cyrilzakka/clinical-trials huggingface dataset:
Carbohydrate Feeding Frequency, Muscle Glycogen and Exercise Capacity in Runners

The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as a trained runner
* Regularly participate in running activity (\>2 times a week)
* Participated in running based training for a minimum of 2 years
* Be willing to undertake exercise sessions until volitional exhaustion
* Be willing to have the necessary samples taken during the testing protocols
* Not a habitual smoker
* Have the capacity and willingness to provide informed consent (oral and written)
* Successful completion of the physical activity readiness questionnaire (PAR-Q)

Exclusion Criteria:

* Female
* \<18 or \>50 years old
* Not regularly participating in running activity (\<3 times a week)
* Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
* Habitual/previously habitual smoker
Green Light Exposure in Healthy Volunteers Exposure in Normal Human Volunteers

This research project is intended to understand the mechanisms of action for the pain-relieving properties of visual green light exposure.

The investigators have shown previously that greenlight exposure decreased acute and chronic pain in both animals and humans. However, the investigators do not yet understand how green light exposure is capable of such function.

Pain is a biological function. There are several pain centers in the brain that modulate the intensity of the pain signal perceived by the brain. Part of the modulations takes place through two separate pathways. The first pathway mediates pain signals and is known as the ascending facilitator pain pathway. The main function of this pathway is to relay the pain signal to the brain to be processed.

The second pathway is known as the descending inhibitory pain pathway. The main function of this pathway is to inhibit the pain signal mediated by the first pathway.

Normal humans typically have a balance between the activities of the ascending and descending pain pathways.

The investigator animal studies suggest that green light therapy exhibits its pain-relieving effects through altering the balance between the ascending and descending pain pathway in a manner to result in an overall reduction or normalization in pain perception.

To test this hypothesis, the investigators propose recruiting 30 healthy human volunteers. The participants will be equally randomized into either green light (treatment) or white light (control) exposure groups. The investigators will initially test the activities of the ascending and descending pathways using thermal and mechanical stimulations. The investigators will also test brain wave activities using a non-invasive EEG device. After establishing the baseline activities of the pain pathways and brain waves, the volunteers will be exposed to the green light or white light at low intensity (4-100 lux) for two hours in our laboratory. After two hours of light exposure, the investigators will again test the activities of the pain pathways using thermal and mechanical stimulation and measure the brain wave EEG activities.

Eligibility Criteria:
Inclusion Criteria:

1. 18-50 years healthy men or women
2. Able to speak and understand English
3. No history of Chronic pain
4. No known neuropathies in areas that testing will take place, (forearms, muscle at the base of thumb on the palm of the hand and upper back/shoulder area.

Exclusion Criteria:

1. Serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. This will be assessed during the screening interview.
2. Colorblindness or uncorrected cataracts.
3. Tissue damage in areas that testing will take place, (forearms, muscle at the base of the thumb on the palm of the hand, and upper back/should area.
Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears

The use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by large to massive lesion according to Gerber involving supraspinatus and infraspinatus tendons
* tendon retraction \<=3 according to Thomazeau
* fatty degeneration \<=3 according to Goutallier
* possibility to obtain tendon reduction,
* pre-operative Magnetic Resonance Imaging,
* ability to read, understand and complete outcome scores

Exclusion Criteria:

* patients affected by osteoarthritic degeneration,
* frozen shoulder,
* symptomatic acromioclavicular arthritis,
* revision surgeries,
* inability to cope with post-operative rehabilitation regimen,
* autoimmune connective tissue disease,
* current or past hematologicaldisorders,
* comorbidities affecting healing,
* active infections,
* cancers,
* pregnancy and lactation
Patient Reported Outcomes With WaveLight LASIK

This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
* Age: 21 to 35 years of age at the time of surgery.
* Preoperative myopic sphere of -1.00 D to -8.00 D
* Preoperative regular astigmatism of 0.00 D to -3.00 D.
* Stable refraction preoperatively defined as \< 0.5 D of change over at least 1 year.
* Refractive target of bilateral emmetropia.

Exclusion Criteria:

* Corneal ectatic disorders.
* Patients with a calculated residual stromal depth of \< 300 um.
* Pre-existing retinal or corneal pathology, or irregular astigmatism.
* Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
* Previous corneal surgeries prior to LASIK.
* LASIK enhancements.
Long-Term Safety and Efficacy Evaluation of EPI-743 in Children With Leigh Syndrome

EPI-743 in Leigh syndrome participants that participated in previous EPI743-12-002 (NCT01721733) study.

