cyrilzakka/clinical-trials huggingface dataset:
Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients

The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.

Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor...) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity...). As it is a feasibility study, only 5 patients will be included.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache
* Patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon
* Patients implanted with a deep brain stimulation system PerceptTM Medtronic®

Exclusion Criteria:

* Secondary cluster headache
* Patients implanted with another device of deep brain stimulation
Forced Oscillometry in Infants with Bronchopulmonary Dysplasia

The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)

Pulmonary function testing has been the standard of care to diagnose and evaluate response to therapy in various respiratory diseases in adults and children. There are several equipment and techniques that are FDA approved for these purposes. However, there are currently no lung function tests that are practically feasible, clinically meaningful and widely used in infants.

The forced oscillation technique (FOT) is a non-invasive method that had been used to measure respiratory mechanics. FOT employs small amplitude pressure oscillations superimposed on the normal breathing and therefore has the advantage over conventional lung function techniques that it does not require the performance of respiratory maneuvers. To date, the use of this technique is FDA approved in adults and children but remains largely experimental in infants and newborns. THORASYS has recently developed a new respiratory function test device aimed specifically at newborn and infants (0 - 2 years age group) called tremoflo N-100 ("Neo"). This new device measures lung function in only a few minutes while the newborn or infant is sleeping normally. It uses an adapted version of the Airwave Oscillometry (AOS) to calculate the impedance of the lungs and quantify airway obstruction.

Diuretics and bronchodilators are two on the most commonly used medications to ameliorate the symptoms of BPD. The benefits of these therapies have not been shown to prevent the development of BPD in a randomized control trial (RCT). More recently, there have been some evidence from pharmacogenetic studies that the variability in bronchodilator responsiveness in patients with asthma, (and possibly BPD) may lie on the gene encoding the B2-adrenergic receptor (ADRB2) as well as within the associated G-protein receptor pathway, the nitric oxide biosynthetic pathway and other novel loci identified in recent genome-wide studies. This part of the study will be hypothesis generating to try to understand the variability in bronchodilator response in infants with BPD. Normative data will be established in term neonates.

Eligibility Criteria:
Inclusion Criteria:

Preterm Cohort:

* Premature infants with BPD who are in room air based on the (per NICHD definition)
* Premature infants with BPD who are receiving low flow O2 support and able to maintain normal spO2 in Room air for brief period ( up to 3 minutes) Term Cohort without pulmonary disease
* Infants \>36 weeks gestational age without pulmonary disease
* Infants \< 4 weeks of age

Outpatient Cohort:

* Former preterm infants \< 32 weeks at birth
* Those with BPD based on NIH 2001 definition
* Seen prior to 2 years of age

Exclusion Criteria:

* Infants with BPD requiring invasive or non-invasive positive pressure ventilation
* Infants with BPD who have associated genetic diagnosis or major congenital anomalies.
Newborn Genomic Sequencing Pilot Study

The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:

* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?
* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?
* What are the potential issues related to implementing DWGS in this population?

Enrolled newborns will have a blood sample taken and will receive three tests:

* DWGS
* BeginNGS
* WES

Newborn screening (NBS) by testing dried blood spots (DBS) identifies newborns with a few diseases for which effective treatments are available to enable treatment at or before symptom onset. Because NBS improves outcomes in these diseases, it is performed on almost all US babies. The current Federal recommended NBS list is limited to 35 conditions and identifies \~6,600 affected children per year. In genetic diseases not screened by NBS, however, outcomes remain poor because of delays in diagnosis and treatment. The investigators recently developed a system for NBS for 434 severe, childhood genetic diseases for which effective treatments are available using whole genome sequencing (WGS), called BeginNGS. Retrospective studies showed BeginNGS to have a true negative rate (specificity) of 99.7% and true positive rate (sensitivity) of 88.8%. The investigators now propose to undertake a first prospective study in newborns admitted to the Neonatal Intensive Care Unit (NICU) at Rady Children's Hospital, San Diego (RCHSD) to compare the sensitivity and specificity of BeginNGS with that of standard, diagnostic rapid whole genome sequencing (DWGS) and whole exome sequencing (WES). This study is in preparation for larger, future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Neonates less than or equal to 10 days old who are admitted to the RCHSD NICU.

