cyrilzakka/clinical-trials huggingface dataset:
Stimulation-evoked Calcitonin Gene-Related Peptide (CGRP) as Biomarker of Migraine

This study aims to improve the management migraine by providing a more profound understanding of the interactions of pain disinhibition on the brain stem level and calcitonin gene-related peptide as a main mediator in the generation of migraine headaches. For this purpose, this observational study investigates established neurophysiological and blood biomarkers parameters in association with the clinical phenotype.

The study's focus is the investigation of mechanisms that are directly related to the pain generation in migraine. In this context, the primary endpoint is an enhancement of trigeminal stimulation evoked calcitonin gene-related peptide (CGRP). The stimulation is normalized using an established protocol to elicit the nociceptive blink reflex, which is a brain stem reflex to study the trigemino-spinal system. We expect CGRP levels to rise more in patients affected by migraine as compared to controls, based on the observation that painful stimulation elicits migraine attacks. Furthermore, baseline CGRP levels and their association with markers of brainstem excitability are probed.

Eligibility Criteria:
Inclusion Criteria:

* Migraine according to ICHD-3 criteria (cases)
* No headaches or tension-type headache frequency \<1x/year (controls)

Exclusion Criteria:

* other chronic pain disorder
Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer

The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation of target volumes and to estimate the proportion of recurrences that could possibly be prevented by the use of PET/CT-based target volume, instead of CT-based. Patients will recieve radiotherapy using CT-based planning, but a PET/CT-based treatment plan will also be made. CT-based and PET/CT-based target volumes will be compared after treatment has been completed. If a locoregional recurrence takes place, the localisation will be compared to the CT-based and PET/CT based clinical target volumes (CTVs). If the local recurrence is located outside the CT-CTV but inside the PET/CT-CTV, the recurrence could possibly have been prevented with PET/CT-based radiotherapy.

This is a prospective cohort study testing the hypothesis that in a proportion of patients, locoregional recurrence, observed at 6, 12 or 18 months after treatment, can be prevented if PET/CT-based treatment planning was used instead of CT-based treatment planning alone.

Patients eligible for the study will undergo definitive radiotherapy with or without concomitant chemotherapy with planning-CT based target volumes, either or not followed by surgery.

A planning-PET/CT will be made for research purposes only, and will be blinded for the treating physicians. This planning-PET/CT will not be used for actual treatment planning.

In case of neoadjuvant chemoradiation the response on this therapy will be analysed at pathologic evaluation of the esophageal specimen.

Routine follow up will be carried out every 6 months, using CT. In case of no locoregional recurrence and/or metastases, patients will be followed up to 18 months for study evaluation.

In case of distant metastases, patients will be censored if locoregional recurrence is excluded. When indicated, palliative treatment will be given.

In case of (suspicion of) locoregional recurrence, PET/CT-based recurrence analysis should be carried out with comparison and co-registration of CT-based and PET/CT-based target volumes.

Eligibility Criteria:
Inclusion Criteria:- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or GEJ

* Locally curable disease without distant metastases (M1b is excluded) (TNM clinical classification UICC 7th edition)
* Planned for high dose radiotherapy with or without chemotherapy with or without surgery
* Age ≥ 18 years;
* WHO performance status 0-2
* informed consent must be given according to ICH/EU GCP, and national/local regulations

Exclusion Criteria:- previous or concurrent malignancies (except basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder cancer (pTa)) in the past five years

* Previous treatment
* Evidence of serious active infections
* any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Sorafenib improves overall survival and progression free survival in advanced hepatocellular carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early phase trials in solid tumours showed trough sorafenib levels were associated with incidence of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately predictive of progression free survival.The trough level of sorafenib may be predictive of survival and response in patients treated with sorafenib for advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* ECOG ≤ 2
* Histologically or cytologically diagnosed hepatocellular carcinoma, or diagnosis on at least one cross-sectional imaging with the characteristic appearance of HCC (i.e. liver lesion with arterial enhancement and portal venous washout)
* Decision to treat with single agent sorafenib at 400mg bid (dose reductions or interruptions are permitted if side effects occur during treatment)
* No prior systemic chemotherapy or targeted therapy
* Child-Pugh liver function class A or B
* At least one untreated target lesion that can be measured in one dimension according to RECIST
* Adequate organ functions

Exclusion Criteria:

