cyrilzakka/clinical-trials huggingface dataset:
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.


Eligibility Criteria:
Inclusion criteria:

* Male and female adults aged ≥40 years.
* Patients with stable COPD according to GOLD strategy (GOLD 2011).
* Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator.
* FEV1/FVC \< 0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC ≥ grade 2

Exclusion criteria:

* History of long QT syndrome or prolonged QTc.
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
* Patients with Type I or uncontrolled Type II diabetes.
* Patients with a history of asthma or have concomitant pulmonary disease.
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
* Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.
Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL065 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL065 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

There will be a total of 3 study periods.

* Screening period of a maximum of 4 weeks prior to the open-label Treatment Period (Baseline Visit - V2). This period can be exceptionally extended for 2 weeks
* Open-label Treatment Period of 12 weeks
* Follow-up Period of 2 weeks after the last intake of the treatment (V5-End of Treatment Visit (EoT)).

During the treatment period, very long chain fatty acids (VLCFA) will be assessed every 4 weeks, to evaluate the kinetics of the PXL065 effect. Neurofilament light (NfL) will be assessed after 8 and 12 weeks of treatment, and other exploratory biomarkers after 12 weeks of treatment. A follow up period will allow continued monitoring the subjects' safety and evaluation of the kinetics of the 2 main biomarkers (VLCFA and NfL) at 2 weeks after the last intake of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects with either a confirmed diagnosis of AMN by genetic testing (mutation in the ATP binding cassette subfamily D (ABCD1 gene)) or a family history of X-linked adrenoleukodystrophy (ALD) together with an elevation in VLCFA obtained from overnight fasting plasma sample at Screening Visit (V1).
* Age: ≥ 18 to ≤ 65 years at informed consent signature.
* Normal brain magnetic resonance imaging (MRI) or brain MRI showing non-specific abnormalities that can be observed in AMN subjects without signs of cerebral form of ALD (C-ALD). MRI must be performed within 6 months prior to V2. If there is no available brain MRI within this period, a brain MRI must be performed before V2

Exclusion Criteria:

* Any progressive neurological disease other than AMN.
* Arrested or progressing C-ALD as defined by cerebral lesions (except for non-specific abnormalities that can be observed in AMN subjects).
* Prior receipt of an allogeneic hematopoietic stem cell transplant or gene therapy
Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons

Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.


Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by:

  * no clinically significant findings from medical history,
  * physical examination,
  * 12-lead electrocardiogram (ECG),
  * vital signs measurements,
  * and clinical laboratory evaluations

Exclusion Criteria:

* History of clinically significant medical conditions including, but not limited to:

  * diseases of the renal,
  * hepatic,
  * respiratory,
  * gastrointestinal,
  * cardiovascular,
  * neurological,
  * musculoskeletal,
  * immunological,
  * haematological,
  * endocrine,
  * and metabolic systems,
  * as well as oncological,
  * psychiatric,
  * dermatological,
  * and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy

The 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (\>4 cm) during the stance phase. The objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. 50 participants will be chosen according to inclusion exclusion criteria of the study which will be randomly allocated into two equal groups . One group will receive treadmill training programme with specifically designed physical therapy program according to child need for one hour for each child. And other group will receive kneel walking programme specifically designed physical therapy program according to child need for one hour for each child. The pre and post assessment of genurecurvatum will be assessed by Goniometer.

Efficiency of walking and the development of independent gait are often the focus of therapeutic interventions for children with CP. Motor learning theory suggests that when encountering a new motor skill or adapting a motor skill to a specific situation, a group of interconnected neurons is selected from a primary neuronal repertoire based on prior experience of the task. Generated movement patterns and postural adjustments are then refined via afferent feedback. Therefore, it has been argued that to develop and improve a motor skill such as walking, opportunities for repetitive practice of the skill need to be offered. For this reason use of a mechanical treadmill may improve walking in children with CP. Treadmill walking provides increased opportunity to repetitively train the whole gait cycle, facilitate an improved gait pattern. Improved walking has the potential to increase the mobility and positively influence the societal participation of children with CP at home, at school and in the wider community.

