cyrilzakka/clinical-trials huggingface dataset:
Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies

This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies.

Memory performances during a fMRI experiment will be assessed in controls and epileptic patients before and after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with drug-resistant epilepsy
* Age of 18 years or more
* Follow-up in the epilepsy unit at Pitié-Salpêtrière Hospital
* Before or after the presurgical evaluation unit including a video-EEG monitoring, a structural brain imaging and a full neuropsychological assessment
* Covered by a social security system
* Signing of consent form

Exclusion Criteria:

* Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
* Refusal to consent form
* Contraindications to MRI
* Pregnancy
* Refusal to be informed in the case of detection of an abnormality during the experiment
Obstructive Sleep Apnea Management in People With Spinal Cord Injury

The prevalence of obstructive sleep apnea (OSA) is a significantly higher in people after spinal cord injury (SCI) than in the general population. As a positive pressure therapy (CPAP) is often poorly tolerated, a mandibular advancement device (MAD) can be used for the treatment of OSA. The purpose of this study is to determine the efficacy of MAD in people with SCI and to verify their adherence to the therapy.

Obstructive sleep apnea (OSA) is a disorder with serious health consequences. Compared to the general population, a significantly higher prevalence of OSA was found in individuals with spinal cord injury (SCI). As treatment, positive pressure therapy in the respiratory tract during sleep (CPAP) is commonly instituted. However, CPAP therapy is often rejected or poorly tolerated by patients. Alternatively, the American Association of Sleep Medicine recommends the use of Mandibular Advancement Devices (MAD). The MAD prevents the upper airway from collapsing by anterior displacement of the mandible.

The aim of the project is to determine the efficacy of MAD therapy in people with SCI and to verify their adherence to the therapy. The research group will consist of 60-80 subjects. The selection of suitable participants will be based on the results of a polygram. The MAD for a group of subjects with an apnea-hypopnea index (AHI) higher than five will be fabricated using their dental impressions. Subsequently, the subjects will be retested while wearing the MAD and outcomes will be compared. The evaluation will include a set of questionnaires. Adherence to therapy will be checked after three and six months.

The investigators anticipate that the results of the study will confirm the effectiveness of MAD devices in the treatment of OSA in the monitored group. Most importantly, the investigators intend to set a standard for a long-term system of diagnosing and addressing OSA in individuals with SCI.

Eligibility Criteria:
Inclusion Criteria:

* AHI \> 5 on polygraphy
* sufficient set of teeth to hold a splint
* written informed consent

Exclusion Criteria:

* use of medication that could affect breathing or sleep
* oxygen-dependent or decompensated lung disease
* decompensated congestive heart failure
* evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia)
* abnormalities of the upper airway
* periodontal problems and untreated caries
* mental disorders
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Eligibility Criteria:
Inclusion Criteria:Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3;KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 1.5x ULN, AST and ALT ≤ 1.5x ULN, BUN and Cr: within the normal range.

Exclusion Criteria: Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia). Unable or unwilling to comply with the study protocol.The expected survival time is less than 3 months. Patients who are anticipated in other clinical trials of brain metastases. Patients who has been treated with WBRT. Pregnant patients or female patients whose HCG is positive. Unsuitable to participate in study, that in the opinion of the treating physician.
A Trial of MitoQ for the Treatment of People With Parkinson's Disease

In Parkinson's Disease, the mitochondrial membranes in cells that produce dopamine become damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of movement and the loss of neurons in the substantia nigra (a part of the brain that is involved in movement). Mitoquinone is targeted to reach the membrane of mitochondria and provide protection from damaging oxidants. There are no treatments currently available to slow the progression of PD and this trial will help advance the development of this unique disease modifying drug.

