cyrilzakka/clinical-trials huggingface dataset:
Incorporation of Vitamin K Into Uremic Lipoproteins

Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.

We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.

The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 years
* Controls: adequate kidney function (GFR \> 60 ml/min/1,73m2)
* Patients: chronic haemodialysis
* Written consent to take part in the study

Exclusion criteria

* Intake of vitamin K antagonists
* gastro-intestinal diseases interfering with vitamin K intake
* profound anemia with an Hb \< 10 g/dl
* judicial or official commitment to an institution
* pregnancy and lactation
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.

Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential.
* Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.

Exclusion Criteria:

* Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine).
* Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer.
* Blood donation of 500 mL or more within the last 56 days.
* Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
Pre-analytical Factors Affecting CtDNA Analysis in Early and Locally Advanced Breast Cancer

This study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctDNA) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. Pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and DNA extraction methods can all affect ctDNA measurements. Inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments. Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect. Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the impact of blood collection/processing. II. To evaluate the impact of long-term storage of plasma and extracted DNA.

OUTLINE: This is an observational study.

Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from standard of care (SOC) procedures and have medical records reviewed.

Eligibility Criteria:
Inclusion Criteria:

* All women \> 18 years of age
* Stage I-III breast cancer
* Subject has consented to IRB 2130-00 Tissue Registry

Exclusion Criteria:

* Stage IV breast cancer
* Unwilling or unable to give consent
* Unable to participate for 1 year
* No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer
Influence of Environmental Factors and Schizophrenia

Schizophrenia is a chronic and severe mental disorder with a lifetime prevalence of about 1 per cent, the symptoms can be very disabling and causing a heavy medical and socioeconomic.

There are significant variations from one population to another. Clinical manifestations of schizophrenia (symptoms, evolution, severity of disability) are highly variable. This variability, both epidemiological and clinical, is due to genetic and environmental factors.

Environmental factors may be either risk factors or modifying factors (changing clinical presentation but do not alter the risk of disease) for schizophrenia.

Environmental risk factors have been identified (eg: urbanity, cannabis, migration), but the investigators don't know neither the components directly responsible, nor the mechanisms by which they increase the risk of schizophrenia.

To date, there is no study has systematically evaluated the role of environmental modifying factors in schizophrenia.

Environmental factors may be individual, unique to each person (eg cannabis, migration.), or population-based (eg ethnic density, socio-economic difficulties.) The identification/ identifying of environmental risk factors or modifiers, both individual and population, may have theoretical implications (understanding of etiopathogenic mechanisms) and practical (implementation of preventive measures). The potential effectiveness of preventive measures is even greater than the risk attributable to certain environmental factors is important.

Most studies on environmental factors in schizophrenia were conducted in Anglo-Saxon countries and northern Europe, but no study of these risk factors has been conducted in France.

There are important differences environment based on study populations, these results are not generalizable to other countries, including France.


Eligibility Criteria:
Inclusion Criteria:

All subjects

* Age \> 18 years
* Somatic state / condition and level of understanding (language, intellectual level) compatible with the data collection (interview, self-administered questionnaires)

Patients

* Diagnosis of schizophrenia according to DSM-IV criteria
* Living in catchment areas

Non-Inclusion Criteria:

All subjects

* Not affiliated to the social security scheme
* inability to provide informed consent
* Decompensated schizophrenic underway

Relatives

* Protective Measures (tutor, curator)

Exclusion criteria:

Patients

* The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data
Outcomes of Sleep Disorders in Older Men

To determine the effects of sleep disorders on cardiovascular function and disease in older men.

BACKGROUND:

It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption, while about 20 percent suffer from chronic insomnia. Obstructive sleep apnea, a major cause of daytime drowsiness, occurs in an estimated 20-60 percent of older people, depending on the definition used and the specific population being studied. Despite the high prevalence of sleep disorders in the elderly, there have been relatively few studies focused on the consequences. Most studies have been limited by cross-sectional design, small sample size, or lack of comprehensive and objective assessment of sleep. The study, Outcomes of Sleep Disorders in Older Men, will take advantage of the established cohort that has been recruited for the Osteoporotic Fractures in Men (MrOS) Study (5U01AR045647-Dr. Eric Orwoll, PI). MrOS, a 7-year study that began in July 1999, is a multi-center prospective study of approximately 6,000 men aged 65 and older. During the MrOS baseline visit, a broad variety of measurements were collected, including body composition and body fat distribution by dual energy X-ray absorptiometry (DEXA) and quantitative computed tomography, bone density, anthropometry, performance-based tests of strength and balance, medical history, medication use, smoking and alcohol use, and other parameters. Blood, urine, and DNA specimens have been archived for use in future studies of importance to the health of older men.

DESIGN NARRATIVE:

In a subcohort of 3,000 MrOS participants, comprehensive and accurate assessments of sleep will be added using in-home polysomnography, wrist actigraphy, questionnaires and other measures; and prospective adjudication of cardiovascular disease (CVD) events, to the extensive measures that have already been performed or planned in the MrOS cohort study. These new measures will enable testing of several important hypotheses: 1) to characterize the associations between sleep disruption and subsequent CVD events during 3.5 years of follow-up, 2) to determine if sleep disturbances are associated with an increased risk of total and cause-specific mortality in older men, 3) to test whether sleep disturbances are associated with increased risk of falls and decreased physical function, 4) to test whether sleep disturbances are associated with impaired cognitive function in older men, and 5) to test whether sleep disorders are associated with bone density and fracture risk in older men. The bank of MrOS specimens will be supplemented to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions.

