cyrilzakka/clinical-trials huggingface dataset:
Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over

The objective of this study is to evaluate the efficacy and safety of surgical resection in elderly patients 70 years or older with a supratentorial glioblastoma de novo. The sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of malignant glioma in the elderly will also be studied.

Currently, the standard treatment for gliomas is based on surgical resection followed by radiation therapy.

However in patients 70 and older, surgery is not systematic, before radiotherapy. Moreover, at these ages, surgery is likely to be less well tolerated in general terms.

The aim of this study is to try to determine the best treatment between radiation therapy associated with the surgical treatment and care by radiotherapy alone, after a brain biopsy. This is a randomized, two arms, multicenter, open study.

In the two weeks following the radiological diagnosis of a lesion highly suggestive of a high-grade glioma, patients will be randomized to either arm surgery (partial or complete excision) + radiotherapy or in the radiotherapy alone arm. Within 5 weeks after surgery (biopsy or excision), all patients will receive treatment with focal radiotherapy.

A central review blades and MRI data will be organized after the inclusion of patients.

A maximum of 135 patients will participate in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Highly suggestive radiological aspect of a high-grade glioma
* Operability of the lesion, defined according to standard criteria of literature: lobar tumor, cortico-subcortical, well limited, without deep infiltration and without involvement of the basal ganglia. This operability is to reassess based on surgical experience and the ability to remove more or less completely a tumor of this type in a given location
* Age greater than or equal to 70 years
* Preoperative Karnofsky Index ≥ 50
* Information given to the patient or his family and signed written consent.

Exclusion Criteria:

* Existence of a cons-indication to MRI
* Non operability of the lesion
* Unbalanced concomitant serious pathology that might be an indication against-formal anesthetic (ASA 4-5) (see annex)
* Previous history of radiotherapy or chemotherapy prior to this injury
* Patient under guardianship or under judicial protection
Optimisation Strategy for Emergency Tracheal Intubation

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient adult (≥ 18 years) presenting with vital distress requiring emergency tracheal intubation as assessed by the emergency physician in the out-of-hospital setting.
* Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest will be included.

Exclusion Criteria:

* Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist).
* Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis).
* Patient that are not members of a medical aid scheme (beneficiary or main member).
* Patient under specific protection measures: pregnant, parturient or nursing women; legal protection or deprived of liberty: patient under judicial protection, patient under guardianship/curatorship.
BIOTRONIK 4French for AMBulatory Peripheral Intervention

BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory setting: BIO4AMB

Controlled, multicenter, non-inferiority trial to compare the rate of access site complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Ability to walk
* Subject must be willing to sign patient Informed Consent (PIC)
* Patient with infrainguinal arteries lesion(s) suitable to be treated during an ambulatory endovascular intervention

Exclusion Criteria:

* No possibility of an ambulatory management
* Physical fitness classified as ASA ≥ 4 (American Society of Anaesthesiologists)
* Coagulation disorders
* Acute ischemia
* Less than 1month live expectancy
* Pregnant or breast feeding females or females who intend to become pregnant during the time of the study (pregnancy test required for all women with child bearing potential)
* Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures
* Patient contraindicated for antiplatelet therapy, anticoagulants and antithrombotics
* Other access than common femoral
* Home alone the first night
Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)

This study aims to characterize the epidemiology of interstitial lung diseases (ILD) associated to connective tissue disease (CTD) in Mexico, and to study its correlation with the different comorbidities and treatments used, as well as the possible impacts of these factors on the outcome of progression, exacerbations, and mortality in patients with ILD associated to CTD.


Eligibility Criteria:
Inclusion Criteria:

For newly data collection:

* Male and female Patients.
* Patients over 18 years old.
* Patient who gives his/her signed informed consent to be able to use information about their condition.
* Patient who has the diagnosis of: rheumatoid arthritis, connective tissue disease (CTD) (systemic sclerosis or scleroderma; inflammatory myopathy: antisynthetase, dermatomyositis, polymyositis, mixed connective tissue disease; systemic lupus erythematosus; primary Sjögren syndrome; pulmonary fibrosis associated with non-specific autoimmunity; primary systemic vasculitis; psoriasis, anchylosing spondylitis, reactive arthritis) Spondyloarthritis (SpA) or sarcoidosis, (accordingly with the updated clinical criteria for each pathology).

Patient with any interstitial lung diseases (ILD) diagnosed clinically and by a high-resolution computed tomography study with an interstitial pattern (supervised by an expert radiologist).

