cyrilzakka/clinical-trials huggingface dataset:
Venous Irregularities, Flow and Perfusion in MS Study

1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS patients and controls.
2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain perfusion and Cerebrospinal flow before and after the procedure on a large number of patients to determine these outcomes

The purpose of this study is to compare a MS subject to a non-MS, non-blood related subject. The 3D structural information provided by the protocol combined with the ability to observe and quantify flow through the major vessels of the neck, as well as the azygous vein, make it an ideal method for evaluating subjects' venous outflow. The protocol also has the potential to confirm the diagnosis of Multiple Sclerosis, observe any changes in the parenchyma, as well as provide data on any potential co-morbidity which may have been previously overlooked or non-emergent. The baseline scan data acquired on normal and pre-treatment MS patients can be tracked longitudinally for MSpatients for changes in: arterial and venous cross sectional area; morphological changes of vessels, brain structures, and lesions; flow distribution and flow patterns in arteries, veins, and cerebrospinal fluid (CSF); iron quantification in the deep basal ganglia and thalamus; parenchymal lesion volume and morphology; atrophy or ratio of gray matter, white matter; and CSF in the intracranial space; and appearance of intracranial veins and potential iron lesions in the parenchyma. A major benefit is that MRI is independent of operator bias and acquisition can be easily reproduced.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend the nature of the study, including the risks and benefits
* Ability to execute an informed consent
* Males or Females between the ages of 20 and 65 years of age
* Voluntary agreement to participate in the study: Venous Irregularities, Flow and Perfusion in MS study (VERIFY MS Study)

Exclusion Criteria:

* Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
* Any person who has a contraindication to contrast administration.
* History of claustrophobia
* Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes

The aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. Subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.

This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes.

All patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.

Eligibility Criteria:
Inclusion Criteria:

* Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
* Ages 40-80 years;
* Non-smoker;
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Changes in oral glycaemic-control medications in the last 3 months;
* Subjects with HbA1c levels under 6.4% or above 10%;
* Subjects under insulinotherapy;
* Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL);
* Intake of antibiotics in the last 12 weeks;
* Subjects not willing to avoid drinking beer during the study;
* Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS;
* Pregnant women or women planning to become pregnant during the study.
Effectiveness of Trauma Therapy in Patients With PTSD and Comorbid Psychotic Disorder

Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder

Background and goals: Patients with psychotic disorders often report traumatizing experiences in their biography and show symptoms of a trauma-related disorder. It is assumed that around 30 percent of patients with a psychotic disorder also meet the criteria for PTSD. For the vast majority of patients, psychosis is the focus of mostly pharmacological treatment, while PTSD is not part of the therapy. In a first randomized controlled study, van den Berg's Dutch working group was able to show that psychosis patients with comorbid PTSD who were given a classic trauma exposure procedure showed a high response to PTSD symptoms (van den Berg et al., 2015). It is also important that in this study the trauma exposure did not lead to an increase in psychotic symptoms or undesirable side effects (e.g. suicidality). In order to examine the question of the generalizability of the effects, a randomized controlled study in the German-speaking health care system is necessary. In the following efficacy study in which psychosis patients with PTSD are treated using prolonged exposure. METHODS AND RESULTS: It is a multicenter, controlled, prospective, randomized study (RCT). It is investigated whether trauma therapy reduces PTSD and psychosis symptoms compared to the Treatment-As-Usual Waiting Group (TAU). The primary endpoint is the severity of the PTSD symptoms between the baseline measurement and the 6-month follow-up. Secondary endpoints are subjective PTSD symptoms, paranoia, hallucinations, and wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of a Post Traumatic Stress Disorder (PTSD spectrum disorder (ICD-10, F43.1, confirmed by SCID-5 and CAPS)
* have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)
* patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the PSYRATS-AH;
* be ≥ 18 years of age
* good knowledge of the German language
* Willingness to participate in randomization and trauma-focused therapy

Exclusion Criteria:

* Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects)
* Any substance addiction with continued use other than nicotine and / or caffeine addiction
* IQ of 70 or less
* Acute suicidality
* Pregnant women
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-70
* Women in postmenopausal
* Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
* PASI \> 10 e/o BSA (Body Surface Area) \> 10

Exclusion Criteria:

* Drug induced psoriasis
* Pustular or erythrodermic psoriasis
* Fertile women
* Pregnancy or lactation
* cholesterol \> 230mg/dL e triglyceride \> 200 mg/dL
* Known intolerance to efalizumab and acitretin
* Serious infection at enrollement
* History of previous neoplasia
The Lolland-Falster Health Study

The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Individuals registered in Lolland or Guldborgsund municipality

Exclusion Criteria:

* Adults with incapacity guardianship
* Incapacity to give informed consent
* Individuals with address protection
* Severe physical immobility
* Non-Danish and Non-English speaking
AsseSSing Impact in pSoriatic Treatment

Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.

This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.

This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

This is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with PsA. Participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why.

The study will be conducted in 25 rheumatology centres in Europe (UK, France, Germany, Spain and Italy) with five centres in each country. Each participant will only attend for one single study visit which is likely to last around 30 minutes in total. This will be alongside the participant's routine clinic visit. The PsAID-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper CRFs and transferred to a database for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language.
* Aged 18 years or above.
* Diagnosed with PsA according to the ClASification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist (Taylor 2006).

Exclusion Criteria:

* Patients who don't speak or read the local language
* Patients who are not comfortable filling in an app-based questionnaire or paper CRF.
* Patients with a new diagnosis of PsA at the current clinic visit
Circadian and Seasonal Variation in Acute Myocardial Infarction

Circadian and seasonal variation in acute myocardial infarction .

Circadian and seasonal variation in acute myocardial infarction and relation between circadian rhythm and seasonal variations with biological and physiological markes of normal human being.

Eligibility Criteria:
Inclusion Criteria:

* 1.All patients above (16) years old 2.Complaint occur during acute climate changes

Exclusion Criteria:

* 1.Patients below 16 years old 2.Complaint during normal climate
Anorexia Nervosa and Brain in Adolescence

Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.

Anorexia nervosa is severe mental health problem with increased incidence rates in adolescence. Etiology of anorexia nervosa is still mostly unkonwn. Adolescence is also critical period of brain development.

Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in both acute and remission state of anorexia nervosa in adolescence.

Study group are young anorexia nervosa patients, and control group are healthy same-aged students.

Research methods include non-invasive brain imaging methods such as Transcranial Magnetic Stimulation (TMS), and Magnetic Resonance Imaging (MRI). Other research methods are assessment of body composition, laboratory tests, self-rated questionnaires and psychiatric interview.

Eligibility Criteria:
Inclusion Criteria:

Study group: 1) age 16-19 years, 2) BMI below 17.5, 3) diagnosis: anorexia nervosa or atypical anorexia nervosa 4) diagnosed within last two years. Inclusion criteria.

Control group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.

Exclusion Criteria:

1) glucose metabolism disorder or any chronic medical disorder, or medicine with possible effects on neurotransmitters, 2) previous mental health problem (excluded anorexia nervosa or atypical anorexia nervosa in study group), 3) smoking, nicotine products, alcohol or any other substance abuse or dependence, 4) contraindication for used brain imaging method.
Can Cognitive Behavioural Therapy Help Incarcerated Men Quit Smoking? Efficacy and Predictors of Treatment Outcomes

The goal of this clinical trial is to evaluate whether a brief group-based psychological intervention using cognitive-behavioral therapy (CBT) helps people in prison quit smoking. Researchers will compare this intervention to a health education program and a control group (waitlist) to see which approach is most effective.