* Prior systemic chemotherapy or molecularly targeted therapy
* Concurrent active malignancy
* Concomitant strong CYP3A4 induced or inhibitor at a therapeutic dose (see section 6.4.1)
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Hypertension that cannot be controlled by medications (\> 150/100 mmHg despite optimal medical therapy)
* History of, or known brain metastases (skull metastases allowed), carcinomatous meningitis, or leptomenigeal disease
* Major surgery (e.g. open abdominal therapy, pelvic, thoracic, orthopaedic or neurosurgery) within 4 weeks of the date of first dose
* Local-regional treatment (i.e. percutaneous and trans-arterial procedures) within 4 weeks. Restaging CT or MRI scan must be repeated at least 4 weeks after local-regional treatment and within 3 weeks before the date of first dose
* For patients treated with Yttrium (90Y) radiotherapy, a washout period of 2 months is required.
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol
* Pregnancy or breast feeding
Quercetin Phytosome® Chronic Fatigue Symptoms

The purpose of this study is to evaluate whether a 3-month period of quercetin supplementation (500 mg of Quercetin Phytosome®) is useful in the treatment of chronic fatigue, as assessed by the Fatigue Impact Scale (FIS-40). Secondary end points are sleep assessment through Pittsburgh Sleep Quality Index (PSQI) and muscle performance assessment through the Short Physical Performance Battery (SPPB) and body composition assessment using DXA.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* Chronic fatigue symptoms recorded using a self-reported fatigue score assessed using the validated Fatigue Impact Scale (FIS- 40) that comprised chronic tiredness impacts related to physical, cognitive and psychosocial functions.

Exclusion Criteria:

* Patients with any active medical condition that explains chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, drug side effects, and iron deficiency anemia)
* Previous diagnosis not unequivocally resolved (chronic hepatitis, malignant tumors)
* Past neuropsychiatric disorders or current severe depressive disorder with psychotic or melancholy features, bipolar disorder, schizophrenia, delusional disorder, dementia, anorexia nervosa, bulimia nervosa
* Participation in another clinical trial of the same or different nature within 30 days prior to inclusion in the study
* Failure to provide signed informed consent
* Consumption of certain drugs/supplements that could affect outcome measures in the past 90 days or whose discontinuation could be a significant problem
* Anticoagulant treatment
* Pregnancy or breastfeeding
* Smoking, alcohol or substance abuse
* Obesity (BMI \> 30 kg/m²)
Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female，35-75 years old.
2. The surgery time should be \> 6 hours after symptom onset.
3. Glasgow coma score (GCS) was 9-15.
4. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
5. Signed informed consent obtained from the patient or patient's legally authorized representative.

Exclusion Criteria:

1. Glasgow coma scale of \<8.
2. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
3. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
4. Lactating or pregnant woman.
5. Refuse to sign informed content.
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery.

This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Receiving cutaneous surgery
3. In good general health as assessed by the investigator

Exclusion Criteria:

1. Participants with an allergy to bupivacaine or other amide anesthetics
2. Participants unwilling to sign an IRB approved consent form
3. Participants with a contraindication to narcotic medication
4. Participants who are pregnant or will become pregnant
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
Psychoeducational Group for Depression

The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression


Eligibility Criteria:
Inclusion:

* Both sexes;
* Ages between 18 and 65 years old;
* Diagnosis of Major Depressive Disorder (MDD) made by a clinician according to Diagnostic Statistical Manual criteria-5-Text Revised (DSM-5-TR)
* Patients with Hamilton Depressive Rating Scale-17 items (HDRS-17) scores 14-23;
* Informed and signed consent form.

Exclusion:

* Unstable serious clinical or neurological diseases;
* Postpartum depression or other types of depressive disorders (disruptive mood dysregulation disorder, pre-menstrual, substance/medication-induced depressive disorder, depressive disorder due to another medical condition, another disorder specified depressive disorder and unspecified depressive disorder);
* Other psychiatric disorders;
* Patients with active psychotic symptoms;
* Suicidality risks
* Patients already undergoing any other psychological treatment for MDD;

Discontinuation:

* More than two absences during treatment;
* Those who miss more than two sessions/consultations, whether medical treatment or the psychoeducational program;
* Non-response to the use of Sertraline over the initial eight weeks; Presence of hypomanic symptoms at any time during treatment (Young \&lt;7)
SPI-guided Analgesia During FESS for Intraoperative Blood Loss

The aim of this randomized trial is to assess the utility of Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and its influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane

Intraoperative blood loss during FESS constitutes a major problem for a surgeon because it influences quality of surgical field. Each incident of haemorrhage makes the operator stop the procedure in order to bring back the optimal visualization of the intranasal anatomy. In the end it prolongs the time of procedure.

