cyrilzakka/clinical-trials huggingface dataset:
Psychological Determinants of the Therapeutic Observance of Osteoporotic Patients

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures.

On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy.

The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.


Eligibility Criteria:
Inclusion Criteria:

* Be treated with an anti-osteoporotic drug for at least three months
* Mastering the French language orally and in writing
* Have obtained the patient's oral agreement to participate in the research
* Present post-menopausal osteoporosis
* Present a densitometric osteoporosis with a T-score (-2.5) treated medically per OS (example: biphosphonates) or by subcutaneous injection (example: prolia)
* Present a history of severe osteoporotic fractures after falls of its height.

Exclusion Criteria:

* Present a psychiatric history
* Present an intellectual disability
* Present major cognitive disorders related to neurodegenerative disease or other nervous system disorders.
Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity

Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.

The project is divided in three different work packages that cover the life cycle of P. falciparum :

1. In Work Package 1 (WP1) the investigators will assess whether S. haematobium infection increases the human reservoir of P. falciparum by increasing the carriage rate and incidence of P. falciparum gametocytaemia as well as by increasing the proportion and incidence of subject with sub-microscopic P. falciparum infection. The investigators will also determine whether this increase in gametocyte carriage is a consequence of an impairment of the immune response of helminth infected subjects to P. falciparum.
2. In Work Package 2 (WP2) the investigators will determine whether the transmission of the sexual forms of P. falciparum from the human host to mosquito is increased in S. haematobium infected subjects compared to uninfected controls. Moreover the investigators will study whether the immunological changes induced in S. haematobium infected subjects lead to a decrease of the transmission reducing activity of IgG specific to Pfs48/45 and Pfs230 (both capable of blocking/impairing further development of P. falciparum in the mosquito gut).
3. Finally in Work Package 3 (WP3) the investigators will assess whether S. haematobium infection affects the transmission of P. falciparum from the mosquito to the human host. This effect will be determined indirectly by assessing whether S. haematobium infected subjects are more attractive to mosquitoes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 6 to 30 years
* Without severe or moderate disease
* Agreement to be enrolled in the study (written informed consent or consent by the legal representative and assent)
* Living in the study area for at least 1 year

Exclusion Criteria:

* Anaemia with haemoglobin less than 8g/dl
* Know sickle cell disease
* Macroscopic haematuria
* Any other know severe disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criterion applicable to All Groups

* Subjects aged 2 to 17 years (inclusive) at enrollment
* weighing at least 13 Kg at the time of enrollment

Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies

Inclusion criterion applicable to Group B

- Subjects at risk of meningococcal disease because of functional or anatomic asplenia

Inclusion criterion applicable to Group C - healthy subjects

Exclusion Criteria:

Exclusion criteria applicable to All Groups (A, B and C)

* History of any previous immunization with a meningococcal B vaccine
* History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
* Known HIV infection
* History of any progressive or severe neurologic disorder or seizure disorder
* Contraindication to intramuscular injection or blood drawn
* Females who are pregnant, planning a pregnancy or nursing (breastfeeding)
* Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
* History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects

Exclusion criterion applicable to Groups A and B

- Previous known or suspected disease caused by N. meningitidis in the last year.

Exclusion criteria applicable to Group C

* Previous known or suspected disease caused by N. meningitidis
* Known or suspected impairment/alteration of the immune system
Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.

Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.

Eligibility Criteria:
Inclusion Criteria:

* patients with femoroacetabular impingement of the hip
* 18 years of age or older
* grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.

Exclusion Criteria:

* identified isolated labral tear
* inflammatory or post-infectious arthritis
* previous arthroscopic treatment for hip osteoarthritis
* previous major hip trauma
* Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
* patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.
Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF)

This study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. Participants will be randomly assigned to usual care alone or with the addition of a pharmacist to help manage medications. They will be followed for 3 months by telephone/electronically-administered questionnaires, and 12 months using administrative health records. Outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record on heart failure events.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥19 years;
2. Attending their initial visit to the PDMC;
3. Diagnosis of HF.

Exclusion Criteria:

* None.
Augmented Reality Heads-up Display to Improve Ultrasound Guided IV Access

The purpose of this study is to assess the utility of an augmented reality headset for visualization of ultrasound images during ultrasound guided placement of an intravenous catheter.

After being informed about the study, patients who require image guided intravenous access and give consent will have their intravenous catheter placed by a physician wearing mixed reality smart glasses. The mixed reality smart glasses will have an application that allows the physician to view the ultrasound images in a virtual monitor. The physician will then use the images viewed on this virtual monitor to guide placement of the intravenous catheter.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Referral for US assisted placement

Exclusion Criteria:

- Urgent/emergent requirement for IV
Randomized Trial of Fluticasone in Bronchial Premalignancy

The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. The purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of \>10 pack-years and patients cured of head and neck cancer or lung cancer. Participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. After 6 months, biopsies are taken from the same locations. Efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and hTERT expression.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age over 18
* metaplasia index \> 15%
* over 25 pack years smoking history or history of lung- or head\&neck cancer
* male/female of non-childbearing potential or using approved contraception

Exclusion Criteria:

* use of inhaled/systemic corticosteroid drugs in the preceding 12 months
* contraindications for bronchoscopy/use of fluticasone
* major illness
* Baseline FEV1\<1000ml
* Previous participation in clinical study
* nodules \> 1cm on CT
Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)

Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 associated moderate to severe ARDS
* Invasive mechanical ventilation
* Prone positioning
* admitted to ICU

Exclusion Criteria:

* already sustained prone positioning in referring hospital
* pronation during ECMO only
* denied consent for data analysis
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008

Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital

Exclusion Criteria:

* None
Plasmapheresis: a Multi-modal Approach

Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.