Exclusion Criteria:

1. Neonates who have enrolled in another clinical study at Rady Children's Institute for Genomic Medicine or in whom DWGS has been ordered or is being considered.
2. Neonates whose mother is less than 18 years of age.
3. Neonates who are wards of the state.
4. Neonates whose parent/legal guardian is unable to provide consent.
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer

Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
2. Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
3. Patients must have previously controlled disease for at least six months on current systemic therapy
4. Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions

Exclusion Criteria:

1. Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
2. Progression on 2nd line or subsequent lines of therapy
3. Lacks CT or bone scan Imaging within previous 45 days;
4. Progression in \>3 sites in the liver or lung;
5. Hormone positive disease on endocrine therapy only at time of enrollment;
6. Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
7. Lesions deemed not amenable to SBRT due to large size or location;
8. Unacceptable fracture risk according to clinician judgement for bone lesions;
9. Brain metastasis or Spinal cord compression;
10. History of major radiosensitivity syndrome or contraindications to radiotherapy.
Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease

Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6% of the general population and up to 40% of the CLBP according to studies. Following the discovery of this recent diagnostic entity, responsible for low back pain, the question of its management is debate in the medical community. Early studies demonstrate the effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest the contrary, infectious, incriminating a pathogenic role of certain bacteria such as Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment with prolonged antibiotic therapy. This study will aim to assess the effectiveness of intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work will be to assess these infiltrations in various subgroups such as patients with a previous surgery of the spine or a history of scoliosis or spondylolisthesis.

1. Primary objective:

   Evaluate the effectiveness of intra-disc infiltrations conducted in the rheumatology department of pain in the active disc disease.
2. Secondary objectives:

   * Evaluate the duration of the benefit on pain caused by gesture
   * Assess the impact of the gesture on NSAIDs and / or analgesics
   * Analysis of different subgroups (antecedent of surgery, spondylolisthesis, scoliosis) Inclusion / non-inclusion: Patients older than 18 who were hospitalized between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration.

Methodology: A retrospective, single-center, non-interventional Study duration: 6 months Acquisition of data: demographic data, data on the disc disease, data on the assessment of pain, the effectiveness of infiltration of analgesics and / or NSAIDs, or need infiltration surgery for the gesture.

Supports: patient questionnaire report hospital, medical, Excel grid of data collection), analysis (statistic: local management) Anonymised data in the Excel spreadsheet Development of the study: Data collection, statistical analysis, literature review Retrospective study based on recovering data regarding efficacy of infiltrative gesture that some patient was performed in 2007, with possibility of bias on the recovery of data in view of the age of the gesture for some patients.

An analysis of each folder from the hospital report will be carried out in parallel in order to compare the data collected by the questionnaire with the reporting. The sending of questionnaires and letters will be performed by the service attaches where a pre-stamped letter. The address of the patients will be that recorded in the base DxCare.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18yo
* Hospitalization between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration

Exclusion Criteria:

* None
Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid

Adapt and evaluate a decision aid for patients with rectal cancer. Phase1: decision aid testing (Delphi) A pilot version of the Belgian decision aid was developed and validated through a double Delphi procedure. In this study, the assessment is extended to several multicentre experts. The panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. They are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. They score the items of the decision aid using a 4-point Likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see Appendix 2 to this application). To quantify the degree of content validity, the Content Validity Index (CVI) is used.

Phase2: pilot test decision aid The final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. The aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. With the feedback from the patients and the healthcare professional, the decision aid can be further refined.

During the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. Participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. After the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. This will be done by means of an interview for the patients, informal carers and care workers involved. The interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. The interview with the caregiver takes place in the hospital where the caregiver works. If the current Covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.

