cyrilzakka/clinical-trials huggingface dataset:
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.

Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.

Eligibility Criteria:
Inclusion Criteria:

1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4

Exclusion Criteria:

1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
2. Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
3. Evidence of a stroke or mass lesion on structural brain imaging (MRI).
4. Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
5. Severe claustrophobia precluding MR or PET imaging.
6. Subjects limited by participation in research procedures involving ionizing radiation.
7. Pregnancy (test within 48 hours of each PET session) or breastfeeding.
8. Subjects with active and unstable mood or anxiety disorders
9. Subjects with active ear infections or perforated eardrums
Predictors of Hypofibrinogenemia in Severe Trauma

In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen \<1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* severe trauma

Exclusion Criteria:

* age \<18
A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented prostate cancer with evidence of metastatic disease on radiological evaluation, with or without symptoms (defined according to the BPI scale, with use of analgesics or narcotics)
* Has received a first line docetaxel based chemotherapy (as a monotherapy) every 3 weeks schedule of administration with corticosteroids for a minimum of 6 cycles with a cumulative dose ≥360 mg/m2. Any combination with investigational or non investigational agent is prohibited
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Docetaxel-related adverse effects must have been resolved to NCI-CTCAE v4.03 (Common Toxicity Criteria for Adverse Effects) Grade ≤1. Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed
* No progressive disease at the end of docetaxel treatment defined according to RECIST criteria, no new lesion(s) assessed by bone scan and no elevated prostate specific antigen (PSA) for the three last tests with PSA3≤PSA2≤PSA1. The time between each PSA test should be preferably at least 14 days, however, a minimum of 7 days is acceptable.

Note: PSA value can be rounded to the nearest whole number if PSA\>10 ng/mL. If the PSA3 value is above the PSA2, a fourth PSA test will be performed. The PSA4 value should be below or equal to PSA2

* Last dose of docetaxel administered between 21 and 42 days before randomisation
* Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L)

Exclusion Criteria:

* Has concurrent use of other anticancer agents or treatments, with the following exceptions: ongoing treatment with luteinising hormone-releasing hormone agonists or antagonists, denosumab or bisphosphonate (e.g., zoledronic acid) is permitted if started ≥4 weeks prior to Screening. Ongoing treatment should be kept at a stable dose regimen
* Has ongoing treatment with warfarin
* Had prior radiation therapy since starting docetaxel. Exceptions may be made for palliative non-myelosuppressive radiation therapy administered more than 2 weeks prior to randomisation
* Had prior strontium, samarium or radium therapy or prior treatment with tasquinimod, or any agents with antiangiogenic properties
* Has ongoing treatment with corticosteroids at \>10 mg/day prednisolone equivalent
* Has prostate cancer pain that warrants the initiation of radiotherapy or chemotherapy
* Has known brain or epidural metastases. Patients with previous medullary cord compression without any neurological deficit could be included
* Has a history of other malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated, without evidence of disease for \>5 years
Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)

Monocentric, prospective, randomized, open-label, cross-over study.

Current literature data suggest that dental occlusion has an influence on postural control in the general population, and more markedly in high-level athletes. The link between dental occlusion and the postural stability of top athletes has been studied in several disciplines such as basketball, shooting, golf and running. There is currently no data in the field of rowing. But this sport requires optimal postural control for synchronous and symmetrical muscle solicitation.

The present study aims to evaluate the influence of dental occlusion on postural stability and the performance of high level rowers.

Our assumptions are as follows:

* Occlusal disturbance alters the muscular power developed by high level rowers
* occlusal disturbance alters the static postural stability of high level rowers

Eligibility Criteria:
Inclusion Criteria:

* High level rower, part of the Lille Rowing Hope Pole;
* At least 15 years old;
* Training at the Centre de Ressources, d'Expertise et de Performance Sportive (CREPS) de Wattignies during the period from 01/09/2017 to 31/10/2017;
* Having at least 28 natural or prosthetic teeth in occlusion;
* Not having consumed alcohol in the last 24 hours before the recordings;
* whose parents have given free, informed and written consent for minors;
* Having given free and informed consent, in writing supplemented by the consent of at least one holder of parental authority, if he is a minor;
* Affiliated, himself or through his parents if he is a minor, to a social security scheme.