Currently, intraoperative blood loss is estimated based on Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).

Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into above mentioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. SPI\>10 or any SPI\>50, were proposed to constitute the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of SPI-guided analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery in patients undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or volatile anaesthesia using sevoflurane or desflurane.

Currently, FESS is most often performed using total intravenous anaesthesia (TIVA) which is by majority of anaesthesiologists believed to reduce the intraoperative blood loss compared to general anaesthesia using volatile anaesthetics, but current literature provides conflicting findings in this area if the sort of anaesthetic used influences quality of the surgical field.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo functional endoscopic sinus surgery under general anaesthesia
* ASA (American Society of Anesthesiologists) I-III

Exclusion Criteria:

* age under 18 years old
* allergy to propofol
* pregnancy
* any anatomical malformation making SE measurement impossible
* necessity of administration of vasoactive drugs
Heartsbreath Test for Heart Transplant Rejection

The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).

This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to cooperate with study, understand the scope of the study, and gives signed informed consent to participate.
* Subject is the recipient of a heart transplant within the previous 12 months
* Subject is scheduled for a routine endomyocardial biopsy
* Subject is 18 years or older

Exclusion Criteria:

* Evidence of acute intercurrent disease other than rejection reaction
Breast Cancer Survivorship Biorepository

This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.

PRIMARY OBJECTIVE:

I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.

SECONDARY OBJECTIVES:

I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues.

II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies.

OUTLINE:

Patients complete surveys, undergo collection of blood samples, and review of medical records on study.

Eligibility Criteria:
Inclusion Criteria:

* Women of all racial and ethnic groups 18 years of age or older
* Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
* Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
* Prior participation on clinical trials is allowed

Exclusion Criteria:

* Current receipt of interventional clinical trial participation
* Stage IV (metastatic) cancer
* Prior history of recurrence (except recurrence following ductal carcinoma in situ)
* Inability to give informed consent
* Unable to speak English, Spanish, Chinese, or Korean
Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain

The aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the p3RP integrated with a commercial DMD, the Fitbit.

The study has three phases. In phase I, the investigators are adapting the 3RP as a multidisciplinary team, and then conducting two focus groups. In phase two, the investigators are piloting the p3RP and p3RP-DMD. In phase three, the investigators are conducting a small randomized-controlled trial of the p3RP versus p3RP-DMD.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18 years or older
* Have nonmalignant chronic pain for more than 3 months
* Able to perform a 6-minute walk test
* Owns a smartphone with Bluetooth 4.0
* Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
* Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
* Cleared by a medical doctor for study participation
* Leads a sedentary lifestyle

Exclusion Criteria:

* Diagnosed with medical illness expected to worsen in the next 6 months
* Serious mental illness or instability for which hospitalization may be likely in the next 6 months
* Current suicidal ideation reported on self-report
* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
* Current substance use disorder, within the past 6 months
* Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
* Regular use of DMD in the last 3 months
* Engagement in regular intensive physical exercise for \>30 minute daily
* Unable to walk without use of assistance (e.g., wheelchair, walker)
Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.

Dyslexia is characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. However, no clinical trial of a standardized rehabilitation has shown an impact on reading fluency. In the era of intensive rehabilitation, a new protocol based on the current data from the medical literature has been designed.


Eligibility Criteria:
Inclusion Criteria:

* Children from 8 to 12 years old,
* Living in and around 50 kilometers from Besançon.
* Diagnosis of dyslexia according to the DSM-V or CIM-10 requirements.
* Consent form signed by the parental authority and the child,
* Affiliation to a social security system.

Exclusion Criteria:

* Mother's medical history of pregnancy or delivery complications,
* Patients's medical history of neurological infectious, vascular or tumoral events,
* Patient's medical history of intellectual deficiency,
* Patients's medical history of visual or hearing disorders,
* Patient's medical history of psychiatric disorders (especially diagnosis of Attention Deficit / Hyperactivity Disorders (AD/HD)),
* legal incapacity,
* limited cooperation suspected by the investigator.