Eligibility Criteria:
Delphi procedure

Inclusion Criteria:

* expert healthcare professionals caring for patients with rectal cancer

Exclusion Criteria:

* none

Interviews Inclusion criteria

* Patients in which the decision aid was tested
* patients with a tumor in the last 10cm of the rectum
* healthcare professionals who have used the decision aid tool
* informal carer indicated by the patient Exclusion
* patients who have no treatment choice due to oncological reasons
Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss

The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.


Eligibility Criteria:
Inclusion Criteria:

* 30-65 years old,
* overweight or obese but otherwise in good health

Exclusion Criteria:

* cardiovascular disease,
* cancer,
* HTN,
* type I or II DM,
* food allergies
A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.

The primary purpose of this study is to evaluate the intrapulmonary PK, including epithelial lining fluid (ELF) and alveolar macrophages (AM) concentrations, of SPR719 compared to plasma concentrations of SPR719 (the active moiety in plasma of the prodrug SPR720) after oral administration of SPR720 1000 milligram (mg) capsules every 24 hours for 7 consecutive doses.


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index (BMI) ≥18.0 and ≤32.0 kilograms per meter square (kg/m\^2) and weight between 55.0 and 100.0 kilograms (kg) (inclusive).
2. Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening visit.
3. Have suitable venous access for blood sampling.
4. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food or product containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).

Key Exclusion Criteria:

1. History of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
2. Known history of clinically significant hypersensitivity reaction or anaphylaxis to SPR720 or an aminobenzimidazole.
3. Any condition possibly affecting drug absorption (e.g. previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]).
4. Participants who are unable to demonstrate the ability to swallow the dosage forms.
5. Receipt of any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit in the previous study to Day 1 of the current study).

NOTE: Other inclusion and exclusion criteria as per protocol may apply.
Renal Replacement Anticoagulant Management

Observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (CRRT) for patients treated on non-specialist Intensive Care Units (ICUs) in England and Wales.

RRAM is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. This study will use existing high quality clinical data collected for the Case Mix programme (CMP) - the national clinical audit for adult critical care - linked with Hospital Episodes Statistics, Office for National Statistics, and UK Renal Registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (SHA) to regional citrate anticoagulation (RCA) during CRRT for patients treated on non-specialist ICUs in England and Wales. This will include data from approximately 85,000 patients treated with CRRT between 1 April 2009 and 31 March 2017 in 184 English non-specialist intensive care units within the ICNARC CMP.

Specific objectives of the RRAM are to:

1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation.
2. Provide information on the subsequent development of end-stage renal disease (ESRD).
3. Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or greater
* Admitted to an ICU participating in the ICNARC Case Mix Programme (CMP) in England between 1 April 2009 and 31st March 2017

Exclusion Criteria:

* Pre-existing end-stage renal disease (ESRD)
* Admitted to an ICU after kidney or kidney-pancreas transplantation
* Primary admission with acute hepatic failure
Dexmedetomidine Infusion Impact on Chronic Pain Patients

Chronic pain (CP) was defined as pain experienced daily or on most days and induced restriction of at least one activity. CP is one of the commonest complaints confronted in outpatient clinics and constitutes a challenge for all medical provisions. CP is a multifaceted condition; postoperative CP is frequently encountered in clinical practice and may be of debilitating severity leading to worse quality of life (QOL) especially CP with a neuropathic component as post-mastectomy pain syndrome and post-amputation pain and chronic post-sternotomy pain that seriously impacts patients' QOL and affects patient recovery till 12 months after cardiac surgery. Chronic musculoskeletal pain as defined by the International Pain Association is the persistent or recurrent pain involving spine, bones, joints, and/or musculo-soft tissue.

Chronic pain was considered as a long-lasting stressor that might induce disordered mood varying between depression and anxiety with consequent challenge of this combination on treatment outcomes and consumption of health resources. This necessitated psychological screening of CP patient to identify and manage patients with disordered mood to improve CP treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple-level spinal canal stenosis who refused surgical management.

Exclusion Criteria:

* Patients with other causes for CP;
* maintained on opioid analgesia;
* had cardiac lesions;
* maintained on antihypertensive therapy;
* hepatic impairment;
* Patients can't attend the clinic to complete the course of Dexmedetomidine infusion sessions.