cyrilzakka/clinical-trials huggingface dataset:
Tricaprilin Phase 2 Pilot Study in Migraine

This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants with frequent migraine.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
2. Participants who have frequent (episodic or chronic) migraine with or without aura, for at least 1 year, according to the International Classification of Headache Disorders version 3 beta (ICHD 3-beta), age at time of onset must be \<50 years.
3. Participants must have a certain number of migraine headaches days per month, as confirmed by the baseline measurement period.
4. Use of one allowed migraine prophylactic is permitted if the participant has been on a stable dose for at least 2 months prior to the screening.
5. Participants must have failed (no therapeutic response) 1-4 migraine prophylactic treatments.
6. The participant is able to tolerate a 12.5g dose of AC-SD-03 (containing 5g of tricaprilin) as per sentinel dose challenge at the Baseline Visit.
7. From Visit 2 to Visit 3 (baseline measurement period), the participant has sufficient compliance (at least 80%) with daily eDiary headache entries.

Exclusion Criteria:

1. In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the participant at risk.
2. Use of barbiturates (and/or butalbital-containing analgesics) or opioids (and/or opioid-containing analgesics) for migraine acute treatment ≥ 4 days per month on average and/or in the last month prior to Screening Visit.
3. Use in the last 3 months prior to Screening Visit of CGRP agents, Botox injections, TENS, cranial nerve blocks, trigger-point injections, acupuncture, CBD-containing products, infusion therapy.
4. Current use, or use within 3 months of Visit 2 (baseline), of Axona® or other MCT-containing products (such as coconut oil). Use of MCT-containing products is not allowed at any time during trial participation.
5. Current use, or use within 3 months prior to Screening, of a ketogenic diet, low-carb diet, intermittent fasting (including the 5:2 diet). Ketogenic diets, low-carb diet, intermittent fasting (including the 5:2 diet) are not allowed during the study.
Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment

This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

HCC occurs in the vast majority of cases in the context of cirrhosis. Cirrhosis is considered a pre-cancerous state, which justifies systematic screening for HCC. Screening currently relies on measurement of alpha-foetoprotein (AFP) levels and ultrasound scans every 4 to 6 months. However, AFP has poor sensitivity as a marker for HCC. We have recently shown that plasma proteasome levels have a higher sensitivity than HCC for detecting HCC in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. The goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with HCC decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). Plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. The variation of proteasome levels will be compared to AFP levels. The sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to AFP.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with hepatocellular carcinoma proven by histological examination of a biopsy specimen, eligible for curative treatment (radiofrequency, surgical resection, liver transplantation)
* Patient able to give informed consent
* Patient with Social Security coverage

Exclusion Criteria:

* Secondary liver tumors
* Non hepatocellular carcinoma primary liver tumor
* Hepatocellular carcinoma without cirrhosis
* Patients with hepatocellular carcinoma and cirrhosis not eligible for curative treatment
* Prisoners
* Adults under guardianship or curatorship
* Pregnancy
Low Birth Weight Fetuses With Caffeine Use

Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .

Low birth weight is not only associated with neonatal mortality and morbidity.

but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life

Eligibility Criteria:
Inclusion Criteria:

* Age group: 18-40
* Pregnant females attending regular post-natal care visits

Exclusion Criteria:

* • Female patients with other acute or chronic illness

  * Cardiovascular disease
  * Neoplasms
  * Current diabetes mellitus, pregnancy induced diabetes
  * Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).
Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R + develop CMV. The number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. In case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached.

Rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection reported in.

QuantiFERON-CMV ® is a fast and standardized test that evaluates the CMV specific cellular immunity measuring the amount of secreted Interferon gamma (IFN gamma) in plasma by ELISA. It uses more epitopes of proteins including CMV glycoprotein B (gB), protein IE-1 and protein pp65 and protein pp50, which are specific for (human leukocyte antigen) HLA class I. Pretreatment of the sample is simple and plasma can be stored, frozen, for a delayed dose of interferon.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient
* Immunized against the Cytomegalovirus

Exclusion Criteria:

* Not willing to participate, no health insurance
* clinical evidence of active viral infection
* renal transplant recipient whose treatment includes induction antilymphocyte antibodies
Visual Perception After Virtual Implantation

Evaluation of visual perception through diffractive optical lens designs by virtual implantation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between and including 18 and 50 years of age;
* Healthy eyes;
* Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
* Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Negative COVID19 screening test prior to every trial visit.