To monitor the long-term safety and neurodevelopmental effects of EPI-743 on children who complete the EPI743-12-002 placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Leigh syndrome with genetic confirmation
2. Completion of EPI743-12-002 protocol and initiation of treatment within 14 days of Month 12 visit in EPI743-12-002 study
3. Participant or participant's guardian able to consent and comply with protocol requirements
4. Continued abstention from supplements excluded in EPI743-12-002 study
5. Botox® is allowed if approved by the sponsor

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil
2. Allergy to vitamin E
3. Clinical history of bleeding or abnormal baseline prothrombin time (PT)/partial thromboplastin time (PTT)
4. Hepatic insufficiency with liver function tests (LFTs) greater than two times upper limit of normal
5. Renal insufficiency requiring dialysis
6. End-stage cardiac failure
7. Fat malabsorption syndromes precluding drug absorption
8. Use of anticoagulant medications
9. Participation in other clinical research studies/taking other experimental agents
10. Participation in elective procedures that required sedation
Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock

A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.

The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.

There are two secondary objectives:

* Validate a prognostic score for death at the end of the first week from initial data.
* Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).

As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.

The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr

Eligibility Criteria:
Inclusion Criteria:

* patient (or representative) received the information notice
* patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
* body temperature \> 38.3°C or \< 36°C
* heart rate \> 90 bpm
* Tachypnea \> 20 C/min or PaCO2 \< 32 mmHg or mechanical ventilation
* leukocytes \> 12000 µL-1 ou \< 4000 µL-1 ou \> 10% immature forms
* oliguria \< 0.5 ml/kg/h for at least 2 hours
* abrupt alteration (24 h) of conscienceness
* thrombocytopenia \< 100 000 G/L or disseminated intravascular coagulation
* mottled skin and / or capillary refill time\> 3 sec
* PaO2/FiO2 \< 300 mmHg ou \< 40KPas
* Lactatemia \> 2mMol/l
* septic shock: Systolic Blood Pressure (SBP) \> 90 mmHg or need for vasopressors to maintain SBP\> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP\> 40% in the hypertensive)

Exclusion Criteria:

* patient is dying or limitation or cessation of active treatment
* patient is already included in another trial
* patient or family refusal
* patient not affiliated with a social security system
Postpartum Visit Timing and the Effect on Visit Attendance

The objective of this study is to assess if the addition of an early postpartum visit improves attendance at postpartum visits. We seek to evaluate if an additional early postpartum visit improves patient education, satisfaction, or trust in the clinicians during the postpartum period; all of which may ultimately facilitate improved outcomes. Additionally, we seek to explore patient preferences for postpartum care delivery.

Maternal mortality in the United States is currently at a record high of 17 deaths per 100,000 live births and the majority of pregnancy related deaths occur in the postpartum period due to complications from chronic disease exacerbation, pregnancy-related hypertension, or psychiatric conditions that lead to suicide. Optimal postpartum care would reduce mortality risk, but numerous studies have demonstrated current care is inadequate. Up to 40% of women do not attend their postpartum visit at 4-6 weeks after delivery and the 15-minute visit is too short to achieve the comprehensive goals that the American College of Obstetricians and Gynecologists (ACOG) sets for this visit: a full assessment of physical, social, and psychological well-being. In addressing the current gap between optimal and actual care, ACOG recently recommended that practitioners shift from the standard, single six-week postpartum visit to two postpartum visits, the first within three weeks of delivery. While this change is intended to address current sub-optimal outcomes, the effects of this change are entirely unknown.

The long term goal of our program is to improve postpartum care for women in Rhode Island. The primary objective of this project is to determine if the ACOG proposed additional postpartum visit within three weeks of delivery improves attendance to postpartum appointments compared to routine postpartum care. Additionally, we intend to examine whether having two scheduled postpartum visits (one within three weeks and the other at the standard 4-6 week postpartum time point) which we describe as "early and often" postpartum care-improves patient knowledge, satisfaction and trust in clinicians compared to routine care as well as explore patient preferences for postpartum care. Our central hypothesis is that early and often postpartum care will lead to improved patient visit attendance compared to routine care.

Eligibility Criteria:
Inclusion Criteria:

* age 13 to 50 years old
* literacy in English or Spanish
* receipt of prenatal care at the Obstetrics and Gynecology Care Center of Women \& Infants Hospital
* delivery at Women \& Infants Hospital during the study time period

Exclusion Criteria:

High risk pregnancy defined as one or more of the following:

* chronic hypertension
* gestational hypertension
* preeclampsia
* eclampsia
* third degree perineal laceration
* fourth degree perineal laceration
* blood product transfusion
* intensive care unit admission
* who were prescribed anxiolytic or antidepressant medications in the antepartum period
Migraine in Poland - a Web-based Cross-sectional Survey

A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. The obtained data should allow for defining disease parameters, burden and received treatments. Additionally questions regarding patients rhinological symptoms and COVID-19-related history were included.


