cyrilzakka/clinical-trials huggingface dataset:
Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre

Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.

Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. Its prevalence and incidence are difficult to assess, however, in France, a population survey conducted in Seine-St-Denis calculated a prevalence of 161 cases per million inhabitants.

The pathophysiology of SSc, the exact etiology of which remains unknown, involves an interaction between genetic and environmental factors. Its evolution can impact the aesthetic, functional and even vital prognosis of the affected patient.Within the analysis of SSc pathophysiology, a " very early systemic sclerosis " form of disease has been defined according to the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).

At present, no treatment to control this disease is available. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to research remains the development of well-documented patient cohorts with quality biological samples. The investigators had the opportunity to start a major work on this plan with the VISS study (Vasculopathy and Inflammation in Systemic Scleroderma study) in 2012 as part of a project promoted by the University Hospital of Bordeaux (NCT02562079). This project has paved the way for many local, national and international collaborations. It has made it possible to structure and federate various partners of the Bordeaux University Hospital around translational research on SSc.

The investigators wish to continue our research and collaborations by further strengthening our expertise in the collection of rare and valuable biological samples for this disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
* Person affiliated or benefiting from a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research)

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship, curatorship or any other legal protection regime
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 years or older
* Moderate to severe GL at maximum frown as assessed by the Investigator
* Moderate to severe GL at maximum frown as assessed by the subject

Exclusion Criteria:

* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
* Female who is pregnant, breast feeding or intends to conceive a child during the study.
The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study

Exclusion Criteria:

* Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.
Multidimensional Measurement of Psychopharmacological Treatment Response

The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.

Baseline actigraphic measurements, multi-symptom operationally defined observations and psychometric data will be established and repeated to measure treatment response. Additional biological and biometric measures that have potential to further characterize the cohorts under study or treatment response will be collected as practical and when possible.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of:
* Autism Spectrum Disorder
* Mood Disorder
* Attention Deficit Hyperactivity Disorder
* Unaffected First Degree Relative of Study Subject
* Anticipation of pharmacological intervention or current pharmacological intervention

Exclusion Criteria:

Inability to wear an actigraphy watch
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).


Eligibility Criteria:
Inclusion criteria:

* Must be outpatients.
* Diagnosis of VMR (vasomotor rhinitis).
* Literate in English or native language.

Exclusion criteria:

* Significant concomitant medical condition.
* Use corticosteroids or other allergy medications during the study.
* Used tobacco products within the past year.
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.


Eligibility Criteria:
Inclusion criteria:

* Have compensated chronic hepatitis B.
* Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
* Ability to read, understand, and sign the informed consent.
* Have a positive serum HBV-DNA \>= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

* Having or suspected of having liver cancer.
* Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
* Autoimmune hepatitis.
* Received any previous transplantation or having a plan for any transplantation.
* Existence of any serious complication, except hepatitis B.
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery

The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective CABG and aortic valve patients in cardiac surgery,
* previous use of betablocker therapy

Exclusion Criteria:

* previous atrial fibrillation or flutter,
* thyroid disease,
* uncontrolled heart failure,
* II or III degree atrioventricular block
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib.

This is a mandatory Post-Marketing Surveillance (PMS) requested by Pharmaceuticals and Medical Devices Agency (PMDA) as a part of the Japan-Risk Management Plan (J-RMP).

Eligibility Criteria:
Inclusion Criteria:

* All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.

Exclusion Criteria:

* Not applicable.
Effect of a Low FODMAP Diet on SIBO

Bloating is the most common symptom associated with disorders of brain-gut interaction (i.e., functional bowel disorders) such as irritable bowel syndrome, a disorder characterized by abdominal pain and altered bowel habits which affects up to 11% of world population. A common cause of bloating is small intestinal bacterial overgrowth (SIBO), a condition defined by excessive and/or abnormal type of bacteria in the small bowel. The potential role of SIBO for irritable bowel syndrome (IBS) was initially proposed by Pimentel et al. Using lactulose breath tests (LBTs), 78% of patients with IBS were also diagnosed with SIBO. After antibiotic therapy, 48% of patients no longer met the Rome criteria for IBS. A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS.

