cyrilzakka/clinical-trials huggingface dataset:
The Neural Code and Dynamics of the Reading Network.

The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.


Eligibility Criteria:
Inclusion Criteria:

* patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes (including depth electrodes) to localize the site of seizure onset and to map the locations of critical language and motor regions
* patients with epilepsy, brain tumors or cortically based vascular malformations (cavernous malformations or arterio-venous malformations) with lesions that are/were proximate to crucial brain regions, and who are scheduled to undergo or have previously undergone intra-op mapping of motor, visual or language function, or a Wada test, or maybe part of an awake craniotomy.
* proficiency in English

Exclusion Criteria:

* Gross structural abnormalities (large hamartomata, tumors, large vascular malformations, very large diffuse malformations of cortical development) that may have impacted upon the location of critical brain areas.
* Unable to participate in testing due to impaired cognition or mental retardation.
* Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices
* Patients with claustrophobia who cannot undergo an MRI scan without sedation
Prevalence of Visual Dysfunction in Neurological Disorders

The objective is to determine the prevalence of visual dysfunction in People with Parkinson's Disease (PwP). The investigators will administer the: Visual Impairment in Parkinson's Disease Screen and Revised-Self-Report Assessment of Functional Visual Performance. Patients seen at Fixel Institute and their caregivers will be invited to participate. Responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in PwP compared to those both with and without other neurological conditions.

The purpose of this study is to identify the prevalence of visual dysfunction among Persons with Parkinson's Disease, compared to other neurological conditions and controls without neurological conditions.

Data will be collected anonymously via RedCap. Patients seen at the Fixel Institute that have consented to be contacted regarding research opportunities will be recruited via blast email and advertisement in our Institute's monthly newsletter, the Movement Messenger. The email and newsletter will contain a link for participation in surveys within RedCap so the surveys can be completed anonymously at home. Participation will be completely voluntary and responses will be recorded anonymously. Data will include responses to the following: screening questions, the VIPDQ (Visual Impairment in PD Questionnaire), and the R-SRAFVP (Revised-Self-Report Assessment of Functional Visual Performance).

The investigators will calculate the prevalence of visual impairment (from the VIPDQ) and dysfunction in performance of daily activities (from the R-SRAFVP) for PwP and compare this to the prevalence occurring in other neurological populations as well as the population without any neurological conditions. Other data are collected so the investigators can then evaluate potential confounds or covariates. To ensure statistical methods are accurate, a statistician will be consulted.

Eligibility Criteria:
Inclusion Criteria:

* Persons with Parkinson's Disease: Confirmed diagnosis of Parkinson's Disease without presence of any other neurological condition.
* Persons without Parkinson's Disease (Controls): No previous diagnosis of any neurological condition
* Persons with a single other neurological disorder (Neuro Controls): Confirmed diagnosis of other neurological condition (e.g. ALS, multiple sclerosis, essential tremor, ataxia, etc).

Exclusion Criteria:

* Children (ages younger than 18 years of age)
* Persons with more than one diagnosed neurological condition.
Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals

The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals

Male and female MCADD patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days.

The study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (MCFA) or long-chain fatty acids (LCFA) in the form of triacylglycerol oils. The order of fatty acid oils ingested is determined by randomization.

Eligibility Criteria:
Inclusion Criteria MCADD patients:

* Male or female
* Age between 18-80 years old
* Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD

Inclusion Criteria Healthy Participants:

* Male or female
* Age between 18-80 years old

Exclusion Criteria both MCADD patients and healthy participants:

* Diabetes
* Kidney- or liver disease
* Use of beta blockers or diuretics
* Pregnant, lactating or planning to become pregnant within the study period
* Regular intake of substantial amounts of coconut oil, palm kernel oil or any other source abundant in MCFA
* Ongoing cancer treatment
* Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption
* Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible
A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing

A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing

Eligibility Criteria:
Inclusion Criteria: The patient will be included if:

* Has no medical contraindication
* Presents for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Class 1 or Higher)
* Is at least 18 years of age
* Signs a written informed consent
* Understands and accepts the obligation to present for scheduled follow-up visits
* Understands that the GFX procedure may not be successful
* Presents at the one month follow-up visit with an improvement from the base line RNKLS score

Exclusion Criteria: The patient will be excluded if:

* Has had an injection of botulinum toxin to the target area within the previous 4 months and still exhibits a positive cosmetic effect to the glabellar frown.
* Has had silicone, fat, collagen or a synthetic material placed in the glabellar region or surgical correction or excision of the glabellar furrows
* Has a known bleeding disorder
* Pregnant
* Has received or is anticipated to receive anti-platelets, anti-coagulants, thrombolytics, or cancer therapy
* Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable)
* Has a history of chronic or recurrent infection or compromised immune system
* Has severe allergies manifested by a history of anaphylaxis
* Has known lidocaine hypersensitivity
* Is enrolled in another study
* Has history of keloid formation
* The investigator believes the patient is not a suitable candidate for the GFX procedure, or is not likely to receive cosmetic benefitPresents at the one month follow-up visit with no improvement from the base line RNKLS score
Tissue Plasminogen Activator & Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis

Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.