The main questions this study aims to answer are:

* Does the CBT-based group intervention help more participants quit smoking compared to the health education group and the control group?
* Do participants in the CBT-based group intervention smoke fewer cigarettes per day one month after the intervention compared to the other groups?
* Do participants in the CBT-based group intervention have lower carbon monoxide (CO) levels compared to the other groups?
* What individual factors (e.g., motivation to quit, nicotine dependence, craving intensity, symptoms of anxiety, depression, ADHD, and PTSD) predict success in the CBT intervention?

Participants will be randomly assigned to one of three groups:

* CBT group: Three group sessions (1.5 hours each) using CBT and motivational approaches to quitting smoking.
* Health education group: One group session (1 hour) providing information on smoking and its health risks.
* Control group: No intervention for three months (waitlist). All participants will complete an initial assessment, attend their assigned group sessions, and return for follow-up visits at 1 month and 3 months. Their smoking status will be measured through self-reports and carbon monoxide (CO) expired levels.


Eligibility Criteria:
Inclusion Criteria:

* Male individuals currently incarcerated at Maison d'Arrêt Paris-La Santé.
* Aged 18 years or older at the time of inclusion.
* Current smoker, defined as having smoked daily in the past 30 days, or having an occasional smoking pattern of at least 5 cigarettes during the past 30 days.
* Able to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
* Sentence length of at least 6 months, or if in pretrial detention, having a scheduled trial date within at least 6 months.

Exclusion Criteria:

* Age under 18 years at the time of inclusion.
* Inability to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
* Sentence length of less than 6 months, or if in pretrial detention, having a scheduled trial date in less than 6 months or no available information about the trial date.
* Severe cognitive impairment that affects comprehension and participation in the study.
* Unstable psychiatric conditions (including acute psychotic disorders, severe mood disorders, severe anxiety disorders).
* Individuals under legal guardianship or conservatorship (e.g., placed under tutelage, curatorship, or temporary guardianship).
SwissTAVI Registry

The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.

The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population.

Methods

This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Native aortic valve stenosis
* Native aortic valve regurgitation
* Degenerated aortic bioprosthesis requiring treatment

Exclusion Criteria

* Patients refuses informed consent to participate in the registry
* Contraindication for TAVI
* High probability of non-adherence to the follow up - requirements
Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease

The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. The research is being conducted at up to 10 clinical research sites in the US.

A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following visilizumab administration.

Eligibility Criteria:
* Patients who develop Grade II, III, or IV acute GVHD following allogeneic hematopoietic cell transplantation
* Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus
* Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
* Patients with an onset date of acute GVHD that is less than or equal to 100 days posttransplant.
Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes

The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).


Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None
Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (\> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Eligibility Criteria:
Inclusion Criteria:

* palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
* primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
* performance status of 0 to 2 (WHO scoring system)
* renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
* signed inform consent

Exclusion Criteria:

* distant metastasis
* previous history of cancer
* previous radiotherapy or chemotherapy
Implementation of Precision Medicine in High-risk Prostate Cancer

This project's objective is to initiate a prospective non-interventional clinical study to perform full molecular characterization and subtyping of the primary tumor prostate cancer patients.

It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.

This prospective study includes molecular characterization of the primary tumor, biobanking of urine and blood, questionnaires, collection of health economic parameters, cross-checking of registries to link both other diagnoses and drug use to the different biomarkers and socio-economic parameters.

Clinical variables including imaging and routine pathology and the outcome of the molecular diagnostic analysis should, in addition to the basic scientific purpose, also be able to identify men who may be eligible for other studies, both pharmaceutical company-funded and investigator-initiated studies.

One aim is also to develop the national medical information system already in place for prostate cancer (individual patient record) with molecular profiling and other variables for health estimation, health economics and also enable retrieval from more registries.

This study will form the basis for the start of a nationwide study with the aim to prioritize biomarkers for the development of treatment predictive algorithms

Eligibility Criteria:
Inclusion Criteria:

* Men investigated for suspected prostate cancer
* Signed consent form

Exclusion Criteria:

* Difficulties understanding information about the study due to linguistic, cognitive or other reason