This trial will enroll 120 participants with untreated early onset of PD. Participants will be randomized to receive 1 of 3 treatments: 40 mg of MitoQ tablets, 80 mg of MitoQ tablets or placebo. The researchers, participants and sponsor will all be blinded to the treatment allocation. Participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and again 28 days after their last dose. The effectiveness of the trial drug will be measured via the Unified Parkinson's Disease Rating Scale (UPDRS). The safety of the trial drug will be monitored via regular participant examinations, blood tests, ECG and collecting information on adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. 30 yrs or older
3. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity)
4. Adequate contraceptive measures (females)

Exclusion Criteria:

1. Malignancy within last 2 years
2. Pregnancy \& breast-feeding
3. Treatment with any anti-PD drugs within 30 days of enrolment
4. Prior treatment with anti-PD medication exceeding 42 days in total
5. Medication-induced PD/PD not of idiopathic origin
6. CoQ10/idebenone doses of 300mg/day or higher within 120 days, \>25mg/day within 7 days of enrolment
7. Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment
8. CNS medications at unstable doses within 60 days of enrolment
9. Dietary supplements \> 5 x RDI
10. Hypersensitivity to CoQ10, idebenone or any components of the study drug
11. Unable to swallow
12. Diseases with features of PD
13. Seizure(s) within 12 months prior to enrolment
14. UPDRS tremor score of 4
15. Hamilton Depression Rating Scale score \> 10
16. History of stroke
17. Requirement for dopaminergic drugs
18. Modified Hoehn \& Yahr score \> 2.5
19. History of brain surgery for Parkinson's disease
20. History of structural brain disease / congenital brain abnormality
21. History of ECT
22. Any other clinically significant medical or psychiatric condition or lab abnormality
23. Enrolment in any other pharmacological study within 30 days of enrolment
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive subjects with recent onset rheumatoid arthritis
* Signed informed consent

Exclusion Criteria:

* Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
* Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis
A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study

This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.

This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.

The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir.

In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

  * Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b)
  * Patient and partner(s) must agree to use acceptable methods of contraception
  * Patient must be able to read and understand English and/or Spanish
  * Written informed consent

Exclusion Criteria:

* Currently taking or planning on taking any prohibited medications (see US PI)

  * Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  * Abnormal lab values, including:

    * Hemoglobin (Hgb) \<8 g/dL
    * Platelets \<25,000 cells/mm3
    * Absolute neutrophil count (ANC)\<500 cells/mm3
    * Bilirubin \>3
    * INR\>2.3 ALT/AST \> 10 x ULN
    * Serum albumin \<2.8
    * GFR \<30 mL
  * Alcohol use: \>3 drinks per day consistently
  * Uncontrolled HIV or HBV coinfection
The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity

This study evaluates the effects of Horner's syndrome on cardiac autonomic nervous activity after interscalene brachial plexus block. Cardiac autonomic nervous activity and bilateral pupil diameters will be measured in a scotopic light condition, 30 minutes after interscalene brachial plexus block under ultrasound guidance and 15 minutes after the subsequent sitting position.

Stellate ganglia provide sympathetic fibers to the heart. Ipsilateral stellate ganglion block accompanied by interscalene brachial plexus block causes Horner's syndrome presenting with miosis, ptosis, and anhidrosis. The extent of Horner's syndrome can be represented by the difference in pupil diameter between bilateral eyes. Cardiac autonomic nervous activity affected by stellate ganglion block can be measured by calculation of heart rate variability parameters.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1
* Arthroscopic shoulder surgery under interscalene brachial plexus block

Exclusion Criteria:

* Coagulopathy
* Infection at the site of brachial plexus block
* Peripheral neuropathy or neurologic sequelae on the operative limb
* Allergy to local anesthetics or history of allergic shock
* Psychiatric diseases
* Patient refusal
* Difficulty communicating with medical personnel
* Arrhythmias
* Ischemic heart disease
* Hypertension
* Diabetes mellitus
* Thyroid dysfunction
* Conduction abnormalities on electrocardiogram
* Electrolyte imbalance
* Medications affecting cardiac conduction
* Contralateral vocal cord palsy
* Contralateral hemidiaphragmatic paresis or paralysis
* Contralateral pneumothorax or hemothorax
the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)

the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were investigated in obese pregnant women compared with normal-weight pregnant women.

All pregnant women underwent a comprehensive fetal anomaly screening. One obstetrician (S.D.) assessed all of the measurements. Every measurement was performed using a convex 2-5 MHz Voluson E8 probe (GE Healthcare, Milwaukee, WI). Fetal biometry, UA, MCA Doppler, cerebroplacental ratio (CPR), modified MPI (mod-MPI), and EFT were assessed in accordance with the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines

Eligibility Criteria:
Inclusion Criteria:

* Obese pregnant women
* normal-weight pregnant women
* 24-40 gestational week

Exclusion Criteria:

Twin pregnancies, structural and chromosomal abnormalities, fetal rhesus isoimmunization, fetal growth restriction, cases with infections detected by maternal serological tests, pregestational or gestational diabetes (All patients underwent a 75-gram glucose load test at 24 weeks to rule out diabetes), preeclampsia, premature rupture of membranes were excluded from the study -
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age

The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that:

- There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?