Exclusion Criteria:

* Subjects of less than 18 or more than 50 years of age;
* Monocular CDVA of dominant eye \< 1.0 decimal (\> 0.0 logMAR) without cycloplegia;
* Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
* Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
* Pseudophakic subjects;
* Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;
* Pathologic miosis;
* Intake of drugs affecting vision;
* Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
* Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;
* Hyperopes with more than +6 D refraction.
DNA Methylation and the Increased Risk of Cervical Cancer Development

This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study

This study is a multicenter matched case-control study. The inclusion and exclusion criteria are verified by collecting HPV test results, TCT examination results, and for the case group, participants' histopathological results are also collected. Participants who meet the inclusion and exclusion criteria have their HPV DNA test original secretion samples and TCT examination original cervical scrape cell samples (preserved in RNA preservative solution) collected. Enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. The discovery cohort undergoes multi-target DNA methylation testing, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing; the validation cohort undergoes PCR validation of DNA methylation sites related to cervical cancer, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-50 years old, with a history of sexual activity
2. HPV and TCT tests are performed concurrently in the gynecology clinic
3. Those with abnormal HPV and TCT test results undergo tissue pathological testing

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE
3. Those who have had organ transplants or are currently using immunosuppressive agents
4. Use of vaginal douching within 48 hours before sample collection
5. Use of vaginal probiotics within one month before sample collection
6. Use of vaginal antibiotics or antifungal treatments within one month before sample collection
7. History of surgery related to cervical intraepithelial neoplasia (CIN), including but not limited to conization of the cervix, LEEP procedures, etc.
8. Blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.
Quality of Life of Children/Adolescents in Palliative Care Settings

Investigators will propose to each family monitored by the teams to participate in the study (children between 1 and 18 years old, families understanding and speaking a minimum of French).

Semi-directed interviews are organized with children/adolescents and their parents who have agreed to participate in the study. The interviews are conducted by the care teams themselves. Socio-demographic data are collected.

An information letter will be distributed to the children and parents and their non opposition to their participation will be sought (or assent for the child via a written document adapted to the age) will be systematically requested.

Several instruments will be used by the members of the paediatric teams during their routine home or hospital visits to children and their families: the CPOS (Downing 2018), the KINDL (generic questionnaire on quality of life validated for healthy children, Erhart et al. 2009), the QOLLTI-F v.2 (questionnaire on quality of life for parents, Cohen 2007, 2015).

The interviews will therefore be semi-directed interviews with children/adolescents and their parents who have agreed to participate in the study. The interviews will be conducted by the care teams themselves. In addition to the CPOS, KINDL and QOOLTI-F, socio-demographic data are collected.

Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents aged 1 to 18 years with a serious illness and requiring follow-up by a regional pediatric palliative care resource team and/or temporarily hospitalized.
* Having given his non-opposition to his participation.
* A minor of whom at least one of the two holders of parental authority has given his or her consent to the participation of their child.
* Child of whom one of the two holders of parental authority has himself agreed to participate in the study.

Exclusion Criteria:

* Children/adolescents at the end of life (imminent death foreseeable).
* Children/adolescents and their parents who do not understand French.
* Child or parent under legal protection (guardianship, curatorship).
NG101m Adjuvant Therapy in Glioblastoma Patients

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.

Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal, safe resection, followed by radiation therapy of 60 Gray (Gy) with concomitant oral temozolomide (TMZ) for 6 weeks, then continue with six cycles of high-dose temozolomide. The median survival rate for newly diagnosed GBM patients is 14.6 months with a 2-year overall survival (OS) rate of 27.2%. This clinical trial evaluates the 2-year OS of oral NG101m as an adjuvant therapy to chemoradiotherapy in newly diagnosed GBM subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age
* Must be newly diagnosed with GBM
* Primary treatment must consist of a chemoradiation therapy (CRT) regimen
* Hemoglobin \> 9 g/dL
* White blood count 3,600 - 11,000/mm3
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Absolute lymphocyte count (ALC) ≥ 1,000/mm3
* Platelet count 100,000/mm3
* BUN ≤ 1.5 times upper limit of normal
* Creatinine clearance rate \> 40 mL/min
* ALT ≤ 3 times upper limit of normal
* AST ≤ 3 times upper limit of normal
* Alkaline phosphatase ≤ 3 times upper limit of normal
* Total bilirubin ≤ 2.0 mg/dL
* Karnofsky Performance Status ≥ 70
* Must not be on any other alternative therapies
* Not pregnant

Exclusion Criteria:

* Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components
* Known allergy to vitamin A, vitamin D3, and/or L-citrulline
* Pregnant women
* Breastfeeding women
* Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent
* History of immunodeficiency diseases or autoimmune diseases
* History of peptic ulcer disease or gastrointestinal perforation
ROTATEQ™ Post-Marketing Surveillance in the Philippines

This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.