Eligibility Criteria:
Inclusion Criteria:

* consent to participate in the study

Exclusion Criteria:

* responses missing in questionnaire
Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.

This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with chemotherapy combined with immunotherapy as 1st line treatment at approximately 5 institutions. The patients should have received at least 1 cycle of immunotherapy and chemotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed as esophageal squamous cell carcinoma;
2. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
3. Patients had received no previous systemic therapy
4. Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
5. Complete medical records;
6. ECOG0-2;

Exclusion Criteria:

1. Surgery for esophageal cancer;
2. Esophageal fistulae due to infiltration of the primary tumour.
3. Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
4. Those who have a history of autoimmune disease or have been treated with immunosuppressants within the last 3 months.
5. Those who have received organ transplant surgery.
6. Patients with a previous history of malignant tumor (skin basal cell carcinoma and cervical carcinoma in situ) survived tumor-free for 3 years after treatment.

   Except for the above).
7. There are other serious diseases, such as myocardial infarction, cerebral infarction or severe cardiopulmonary insufficiency within 6 months
Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy

Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy.

Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* children aged 18 months to 17 years old
* drug resistant focal epilepsy
* scheduled for deep brain electrodes exploration to assess surgical indication

Exclusion Criteria:

* contraindication to anesthesia or surgery
* refusal (of parents or child) to participate in the study
* no health insurance coverage
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate
* Bone-scan documented metastases
* Age \> 18 years
* Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
* Life expectancy \> 3 months
* Written informed consent

Exclusion Criteria:

* New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
* Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
* Bisphosphonate therapy within 8 weeks before study entry
* Abnormal renal function (serum creatinine \> 2 x the upper normal limit or creatinine clearance \< 30 ml/min)
* Corrected serum calcium \> 3 mmol/L or \< 2 mmol/L
* Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
* Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
* Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)

Other protocol-defined exclusion criteria may apply.
Multi-modal Neuroimaging in Children With Cerebral Palsy or Brachial Plexus Birth Palsy

The main goal of this study is to identify abnormal functional and anatomical brain reorganization associated with hand, foot, and shoulder function in children (0-18 years old) with cerebral palsy (CP) due to periventricular white matter injury (PV-WMI) or brachial plexus birth palsy (BPBP) using a multi-modal neuroimaging approach.

This is a non-interventional study designed to assess changes in the sensorimotor cortex of children with CP as a result of PV-WMI and children with BPBP that combines multiple neuroimaging techniques to better visualize the resulting brain reorganization. The study design will be a mixed 3 (group: CP, BPBP, TD) x 2 (hemisphere: more affected, less affected) analysis of variance (ANOVA), with group being a between-subject factor and hemisphere a within-subjects factor.

The research study plans to recruit and test 30 children with CP due to PV-WMI, 30 children with BPBP, and 30 aged-matched and typically developing (TD) children aged from 0 to 18 years old.

Data from the participants will be collected over the course of four visits: (i) the recording session for the MEG, (ii) the recording session for the EEG, (iii) the MRI scanning session, and (iv) the TMS session. TD, CP, and BPBP subjects will be asked to commit to these visits.

The MEG session will last \~3 hours with the actual measurements lasting \~60 minutes, the EEG session will last \~2 hours with the actual measurements lasting \~60 minutes, the MRI visit will last \~1 hour with the actual acquisition scan timing lasting \~30 minutes, and the TMS visit will last \~1 and a half hours with the actual acquisition time lasting \~45 minutes. Depending on the participant, the behavioral tests may be administered during any of the visits that the child is most comfortable and able to perform them.

Eligibility Criteria:
Inclusion Criteria:

Children with Cerebral Palsy should have:

* An evaluation by a pediatric neurologist with a diagnosis of CP due to PV-WMI,
* Absence of any genetic syndrome diagnosis,
* No history of trauma or brain operation,
* Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS)32.

Children with Brachial Plexus Birth Palsy should have:

* An evaluation by a hand and upper extremity surgeon with a diagnosis of BPBP
* May or may not have undergone primary microsurgical or secondary reconstructive operations prior to this study.

Typically Developing children should have:

* No history of neurological disorder or brain injury.

Exclusion Criteria:

Children will be excluded if they meet any of the follow criteria, determined via their medical and developmental history:

* Having a hard time sitting still,
* Presence of any metal implants,
* Baclofen pumps,
* History of traumatic brain injury or brain operation.