Eligibility Criteria:
No eligibility criteria
Effects of Exercise Training in Bariatric Patients

Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* body mass index ≥ 35 kg/m2
* not engaged in physical activity programs
* without any physical limitation that could preclude exercise participation

Exclusion Criteria:

* body mass index \< 35 kg/m2
* regular participation in physical activities programs
* cancer or any other disease that could limit participation in exercise
Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children

In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.

Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults.

The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.

The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C \> T and rs2854116 T \> C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound.

As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C \> T and rs2854116 T \> C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years old
* Obesity definition: BMI \> 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan
* Willing to give written informed consent by parents

Exclusion Criteria:

* Alcohol consumption
* Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
* Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder
Satisfaction and Preferences About Motor Rehabilitation in People With Cerebral Palsy: ESPaCe, a French Survey

This national cross-sectional ESPaCe survey (Enquête Satisfaction Paralysie Cérébrale) was conducted to evaluate perceived needs, barriers and expectations regarding Motor Rehabilitation services further to a preliminary qualitative work.

From June 2016 to June 2017, participants answered a web-based or postal questionnaire, by themselves or with the help of a family member.

ESPaCe was a cross-sectional national survey designed to collect data on Cerebral Palsy (CP) motor rehabilitation from individuals with CP and their families in France.

Needs, barriers and expectations regarding PT services were identified in a series of standardised individual interviews and group discussions developed by a multidisciplinary group composed of individuals with cerebral palsy, families, professional organisation representatives, therapists and rehabilitation specialists, described as "ESPaCe working group". The issues identified in the preparatory qualitative work were structured in a questionnaire and tested in a feasibility study.This study was carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). Informed consent was not required for this survey according to current French legislation.The study included all individuals with cerebral palsy aged 2 y.o. or more, whether they were receiving physiotherapy (PT) services at the time of the survey or not. CP features were self-reported. Eligibility was confirmed by cross-checking the responses to questionnaire items related to history, diagnosis and clinical description of CP. The questionnaire was completed either by individuals with cerebral palsy, a family member or a caretaker.

Participants were described with the following characteristics: age, gender, Gross Motor Function Classification System (GMFCS) level, CP subtype, associated impairments, frequency of pain, mother education (as a proxy for socio-economic status), and PT service provider.

Participation in the ESPaCe survey was promoted through local and national patient advocacy groups and professional networks. The questionnaire was completed online or mailed-in. Data collection was open from June 2016 to June 2017.Participation in the ESPaCe survey was promoted through local and national patient advocacy groups and professional networks.

Eligibility Criteria:
Inclusion Criteria:

* Anyone living in France with a motor impairment consistent with the definition of Cerebral Palsy (whether undergoing or not motor rehabilitation sessions)

Exclusion Criteria:

* Individuals who were not diagnosed with CP or when descriptive information provided in the survey regarding motor impairment was insufficiently detailed or did not meet the definition of CP (e.g., progressive disorders).
* Individuals for whom a questionnaire was already completed by a family member or caregiver

Of note main analyses will be run for participants \> 2 years old (data for participants \< 2 y o considered as exploratory data)
Daily Disposable Comparison Study

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome

In mechanically ventilated patients the PaO2/FiO2 ratio might not be the best reflection of the severity of ARDS. It does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (PEEP), inspiratory time to expiratory time ratio (Ti:Te), and the peak alveolar pressure (Palv). The aim is to identify a new oxygenation index for stratification of severity of ARDS


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving mechanical ventilation in the Intensive Care Unit.
* Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis.

Exclusion Criteria:

* Patients in whom arterial blood gas could not be obtained or not ordered.
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.


Eligibility Criteria:
Inclusion Criteria:

* Women age \> 18
* Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.
* 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)
* ECOG performance score of 0-2

Exclusion Criteria:

* Life expectancy \< 3months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits
* CNS only disease on recent imaging
Carbon Dioxide Versus Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)

Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy.

To achieve a satisfactory examination of the GI tract it needs to be distended during endoscopic procedures. After the examinations many patients complain of abdominal pain and discomfort. This pain has been substantially reduced by substituting room air with CO2 in both colonoscopies and ERCPs. The use of CO2 during colonoscopy has become routine practice at many endoscopy centers.

In our study we will test the hypothesis that abdominal pain after gastroscopies also can be reduced by substituting room air with CO2.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for OGD at the outpatient clinic of Telemark Hospital

Exclusion Criteria:

* Age \<18
* Inability to give an informed concent
* Unsatisfactory norwegian language skills
* Patients not willing to participate
* COPD with dyspnoea NYHA 3-4
Self-induced Cognitive Trance for Chronic Pain Management

The need to find complementary approaches, based on a holistic perspective of the human being, takes on its full meaning in a political context that recommends efficient health programs. Self-induced cognitive trance is one of these complementary approaches, which induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether learning self-induced cognitive trance can improve the quality of life of people with chronic pain. Participants will participate in two times two days workshop aiming at learning how to self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12 months afer the last workshop will be caried out were outomes will be assessed. Furthmore, questionnaires related to the phenomenology of self-induced cognitive trance will be adeministrered. Investigators also proceeded to interveiwes after the second workshop to gather qualitative information.


Eligibility Criteria:
Inclusion Criteria:

* French speacking
* Chronic pain
* On stable pharmacological treatment over the last four months

Exclusion Criteria:

* Psychiatric disorders,
* drug addiction
* alcoholism