For existing data collection:

* Medical Records from patients with whom contact was permanently lost for any reason since 2012 till the study start date.
* Medical Records from male and female Patients.
* Medical Records from patients over 18 years old.
* Medical Records of patients that have at least: patient initials, date of birth, gender, date of diagnosis, full diagnosis of:

  * Patient who has the diagnosis of: rheumatoid arthritis, CTD (systemic sclerosis or scleroderma; inflammatory myopathy: antisynthetase, dermatomyositis, polymyositis, mixed connective tissue disease; Systemic lupus erythematosus; primary Sjögren syndrome; pulmonary fibrosis associated with non-specific autoimmunity; primary systemic vasculitis; psoriasis, anchylosing spondylitis, reactive arthritis) SpA or Sarcoidosis, (accordingly with the updated clinical criteria for each pathology).
  * Patient with any ILD diagnosed clinically and by a high-resolution computed tomography study with an interstitial pattern (supervised by an expert radiologist).

Exclusion Criteria:

* Patient with a biopsy definition of usual interstitial pneumonitis, related to any other non-CTD.
* Patient with post-chemotherapy or post-radiotherapy pneumonitis.
* Medical Records of patients without full diagnostic of ILD (clinically and by biopsy or high-resolution computed tomography).
Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222

This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 in adults vaccinated in real-world settings.

The study will use an innovative digital platform (study app and web portal) as well as a traditional call centre to collect participant responses to a series of health and well-being questionnaires over an 18-month period.

Research coordinators at vaccination sites will invite vaccinated adults to join the study. Participants can enrol at the vaccination site with assistance from a research coordinator or can take home a study information brochure and enrol within 28 days after the first dose of AZD1222. Research coordinators and the study call centre will be available to assist with enrolment and informed consent, as needed. Electronic consent using the study app will be an option where permitted.

Participants using the digital platform will set up a secure account, complete the enrolment questionnaires, and provide details of their vaccination to confirm eligibility. Non-digital participants will complete the enrolment questionnaires and confirm eligibility at a vaccination site or by a telephone call to the call centre. After enrolment, participants will be contacted to complete follow-up questionnaires at timed intervals over an 18-month period after their first AZD1222 dose. Digital participants will receive push notifications or emails and non-digital participants will receive phone calls. Participants can also submit unscheduled adverse event (AE) reports through the digital platform and call centre.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older at the time of vaccination.
* Received AZD1222 as the first dose of COVID-19 vaccination in the prior 28 days.
* The participant has provided sufficient details to validate the vaccination (vaccination card, batch/lot number, and/or regional vaccination register details).
* Provided informed consent to participate in the study, either personally or through a legal representative.
* Able and willing to provide responses to study notifications using the mobile device app, web portal, or call centre or have a proxy (a caregiver, family member, or other trusted individual) who can do so on their behalf.
* Able and willing to grant, personally or through a legal representative, permission to contact the participant's healthcare providers and to access the participant's medical records at the time of vaccination and during the post-vaccination follow-up period.
Evaluating Online Messages About Colon Cancer Screening

The goal of the study is to determine, using a choice-based approach, what messages (pulled from various online sites) people find more and less persuasive and shareable on the topic of colorectal cancer screening. As a secondary goal, the study is interested how various information behaviors, such as people's self-reported seeking of health information and encountering of health information, demographic variables, individual difference variables, and message exposure associate with their intentions to adhere to recommended colorectal cancer screening guidelines from the National Cancer Institute. The study is interested at differences specifically among Black and White Americans of recommended screening age (45-74).


Eligibility Criteria:
Inclusion Criteria:

* Identify as white/Caucasian or Black/African American.

Exclusion Criteria:

* Do not identify as white/Caucasian or Black/African American.
* Previously diagnosed with colorectal cancer
Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.

Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia

A randomised clinical trial will be conducted in which there will be 3 groups. One control group and 2 experimental groups; one of them will undergo dry needling of the upper trapezius fibres and the other will undergo passive stretching of the upper trapezius fibres. Both groups will have the joint range of cervical lateral tilt, pain measurement by algometer and visual analogue scale (VAS) measured. All these measurements will be taken before and after treatment. The participants of the study will be people who have been diagnosed with fibromyalgia at least 6 months before the start of the study, who are members of the FIBROFAMUR association. Association of Fibromyalgia, Chronic Fatigue, Rheumatic and Musculoskeletal Diseases of Murcia. The data collected will be: socio-demographic data, age, sex, measurement of cervical joint range using a goniometer and measurement of pain using an algometer and visual analogue scale (VAS). As undesirable effects, in exceptional cases, the dry needling technique may produce residual discomfort in the puncture area that may last between 1 and 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of fibromyalgia at least six months before the start of the study.
* Be of legal age.
* Report at least one episode of neck pain in the last six months.

