cyrilzakka/clinical-trials huggingface dataset:
Clinical Phenotyping and Characterization of Neural Networks and Cognitive Processes Involved in Mental Retardation X-linked

X-linked Mental retardation (XLMR) represent 10% of the causes of mental retardation with a prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (Opitz et al., 1986). This heterogeneous group of XLMR includes dozens of rare diseases, some of them affecting only a few patients. Molecular diagnosis is currently available in France for 25 XLMR genes, within the national network of XLMR molecular diagnosis. However, whereas some syndromes such as Fragile X syndrome, are now well clinically defined, this is not the case for recently identified syndromes for which very few data is available, preventing clinicians to focus molecular diagnosis on a specific gene.

Therefore, this study aims to :

* Achieve a description of the clinical phenotype specific to each XLMR gene (Phase 1 of the study, n=200)
* Characterize the cognitive learning mechanisms and dysfunctional neural networks involved (Phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in the same gene). These two elements constitute key steps to develop appropriate rehabilitation strategies and targeted pharmacological therapies.

Moreover, the impact of mental retardation on the primary caregiver within the family and the induced burden in terms of psycho-social, organizational and economic burden will also be assessed. These elements, directly related to the patient's environment, are very important to characterize in order to better understand the consequences of each gene mutation (Phase 3 of the study, n=283). For example, it is necessary to better understand the impact of Fragile X syndrome in terms of capacity and behavior, lifestyle, and health care needs of the patients While advancing knowledge allows to consider innovative therapeutics, the implementation of these therapeutics and assessment of their impact on the patients' life trajectory, require precise characterization of the population to be treated in medico socioeconomic terms.


Eligibility Criteria:
Inclusion Criteria:

* Age : from 2 to 60 years old
* Having a pathogenic mutation of one of the X chromosome genes associated with :

  * For boys : mental retardation (IQ\<70), and/or developmental delay (DQ\<70) and/or pervasive developmental disorder (autism, Asperger...)
  * For girls : mental retardation (IQ\<70), and/or developmental delay (DQ\<70) and/or pervasive developmental disorder (autism, Asperger...) and/or specific learning disabilities

Exclusion Criteria:

* patient or parents refusal to participate in the study
* genetic polymorphism in a X chromosome gene involved in mental retardation but not considered as pathogenic
* person refusing to be informed if an abnormality would be discovered during medical examination
HandiHaler® vs. Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the learning retention of the administration technique for the HandiHaler® vs. MDI and to compare the ease of use for HandiHaler® vs. MDI


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:

  * Historical data (not older than 6 months) of stable airway obstruction with an forced expiratory volume at one second (FEV1) ≤ 80% of predicted normal and FEV1 ≤ 70% of forced vital capacity (FVC)
* Male or female patients with 40 years of age or older
* Smokers or ex-smokers with a smoking history of more than 10 pack-years
* Currently using a prescription bronchodilator (such as Atrovent®, Berodual®, Combivent®, salbutamol, etc.) administered at least once daily
* Able to read and understand written instructions, understand verbal instructions and fill out written questionnaires regarding the devices
* Able to give informed consent prior to participation in the trial, including discontinuation of any medications, sign an approved consent form, and be willing and able to complete all trial procedures

Exclusion Criteria:

* Any acute or chronic illness which could interfere with the conduct of completion of the trial, including but not limited to cardiovascular, renal, neurologic, liver, immunologic, or endocrine dysfunction if clinically significant
* Current or recent (past 2 years) history of drug or alcohol abuse
* Participation in any other clinical trial or use if any investigational drug within the last 30 days prior to visit 1
* Experience with the HandiHaler®
* Discontinued use of regularly prescribed use of MDI within the last 12 months.
* Treatment with any oral or injectable β-blockers within the recent 4 weeks prior to visit 1
* Treatment with oral β-adrenergics within the recent 4 weeks prior to visit 1
* Current or recent (last 6 weeks prior to visit 1) respiratory illness including, but not limited to upper or lower respiratory tract infections or asthma
* Patients who are in a pulmonary rehabilitation program or who had completed a pulmonary rehabilitation program in the 6 weeks prior to visit 1
* Patients with known hypersensitivity to ipratropium bromide, lactose or any other components of the inhalation capsule delivery system
* Patients with known sensitivity to inhaled β-agonists
* Patient using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
* Pregnant or nursing women or women of childbearing potential not using medically approved means of contraception
Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 years old
* to be operated on for pituitary surgery
* to have express no objection to the study

Exclusion Criteria:

* refusal to participate in the study
* pregnant women
* to be Under the age of 18
* not being able to understand and accept participation in the study
* to have a life expectancy of less than a year
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function

Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from ICU.

Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Endotracheally intubated
* Expected time on ventilator \> 24 hours
* Age ≥ 18 years
* Informed consent

Exclusion Criteria:

* Severe head trauma where therapeutic coma is indicated
* Therapeutic hypothermia where therapeutic coma is indicated
* Status epilepticus where therapeutic coma is indicated
* Patient has participated in the study before
* Patient is transferred from another ICU with length of stay \> 48 hours
* Patient is comatose at admission
* PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
* Patient does not speak Danish, swedish or norwegian at a reasonable level
Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Have a newly diagnosed, biopsy-proven adenocarcinoma of the pancreas.
* Tumor must be deemed resectable by the study team
* Patient's acceptance to have a tumor biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
* For both Women and Men, must use acceptable form of birth control while on study.

Exclusion Criteria:

* Received any anti-pancreatic cancer therapy (symptomatic therapies are allowed), or any prior anti-cancer immunotherapy.
* Diagnosed with another cancer whose natural history or treatment could interfere with safety or efficacy assessments on this study.
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
* Active autoimmune disease.
* Systemic steroid therapy (\> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
* Active infection requiring systemic therapy.
* Known history of human immunodeficiency virus (HIV).
* Active or chronic hepatitis B or hepatitis C.
* Known active tuberculosis.
* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
* Prior allogeneic stem cell transplantation or organ transplantation.
* Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
* Received a live vaccine ≤ 28 days before first dose of study drug.
* History of severe hypersensitivity reaction to any monoclonal antibody
* Concurrent participation in another therapeutic clinical study
* Pregnant or breastfeeding
The Effect of Exercise on Cognitive Status in Older Adults

The purpose of the study is to demonstrate the effectiveness of the different combinations of exercises on the cognitive status of older adults with cognitive decline.

This study is planned to examine the effects of combined exercise on cognitive status, lower extremity muscle strength, mobility, physical performance, mood and quality of life in older adults with Mild Cognitive Impairment. Aerobic exercise training and lower limb (extremity) strengthening exercises were applied to the first group, dual-task training and lower limb strengthening exercises were applied to the second group, and aerobic exercise training, dual-task training and lower limb strengthening exercises were applied to the third group.

Eligibility Criteria:
Inclusion Criteria:

* Not had a fall in the last six months.
* Older adults with an mini mental state examination score between18-23.
* Age ≥ 65years.

Exclusion Criteria:

* having central nervous system pathology that will affect balance
* diagnosed with vestibular pathology,
* having deformities in the waist, hip, and knee joints,
* having lower extremity amputation,
* with lower extremity operation history,
* malignancy affecting the lower extremity,
* having moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease,
* participants who cannot cooperate,
* participants who use an assistive walking device,
* participants having vision problems.
Evaluation of Physical Performance and Functional Asymmetries in Female Football

Worldwide, soccer has grown increasingly popular among female players. According to the Women´s Football Survey of the Fédération Internationale de Football Association (FIFA), there were more than 30 million registered women soccer players in 2014. Elite female soccer players cover approximately a total distance of 10 km with 1.7 km completed at high-speed (\>18 km/h-1), between 1350 and 1650 changes of activity like passing, dribbling, tackling and trapping and 5.1 and 31.2 repeated sprinting and high intensity bouts, respectively. Thus, it seems that those strategies addressed to improve such high-intensity activities should be considered a priority for female soccer players.

Different training methods to improve soccer specific variables have been developed such as, high-intensity interval training, resisted sprint training, strength training or plyometric training. Whilst individual training interventions have been shown to produce enhancements in measures of athletic performance for soccer players, there is a paucity of studies looking at the effectiveness of strength and power training specifically on performance measures in female soccer populations.