Eligibility Criteria:
Inclusion Criteria:

* GMFM level (I \& II)
* knee hyperextension ranged from 10 to 20 degrees

Exclusion Criteria:

* Children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study.
* Children who recently have botulinum toxin injection.
A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.

KER-050 is a therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in patients with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease.
2. \< 5% blasts in bone marrow.
3. Peripheral blood white blood cell count \<13,000/µL.
4. Anemia defined as:

   1. In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
   2. In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
   3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
6. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.

Key Exclusion Criteria:

1. Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
2. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
3. Vitamin B12 deficiency.
4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
5. Treatment within 28 days prior to Cycle 1 Day 1 with:

   1. Erythropoiesis stimulating agent (ESA) OR
   2. Granulocyte colony-stimulating factor (G-CSF) OR
   3. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
6. Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
7. Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
8. Treatment with another investigational drug or device or approved therapy for investigational use \< or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
9. Platelet count \> 450 x 10\*9/L or \< 30 x 10\*9/L.
10. Transferrin saturation \< 15%.
11. Ferritin \< 50 µg/L.
12. Folate \< 4.5 nmol/L (\< 2.0 ng/mL).
13. Vitamin B12 \< 148 pmol/L (\< 200 pg/mL).
14. Estimated glomerular filtration rate (GFR) \< 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\].
15. Pregnant or lactating females
Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents

This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state


Eligibility Criteria:
Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate
Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris

The prevalence of pruritus has been studied in frontal fibrosis alopecia (FFA) and lichen planus pilaris (LPP), but there are no studies evaluating the characteristics of pruritus, the correlation between pruritus and disease activity, and its impact on quality of life.

The knowledge of the characteristics of pruritus, of the link "disease activity - pruritus", and its impact on the quality of life could allow us to modify the management of the patient (modification or intensification of therapy, close monitoring...)


Eligibility Criteria:
Inclusion Criteria:

* Major patient.
* Fibrosing frontal alopecia or lichen planus pilaris
* Presence of pruritus of the scalp : a positive response to the question "do you experience itchy scalp?"
* The patient received an information note and did not object to the study

Exclusion Criteria:

* Patients under 18 years of age.
* Other pathologies causing scalp pruritus (seborrheic dermatitis, contact dermatitis, lupus, Quinquaud's decalcifying folliculitis, ectoparasitosis, scalp psoriasis, ringworm, red sclap syndrome, dermatomyositis, central centrifugal cicatricial alopecia (CCCA))
* Refusal to participate by the patient.
* Patient under legal protection (curatorship, guardianship, ...)
* Patient not covered by social security
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

The purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)

Patients with FAP are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. In 30% to 92% of FAP patients duodenal adenomas are detected, with a lifetime risk approaching 100%. Of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in FAP patients.

Endoscopic surveillance is nowadays the standard of care to prevent FAP patients from developing duodenal cancer. The severity of duodenal polyposis is assessed using the Spigelman classification system. This classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-IV, guiding surveillance intervals and treatment.

Concerns are rising on the accuracy of the Spigelman score as predictor for duodenal cancer, especially for ampullary cancer. Over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. A clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates.

With this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (\>100 colorectal adenomas in combination with a positive family history of FAP)
* Age 18 years or older

Exclusion Criteria:

* Endoscopic removal of all polyps with an indication for removal not possible/feasible
* Gastric or duodenal cancer at baseline endoscopy
* Need for surgery
Abdominopelvic Cancer Prehabilitation

The main objective of this research is to determine the effectiveness of a Prehabilitation consultation in self-care and physical exercise aimed at patients diagnosed with abdominopelvic cancer with initial surgical indication as part of their therapeutic plan.


Eligibility Criteria:
Inclusion Criteria:

* Majority (greater than or equal to 18 years).
* Diagnosis of abdominopelvic cancer and initial surgical indication as part of its therapeutic plan from the General Surgery Services of the General University Hospital of Castellón.
* Ability to give informed consent.