30 subjects were enrolled in this study and divided into: Group I (Control Group): 10 periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD. Gingival samples were collected from all subjects at baseline and at 3 months after OFD from the CP patients. Then, Hematoxylin and eosin (H\&E) stained slides were examined and gene expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe chronic periodontitis
* Pocket depth (PD) of ≥5 mm
* Clinical attachment level (CAL) ≥5 mm

Exclusion Criteria:

* Pregnant women
* Subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study
* Subjects who received periodontal treatment within the past 6 months
* Smokers
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).

This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and \< 17 years with PHID.

Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 2 to \< 17 years of age, at the time of signing the informed consent
* Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
* Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
* Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
* Subject who is willing to comply with all requirements of the protocol

Exclusion Criteria:

* Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
* Subject who has IgA deficiency and is known to have antibodies to IgA
* Subject who has secondary immunodeficiency
* Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
* Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
* Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
Evaluation of Coaching Impact on Surgical Outcomes

This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events. Trends in surgical outcomes before and after the intervention will be compared between surgeons randomly assigned to the coaching program against non-exposed surgeons.


Eligibility Criteria:
Inclusion Criteria:

* All adults needing a surgery who are operated by one of the participating surgeons

Exclusion Criteria:

* Age \< 18 years old
* Absence of surgical procedure
* Palliative care
* Organ transplantation
* Refusal for personal data sharing
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Objectives:

1. To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
2. To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
3. To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
4. To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.

Eligibility Criteria:
* Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on CALGB 8461 is strongly encouraged.
* Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
2. Age ≥ 18 at the time of initiation of ribociclib therapy;
3. Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
4. It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
5. Provision of written informed consent.

Exclusion Criteria:

1. Patients participating in any interventional clinical study at the time of signing the informed consent;
2. Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
Evaluation of Programs of Reeducation for Urinary Incontinence in Woman

The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)


Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years old and less than 75 years
* Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder
* Patients with a perineale reeducation prescription
* Patients affiliated to a national insurance scheme or benefiting from such a program
* Patients having given her written consent form

Exclusion Criteria:

* Nulliparous woman
* Patients already operated for their incontinence
* Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)
* Pregnant women
* Patients presenting an associated anal incontinence,
* Patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control
* Patients having given birth less than 6 months before the care
* Patients having benefited from a pelvi-périnéale reeducation in the previous 12 months,
* Patients presenting psychiatric disease
* Patients presenting a vaginismus,
* Patients presenting a contraindication to the practice of the electrostimulation.
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)

This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.

Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with gestational age of \<14 weeks
* Maternal age between 18 and 45 years old
* With at least one of FGR high risk factors:

  1. Maternal age \>40 years
  2. Nulliparous, Maternal age \>38 years
  3. Previous pregnancy with FGR, PE or placental abruption
  4. Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
  5. Recurrent spontaneous abortion (RSA) \> 3 times with unknown causes
* Or with at least two of the following FGR high risk factors:

  1. Maternal age 35\~40 years
  2. BMI ≥ 28 kg/m2 or BMI \< 18.5 kg/m2
  3. Conception with assisted reproductive technology
  4. Interval from previous delivery: \> 5 years or \< 6 months

     Exclusion Criteria:
* Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
Effects of Dextrose Prolotherapy in Rotator Cuff Disease

The aim of this prospective, randomized, controlled, single-blind study is to determine the effects of dextrose prolotherapy on shoulder pain and functions in patients with chronic rotator cuff disease.

Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments to reduce pain and improve function have included therapeutic exercises, NSAIDs, subacromial corticosteroid injections. However, some patients are resistant to these conservative treatments. In recent years, prolotherapy has increased in popularity for the treatment of musculosketal conditions. Regenerative injection methods can be applied in resistant chronic rotator cuff disease. In this prospective, randomized controlled, single blind, interventional study, a total of 60 patients with shoulder pain due to rotator cuff disease who meet eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the two groups using computer-generated random numbers. In the dextrose prolotherapy group, ultrasound-guided prolotherapy injections will be applied under aseptic conditions at 0, 3, and 6 weeks. In the salin injection group, salin injections will be applied under aseptic conditions at 0, 3, and 6 weeks. Home exercise program will be apply to both groups. Participants are going to evaluate before injection, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Shoulder Pain and Disability Index (SPADI) change in pain and disability score, with The University of California and Los Angeles Rating Score (UCLA) change in pain and functional score and the change in the Ultrasound Shoulder Pathology Rating Scale (USPRS).

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain for more than 3 months
* Being resistant to conservative treatment for at least 3 months
* Being in the age range of 30-65
* Presence of rotator cuff disease detected in current magnetic resonance imaging and confirmed by clinical examination.

Exclusion Criteria:

* Presence of rheumatic disease or other systemic inflammatory diseases
* Having a diagnosis of uncontrolled diabetes mellitus
* Evidence of infection (systemically or locally on the shoulder)
* The presence of a previous operation on the shoulder
* Bleeding tendency (acquired or hereditary) \[INR\> 2 in the patient using coumadin\]
* Injected shoulder within the previous 8 weeks
* The presence of local anesthesia and corn allergy
* Passive shoulder abduction \<100 ° or external rotation \<25 °
* Rotator cuff calcification diameter\> 0.8cm in current direct graph or Usg
* Presence of serious comorbidity