Eligibility Criteria:
Inclusion criteria:

* male,
* age between 18-50 years
* BMI between 20-28 kg/m2
* aptitude to perform maximal physical efforts assessed by the physical activity readiness questionnaire (PAR-Q)

Exclusion criteria:

* The specific exclusion criteria of the Rode Kruis Vlaanderen for blood donation will not be systematically applied to the present study to increase the pool of recruitment.

  * In case the subjects do not comply with the criteria of the Rode Kruis Vlaanderen, their plasma donations will be thrown away.
  * In case the subjects comply, their plasma donations will be handled as usually.
* The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.
Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine \& IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.

So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I or II.
* Undergoing laparotomy
* Undergoing oophorectomy
* Undergoing hysterectomy
* Undergoing rectal mass excision

Exclusion Criteria:

* Patient refusal.
* Hypersensitivity to amide local anesthetics.
* General contraindications to spinal anesthesia.
* Cardiac diseases.
* Hepatic failure.
* Renal failure.
* Respiratory failure.
* Communication barriers.
Safety and Efficacy Study of MGuard Stent After a Heart Attack

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria

* 18 years of age
* ST-segment elevation (more than 2mm in more than contiguous leads)
* MI with symptom onset less than 12h
* The patient is willing to comply with specified follow-up evaluations
* Signed ICF
* Single de novo lesion in the target (culprit) vessel
* Target lesion maximum length is 33 mm (by visual estimation)
* Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation
* Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization Exclusion Criteria
* Pregnant or nursing patients
* Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality
* Impaired renal function
* Prior coronary artery bypass graft surgery
* Bleeding diathesis
* Contraindication to aspirin
* cardiopulmonary resuscitation
* Cardiogenic shock
* chronic warfarin anticoagulation
* LVEF less than 20%
* other medical illness
* participation in another investigational drug or device study that has not reached its primary endpoint
* Left main coronary artery disease with 50% stenosis
* Ostial target lesion
* Failure to visualize vessel anatomy distal to the culprit lesion
* Moderate to heavily calcified target lesion or vessel
* excessive tortuosity
* bifurcation with a side branch more than 2.0 mm in diameter
* A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent
* Diffuse disease distal to target lesion with impaired runoff
* Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion
* PCI of another lesion performed within 6 months before the index procedure
* Target lesion located in a saphenous vein graft
Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)

This is a pilot, proof-of concept investigator-initiated trial planned for 22 patients with the diagnosis of Stiff Person Syndrome (SPS). The study will compare efficacy of treatment using subcutaneous immunoglobulin therapy (SCIg) compared to intravenous immunoglobulin (IVIg) therapy. The majority of IVIg naïve subjects (those not already receiving IVIg) are typically managed with non-immunotherapy mostly Gamma Aminobutyric Acid (GABA) -enhancing drugs such as Baclofen or Diazepam.

Study Design:This is a proof of concept observational prospective, open label, study on the safety, efficacy and convenience of treatment with SCIg study of 22 patients at Thomas Jefferson University Hospital. Two cohorts of patients within the total of 22 will be included; half of them (11 patients) currently receiving and responding to IVIg and the other half starting de novo on SCIg. Patients diagnosed with SPS according to defined sets of symptoms will be eligible to enroll.

The primary clinical outcome will be based on clinical efficacy measures, as used before for the IVIg trial, based on changes in the Stiffness Index and Heightened Sensitivity scores, using the validated scales that the investigators have had previously utilized and validated (Dalakas et al 2001; see attached at the end of the protocol). These same measurements will be applied while on IVIg (weeks 0, 4, 8, 12) and will be compared to the measurements obtained during SCIg (weeks 16, 20, 24, 28). The secondary outcome will be Quality of Life (QoL) responses and patient preference for each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged \>18 years
* Diagnosis of SPS based on standard criteria
* IVIg Group: Receiving the equivalent of 1-2 g/kg IVIg every 4 weeks with dependence\* on IVIg to maintain clinical response \*Dependence is clinically determined either by symptomatic worsening of condition at the end of the inter-dose interval or by worsening after dose reduction or discontinuation within the previous 3 months.
* IVIg-Naïve Group: Patients with symptomatic SPS and never treated with IVIg (IVIg-naïve group), poorly controlled with standard therapy

Exclusion Criteria:

* Pregnancy, planned pregnancy, breast-feeding or unwillingness to practice contraception
* Severe concurrent medical conditions, which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies
* Initiation of immunomodulatory treatment other than IVIg in the past 3 months
* Participation in a trial of an investigational medicinal product in the past 12 weeks
* Presence of any medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.
Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis. Three previous studies show that the yoga pose is effective for reversing scoliotic curves; Botulinum toxin has been approved by the FDA for teenagers. However, no studies using the two of them together have been done until this one.

The randomized control 6-month study employs an isometric yoga-like posture to strengthen the weak side, and one set of botulinum injections to weaken the strong side of adolescent idiopathic lumbar scoliosis between 25 and 60 degrees. It is open to people between 12 and 18 years of age who are willing to do the pose every day for three months.

This is a crossover study: After 3 months, every patient who was placebo will be offered the actual proven yoga pose and botulinum toxin injections. Two additional free X-rays at 3 weeks and 3 months following the botulinum injection will also be available to each placebo patient.

In this way every patient - placebo or not - will receive the full proper treatment within 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Fourteen - 18 years of age, 2. Scoliotic curve greater than 25 degrees, less than 45 degrees, 3. Stated willingness to do the yoga and yoga-like poses daily, 4. Written, signed consent by patient and parent/guardian 5. Pre-test Cobb films no less than 3 months old read by independent radiologists.

* Exclusion Criteria:

  1. Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
  2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
  3. Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
  4. Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.