Many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. So that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. These types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. A limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. Study Design: A prospective, randomized, single-blind, pre-post-test, controlled trial.

Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.

Eligibility Criteria:
Inclusion Criteria:

All girls diagnosed with female athlete triad resulting in osteopenia

* Their age between 14-18 years old
* Their body mass index is less than 5 percent according to the gross motor chart
* All participants are gymnastics players
* All are medically stable
* They will be able to follow instructions

Exclusion Criteria:

* Marriage
* Pregnancy
* Taking any hormonal treatment
* Receiving any other form of traditional physical therapy modalities
A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome

The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Large amounts of protein in the urine is often an early sign of kidney disease.

Information needs to be collected in boys who are not taking medications known as angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain accurate data about the length of time between the onset of microalbuminuria and the start of overt proteinuria. This new information will give physicians a better understanding of how to treat patients with Alport syndrome.

The information we gather by conducting this study will aid in planning future clinical trials because the identification of time points in disease progression, such as microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical benefit of a new treatment option.

The study has been approved by the University of Minnesota's Institutional Review Board.

Study Aims

1. To determine the average ages of onset of microalbuminuria and overt proteinuria in untreated boys with Alport syndrome
2. To determine the average duration of microalbuminuria before transition to overt proteinuria in untreated boys with Alport syndrome

This study does not involve treatment and is anticipated to last 3-5 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alport syndrome, confirmed by skin biopsy, kidney biopsy, or molecular genetic analysis
* Diagnosis of Alport syndrome, based on presence of hematuria and confirmed diagnosis of Alport syndrome in a first-degree relative
* Male gender
* Absence of overt proteinuria, defined as urine protein:creatinine ratio less than 0.2 mg/mg
* Subject is not currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria:

* Female gender
* Presence of overt proteinuria
* Current treatment with ACEI or ARB
* End-stage kidney disease (on dialysis or kidney transplant recipient)
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.


Eligibility Criteria:
Inclusion Criteria:

* male or female, ages between 8 and 17
* Body Mass Index \> 30
* fasting blood sugar between 90-100 mg/dl
* 2 hour post prandial \>140 \<180 mg/dl
* meets criteria for a diagnosis of ADHD, any subtype

Exclusion Criteria:

* known cardiovascular disease or diabetes
* structural cardiac abnormalities, abnormal ECGs, family history of sudden death
* positive urine drug screen
* fasting blood sugar level \> 126 mg/dl
* HbA1c \> 6.5 %
* Weight \> 300 lbs
Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer

This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.

Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Left-sided breast cancer
2. Underwent breast conserving surgery
3. Planned for postoperative whole breast +- regional nodal radiotherapy
4. No basic heart disease

Exclusion Criteria:

1. Abnormal cardiac baseline examination
2. History of chest radiation
3. Can not tolerate deep inspiratory breath-holding
Role of miRNAs in CVD and Periodontitis

Several micro-RNA plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease. The investigators compared the impact of gingival health, periodontitis (CP), cardiovascular disease or of both diseases (CP +cardiovascular disease) on gingival crevicular fluid miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p levels.

The investigators compared the impact of gingival health, periodontitis (CP), cardiovascular disease or of both diseases (CP +cardiovascular disease) on gingival crevicular fluid miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p levels.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.

Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.

Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.

And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).

A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.

Assessing the impact of a geriatric action (Team Mobile Geriatrics, EMG, or if the geriatric facility team when it does not have EMG) on the rate of nutritional support perioperative elderly subjects (≥ 70 years) who underwent a colorectal cancer according to ESPEN recommendations and SFNEP.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 70 years
* Colorectal or tumor resection with/without synchronous metastases

Exclusion Criteria:

* Emergency resection of colorectal tumor
* Unresectable colorectal tumor with/without synchronous metastases