visit.
* Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.

Exclusion Criteria:

* Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control.
* Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
* Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
* Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.

For healthy controls only:

* Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.

For MS patients only

* Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).
* Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event (McDonald et al. 2001). The abnormality must have been present for at least 24 hours and occurred in the absence of fever (\< 37.5°C) or known infection.
* Patients who have been undergoing disease-modifying therapy for less than three months
Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Born to a mother aged 16 or over
* Admitted to the Newborn Care Unit, John Radcliffe Hospital
* Born prematurely (before 37 weeks' gestation)
* Parent given informed written consent
* Receiving caffeine citrate

Exclusion Criteria:

* Known chromosomal abnormality or life-threatening congenital abnormality
* Severe hypoxic insult at birth
* Intraventricular haemorrhage grade III or IV or other severe neurological pathology
Microarchitecture of Vitreoretinal Contact

Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.

Purpose: to study the features of the macular ILM, to study the features of the preretinal structures of the vitreous body of the Central retinal region, morphofunctional features of preretinal hyalocytes, and the mechanism of vitreoretinal adhesion.

Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling material for corneal transplantation.

Research method: scanning electron microscopy (SEM) of the central retina (macular and paramacular zone): ILM, preretinal vitreous.

Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly fixed to the retinal surface) and the cortical vitreous.

Expected results: determination of ILM thickness in the macular zone, microanatomy of preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion, establishing the possibility of intravital synthesis of collagen fibers synthesis in the adult vitreous.

Eligibility Criteria:
Inclusion Criteria:

* eyes from donors without concomitant multiple organ pathology and ophthalmic pathology

Exclusion Criteria:

* eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases
A Study of the Use of 3D Technology to Guide Head and Neck Surgery

The purpose of this study is to test how the new 3D technology can be used to help improve the surgeon's ability to use information from standard imaging scans to guide head and neck surgery. Researchers will use the Scaniverse app during a standard ultrasound to create 3D images of participants' head and neck before their standard surgery. Researchers will see if the creation of a 3D framework profile with superimposed standard imaging scan information can be useful to the surgeon for guiding head and neck surgery


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK

  o Note: If, for some reason, the participant is not scheduled to have standard preoperative imaging procedures, then the participant will have an ultrasound of the head and neck for research purposes.
* Scheduled to undergo standard of care preoperative imaging (ie, ultrasound (US), computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)) in the Radiology Service at MSK
* Ability to understand and sign (or their legally acceptable representative (LAR) must sign) the written informed consent

Exclusion Criteria:

* Previous head and neck surgery or head and neck radiation
* Any condition which, in the judgement of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
The Stroke Warning Information and Faster Treatment Study (SWIFT)

The purposes of this study are to determine the effectiveness of an interactive stroke educational program compared to standard educational materials and usual care, to increase stroke knowledge, and to improve emergency room arrival times upon onset of stroke symptoms.

Rapid diagnosis and treatment of acute ischemic stroke is critical to reduce disability and death caused by stroke. While recombinant tissue plasminogen activator, or rt-PA, is the only approved treatment for acute ischemic stroke, less than 2-3 percent of individuals with stroke actually receive treatment. The inability to capture acute ischemic stroke cases within 3 hours of symptom onset is one critical factor. Populations at highest risk for stroke are significantly undereducated about the need for rapid, intervention upon onset of stroke symptoms. This is especially true among vulnerable populations including African Americans, Hispanics, and the poor.

The purpose of this study is to evaluate the effectiveness of a 2-session, culturally-sensitive, interactive stroke educational program compared to standard educational materials and usual care. In this study, the scientists will determine if the interactive program increases knowledge about stroke, and results in earlier arrival to the emergency room in the case of stroke.

The study will enroll 1400 individuals who have had a stroke or transient ischemic attack (TIA). Participants will be randomized to receive usual medical care--which includes standard educational information on stroke, stroke warning signs and risk factors--or usual medical care plus a 2-session interactive stroke educational program. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. In additional, participants will be contacted every 12 months to check health status and document new stroke events associated with emergency room arrival time.

The SWIFT study is part of the Specialized Program for Translational Research in Acute Stroke (SPOTRIAS), which seeks to understand why certain people may be at increased risk for stroke. The goal of the study is to increase stroke knowledge, change behavior, and improve emergency room arrival times upon onset of stroke symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral infarction/TIA hospitalized at New York Presbyterian Hospital (Milstein Hospital and Allen Pavilion)
* 18 year-old and older at onset of the stroke
* Self-identified as of White, Black or Hispanic race-ethnicity
* Living in a household with a telephone

Exclusion Criteria:

* Patients unable to give informed consent
* Discharged to nursing home or requiring 24 hour care.
* A Modified Rankin score \> 4 at baseline
* Severe aphasia or severe cognitive impairment limiting comprehension
* Pre-stroke dementia history
* Patients with end stage cancer, or other medical conditions resulting in mortality \</= 1 year
Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity

The main objective of this observatory is to evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity

This observatory evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity, after a one-month treatment with Bibidobacterium longum 35624, 1x10\^9 CFU/capsule, 1 capsule/day.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age
* Gastroenterology consultation for an Irritable Bowel Syndrome according to Rome IV criteria
* Having received a first prescription of Bifidobacterium longum 35624 during the consultation (independently of participation in the observatory)
* Informed and having declared his/her non-opposition to the study.