Despite the clinical efficacy of LFD in improving symptoms of IBS-D, its mechanism of action is not clear. Recently, Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models, both of which are reversible when rats were fed an LFD. They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level. However, studies evaluating the effect of LFD on colonic permeability of humans are lacking. Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO. Thus, the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years at the time of screening
* Meet Rome IV criteria for functional bloating
* IBS-SSS score of at 176 (0-500)
* SIBO positive

Exclusion Criteria:

* individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
* individuals with peanut, soy, or seafood allergies or insulin-dependent diabetes
* known history of celiac disease, inflammatory bowel disease or microscopic colitis
* prior small bowel or colonic surgery or cholecystectomy
* pregnant patients
* antibiotics, excluding topical, in the past 3 months
Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel

This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.

To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 9 years of age (at least 12 years of age for Control Gel);
2. Verbal and signed written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema;
3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
4. Subjects with a facial beard or mustache that could interfere with the study assessments;
5. Subjects with more than two (2) facial nodules;
6. Evidence or history of cosmetic-related acne
The Effect of Yoga on the Fitness of Children

This study aims to evaluate the effect of yoga on physical fitness among healthy primary school children using a randomized control design. A total of 52 children, ages 8-13, will be randomly assigned to either the Yoga Group or the Control Group. Participants will be assessed using the EUROFIT Test Battery as the primary outcome measure.

The Yoga Group will do 45-minute yoga sessions twice a week for 10 weeks, while the Control Group will not receive any intervention. Outcome assessments will be repeated at the end of the 10-week intervention period.

This investigation is a randomized controlled trial designed to assess the physical fitness levels among primary school-age children subjected to diverse yoga interventions, comparing them with the outcomes observed in a control group devoid of such interventions.The study encompasses a 10-week intervention phase, during which participants undergo evaluation at two specific time points: Initial assessment (M1), conducted one week preceding the commencement of the exercise program, and subsequent evaluation (M2), executed one week post the conclusion of the program.Anthropometric measurements will determine the height of the participants using a non-elastic measuring tape (SECA brand) attached to the wall. Body Mass Index (BMI) will be calculated with the Tanita MC-180MA III device.The physical fitness of children will be measured with the Eurofit test battery.

Eligibility Criteria:
Inclusion Criteria:

* Participants who do not have any mental or physical disabilities
* Participants who have not participated in any exercise regime for the previous six months

Exclusion Criteria:

• Individuals who do not participate in 90 percent of the 10-week yoga training program.
Effect of Refnot on Immunity in Cancer Patients

The study was planned to include disseminated patients with various solid tumors (melanoma, soft tissue sarcoma, breast cancer, colon cancer, etc.). The study drug was administered subcutaneously at a dose of 400,000 IU once a day, 3 times a week (every other day), for 4 weeks. In the absence of disease progression - an additional 4 weeks.

The study was planned to include 50 disseminated patients with various solid tumors. The patients were divided into 2 groups: 1 - Refnot, monotherapy, 2 - Refnot together with chemotherapy.

Refnot is administered at a dose of 400,000 IU subcutaneously 3 times a week for 4 weeks. 4 weeks constitute 1 course of treatment with Refnot. Immediately before use, 1 ml of water for injection is added to 4 vials (100,000 IU each) or to a vial containing 400,000 IU. After dilution, the drug is injected subcutaneously into the outer surface of the shoulder or thigh. Injection sites should alternate. In the absence of progression of the disease - an additional 4 weeks. Chemotherapy may be used after 4-8 weeks of Refnot use.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have exhausted standard methods of treatment.
* Morphological (histological or cytological) confirmation of the diagnosis.
* Age no more than 75 years.
* General condition 0-2 (WHO).
* Estimated life expectancy of at least 3 months.
* Consent to treatment under this protocol.
* The number of granulocytes is more than 2000/mm, platelets are more than 150000/mm.
* The level of creatinine should not exceed 1.5 norms, liver enzymes (ALT, AST and alkaline phosphatase) should not exceed 3 norms.
* For common disease, patients should receive standard treatment earlier.