Exclusion Criteria:

* Surgical interventions or scars at cervical level.
* Dizziness or vertigo.
* Dermatological problems.
* Severe psychiatric disorders.
Effect of Surgical Wound Infection on Health

A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body

Morbidity and mortality were associated with increase of surgical site infections (SSIs).Besides, it was a financial burden and negatively impact of SSIs on patient quality of life (QoL).

Eligibility Criteria:
Inclusion Criteria:

* wound who had infection post surgery

Exclusion Criteria:

* women who had no infection
Study of Gene Associations and Infertility

The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.

Experimental strategies seek to discover small variants in DNA sequences, which are associated with certain infertility parameters. The alleles being analyzed in in vitro fertilization (IVF) population are sought to be associated with functional differences in the expression of the gene product that are then mechanistically linked to infertility.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing fertility care

Exclusion Criteria:

* none
The Effects of Attention Retraining in MS

The purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with MS. The hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, QoL and perceived cognitive deficits.

Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS). According to previous studies, neuropsychological rehabilitation may improve cognitive performance in MS. However, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest.

Objective: To study whether neuropsychological rehabilitation improves cognitive performance, QoL and perceived cognitive deficits in patients with MS.

Methods: Altogether 100 patients with MS are randomised either to intervention or to control group in three different study sites. All the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. Patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. Patients in the control group do not receive any intervention.

Results: The effects of intervention on cognitive performance, QoL and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group.

The present status: The baseline assessments have been performed and the intervention will be conducted between September and December, 2011.

Eligibility Criteria:
Inclusion Criteria:

* clinically definite MS
* EDSS \< 6
* age 18-58 years
* subjective cognitive problems and objective decline in attention

Exclusion Criteria:

* other neurological disease than MS
* psychiatric diagnosis
* severe depression
* secondary progressive or primary progressive course of MS
* EDSS\>=6
* alcohol or drug abuse
* relapse during the preceding month of study entry
* neuropsychological rehabilitation during the study
* no subjective cognitive cognitive problems and /or no decline in attention
* overall cognitive impairment (performance in all tests of BRBNT under -1.5 SD compared to norms of healthy controls)
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth

The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).

The childbirth process is associated with the risk of developing postnatal depression (PND) and persistent postpartum pain (PPP), which could contribute to maternal morbidity. There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP. Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth.

The investigators propose an integrated psychological program (IPP) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat PND and PPP. The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth. The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale (EPDS) scores in a subgroup of laboring women (with outcomes of vaginal or emergency Cesarean delivery) that may have increased risk factors for PND. The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). A total of 1480 women undergoing childbirth will be recruited in this randomized controlled trial.

This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP. The IPP will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.

Eligibility Criteria:
Inclusion Criteria:

* healthy (American Society of Anesthesiologists physical status 2)
* parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
* with a singleton fetus;
* to have delivery in this institution.

Exclusion Criteria:

* current active psychiatric care;
* history of intravenous drug or opioid abuse;
* previous history of chronic pain syndrome.
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

To determine, in subjects with Type 2 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

* Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
* Subjects on insulin pump during 2 months prior to screening.
* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Gamma Entrainment Improve the Recovery of Awareness

The purpose of this study is to elucidate the occurrence of Gamma entrainment and optimize the acousto-optic stimulation parameters to induce it in patients with disorders of consciousness (DOC), to explore the prognostic value of gamma entrainment in patients with DOC, and to clarify the effect of gamma entrainment on the recovery of awareness in DOC patients. This study is divided into three parts. The first and third parts are prospective cohort studies, the second part is a randomized cross control study. We recruit DOC patients, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS). The patients receive sound and light stimulation in the Gamma band, and the changes of EEG are observed simultaneously to explore the occurrence of Gamma entrainment. Meanwhile, the changes of clinical behavior of patients before and after stimulation are evaluated.


Eligibility Criteria:
Inclusion Criteria:

Age 16-80 years; Clinical diagnosis of VS/UWS or MCS according to the CRS-R score within one week after admission; Time post-onset \> 28 days.

Exclusion Criteria:

Previous history of acquired brain injury or psychiatric or neurodegenerative diseases; Clinical diagnosis of epilepsy; Visual or auditory pathway damage; Life threatening comorbidity, coexisting neoplasms, severe organ dysfunction, or unstable clinical condition (e.g., hemodynamic instability or severe respiratory failure); Incomplete clinical data.