Unilateral strength asymmetry can be a risk factor of musculoskeletal injuries. In recent years, inter-limb asymmetries have been included in battery tests performed by different soccer clubs due to their relation with lower-limb injuries. Few studies have analysed the change of an intervention on inter-limb asymmetry in female soccer players, hence, more studies for this population are warranted.

The main aim of this research project is therefore, to evaluate the effect of a physical intervention on the performance and inter-limb asymmetries of female soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian, Healthy participant, from 12 to 20 years old, with a history of training at least 3 years.

Exclusion Criteria:

* Non-caucasian, injury.
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.

The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 30 and 80 years of age.
2. Patients with noncardioembolic ischemic stroke
3. Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
4. LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
5. Patients taking clopidogrel as antiplatelet therapy when providing informed consent
6. Patients considered to be able to visit the study site
7. Patients who provided written informed consent

Exclusion Criteria:

1. Any haemorrhagic stroke or haemorrhagic infarction
2. Familial hypercholesterolemia
3. Patients with uncontrolled angina pectoris or congestive heart failure
4. Patients with severe liver or renal dysfunction
5. Patients with a malignant tumor requiring treatment
6. Patients with uncontrolled diabetes mellitus
7. Patients with secondary dyslipidemia (due to corticosteroid etc)
8. Patients with a history of myopathy
9. Patients considered by the investigator to be unsuitable for participating in this study
Beat-to-beat Variability in Persistent Atrial Fibrillation

Heart rate variability (HRV) in patients with atrial fibrillation (AF) is hardly studied. Though a reduced HRV in patients with heart failure and reduced ejection fraction (HFrEF) has been associated with poor prognosis. Data on HRV in AF-patients without a reduced ejection fraction is lacking. We hypothesize that those patients with persistent atrial fibrillation and larger beat-to-beat variability would be more symptomatic than does those with smaller HRV. To asses this theory we intend to perform a prospective observational trial. Symptoms of Atrial fibrillation will be assessed using Quality of Life questionnaires and 6 minutes walking test. Heart rate variability will be assessed using 24 hour Holter ECG monitoring.

The correlation between symptoms and heart rate variability will be then assessed.


Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation
* No previous ablation for atrial fibrillation
* At least 18 years old
* Signed written patient's informed consent

Exclusion Criteria:

* Paroxysmal atrial fibrillation
* Previous ablation therapy for atrial fibrillation
* Reduced left ventricular ejection fraction (LVEF\<35%)
* Permanent ventricular pacing (including cardiac resynchronization therapy CRT)
* Acute coronary syndrome (ACS) during past 6 weeks.
* Stroke or TIA within past 6 weeks.
* Cardiac surgical operation/ intervention within past 3 months.
* Acute decompensated heart failure
* Treatment with IV Inotropic medications (e.g. Dobutamine, Levosimendan)
* Mitral valve replacement or rheumatic mitral valve stenosis
* Neurological or psychological disease that may impair patient's judgement or compliance
* Pregnancy or Breast-feeding women.
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma \[FL\], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT.

Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response \[CR\] or partial response \[PR\]) or stable disease according to the International Working Group criteria by the end of Cycle 13.

Eligibility Criteria:
Inclusion Criteria:

* Participants who had been diagnosed with iNHL that had progressed.
* Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
* Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
* Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
* Adequate renal and hepatic function.

Exclusion Criteria:

* Candidate for potentially curative therapies in the opinion of the investigator.
* Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
* Prior history of allogeneic hematopoietic stem cell transplant.
* Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
* Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
* Symptomatic central nervous system NHL.
* Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
* Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies.
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study

Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.

The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.

There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial is an extension of the former CAROT trial NCT00655941. The participants of this trial are recruited for a prolongation of the dietary intervention consisting of a group therapy with low-energy diet in a randomized, two group (each n = 75 patients) study of maintenance of weight loss by continuing with supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The hypothesis is that maintenance of the already induced weight loss is most efficiently ensured by the once-daily program.

Any patient with osteoarthritis (OA) of the knee was invited to participate in the preceding trial. Eligible for this study will be patients, who have completed the one-year phase 2 of the CAROT. Exclusion criteria are planned knee alloplasty of both knees.

Eligibility Criteria:
Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

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Exclusion Criteria:

Bilateral knee alloplasty -