Exclusion Criteria:

* Current antecedent(s) or pathology(s) likely to disturb the balance: neurological, ear nose and throat, ophthalmological, orthopedic;
* Temporomandibular joint disorder (s) (pain and / or noise);
* Orofacial symptoms (headache, tinnitus, facial myalgia, bruxism);
* Dental and / or periodontal care in progress;
* Chronic pain requiring daily use of analgesics for more than three months;
* Pregnant or lactating woman;
* Concurrent participation in another study;
* Major persons subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.
Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India

PRAAN is a post-market registry designed to collect real-world data associated with the use of Medtronic market release neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.

The objective of this registry is to access clinical outcomes associated with the use of these device in patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well.

Real-world evidence per Standard-of-care (SOC) will be generated using Medtronic neurothrombectomy devices approved in India, using on-label indications for use in this post-market clinical follow-up registry.

Eligibility Criteria:
Inclusion Criteria:

1. Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
2. Subject is 18 years of age or older
3. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
4. Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
5. Subject is willing to participate in a 90-day follow-up visit
6. Treatment within 24 hours of last known well. For subjects with stroke onset \>6 hours:

   * ASPECTS score \>5 (per DW-MRI) or \>6 (per NCCT)
   * NCCT Core Infarct \< 70 ml or MRI DWI with \< 70 ml core volume or CTP Ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml
7. Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
8. Pre-treatment National Institutes of Health Stroke Scale (NIHSS)

   * ≥6 and ≤30 for patients with ≤6 hours of stroke onset.
   * ≥10 and ≤30 for patients with \>6 hours of stroke onset.

Exclusion Criteria:

1. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis
2. Patients meeting the contraindication as mentioned in the IFU of devices.
3. Significant mass effect with midline shift
Pain Detection and Interception in Neonates

Hypothesis:

1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
2. Compare the effect of venous and capillary blood sample method

introducing the: Newborn Individualized Developmental Care and Assessment Program

Eligibility Criteria:
Inclusion Criteria:

* Born gestation age 31-36

Exclusion Criteria:

* Infection, respiratory distress
Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
* Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
* Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate

Exclusion Criteria:

* Treatment with tocilizumab more than 8 weeks prior to enrollment
* Failure to meet local tocilizumab label indication criteria
* Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
* Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
* History of any other autoimmune or joint inflammatory disease
Bologna IBD Markers

Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.

This trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease and with indication for anti-TNF therapy according to the normal clinical practice.

Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.

Eligibility Criteria:
Main Inclusion Criteria for IBD patients:

* Adult patients (Caucasian)
* Moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L)
* Indication for anti-TNF therapy according to the normal clinical practice
* Informed consent signed

Main Exclusion Criteria for IBD patients:

* Changes of Crohns disease treatment gastrointestinal medication (including corticosteroids) within the previous 2 weeks prior to enrollment
* Pregnant or breast-feeding (at index date) female patients

Main Inclusion Criteria for no-IBD controls:

* No-IBD adult controls (Caucasian) with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic
* Informed consent signed

Main Exclusion criteria for no-IBD controls:

* Medical history of digestive diseases
* Digestive, renal or metabolic disease, as determined by the medical visit and sa blood chemistry analysis
Adipose Tissue Cellular Response to Exercise in Healthy Humans

The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.

Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 20-27 kg/m2
* Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Blood pressure greater than 140/90 mm Hg
* Pregnant or lactating
* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism, or inflammation
Effects of Inspiratory Muscle Training on Lymphedema

The aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. Two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.

All patients will be treated 5 days a week, 4 weeks, with each session lasting 45-60 minutes. While only decongestive treatment will be applied to the control group, inspiratory muscle training will be given to the interventional group in addition to decongestive treatment. Evaluations of the patients will be made before and after of 4-week treatment program.

Eligibility Criteria:
Inclusion Criteria:

Having been diagnosed with lymphedema in the upper extremity at least 6 months ago

* Having stage 2 lymphedema
* Having a 2-8 cm circumference difference between the affected extremity and the healthy extremity at any reference point
* Being between the ages of 18-60
* Voluntarily agreeing to participate in the study
* Not having received any lymphedema treatment in the last 6 months.
* Not having any physical, respiratory, neurological and/or systemic disease that would prevent participation in the treatment program.