Eligibility Criteria:
Inclusion Criteria:

* Received ROTATEQ™
Multidisciplinary Return-to-work Rehabilitation and Return-to Work Follow-up

The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large cost for the Norwegian society.

The purpose of this study is to determine whether the patients included return to work after rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is considered to be the effect of Return-to-work rehabilitation measured before, during and after the stay at the rehabilitation centre:

The study specifically looks at the effect of structured and standardized return-to-work follow up of the patient, including contact with stakeholders (general practitioner, social security office and workplace).

In addition there is a need to describe the patients participating in the program. The aetiology of complex symptom disorders is poorly understood and the role of genetics and stress is not translatable to a complex symptom population. This complicates the transition from current biological research to a clinical use regarding these patients. If the investigators can assist in understanding how these patients, who are multiusers of health care and have received sickness benefit for a long time, develop their disorders and symptoms, it will be of great importance to the Norwegian community. Therefore the study consists of multimodal measurements of the patients before, during and after a rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol, medical-, psychological-, physiological diagnostics and work related factors.

Related aims:

Investigate if multidisciplinary treatment based on acceptance and commitment therapy, contributes to normalisation of cortisol release with regards to a standardized stress test.

See wether individual differences regarding the stress profile can predict return to work in patients with complex symptom disorders.

Investigate genetic risk factors in relation to Return to Work rehabilitation and identify treatment moderators in a multidisciplinary rehabilitation program.


Eligibility Criteria:
Inclusion criteria:

* Age between 18-59 years
* A self defined goal of increasing their work ability and work participation within a period of no more than six months
* They fill the criteria of a complex symptom disorder, or they are diagnosed with a common mental disorder
* A satisfactory level of examination and treatment to participate at Hysnes Rehabilitation Centre
* Sick leave \> 8weeks or receiving work ability assessment benefit for any diagnosis, except as stated below.
* On a level of linguistic, physical and mental function required to participate in the rehabilitation

Exclusion criteria:

* Ongoing alcohol/drug abuse
* Ongoing psychosis, ongoing manic episode or suicide risk
* Pregnancy
To Evaluate the Paediatric Analgesia Slide

The Paediatric Analgesia Slide is a device developed for parents. Its development follows research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors. Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel when simulating prescribing to children in hospital.

At present, it is unknown whether this concept can be extended to use by parents when administering paracetamol to their children at home.

Prescribing and administering drugs to children is difficult for both healthcare professionals and parents. The process is often performed poorly with under-dosing and over-dosing a major problem with sometimes fatal consequences.

The British National Formulary for Children (BNFC), introduced in 2005, has given hospital and community prescribers with a valuable reference text.

However, the comprehensive prescribing information presented in the BNFC and in the drug Summary of Product Characteristics is simplified in the Patient Information Leaflet (PIL) for interpretation by parents. When the PIL is analysed, it becomes apparent that the age-range regimens presented may result in under and over-dosing with large differences in the daily dose received by children depending on their age and weight.

The Paediatric Analgesia Slide is a simple device presenting pre-calculated volume (and therefore dose) information for parents. It allows for age/weight specific doses to be given thus minimising the risk of under and over-dosing. It also addresses the deficiency of the prescribing information in the PIL related to over and under-weight children.

Eligibility Criteria:
Inclusion Criteria:

* Any parent accompanying their child who is aged between 1 and 13 years old who is attending a hospital in County Durham and Darlington Acute Hospitals NHS Trust

Exclusion Criteria:

* Those who have professional knowledge of prescribing or dispensing medicine (e.g. as a doctor, nurse or pharmacist);
* Those who already have been given advice on the correct dose of paracetamol for their child as part of the current hospital episode;
* Those who's child is under 1 year or over 13 years old and;
* Those who have participated in this research before.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Slovakia

This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/ subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

Secondary Objective:

* To identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to the Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in an interventional clinical study