Exclusion Criteria:

* Inability to understand the information provided or insufficient knowledge of the Spanish language.
* Inability to carry out the scheduled intervention according to the physician's criteria.
* Neoadjuvant treatment to colorectal surgery.
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
* Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
* Lesion length of the stenosis \>5mm.
* Angioplasty can be performed within two weeks after randomization
* Female subjects of childbearing potential have a negative pregnancy test.
* Signed informed consent prior to entering study

Exclusion Criteria:

* Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
* Life expectancy shorter than 2 years
* Vertebral artery stenosis caused by dissection
* Vertebral stenting felt to be technically impracticable
* Previous stenting in randomized artery
* Pre-morbid modified Rankin scale score of greater than 3
* Currently participating or previously participated in any investigational drug or device study within 6 months.
Real-time fMRI Neurofeedback for Mild/Moderate Depression

The aim of the study is to compare the effects of the self-regulation (neurofeedback) of the fMRI signal of the prefrontal cortex in depression to ones of more conventional non-pharmacological treatment, primarily, psychotherapy.

The study was devoted to the neural, clinical, and psychological effects of the rt-fMRI neurofeedback for mild/moderate depression. Recruited unmedicated patients suffering from depression were assigned either to the fMRI neurofeedback (8 sessions of the left prefrontal cortex activity regulation) or to the active control group, i.e., a double dosage of cognitive-behavioral treatment or EEG neurofeedback (preliminary aborted). Depression symptoms were measured at baseline, at mid-treatment, and at post-treatment points. Some inventories of depression and related traits were also given. In the rt-fMRI group, self-regulation learning was also estimated by means of the fMRI signal change.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of unipolar depressive disorder on ICD-10 (F32, F33, F34.1)
* Sufficient self-regulation ability (verified with 3 sessions of ALAY EEG neurofeedback)

Exclusion Criteria:

* Serious somatic, mental, or substance abuse problem other than depression
* Depression secondary to other mental or somatic conditions
* Psychotic features in depression or comorbid psychotic disorder
* Serious suicide risk
* Seasonal depression
* Receiving or planning to receive psychotropic medications
* Receiving cardiovascular medications
* General MRI exclusions
* Current pregnancy
* IQ\<70 (established with Raven's progressive matrices)
* Previous experience with neurofeedback
Evaluation of Wnt5a and LRP5 Levels in Serum and Saliva Samples and the Relationship Between Clinical Periodontal Parameters

Objectives: Wnt5a is a secreted Wnt ligand that plays an important role in cellular homeostasis. Wnt interaction with coreceptor low-density lipoprotein receptor-related protein 5 (LRP5) induces the proliferation of osteoblasts and prolongs their functional life. The aim of this study is evaluating the levels of Wnt5a and LRP5 in serum and saliva samples and relationship between clinical periodontal parameters.

Method: Saliva and serum samples were collected from 20 systemically healthy patients with stage III periodontitis and 20 periodontally healthy controls. Wnt5a and LRP5 levels were measured using enzyme-linked immunosorbent assay (ELISA). Clinical periodontal parameters including plaque index (PI), probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL) were recorded.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old,
* At least 16 permanent teeth except 3rd molars,
* Individuals who do not use orthodontic appliances,
* Individuals who are not pregnant or lactating,
* Individuals without any systemic disease that may affect periodontal health,
* Systemically healthy individuals,
* Individuals who have not used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
* Individuals who have not received periodontal treatment in the last 1 year

Exclusion Criteria:

* Pregnant/lactating individuals,
* Individuals who have used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
* Individuals who have undergone periodontal treatment in the last 1 year,
* Individuals with psychiatric illness,
* Individuals with any oral infection,
* Individuals with \<16 teeth, excluding molars,
* Individuals with alcohol dependence,
* Individuals with active infectious disease (acute hepatitis, AIDS, tuberculosis), cancer or any systemic condition that may affect periodontal tissues,
* Individuals receiving treatment with drugs known to affect periodontal tissues (phenytoin, cyclosporine A, calcium channel blockers)