Exclusion Criteria:

Having stage 1 and stage 3 lymphedema

* It has been less than 6 months since the diagnosis of lymphedema was made
* Being under 18 years of age and over 60 years of age
* Having a circumference measurement difference of more than 8 cm and less than 2 cm at any reference point between the affected extremity and the healthy extremity
* Lymphedema or elephantiasis with papilloma, hyperkeratosis
* Uncontrolled hypertension, pulmonary edema, presence of serious cardiovascular disease
* Presence of active metastasis
* Acute inflammatory diseases
Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Analyzed the EEG activity and brain network changes before and after stimulation by TMS stimulation of key brain regions, and correlated them with brain function. To verify the "time-frequency-space" neural mechanism of consciousness.

Eligibility Criteria:
Admission criteria for patients with prolonged disorders of consciousness (Total 200) Inclusion Criteria:(1)Age 14-80 years;(2)In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;(3)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(4) right-handed；(5)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements;

Admission criteria for patients with acute disorders of consciousness(Total 300) Inclusion Criteria:（1)Age 14-60 years;（2）Meets diagnostic criteria for coma recognized in international studies；(3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(5) right-handed；(6)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;(5)No spontaneous breathing;(6)Status Epilepticus;(7)Need emergency neurosurgical treatment can not cooperate with the examination;
OAB and the Microbiome

To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).


Eligibility Criteria:
Inclusion Criteria:

* 18 y/o-90 y/o
* Able to consent
* Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2.
* Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.

Exclusion Criteria:

* Pregnant
* Pelvic radiation
* Urinary retention (\>200 ml)
* Renal calculi
* Recurrent urinary tract infection (UTI) (2 in 6 months), or
* Current UTI
* Immunosuppressed or radiation history
* Neurologic disorder
Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women

The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing peripartum mother to child transmission of HIV (Human Immunodeficiency Virus).

The secondary objective was to assess the overall HIV transmission rate between the 2 groups (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the relationship between infection and timing of maternal dose relative to birth, infant feeding method, maternal peripheral blood viral load, and other potential risk factors for transmission.

Following the introduction of the second and third Amendments to the Protocol, 2 substudies were added. The objectives of these substudies were to evaluate the frequency of resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to determine whether there was a reversion of any resistant virus to the wild type; and to determine if the resistant virus was transmitted from the mother to the child.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who present after 38 weeks gestation or in labour after 35 weeks gestation who are tested HIV positive. Estimated gestational age will be determined by one or more of the following:

  * Reliable menstrual history, which corresponds with uterine size
  * Physical examination
  * Estimated fetal weight
* A consent form for the mother and neonate will be signed by either the mother or the guardian prior to inclusion

Exclusion Criteria:

* Mothers who have taken any antiretrovirals in the last 12 months
* Mothers who are not able to take oral medication
* Mothers who present with ARDS (acute respiratory distress syndrome), septic shock or eclampsia
* Mothers presenting in discomfort, i.e. regular painful uterine contractions, or other factors that may contribute to her not being able to understand and sign the informed consent for HIV testing and study participation
* Use of another investigational drug or concurrent participation in another investigational protocol during the current pregnancy
* Unwillingness or inability to reasonably comply with the protocol (i.e., mother and neonate/infant could not be followed for the full 6 weeks of the trial)
* Grade 4 SGPT (Serum glutamate pyruvate transaminase) (\>10 times the upper limit of normal value), if known prior to delivery
* A recent history (6 months preceding the study) or current evidence of drug abuse and/or alcoholism
* Mothers with fetuses with anomalies incompatible with life, if known prior to delivery
* Decision to deliver the infant by elective Cesarean section
* Amniocentesis was indicated
* Infants with severe growth retardation diagnosed before birth

Infants who fall into the following groups will not receive treatment, but the mother-infant pair will remain in the trial

* Infants with malformations incompatible with life
* Life-threatening perinatal conditions which do not allow oral therapy (e.g., sepsis)