Exclusion Criteria:

* Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
* Having already taken Bifidobacterium longum 35624
* Having received probiotics or antibiotics within 2 weeks previous
* Having started within the last 7 days a treatment that can interfere with the investigator's evaluation of the investigational product under investigation
* Participant in another trial
* Pregnant or breastfeeding women
* Being under guardianship or curator.
* Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
Self Defining Memories in Women Victims of Intimate Partner Violence.

A recent report by the World Health Organization demonstrated that 30 % of women worldwide have been victims of intimate-partner violence (IPV). IPV is a public health problem thus it seems important to propose relevant care. It is difficult to carry out an effective therapy. Psychological care is based on cognitive abilities but these women have cognitive impairment. Few studies investigated their cognitive dysfunction. Investigators suggest in this study an exploration of the Self Defining Memories (SDM) which can highlight the loss of identity of these women and a new target of therapy.

Intimate partner violence among women is associated to identity problems. Indeed, the victims have a poor self esteem and difficulties to express their own wishes. In this study investigators suggest an analysis of a type of memory, that is known to be essential, to profile an identity functioning: self-defining memories. To date, no study has explored SDM in women with IPV. The characteristics of the SDM in women victims of IPV will be compared to a group of women who has never been diagnosed in this situation. Those memories could be used in therapy. A French adaptation of the questionnaire proposed by Singer \& Moffitt (1992) will be used (Berna et al., 2011a, 2011b) for the assessment of SDM.

Four elements will be study: specificity, meaning, content, affect.

The two groups will have two visits:

* the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms;
* the last to characterize the SDM.

Eligibility Criteria:
Inclusion Criteria:

For all participants:

* French mother tongue.
* Informed consent.
* Affiliated to social security

For women who are victims of IPV only:

* Having at least two physical aggressions
* To meet criterion A of the diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders DSM (DSM-5) (evaluated using the Mini International Neuropsychiatric Interview, MINI)

For women of the control group only:

- None a victim of IPV

Exclusion Criteria:

For all participants:

* Neurological pathology, brain damage.
* History of head trauma with loss of consciousness.
* Severe, progressive somatic pathology
* Psychotherapy in progress
* Taking psychotropic drugs or beta-blockers (because of their potential impact on memory capacity)
* Pregnant or lactating women
* Under a legal regime for the protection of adults

For women who are victims of IPV only:

* Antecedent or presence of PTSD other than that related to IPV
* History or presence of progressive mental disorders (Axis I DSM-5 - evaluated using Mini International Neuropsychiatric Interview, MINI)

For women of the control group only:

History or presence of progressive mental disorders including PTSD (Axis I DSM-5 - evaluated using Mini International Neuropsychiatric Interview, MINI)
Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand

The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.

This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 5 to 70 years inclusive. If aged \< 18 years the subject must have a parent or guardian in attendance.
2. Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
3. Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
4. Able to tolerate oral therapy.
5. Willing to attend follow-up appointments and undergo study procedures.

Exclusion Criteria:

1. History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
2. Bleeding tendency (by history or based on medical records).
3. Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (\>5% RBCs infected), or prostration).
4. History of allergy to or intolerance of study medications.
5. Mixed malaria infection by Giemsa stain.
6. Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
7. Pregnant woman or nursing mother
Pilot Study of Percutaneous Correction of Hallux Valgus

This is a pilot study with a randomized controlled design.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
* HVA (hallux valgus angle): 20°-40°
* IMA (intermetatarsal angle): 10°-20°

Exclusion Criteria:

* Patients with instability of the first metatarsophalangeal joint
* Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
* patients requiring additional surgical procedures
* patients with severe vascular and neurological systemic pathologies
* systemic pathologies that may impair bone consolidation
Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection

The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)


Eligibility Criteria:
Inclusion Criteria:

* ages 18-49 years old,
* not yet received influenza vaccine for 2019-2020, and
* capable of giving signed informed consent.

Exclusion Criteria:

* Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
* active smoking within past 6 months,
* asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
* pregnancy,
* current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
* prior adverse reaction to influenza vaccine,
* history of Guillain-Barre syndrome,
* egg allergy,
* close contact with an individual with severe immunodeficiency/immunosuppression.