Exclusion Criteria:

* Severe manifestations of cardiovascular diseases in the past and at present (myocardial infarction, hypertension, stroke, phlebothrombosis, coronary insufficiency requiring drug control, etc.).
* Peptic ulcer of the stomach, duodenal ulcer (in the acute phase), uncorrected diabetes mellitus.
* Mental illness preventing understanding of the treatment plan.
* Pregnancy.
* Metastases of a malignant tumor in the brain (according to clinical data).
* Chronic use of corticosteroids or immunosuppressants.
* Various neurological diseases that prevent this treatment.
* Known allergic reactions and/or other significant allergic conditions.
* Any immunotherapy within the last 6 weeks prior to enrollment in the study.
Internet-delivered Cognitive Behavior Therapy for Problematic Alcohol Use in a Working Life Setting

Internet-based cognitive behavioral treatment (ICBT) for mental health issues has been successfully implemented in routine health care and research indicates that ICBT can also be applied to decrease problematic alcohol use in healthcare as well as working life settings. However, qualitative studies investigating the feasibility of implementing ICBT in a working life context have been lacking. The current study will investigate the feasibility of delivering ICBT for problematic alcohol use within an employee assistance program (EAP), and will compare outcomes for ICBT with face-to-face treatment in a naturalistic quantitative study. Recruitment to the study follows employer contact with the EAP regarding an employee's presumed problematic alcohol consumption, leading to a five-session in-person psychological assessment. All assessed employees recommended ICBT or face-to-face treatment will be offered participation in the study. In addition to quantitative evaluation, interviews will be conducted with employees and their employer representatives following ICBT to elucidate both stakeholders' experience and perception of ICBT in the work life context. Thematic analysis and grounded theory will be used to analyze the interview material. Outcome comparisons between ICBT and face-to-face treatment will be assessed quantitatively using a Reliable Change Index and analysis of variance or other relevant statistical analyses such as multilevel modeling.


Eligibility Criteria:
Inclusion Criteria:

18 years; access to the Internet; problematic alcohol use assessed by a licenced psychologist; referred to treatment within a rehabilitation intervention initiated by the work-place; Work-place covers treatment costs;

Exclusion Criteria:

not adequately fluent in Swedish; drug use; suicidality; indications of excessive use of the internet and computer gaming and/or gambling;
A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment

Exclusion Criteria:

* None specified
Melanocytic Nevi in Children Under Chemotherapy

Changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years) suffering from different malignancies were examined every three months during a one-year period after starting chemotherapy. An age and sex matched control group underwent the same skin examinations.At the start of our study, the range of number of nevi in the chemotherapy group was 0-133, in the control group 2-199.

Objectives:

Patients given chemotherapy because of different malignancies have an increased susceptibility to cutaneous tumours and infection and a change of number of nevi during treatment is discussed. We investigated wether total nevi count changes in children undergoing chemotherapy. Therefore 16 (8m, 8f) children suffering from leukaemia (11), lymphoma (2), adenosarcoma of the kidney (1), Ewing´s sarcoma (1) and neuroblastoma (1) aged between 2 and 17 years (median:8 years), under chemotherapy at the pediatric department of oncology, were examined at the beginning and 9-12 months after starting chemotherapy. As control group age and sex matched children of the local population were used.

Materials and Methods:

At the beginning of chemotherapy the nevi were counted on the total body. All nevi were larger in diameter than 1mm and as melanocytic lesion identifiable. Clinical and dermoscopic photographs were taken of every nevus. If the patient had more than 50 nevi, only nevi on the face, right arm, upper back and the buttocks were documented. Reassessment was repeated every 3 month.

Conclusion:

In our patients under chemotherapy during one year the development of new nevi is similar to sex and age matched children of the general population. During this short period development of nevi seems not to be influenced by chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient and/or parents willing to participate in the study
* Age under 18

Study Group Only:

* Patient suffering from a malignancy requiring systemic chemotherapy

Exclusion Criteria:

* Patient and/or parents who decline to participate in the study
Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated.

The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points.


Eligibility Criteria:
Inclusion Criteria:

* age: 18-60 years old.
* Participant must provide witnessed written informed consent prior to any study procedures being performed.

Exclusion criteria:

* Age \> 60 years old.
* severely decreased kidney function.
* severely decreased liver function.
* severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
* severe lung disease.
* severe psychiatric illness or neurological illness.
* any gastrointestinal disease.
* any dyspeptic symptoms.
* pregnant or breastfeeding.